PARACETAMOL BP98
4-Acetamidophenol
CAS: 103-90-2
Molecular Formula: C8H9NO2
PARACETAMOL BP98 - Names and Identifiers
| Name | 4-Acetamidophenol |
| Synonyms | APAP Paracetamol Acetaminphen Acetamiophen Acetaminophen PARACETAMOL BP Paracetamol DC PARACETAMOL BP98 4-Acetamidophenol PARACETAMOL BP2001 4-Acetamino phenol PARACETAMOL POWDER 4-Hydroxyacetanilide PARACETAMOL DC GRADE p-Hydroxyacetanilide PARACETAMOL POWDER BP PARACETAMOL USP23,BP98 N-Acetyl-4-aminophenol Paracetamol (Acetaminophen) N-(4-hydroxyphenyl)acetamide |
| CAS | 103-90-2 |
| EINECS | 203-157-5 |
| InChI | InChI=1/C8H9NO2/c1-6(10)9-7-2-4-8(11)5-3-7/h2-5,11H,1H3,(H,9,10)/i2D,3D,4D,5D |
| InChIKey | RZVAJINKPMORJF-UHFFFAOYSA-N |
PARACETAMOL BP98 - Physico-chemical Properties
| Molecular Formula | C8H9NO2 |
| Molar Mass | 151.16 |
| Density | 1,293 g/cm3 |
| Melting Point | 168-172°C(lit.) |
| Boling Point | 273.17°C (rough estimate) |
| Flash Point | 11 °C |
| Water Solubility | 14 g/L (20 ºC) |
| Solubility | Soluble in hot water or ethanol, dissolved in acetone, almost insoluble in cold water and petroleum ether. |
| Vapor Presure | 0.008Pa at 25℃ |
| Appearance | White crystalline powder |
| Color | White |
| Merck | 14,47 |
| BRN | 2208089 |
| pKa | 9.86±0.13(Predicted) |
| PH | 5.5-6.5 (H2O, 20℃)(saturated solution) |
| Storage Condition | Inert atmosphere,Room Temperature |
| Sensitive | Sensitive to light |
| Explosive Limit | 15%(V) |
| Refractive Index | 1.5810 (rough estima |
| MDL | MFCD00002328 |
| Physical and Chemical Properties | Melting point 168-172°C water-soluble 14g/L (20°C) |
| Use | Antipyretic analgesic |
PARACETAMOL BP98 - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R52/53 - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R36/38 - Irritating to eyes and skin. R40 - Limited evidence of a carcinogenic effect R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. S61 - Avoid release to the environment. Refer to special instructions / safety data sheets. S37/39 - Wear suitable gloves and eye/face protection S22 - Do not breathe dust. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. S7 - Keep container tightly closed. |
| UN IDs | UN 3077 9/PG III |
| WGK Germany | 1 |
| RTECS | AE4200000 |
| TSCA | Yes |
| HS Code | 29242930 |
| Hazard Class | 9 |
| Packing Group | III |
| Toxicity | LD50 in mice (mg/kg): 338 orally (Starmer), 500 i.p. (Dahlin, Nelson) |
PARACETAMOL BP98 - Upstream Downstream Industry
| Raw Materials | 4-Aminophenol Acetic acid Acetic acid Acetic anhydride Charcoal Sodium metabisulfite Iron Hydrochloric acid Magnesium oxide |
PARACETAMOL BP98 - Reference
| Reference Show more | 1. Xu Bingjie, Xu Bin, Du Haijie, etc Simultaneous Determination of Three Typical PPCPs in Water by SPE-HPLC [J] Environmental Science and Technology 2017 040 (011): 37-41. 2. Jiang Zhitao, Lv Ling, Yan Wangxue, etc Determination of paracetamol suppository by UPLC-MS/MS [J] Northwest Pharmaceutical Journal 2018 (4). 3. Fu Qian, Xu Rui, Duan Huan, et al Protective effect of ethyl acetate fraction of Capparis spinosa on liver injury induced by APAP and determination of its antioxidant activity in vitro [J] Shi Zhen, Traditional Chinese Medicine, 30 (03): 14-17. 4. Wang Yangyang, Xu Mingfang, Bai Weibin, Zheng Chunli, Ye Lei, Zheng Qinqin Preparation and quantitative analysis of actin from Siniperca chuatsi by aqueous two-phase method [J] Food Science 2020 41 (12): 234-242 Pharmacology and Clinic of Traditional Chinese Medicine, 2020 (2). 7. Quan Zhengyang, Sun Zhenxiao Study on hepatotoxicity of water extract of Polygonum multiflorum Thunb and its main components based on zebrafish model [J] China Pharmacovigilance, 2018. 8. Yang Hong, Peng Fang, Liu Gang, et al Study on the early toxicity of acetaminophen on drug-induced liver injury in mice based on lipid metabonomics [J] China Pharmacy, 2019 (15). 9. Yang Chaoling, Li Zhongjuan, Shi Jinzhou, et al. Pharmacokinetic study on oral administration of paracetamol in rabbits [J] Journal of Tropical Medicine, 2013 (02): 196-198. 10. Wang Ximei, Wang Ying Study on the improvement of preparation process and quality of acetaminophen oral liquid [J] Heilongjiang Science and Technology Information, 2013 (30): 28. 11. South America Juan, Tang Kai, Zhang Huawei, et al. Study on the liver protective effect of extracts from different parts of Cornus officinalis on mice with acute liver injury [J] China Pharmacy, 2018, v.29; No. 635 (17): 87-91. 12. Shu Guangwen, Qiu Yunhan, Fu Qian, etc Protective effect of total polysaccharide of mulberry on acute liver injury induced by acetaminophen in mice [J] Journal of Central South University for Nationalities: Natural Science Edition, 2019, 038 (003): 377-382. 13. Li Yujuan, Li Panpan, Sun Xinxin, etc Effects of simulated weightlessness on CYP1A2 in rat liver [J] Journal of Beijing University of Technology, 2018, v.38; No.281 (07): 110-114. 14. Yang Hang, Zhuo Hongyi, Lian Xinjie, etc Screening and identification of ganoderma lucidum spore cell wall degrading bacteria [J] Food Research and Development, 2018 (12). 15. Xu Rui, Liu Zhao, Fu Qian, et al Protective effect of Panax japonicus polysaccharides on acetaminophen induced liver injury in mice [J] Journal of Central South University for Nationalities (Natural Science Edition), 2020. 16. Yang Chaoling, Wang Hongliang, Yu Xin, et al Study on the mechanism of moxa leaf polysaccharide in preventing acetaminophen hepatotoxicity [J] Shi Zhen, Traditional Chinese Medicine, 2012, 23 (010): 2540-2542. 17. Gu Xinqi, Zhou Lushan, Peng Xinyi, etc Experimental Study on the Treatment of Second Degree Frostbite Model Rats with Alcohol Extract of Solanum Solanum L. [J] Zhejiang Journal of Integrated Traditional and Western Medicine, 2020 (8). 18. Shu Guangwen, Qiu Yunhan, Li Wei, Fu Qian, Chen Yejun, Deng Xukun The total alkaloids of lotus leaf activate the AMPK/Nrf2 pathway in the liver to alleviate acetaminophen induced acute liver injury in mice [J]. Research and Development of Natural Products, 2019, 31 (02): 198-203+317. 19. Lin Liangcai, Zhao Feifei, Wang Min, et al Protective effect of coirinone sulfate on acetaminophen induced acute liver injury in mice [J] Research and Development of Natural Products, 2018 (5). 20. Li Mengjia, Ainiwal Talif, Cheng Lufeng, etc Protective effect of Sephra mixture on acetaminophen induced liver injury in rats [J] Northwest Journal of Pharmacy, 2019, v.34 (03): 75-79. 21. Xin Qi, Zhou Lushan, Peng Xinyi, Zheng Huihua, Wang Ping. Experimental study on the treatment of second degree frostbite model rats with ethanol extract of eggplant root [J]. Zhejiang Journal of Integrated Traditional and Western Medicine, 2020, 30 (08): 627-630+697. 22. Yang Yusha, Shi Jingzhen, Lei Zhong, Zhou Wei, Liang Yan, Liu Jie, Hao Xiaoyan, Yang Hong. Protective effect of ethyl acetate fraction of blood ginseng on acute liver injury in mice induced by APAP [J]. Shi Zhen, a traditional Chinese medicine, 2018,29 (04): 786-789. 23. Chen Rui, Zhou Wei, Zhang Li, Zhu Gaofeng, Huang Jing, Tang Lei. The effect of coumaric acid A on five common cytochrome P in human liver microsomes_ (450) In vitro inhibition of enzyme [J]. China Pharmacy, 2021,32 (02): 195-200 24. Ali, Adam Yousif Adam, et al. "Exogenous jasmonic acid and humic acid increased salinity tolerance of sorghum." Agronomy Journal 112.2 (2020): 871-884.https://doi.org/10.1002/agj2.20072 25. Wang, Shu, et al. "Evaluation of novel magnetic targeting microspheres loading adriamycin based on carboxymethyl chitosan." Journal of Drug Delivery Science and Technology 55 (2020): 101388.https://doi.org/10.1016/j.jddst.2019.101388 26. Wei, Yingliang, Anting Wang, and Yuanyuan Liu. "Development of a glassy carbon electrode modified with graphene/Au nanoparticles for determination of acetaminophen in pharmaceutical preparation." Russian Journal of Electrochemistry 54.12 (2018): 1141-1147. 27. Qi, Te, et al. "Cytosolic β-glucosidase inhibition and renal blood flow suppression are leading causes for the enhanced systemic exposure of salidroside in hypoxic rats." RSC advances 8.16 (2018): 8469-8483.10.1039/C7RA13295F 28. Wu, Ka, et al. "Biocharacterization of heat shock protein 90 in acetaminophen-treated livers without conspicuous drug induced liver injury." Cellular Physiology and Biochemistry 43.4 (2017): 1562-1570.https://doi.org/10.1159/000482003 29. [IF=3.197] Ka Wu et al."Ameliorative effectiveness of allicin on acetaminophen-induced acute liver damage in mice."J Funct Foods. 2015 Oct;18:665 30. [IF=3.049] Te Qi et al."Cytosolic β-glucosidase inhibition and renal blood flow suppression are leading causes for the enhanced systemic exposure of salidroside in hypoxic rats."Rsc Adv. 2018 Feb;8(16):8469-8483 31. [IF=0] Ka Wu et al."Biocharacterization of Heat Shock Protein 90 in Acetaminophen-Treated Livers Without Conspicuous Drug Induced Liver Injury."Cell Physiol Biochem. 2017;43(4):1562-1570 32. [IF=7.963] Chenzhi Hou et al."Application of multi-parameter population model based on endogenous population biomarkers and flow volume in wastewater epidemiology."Sci Total Environ. 2021 Mar;759:143480 33. [IF=4.616] Huiwen Wang et al."Rapid quality control of medicine and food dual purpose plant polysaccharides by matrix assisted laser desorption/ionization mass spectrometry."Analyst. 2020 Mar;145(6):2168-2175 34. [IF=4.221] Zengbin Wang et al."Interleukin 33 mediates hepatocyte autophagy and innate immune response in the early phase of acetaminophen-induced acute liver injury."Toxicology. 2021 May;456:152788 35. [IF=4.092] Shen Pan et al."Emodin Attenuates Acetaminophen-Induced Hepatotoxicity via the cGAS-STING Pathway."Inflammation. 2021 Aug;:1-14 36. [IF=3.535] Hui Jiang et al."Determination of lipid–water partition coefficient of neutral and ionic drugs by liposome electrokinetic chromatography."Electrophoresis. 2021 Aug;42(14-15):1436-1449 37. [IF=3] Yong-Shen REN et al."Dandelion polyphenols protect against acetaminophen-induced hepatotoxicity in mice via activation of the Nrf-2/HO-1 pathway and inhibition of the JNK signaling pathway."Chin J Nat Medicines. 2020 Feb;18:103 38. [IF=2.72] Yunfeng Bi et al."Ginsenoside Rg1 and ginsenoside Rh1 prevent liver injury induced by acetaminophen in mice."J Food Biochem. 2021 Aug;45(8):e13816 39. [IF=1.978] Zheng Yao et al.Protective Effect of Fresh/Dry Dandelion Extracts on APAP-Overdose-Induced Acute Liver Injury.Chinese Journal of Integrative Medicine.2021 Nov 24 40. [IF=3.935] Hui Jiang et al."Preparation of covalently bonded liposome capillary column and its application in evaluation of drug membrane permeability."J Pharmaceut Biomed. 2022 Feb;209:114513 41. [IF=4.221] Yanni Zhang et al."3D scaffold fabricated with composite material for cell culture and its derived platform for safety evaluation of drugs."Toxicology. 2022 Jan;466:153066 |
PARACETAMOL BP98 - Introduction
Open Data Unverified Data
acetaminophen, molecular formula C8H9NO2, usually white crystalline powder, has antipyretic and analgesic effects, and is used for cold, fever, Arthralgia, neuralgia, migraine, cancer pain and postoperative pain relief. It is prepared from p-nitrophenol sodium by reduction to p-aminophenol and acylation.
Last Update：2022-01-01 08:47:47
PARACETAMOL BP98 - Physical properties
Open Data Unverified Data
prism crystals were obtained from ethanol. The melting point of 169-171 deg C, the relative density of 1.293(21/4 deg C). Soluble in ethanol, acetone and hot water, insoluble in water, insoluble in petroleum ether and benzene. No odor, bitter taste. Saturated aqueous solution pH 5.5-6.5.
Last Update：2022-01-01 08:47:48
PARACETAMOL BP98 - Standard
Authoritative Data Verified Data
This product is 4 '-hydroxyacetanilide. The content of C8H9N02 shall be between 98.0% and 102.0% based on the dry product.
Last Update：2024-01-02 23:10:35
PARACETAMOL BP98 - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; Odorless.
- This product is soluble in hot water or ethanol, soluble in acetone, slightly soluble in water.
melting point
The melting point of this product (General rule 0612 second method) is 168~172 ℃.
Last Update：2022-01-01 11:42:56
PARACETAMOL BP98 - Chemical properties
Open Data Unverified Data
NIST chemical substance information is Acetaminophen(103-90-2);EPA chemical substance information is Acetamide, N-(4-hydroxyphenyl)-(103-90-2).
This product is the metabolism of phenacetin in the body, its inhibitory effect on the synthesis of prostaglandins in the central nervous system is similar to aspirin, but the inhibitory effect on the synthesis of peripheral prostaglandins is weak, so the antipyretic and analgesic effect is strong, the anti rheumatic effect is weak, and has no effect on platelet coagulation mechanism. Oral absorption is rapid, complete, uniform distribution in body fluids, most of the liver metabolism, intermediate metabolites toxic to the liver, in the form of glucuronic acid conjugates or excreted from the kidneys, half-life is generally 1-4 hours.
Last Update：2022-01-01 08:47:49
PARACETAMOL BP98 - Differential diagnosis
Authoritative Data Verified Data
- This product water solution plus three gas iron test solution, that is blue purple.
- take about 0.lg of this product, add 5ml of dilute hydrochloric acid, heat it in a water bath for 40 minutes, and let it cool; Take 0.5, add 5 drops of sodium nitrite solution Dropwise, shake well, dilute with 3ml of water, add 2ml of basic dental naphthol solution and shake to reveal red color.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 131).
Last Update：2022-01-01 11:42:57
PARACETAMOL BP98 - Effect
Open Data Unverified Data
1, used as antipyretic, analgesic, anti-rheumatic drugs.
2, the product is an antipyretic analgesic, the international non-proprietary drug name Paracetamol. It is the most commonly used non-anti-inflammatory antipyretic analgesic, antipyretic effect similar to aspirin, analgesic effect is weak, no anti-inflammatory anti-rheumatic effect, is the best variety of acetanilide drugs. It is particularly suitable for patients who cannot use carboxylic acid drugs. For colds, toothache and other symptoms.
3, organic synthesis intermediates, hydrogen peroxide stabilizer, photographic chemicals.
Last Update：2022-01-01 08:47:49
PARACETAMOL BP98 - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 5.5~6.5.
clarity and color of ethanol solution
take this product l. After being dissolved by adding 10ml of ethanol, the solution should be clear and colorless; In case of turbidity, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 method 1); In case of color development, it shall not be deeper in comparison with the standard colorimetric solution of brown-red No. 2 or orange-red No. 2 (General rule 0901 method 1).
chloride
take 2.0g of this product, add 0801 of water, heat and dissolve, cool, filter, take 25ml of filtrate, check according to law (general rule), and standard sodium chloride solution 5.0ml of the control solution should not be more concentrated (0.01%).
sulfate
take 25ml of the filtrate remaining under the chloride item and check it according to the law (General rule 0802). Compared with the control solution made of 0.02% of standard potassium sulfate solution, it should not be more concentrated ().
p-aminophenol and related substances
new system for clinical use. Take an appropriate amount of this product, precision weighing, and add solvent [methanol-water (4:6)] to make a solution containing about 20mg per 1 ml, as a test solution; Take an appropriate amount of amino phenol reference, precision weighing, add the above solvent to dissolve and make each 1 ml containing about 0.lmg solution, as a reference solution; Take each lml of the reference solution and the test solution in a-100ml measuring flask, dilute to the scale with the above solvent, shake, as a control solution. Test according to high performance liquid chromatography (General 0512). Octanosilane bonded silica gel was used as filler; Phosphate buffer solution (8.95g of disodium hydrogen phosphate, 3.9g of sodium dihydrogen phosphate, dissolved in 10% of water and 12ml of tetrabutylammonium hydroxide solution)-methanol (90:10) as the mobile phase; The detection wavelength is 245nm; The column temperature is 40 ° C.; The number of theoretical plates is not less than 2000 according to the calculation of acetaminophen peak, and the separation degree of the p-aminophenol peak and the p-acetophenyl peak should meet the requirements. 20ul of control solution and 20ul of test solution were respectively injected into human liquid chromatograph, and the chromatogram was recorded to 4 times of the retention time of the main peak. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of p-aminophenol, the peak area shall be calculated according to the external standard method, and the content of p-aminophenol shall not exceed 0.005%, the Peak area of other individual impurities shall not be greater than 0.1 times (0.1%) of the peak area of acetaminophen in the control solution, and the sum of the peak areas of other individual impurities shall not be greater than 0.5 times (0.5%) of the peak area of acetyl amino acid in the control solution.
p-chlorophenylacetamide
new system for clinical use. Take the test solution under p-aminophenol and related substances as the test solution; Take the appropriate amount of P-chlorobenzoacetamide and acetaminophen, the adding solvent [methanol-water (4:6)] was dissolved and a mixed solution containing about 1ug of p-chlorophenylacetamide and 20ug of acetaminophen per 1 ml was prepared as a control solution. Test according to high performance liquid chromatography (General 0512). Octanosilane bonded silica gel was used as filler; Phosphate buffer solution (8.95g of disodium hydrogen phosphate, 3.9g of sodium dihydrogen phosphate, dissolved in 10% ml of water, and 12ml of tetrabutylammonium hydroxide)-methanol (60:40) as the mobile phase; The detection wavelength is 245mn; The column temperature is 40°C; The number of theoretical plate is not less than 2000 according to the calculation of acetaminophen peak, and the separation degree of p-chlorophenylacetamide peak and acetaminophen peak should meet the requirements. Accurately measure 20ul of the reference solution and the test solution, respectively, and inject the human liquid chromatograph to record the chromatogram. The peak area shall be calculated according to the external standard method, and the content of p-chlorophenylacetamide shall not exceed 0.005%.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Heavy metals
take this product l. Add 20ml of water, heat in a water bath to dissolve, cool, filter, take the filtrate and add 2ml of acetate buffer (pH 3.5) and an appropriate amount of water to 25ml, inspection according to law (General Principles 0821, Law 1), containing heavy metals shall not exceed 10 parts per million.
Last Update：2022-01-01 11:42:58
PARACETAMOL BP98 - Content determination
Authoritative Data Verified Data
take about 40mg of this product, precision weighing, put it in a 250ml measuring flask, add 50ml of 0.4% sodium hydroxide solution to dissolve, add water to the scale, shake, take 5ml, add 10ml of 0.4% sodium hydroxide solution to the measuring flask, add water to the scale, shake well, measure absorbance at the wavelength of 257nm according to UV-visible spectrophotometry (General rule 0401), calculated as an absorption coefficient of C8H9N02 of 715.
Last Update：2022-01-01 11:42:58
PARACETAMOL BP98 - Category
Authoritative Data Verified Data
antipyretic analgesic, non-steroidal anti-inflammatory drugs.
Last Update：2022-01-01 11:42:58
PARACETAMOL BP98 - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:42:58
PARACETAMOL BP98 - Paracetamol Tablets
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 95.0% to 105.0%.
trait
This product is a white tablet, film-coated or gelatin-coated tablet, White after removal of the coating.
identification
- take an appropriate amount of fine powder of this product (equivalent to 0.5g of acetaminophen), grind it with 20ml of ethanol to dissolve the acetaminophen, filter it, combine the filtrate, and evaporate to dryness, the residue showed the same reaction according to the tests of (1) and (2) for the identification of acetaminophen.
- take an appropriate amount of fine powder of this product (about equivalent to acetaminophen lOOmg), add acetone 10ml, grind and dissolve, filter, evaporate the filtrate in water bath, dry the residue under reduced pressure, and determine according to law. The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 131 Figure).
examination
- a new anti-amino system was used. Take an appropriate amount of fine powder of this product (about 0.2g equivalent to acetaminophen), weigh it accurately, put it in a 10ml measuring flask, and add an appropriate amount of solvent [methanol-water (4:6)], shake to dissolve acetaminophen, dilute to the scale with solvent, shake well, filter, and take the continued filtrate as the test solution. Take appropriate amount of p-aminophenol reference and acetaminophen reference respectively, and weigh precisely, A solution containing about 20ug of each mixture per 1 ml was prepared by adding the above solvent as a control solution. Determination of p-aminophenol and related substances according to the chromatographic conditions in paracetamol. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the p-aminophenol in the reference solution, the peak area shall be calculated according to the external standard method, and the content of p-aminophenol shall not exceed 0.1% of the labeled amount of acetaminophen.
- dissolution: according to the determination method of dissolution and release (General rule 0931, Method 1), dilute hydrochloric acid (24ml) and water (100 ml) were added as dissolution medium, and the rotation speed was rpm, operate in accordance with the law, after 30 minutes, take the solution and filter, take the appropriate amount of filtrate, dilute with 0.04% sodium hydroxide solution to a solution containing 5 ~ 10ug of acetaminophen per 1 ml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 715), and the elution amount of each tablet was calculated as the absorption coefficient of C8H9NO2 was. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
determination of content
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 40mg equivalent to acetaminophen), put it in a 250ml measuring flask, add 50ml of 0.4% sodium hydroxide solution and 50ml of water, shake for 15 minutes, dilute to the scale with water, shake well, filter, Take 5ml of filtrate precisely, and set it in 100ml measuring flask according to the method under paracetamol content determination item, according to the law, that is obtained.
category
Same as acetaminophen.
specification
(1)0.lg (2)0.3g (3)0.5g
storage
sealed storage.
Last Update：2022-01-01 11:42:59
PARACETAMOL BP98 - Paracetamol chewable tablets
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 90.0% to 110.0%.
trait
This product is colored.
identification
(1) take an appropriate amount of this product (about 0.5g equivalent to acetaminophen), use ethanol 20ml, grind the acetaminophen to dissolve, filter, combine the filtrate, and evaporate to dryness, the residue showed the same reaction according to the tests (1) and (2) under paracetamol,
(2) take an appropriate amount of fine powder of this product (about equivalent to acetaminophen lOOmg), add 10ml of acetone, grind and dissolve, filter, evaporate the filtrate in water bath, dry the residue by torsion reduction and dry, and measure according to law. The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 131 Figure).
examination
- p-aminophenol was newly used. Take an appropriate amount of fine powder of this product (about equivalent to acetaminophen lOOmg), put it in a 10ml measuring flask, add mobile compatible children, shake to dissolve acetaminophen, dilute the mobile phase to the scale, shake and filter, the continued filtrate was used as the test solution; The appropriate amount of the p-aminophenol reference substance and the acetaminophen reference substance was accurately weighed, and the mobile phase was added to dissolve and dilute to prepare a mixed solution containing about l0ug in each lml, as a control solution. Test according to high performance liquid chromatography (General 0512). The mobile phase was 0.05mol/L ammonium acetate solution-methanol (85:15). The detection wavelength was 257nm. The number of theoretical plates shall not be less than 5000 according to the calculation of acetaminophen peak, and the separation degree between acetaminophen peak and acetaminophen peak shall meet the requirements. l0ul of each of the reference solution and the test solution was accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram was recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the p-aminophenol in the reference solution, the peak area shall be calculated according to the external standard method, and the content of the p-aminophenol shall not exceed 0.1% of the labeled amount of acetaminophen.
- In addition to not checking the disintegration time limit, the other items should be consistent with the relevant provisions under The tablet item (General Principle 0101).
Content determination
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 40mg equivalent to acetaminophen), put it in a 250ml measuring flask, add 50ml of 0.4% sodium hydroxide solution and 50ml of water, shake to dissolve p-acetamido, dilute to the scale with water, shake well, filter, and precisely take 5ml of continued filtrate, according to the method under paracetamol content determination, from "in 100ml measuring flask", it is obtained by measurement according to law.
category
Same as acetaminophen.
specification
(l)80mg (2)160mg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:43:00
PARACETAMOL BP98 - Paracetamol effervescent tablets
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 93.0% to 107.0%.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 0.5g equivalent to acetaminophen), use ethanol 20ml, grind it in portions to dissolve acetaminophen, filter it, combine the filtrate, and evaporate it to dryness, the residue showed the same reaction according to the test of identification (2) under paracetamol.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- acidity: Take 1 tablet of this product, add 100ml of water at 15~25 ℃ to disintegrate it, and measure it according to law (General rule 0631). The pH value should be 4.5~6.0.
- p-aminophenol was newly used. Accurately weigh the appropriate amount of fine powder of this product (about 25mg equivalent to acetaminophen), put it in a 50ml measuring flask, add the appropriate flow, shake to dissolve the acetaminophen, dilute to the scale with the mobile phase, shake and filter, the continued filtrate was taken as the test solution; An appropriate amount of p-aminophenol reference substance was weighed accurately, and the mobile phase was added to make a solution containing about 0.5ug per 1 ml as the reference solution. According to the chromatographic condition test under the content determination item, take 10ul of each of the reference solution and the test solution, and inject the liquid chromatograph separately, and record the chromatogram. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the p-aminophenol in the reference solution, the peak area shall be calculated according to the external standard method, and the content of the p-aminophenol shall not exceed 0.1% of the labeled amount of acetaminophen.
- In addition to friability, it shall comply with the relevant provisions under the item of tablets (General rule 0101).
determination of content
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer (pH 4.5)(sodium dihydrogen phosphate dihydrate 15.04g, disodium hydrogen phosphate 0.0627g, water was added to dissolve and diluted to 4.5 ml, and the pH value was adjusted to)-methanol (80:20) as mobile phase; The detection wavelength was 254mn. Take appropriate amount of p-aminophenol control and acetaminophen control; Add mobile phase to dissolve and dilute or contain 10ug of p-aminophenol and acetaminophen per 1 ml. lmg solution, 10u1 injection liquid chromatograph, record chromatogram, theoretical plate number according to the acetaminophen peak is not less than 5000, the separation of acetaminophen peak and the peak of the amino acid should meet the requirements.
- determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 25mg equivalent to acetaminophen), put it in a 50ml measuring flask, add mobile phase to dilute to the scale, shake, filter, take 10ml filtrate accurately, put it in 50ml measuring flask, dilute it to the scale with mobile phase, shake it, use it as test solution, take sample solution 10u1 accurately, inject into the liquid chromatograph, record the chromatogram; Take the appropriate amount of paracetamol reference substance, precise weighing, and the mobile phase is dissolved and quantitatively diluted to make about 0 in 1 ml. lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as acetaminophen.
specification
(1)0.lg (2)0.3g (3)0.5g
storage
sealed storage.
Last Update：2022-01-01 11:43:02
PARACETAMOL BP98 - Synthesis
Open Data Unverified Data
p-aminophenol acetylation
- Add p-aminophenol into dilute acetic acid, then add glacial acetic acid, raise the temperature to 150 ℃, react for 7H, add acetic anhydride, react for 2H, check the end point, cool to below 25 ℃ after passing, the product was washed with water until it had no acetic acid flavor, and dried to obtain crude product.
- The p-aminophenol, glacial acetic acid and acid mother liquor containing more than 50% of the acid are distilled together, and the rate of distilling out the dilute acid is one tenth of the total amount per hour, and the internal temperature is increased to more than 130 ° C, sampling inspection p-aminophenol residue is less than 2.5%, add dilute acid (content of more than 50%), cooling crystallization. The filtrate was filtered, washed with a small amount of dilute acid first, and then washed with a large amount of water until the filtrate was nearly colorless to obtain a crude product. The yield was 90% for Method 1 and 90-95% for Method 2. Refining method: the water is heated to near boiling and the crude product is added. The temperature was raised to full dissolution, activated carbon soaked in water was added, adjusted to pH = 4.2-4.6 with dilute acetic acid, and boiled for 10min. Pressure filtration, filtrate plus a small amount of sodium bisulfite. After cooling to below 20 °c, crystals were precipitated. Spray filter, washing, drying to get the raw material paracetamol finished product.
other production methods
- reduction of P-nitrophenol with zinc in glacial acetic acid and simultaneous acetylation to acetaminophen;
- The hydrazone produced from p-hydroxyacetophenone was placed in an acidic sulfuric acid solution, and sodium nitrite was added thereto to generate acetaminophen by translocation.
Last Update：2024-04-09 19:43:38
PARACETAMOL BP98 - Paracetamol injection
Authoritative Data Verified Data
- This product is a sterile aqueous solution of acetaminophen. Paracetamol (C8H9N02) shall be contained in 95.0% to 105.0% of the labeled amount.
- an appropriate amount of stabilizer and cosolvent can be added to this product.
trait
This product is colorless or almost colorless with slightly viscous clear liquid.
identification
- taking this product, according to the Identification Test (1) and (2) under the item of acetaminophen, the same reaction was shown.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- the pH value should be 4.5 to 6.5 (General 0631).
- new system of related substances in clinical use. Take an appropriate amount of this product with precision, dilute it with mobile phase to make a solution containing about 2.5mg of acetaminophen per 1ml, shake well, and use it as a test solution; Take 1ml with precision and put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake, as a control solution; Another precision weigh appropriate amount of p-aminophenol control, add mobile phase dissolution and quantitative dilution to prepare a solution containing about 2.5ug per 1ml, as a reference solution. According to the chromatographic condition test under the content determination item, the detection wavelength is 245nm, and the l0ul of the test solution, the control solution and the reference solution are respectively injected into the liquid chromatograph, the chromatogram was recorded to 2 times of the retention time of the main component peak. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of p-aminophenol, the peak area shall be calculated according to the external standard method, and the content of p-aminophenol shall not exceed 0.1% of the labeled amount of acetaminophen, the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (1.0%).
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.05mol/L ammonium acetate solution-methanol (85:15) as mobile phase; The detection wavelength was 257nm. The number of theoretical plates shall not be less than 2000 according to the calculation of acetaminophen peak, and the separation degree between acetaminophen peak and adjacent impurity peak shall meet the requirements.
- determination of precision quantity take appropriate amount of this product, diluted with mobile phase to make a solution containing about 0.125mg of acetaminophen per 1 ml, as a test solution, take 10u1 into the liquid chromatograph for precision measurement, record the chromatogram; another acetaminophen reference substance was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as acetaminophen.
specification
(1) 1ml:0.075g (2) lml:0.15g (3)2ml:0.15g (4)2ml:0.25g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:43:03
PARACETAMOL BP98 - Paracetamol Suppositories
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 90.0% to 110.0%.
trait
This product is milky white to slightly yellow suppository.
identification
- take an appropriate amount of this product (about 0.3g equivalent to acetaminophen), add 20ml of water, place it in a 60°C water bath and heat it completely to melt it, shake it for 5 minutes, cool it in an ice bath and filter it, take 5ml of the filtrate and add 1 drop of ferric chloride solution, which shows blue-purple color.
- take 5ml of the filtrate under Item (1) of identification, add 5ml of dilute hydrochloric acid, put it in a water bath and heat it for 30 minutes, cool it, add several drops of Sodium Nitrite test solution and several drops of alkaline piperonaphthol test solution Dropwise, A yellow-orange to Scarlet precipitate was produced.
- Take 3ml of the filtrate under Item (1) of identification, add 1.5ml of hydrochloric acid, boil for 3 minutes, add water to about 10ml, and let go cold, without precipitation; add 0.01667mol/L potassium dichromate solution 1 drop, gradually purple, unchanged red.
- take an appropriate amount of this product (about equivalent to acetaminophen lOOmg), heat 10ml of water, grind and dissolve, ice bath cooling, filtering, filtrate water bath evaporation drying, residue drying under reduced pressure, determination according to law. The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 131 Figure).
examination
should comply with the relevant provisions under suppository (General rule 0107).
Content determination
Take 10 capsules of this product, precision weighing, cut into small pieces, mix well, precision weighing an appropriate amount (equivalent to 0.25g of acetaminophen), put it in a 250ml measuring flask, add 0.Olmol/L sodium hydroxide solution 80ml, shake for 10 minutes, let cool, with O.Olmol/L sodium hydroxide solution is diluted to the scale, cooled in a cold water bath for 1 = hour, filtered, after the filtrate reaches room temperature, take 10ml continuous filtrate accurately, put it in a 100ml measuring flask, dilute with 0.01mol/L sodium hydroxide solution to the scale, shake well, take 5ml, put it in a 50ml measuring flask, use 0.Olmol/L sodium hydroxide solution diluted to the scale, shake. The absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 715), and the absorbance was calculated as of the absorption coefficient of C8H9N02.
category
Same as acetaminophen.
specification
(1)0.125g (2)0.15g (3)0.3g (4)0.6g
storage
sealed and stored in a cool place.
Last Update：2022-01-01 11:43:04
PARACETAMOL BP98 - Paracetamol capsules
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 95.0% to 105.0%.
identification
take an appropriate amount of the content of this product (about 0.5g equivalent to acetaminophen), grind it with 20ml of ethanol to dissolve the acetaminophen, filter it, combine the filtrate, and evaporate it to dryness, the residue showed the same reaction according to the tests of (1) and (2) for the identification of acetaminophen.
examination
- p-aminophenol was newly used. Take an appropriate amount of fine powder of this product (about 0.2g equivalent to acetaminophen), weigh it accurately, put it in a 10ml measuring flask, and add an appropriate amount of solvent [methanol-water (4:6)], shake to dissolve acetaminophen, dilute to the scale with solvent, shake, filter, and take the filtrate as the test solution. Take appropriate amount of p-aminophenol reference and acetaminophen reference respectively, and weigh precisely, A solution containing about 20ug each in 1 ml was prepared by adding the above solvent as a control solution. Determination of p-aminophenol and related substances according to the chromatographic conditions in paracetamol. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the p-aminophenol in the reference solution, the peak area shall be calculated according to the external standard method, and the content of the p-aminophenol shall not exceed 0.1% of the labeled amount of acetaminophen.
- loss on drying: take an appropriate amount of the contents of this product, dry to constant weight at 105°C, and lose no more than 0.5% of the weight (General rule 0831).
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), dilute hydrochloric acid (24ml) was added with water (ML) as dissolution medium, and the speed was 50 rpm, operate in accordance with the law, after 45 minutes, take the solution to filter, take the filtrate of 1ml, put the 50ml measuring flask, dilute with 0.04% sodium hydroxide solution to the scale, shake, according to the method under the item of dissolution Paracetamol Tablets, from the "ultraviolet-visible spectrophotometry", the limit of determination according to law is 80% of the labeled amount, which should be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the difference of loading, mix evenly, weigh an appropriate amount (about 40mg equivalent to acetaminophen) accurately, put it in a 250ml measuring flask, add 0.lmol/L sodium hydroxide solution 50ml and water 50ml, shake, dilute to the scale with water, shake, filter, Take 5ml of continued filtrate with precision, according to the method under the item of acetaminophen, from "in 100ml measuring flask", it is obtained by measurement according to law.
specification
0.3g
storage
sealed preservation.
Last Update：2022-01-01 11:43:05
PARACETAMOL BP98 - Paracetamol granules
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 95.0% to 105.0%.
trait
This product is white or white particles.
identification
take an appropriate amount of this product (about 0.5g equivalent to acetaminophen), use ethanol 20ml, grind it in portions to dissolve acetaminophen, filter it, combine the filtrate, and evaporate it to dryness, the residue showed the same reaction according to the tests of (1) and (2) for the identification of acetaminophen.
examination
- a new anti-amino system was used. Take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about equivalent to acetaminophen lOOmg) accurately, put it in a 10ml measuring flask, add an appropriate amount of mobile phase, and shake to dissolve acetaminophen, dilute to the scale with mobile phase, shake, filter, and take the filtrate as the test solution; Weigh the appropriate amount of p-aminophenol reference and acetaminophen reference respectively, the mobile phase was added, dissolved and diluted to prepare a mixed solution containing about 10ug each per 1 ml as a control solution. Tested according to high performance liquid chromatography (General 0512). With eighteen alkyl silane bonded silica as filler; 0.05mol/L ammonium acetate solution-methanol (85:15) as mobile phase; Detection wavelength of 257nm theoretical plate number according to the acetaminophen peak calculation is not less than 5000, the resolution of paracetamol peak and p-aminophenol peak should meet the requirements. 10 u1 of each of the reference solution and the test solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the p-aminophenol in the reference solution, the peak area shall be calculated according to the external standard method, and the content of the p-aminophenol shall not exceed 0.1% of the labeled amount of acetaminophen.
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), dilute hydrochloric acid (24ml) was added with water (ML) as dissolution medium, and the speed was 50 rpm, operate according to law, after 30 minutes, take 10ml of solution, filter, take the appropriate amount of filtrate, dilute with 0.04% sodium hydroxide solution to make a solution containing about 8ug of acetaminophen per lml, the absorbance was measured at a wavelength of 0401 NM according to UV-Vis spectrophotometry (General rule 715), and the elution amount of each bag was calculated as the absorption coefficient of C8H9NO2 was. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
take the contents under the difference of loading, mix evenly, weigh an appropriate amount (about 40mg equivalent to acetaminophen) accurately, put it in a 250ml measuring flask, add 50ml of 0.4% sodium hydroxide solution and 50ml of water, shake to dissolve acetaminophen, dilute to the scale with water, shake well, filter, and precisely measure 5ml of continued filtrate. According to the method under paracetamol content determination item, start from "placing in a 100ml measuring flask, according to the law, that is obtained.
category
Same as acetaminophen.
specification
(1)0.lg (2)0.16g (3)0.25g (4)0.5g
storage
sealed and stored in a cool place.
Last Update：2022-01-01 11:43:06
PARACETAMOL BP98 - ParacetamolDrops
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a colored clear liquid.
identification
- take 20ml of this product, add 20ml of chloroform, shake extraction, take the chloroform layer, water bath evaporation, take the residue according to the identification (2) test under the item of acetaminophen, the same reaction was shown.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- p-aminophenol was newly used. Take this product, add water to make a solution containing about 2mg of acetaminophen per lml, as a test solution; Take an appropriate amount of the control of the amino phenol, precision weighing, add water to make a solution containing about 2ug per lml, as a control solution. Test according to the chromatographic conditions under the content determination. 10ul of the reference solution and the sample solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the p-aminophenol in the reference solution, the peak area shall be calculated according to the external standard method, and the content of the p-aminophenol shall not exceed 0.1% of the labeled amount of acetaminophen.
- relative density the relative density of this product (General 0601) is 1.070~1.150.
- the pH value should be 4.5 to 6.5 (General 0631).
- Other should comply with the relevant provisions under the item of oral solution (General Principle 0123).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.05mol/L ammonium acetate solution-methanol (85:15) as mobile phase; The detection wavelength was 257mn. The number of theoretical plates shall not be less than 5000 based on the calculation of acetaminophen peak, and the separation degree between acetaminophen peak and internal standard substance peak shall meet the requirements. Preparation of internal standard solution take theophylline, add water to make a solution containing 1.0 mg per 1 ml, and shake to obtain.
- precision measurement: take an appropriate amount of this product and dilute it with water to make a solution containing about 0.6mg of acetaminophen per lml. Take 5ml of this solution and 5ml of the internal standard solution for precision measurement, and place them in a 50ml measuring flask, dilute to scale with water, shake well, as a sample solution, inject 10ul of precision into the liquid chromatograph, record the chromatogram; Take appropriate amount of paracetamol reference substance, precision weigh and determine with the same method. According to the internal standard method to calculate the peak area, that is.
category
Same as acetaminophen.
specification
(l)10ml:lg (2)15ml:l.5g (3)16ml:1.6g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:43:06
PARACETAMOL BP98 - Paracetamol gel
Authoritative Data Verified Data
This product contains paracetamol (C8H9NO2) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a light yellow translucent semi-solid gel.
identification
- take an appropriate amount of this product (about 50mg equivalent to paracetamol), add 10ml of water, place it in a warm water bath and shake it to dissolve the paracetamol, filter it, take the filtrate and add ferric chloride test solution, which shows blue color.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and there was a maximum absorption at a wavelength of Nm.
examination
- acidity of this product l.Og, add water 20ml, heat to dissolve acetaminophen, after cooling, according to the law (General 0631),pH value should be 4.0~5.5.
- others shall comply with the relevant provisions under the item of gel (General rule 0114).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water-phosphoric acid (22:78:0.1) as mobile phase; The detection wavelength was 248nm. The number of theoretical plates is not less than 1000 in terms of acetaminophen peak.
- determine the contents of the test item, mix well, accurately weigh an appropriate amount (about 20mg equivalent to acetaminophen), put it in a 100ml measuring flask, and add an appropriate amount of water, dissolve acetaminophen in warm water bath with shaking, cool down, dilute to scale with water, shake well, filter, take 3ml continuous filtrate with precision, put it in 50ml measuring flask, dilute to scale with methanol, shake well, as a test solution, take 10u1 injection of human liquid chromatograph for precise measurement, record chromatogram; Take appropriate amount of acetaminophen reference, precise weighing, methanol was added to dissolve and quantitatively diluted to prepare a solution containing about 12ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as acetaminophen.
specification
5g:0.12g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:43:07
PARACETAMOL BP98 - Safety measures
Open Data Unverified Data
- ingestion: do not induce vomiting. If awake and alert, rinse with 2-4 full cups of milk or water.
- inhalation: fresh air from site immediately. If you are not breathing, perform artificial respiration. Such as Dyspnea, to the delivery of oxygen. He received medical assistance.
- Skin: received medical assistance. Rinse the skin with plenty of soap and water for at least 15 minutes, remove contaminated clothes and shoes.
- eyes: Rinse eyes immediately with plenty of water for at least 15 minutes and lift the upper and lower eyelids from time to time. The patient visited the hospital immediately.
- eyes: Wear suitable protective glasses or chemical safety goggles, OSHA's eye and face protection regulations 29 CFR 1910.133 or European standard EN 166. Skin: wear appropriate protective gloves and clothing to prevent skin contact. Clothing: wear appropriate protective clothing to reduce skin contact.
- respirators: in accordance with OSHA respirator regulation 29CFR 1910.134 or European Standard EN 149. Be sure to use a NIOSH or European Standard EN 149 approved respirator when necessary.
- fire suppression: self-contained respirator equipment, MSHA / NIOSH (or equivalent), and full-body protective clothing should be worn under pressure. In the event of a fire, irritating and highly toxic gases may be produced by thermal decomposition or combustion. To put out fires, water, dry powder, chemical foam, anti-soluble foam are used.
Last Update：2024-04-09 19:43:38
PARACETAMOL BP98 - Attention to use
Open Data Unverified Data
- inhalation: may cause respiratory irritation.
- Skin: may cause skin allergy.
- eyes: May cause eye irritation.
- ingestion: may cause gastrointestinal irritation symptoms, Nausea, Vomit and Diarrhea. Systemic effects by ingestion: Changes in pancreatic exocrine, Diarrhea, Nausea, irritability, drowsiness, general anesthesia, Fever, hepatitis, renal tubular injury.
- effects of exposure: may lead to human cancer.
- Fire Hazard: The material may be flammable.
- Storage: Store in a cool, dry place. Keep the container closed when not in use.
Last Update：2024-04-09 19:43:38
PARACETAMOL BP98 - Reference Information
Open Data Unverified Data
| pH indicator color change ph range | 5.5 - 6.5 (H?O, 20°C) (saturated solution) |
| LogP | 1.098 at 25℃ |
| (IARC) carcinogen classification | 3 (Vol. 50, 73) 1999 |
| NIST chemical information | Information provided by: webbook.nist.gov (external link) |
| EPA chemical information | Information provided by: ofmpub.epa.gov (external link) |
| Antipyretic analgesics | The chemical name of acetaminophen is N-(4-hydroxyphenyl) acetamide (N-(4 -Hy drox ypheny l)ace tamide), the trade name is paracetamol, which belongs to acetanilide antipyretic analgesics. It was first synthesized by Morse in 1878 and first used clinically by VonMering in 1893. It became an over-the-counter drug in the United States in 1955, and China began production in the late 50s. Its appearance is white crystal or crystalline powder, melting point 168~172 ℃, odorless, slightly bitter taste, soluble in hot water or ethanol, dissolved in acetone, almost insoluble in cold water and petroleum ether. It is stable below 45 ℃, but if exposed to humid air, it will be hydrolyzed into p-aminophenol, and then further oxidation will occur. The color gradually becomes pink, brown, and finally black. Therefore, it should be stored in a cold and dry place. Acetaminophen has an antipyretic effect by inhibiting the synthesis of prostaglandins in the hypothalamic thermoregulation center. Its antipyretic effect is similar to that of aspirin. It inhibits the synthesis of prostaglandins in the central nervous system and blocks the impulse of pain nerve endings. The analgesic effect is weaker than aspirin. Compared with aspirin, it has the advantages of less irritation and very few allergic reactions. The antipyretic and analgesic effect is similar to phenacetin, as many countries restrict or prohibit the use of phenacetin, the application of acetaminophen has increased. Clinically, it is mainly used for fever, headache and relief of mild and moderate pain caused by colds, such as joint pain, muscle pain, neuralgia, migraine, dysmenorrhea, cancer pain and postoperative analgesia; It can also be used for patients who are allergic, intolerant or unsuitable for aspirin: such as chickenpox, hemophilia and other bleeding diseases (including patients with anticoagulant therapy), as well as patients with mild peptic ulcer and gastritis, etc.; in addition, it can also be used for the synthesis of drugs, as well as as organic synthesis intermediates, photographic chemicals and stabilizers of hydrogen peroxide. |
| indications | acetaminophen is a phenolic organic substance, used for fever caused by common cold or influenza, and also used to relieve mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia and dysmenorrhea. |
| Pharmacological effects | This product is an antipyretic analgesic. By inhibiting cyclooxygenase, it selectively inhibits the synthesis of prostaglandins in the hypothalamic thermoregulation center, resulting in peripheral vasodilation and sweating. The antipyretic effect is similar to that of aspirin; by inhibiting the synthesis and release of prostaglandins, etc., it can increase the pain threshold and play an analgesic effect. It is a peripheral analgesic, the effect is weaker than aspirin, and it is only effective for mild to moderate pain. This product has no obvious anti-inflammatory effect. |
| pharmacokinetics | absorption is rapid and complete after oral administration, and the peak time is 0.5~2h. The plasma protein binding rate was 25% ~ 50%. This product is evenly distributed in the body, 90% ~ 95% is metabolized in the liver, and is mainly excreted from the kidney in the form of glucuronic acid binding, and about 3% is excreted with urine in the original form within 24 hours. Its half-life (t1/2) is 1~4h (average 2h). t1/2 is not affected when renal insufficiency occurs, but t1/2 is prolonged in patients with hepatic insufficiency, newborns and elderly patients, while t1/2 is shortened in children. Can secrete through milk. |
| preparation method | 1. nitrobenzene is used as raw material and Pd/C is used as catalyst to catalyze the hydrogenation of nitrobenzene to p-aminophenol under the condition of concentrated sulfuric acid and hexadecyltrimethyl ammonium chloride. Paracetamol was synthesized by direct acetylation without separation with 64.3% yield. The reaction formula is as follows: 2. Paracetamol is synthesized by Pd/C catalytic hydroacylation with p-nitrophenol as raw material. The best solvent is acetic acid, and the dosage is 2~5 times that of p-nitrophenol. The yield of paracetamol can reach 95%. After the catalyst was changed to Pd-La/C, the yield of paracetamol reached 97%. The reaction formula is as follows: 3. Paracetamol is synthesized by microwave radiation technology with p-aminophenol and acetic anhydride as raw materials, zinc powder as antioxidant, activated carbon as decolorant, dilute acetic acid as reaction medium, and the yield can reach 81.2%. The reaction formula is as follows: 4. Paracetamol is prepared by oxime p-hydroxyacetophenone with p-hydroxyacetophenone as raw material, and then Beckmann rearrangement. This method is used to oxime p-hydroxyacetophenone to obtain p-hydroxyacetophenone oxime with 93.5% yield. Then Hβ molecular sieve is used as catalyst and acetone is used as solvent to rearrange acetaminophen with 81.2% yield. With acetone as the rearrangement reaction solvent and Al-MCM-41 molecular sieve as the rearrangement reaction catalyst, the yield reaches the highest when the phosphoric acid content in the catalyst 30%. The reaction formula is as follows: 5. Acetaminophen is synthesized from phenol by acetylation, Fries rearrangement, oxime and Beckmann rearrangement with yields of 82%, 68.6%, 92.5% and 50.5% respectively. The reaction formula is as follows: |
| use | is mainly used for fever, headache and relief of mild and moderate pain caused by colds, such as joint pain, muscle pain, neuralgia, migraine, dysmenorrhea, cancer pain and postoperative analgesia. It can also be used for patients who are allergic, intolerant or unsuitable for aspirin: such as chickenpox, hemophilia and other bleeding diseases (including patients with anticoagulant therapy), as well as mild peptic ulcer and gastritis Patients etc. This product is an antipyretic and analgesic, and the international non-proprietary drug name is Paracetamol. It is the most commonly used non-anti-inflammatory and antipyretic analgesic. Its antipyretic effect is similar to that of aspirin. It has weak analgesic effect and no anti-inflammatory and anti-rheumatic effect. It is the best variety of acetanilide drugs. It is especially suitable for patients who cannot use carboxylic acid drugs. Used for cold, toothache and other diseases. Acetaminophen is also an intermediate in organic synthesis, a stabilizer for hydrogen peroxide, and a photographic chemical. used as antipyretic, analgesic, antirheumatic drug organic synthesis intermediates, stabilizers of hydrogen peroxide, photographic chemicals, non-anti-inflammatory and antipyretic analgesics. |
| usage and dosage | 1. oral administration (1) acetaminophen tablets and capsules: 300~600mg once for adults, 3~4 times a day as required, and the daily dosage should not exceed 2g. The antipyretic treatment generally does not exceed 3 days, and the analgesic administration does not exceed 10 days. Children once 10~15mg/kg, every 4~6h once; The dose for children under 12 years old shall not exceed 5 times a day, and the course of treatment shall not exceed 5 days. This product should not be taken for a long time. 2. Dispersible tablets: when taking, add warm boiled water to disperse. The common dosage for children is 10~15mg/kg once, once every 4~6h, no more than 5 times a day for children under 12 years old, the course of treatment is no more than 5 days, and the dosage under 3 years old is reduced. |
| adverse reactions | 1. allergic reactions: this product has fewer and lighter side effects during treatment. I occasionally see allergic reactions such as rash and urticaria. Individual cases can occur with methemoglobin. 2. Liver and kidney damage: Long-term large-scale administration can cause liver and kidney damage and thrombocytopenia, and even jaundice, oliguria, acute severe hepatitis, leading to coma and death. High-dose administration may also cause nausea, vomiting, stomach pain, stomach cramps, diarrhea, anorexia, hyperhidrosis, etc. 3. Because the liver and kidney functions of children under 3 years old are not yet mature, and the detoxification and excretion function is poor, it should be avoided as much as possible. In addition, patients with liver and kidney dysfunction and pregnant women should be used with caution. Long-term medication should regularly check the blood picture and liver and kidney function. (2016-04-23) |
| taboo | patients with severe liver and kidney insufficiency and those allergic to this product are prohibited. |
| precautions | 1. those who are allergic to this product are prohibited. People who are allergic to aspirin generally do not have allergic reactions to this product. However, it has been reported that in patients with asthma due to aspirin allergy, a small number of patients may develop bronchospasm after taking this product. 2. When ethanol poisoning, liver disease or viral hepatitis, this product has the risk of increasing liver toxicity and should be used with caution. People with renal insufficiency use this product in large quantities for a long time, which has the risk of increasing renal toxicity and should be used with caution. Patients with severe liver and kidney insufficiency are contraindicated. 3. When taking this medicine due to pain, it shall not be used continuously for more than 5 days, and antipyretic treatment shall not exceed 3 days, unless otherwise ordered by a doctor. After taking this product, erythema or edema symptoms should be stopped immediately. This product is only a symptomatic treatment. While using this product, other therapies must be applied to relieve pain or fever. 4. This product can be secreted through the placenta and in milk, so it is not recommended for pregnant women and lactating women. Children under 3 years old should avoid using it because of their liver and kidney dysfunction. Due to the decline of liver and kidney function in elderly patients, this product t1/2 has been prolonged and is prone to adverse reactions. It should be used with caution or appropriately reduced. 5. Interference with diagnosis: ①Blood glucose determination, false low value can be obtained when using glucose oxidase/peroxidase method, while no effect is obtained when using hexokinase/6-phosphate dehydrogenase method; ②Serum uric acid determination, false high value can be obtained when using phosphotungstic acid method; ③Determination of urine 5-hydroxyindole acetic acid (5-HIAA), false positive results can be obtained when using nitrosinophenol reagent for qualitative screening test, quantitative test is not affected; ④ Liver function test, when used in large doses or for a long time, prothrombin time, serum bilirubin, lactate dehydrogenase, and serum aminotransferase can all increase. 6. The rescue of drug overdose should be timely gastric lavage or vomiting, and antagonist acetylcysteine (140mg/kg orally at the beginning, then 70mg/kg, once every 4 hours for 17 times; When the disease is serious, intravenous administration can be carried out, and the drug can be dissolved in 200ml of 5% glucose solution for intravenous drip) or oral administration of methionine, which has protective effect on liver. Activated carbon shall not be given, because it can affect the absorption of rescue drugs. Antagonists should be applied as soon as possible, and the curative effect is satisfactory within 12 hours, and the curative effect is worse if they exceed 24 hours. Other therapies, such as hemodialysis, should also be given. |
| drug interaction | 1. in long-term drinking or application of other liver enzyme inducers, especially in patients with barbiturates or anticonvulsants, there is a risk of liver toxicity when taking this product for a long time or in large quantities. 2. The combination with chloramphenicol can prolong the t1/2 of the latter and enhance its toxicity. 3. When combined with anticoagulants, it can enhance the anticoagulant effect, so the dosage of anticoagulants should be adjusted. 4. When combined with aspirin or other non-steroidal anti-inflammatory drugs in large quantities for a long time, there is a significant increase in the risk of nephrotoxicity. 5. When combined with the antiviral drug zidovudine, it can increase its toxicity and should be avoided at the same time. |
| main points of administration care | 1. according to the general rules of antipyretic and analgesic care. 2. The patient should be instructed to pay attention during medication: ① Do not drink alcohol, drinking alcohol can aggravate the hepatotoxicity of this product; ② Drink more water to reduce the concentration of the drug in the renal tubules and reduce the occurrence of "analgesic nephropathy"; ③ Chewable tablets should be chewed and taken; ④ Do not take other NSAIDS or NSAIDS-containing compound preparations at the same time without authorization to avoid increasing nephrotoxicity. 3. When this product is poisoned, the oral antagonist acetylcysteine (phlegm is easy to clean) should be given as soon as possible, and activated carbon should not be taken orally, because the latter can affect the absorption of antagonist; the initial amount of acetylcysteine is 140 mg/kg, After that, 70 mg/kg will be given every 4 h for 17 times. The taking method is to prepare acetylcysteine into a 5% solution or add 3 times the amount of beverage to shake and take it well to avoid its foul smell and irritation. For those who vomit within 1 h after medication, they should be replenished once, and nasal feeding or rectal administration if necessary. When the condition is serious, the drug can be dissolved in 200 ml of 5% glucose injection for intravenous drip. Antagonists should be applied as soon as possible, and the curative effect is satisfactory within 12 h, and the curative effect is poor after 24 h. In treatment, it is best to monitor the blood concentration and give other therapies, such as hemodialysis or hemofiltration. |
| production method | acetylation of p-aminophenol. Method 1: Add p-aminophenol to dilute acetic acid, then add glacial acetic acid, raise the temperature to 150 ℃ for 7h, add acetic anhydride, then react for 2h, check the end point, cool to below 25 ℃ after passing the test, filter, wash with water until there is no acetic acid taste, spin dry, and obtain crude product. Method 2: Distillate p-aminophenol, glacial acetic acid and acid mother liquor containing more than 50% acid together. The speed of evaporating dilute acid is one-tenth of the total amount of distillation per hour. When the internal temperature rises above 130 ℃, sample and check that the residual amount of p-aminophenol is less than 2.5%, add dilute acid (content above 50%), and cool and crystallize. To filter, first wash with a small amount of dilute acid, and then wash with a large amount of water until the filtrate is close to colorless to obtain a crude product. The yield of method 1 is 90%, and the yield of method 2 is 90-95%. Refining method: When the water is heated to near boiling, put into crude products. Raise the temperature to full solution, add activated carbon soaked in water, adjust to pH = 4.2-4.6 with dilute acetic acid, and boil for 10min. Press filtration, add a small amount of sodium heavy sulfite to the filtrate. Cooling to below 20°C, crystallization is precipitated. The finished product of crude drug paracetamol is filtered, washed with water and dried. Other production methods include:(1) Reduction of p-nitrophenol with zinc in glacial acetic acid, and acetylation to obtain acetaminophen;(2) Place the hydrazone generated by p-hydroxyacetophenone in an acidic sulfuric acid solution, Add sodium nitrite, and transpose to generate acetaminophen. |
| spontaneous combustion temperature | 540°C |
| toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |
Last Update：2024-04-09 19:43:38
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Raw Materials for PARACETAMOL BP98