INDOMETACIN
Indomethacin
CAS: 53-86-1
Molecular Formula: C19H16ClNO4
INDOMETACIN - Names and Identifiers
| Name | Indomethacin |
| Synonyms | INDOCIN INDOMETACIN indometacin Indometacin Indomethacin INDOMETACINE AURORA KA-6542 indomethacin usp indomethacin crystalline indomethacin methanol solution 1-(4-chlorobenzoyl)-5-methoxy-2-methylindol-3-ylacetic acid {1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1H-indol-3-yl}acetate |
| CAS | 53-86-1 |
| EINECS | 200-186-5 |
| InChI | InChI=1/C19H16ClNO4/c1-11-15(10-18(22)23)16-9-14(25-2)7-8-17(16)21(11)19(24)12-3-5-13(20)6-4-12/h3-9H,10H2,1-2H3,(H,22,23)/p-1 |
| InChIKey | CGIGDMFJXJATDK-UHFFFAOYSA-N |
INDOMETACIN - Physico-chemical Properties
| Molecular Formula | C19H16ClNO4 |
| Molar Mass | 357.79 |
| Density | 1.2135 (rough estimate) |
| Melting Point | 158-162 °C |
| Boling Point | 499.4±45.0 °C(Predicted) |
| Flash Point | 255.8°C |
| Water Solubility | Soluble in acetone (40 mg/mL - clear, yellow solution), ethanol (20 mg/mL), ether, castor oil; Soluble in chloroform (50 mg/mL - clear, yellow, extremely viscous solution); decomposed by strong alkali |
| Solubility | Soluble in acetone, slightly soluble in ethanol, chloroform, ether, almost insoluble in water |
| Vapor Presure | 8.61E-11mmHg at 25°C |
| Appearance | White to bright yellow crystals |
| Merck | 14,4968 |
| BRN | 497341 |
| pKa | 4.5(at 25℃) |
| Storage Condition | Store at RT |
| Stability | Stable. Incompatible with strong oxidizing agents. |
| Sensitive | Light Sensitive |
| Refractive Index | 1.6800 (estimate) |
| MDL | MFCD00057095 |
| Physical and Chemical Properties | White or yellowish crystalline powder. Melting point 158-162 ℃. Soluble in acetone, slightly soluble in ethanol, chloroform, ether, almost insoluble in water. Tasteless, almost odorless. |
| Use | Non-hormonal anti-inflammatory and analgesic drugs |
INDOMETACIN - Risk and Safety
| Risk Codes | R28 - Very Toxic if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. |
| Safety Description | S28 - After contact with skin, wash immediately with plenty of soap-suds. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| UN IDs | UN 2811 6.1/PG 1 |
| WGK Germany | 3 |
| RTECS | NL3500000 |
| FLUKA BRAND F CODES | 8-10 |
| TSCA | Yes |
| HS Code | 29339900 |
| Hazard Class | 6.1 |
| Packing Group | I |
| Toxicity | LD50 i.p. in rats: 13 mg/kg (Klaassen) |
INDOMETACIN - Upstream Downstream Industry
| Raw Materials | p-Anisidine 4-Chlorobenzoyl chloride Levulinic acid |
INDOMETACIN - Reference
| Reference Show more | 1. Zhang Yongping, Xu Jian, Wu Jinglan et al. Effects of pH on physicochemical properties and transdermal parameters of indomethacin in vitro [J]. China Pharmacy 2016(34). 2. The sound of the rain, Zhang, Jun, Yongtian, Guan, Qiang, et al. Wnt/β-catenin/TCF-4 signaling pathway regulates livin expression in renal cell carcinoma cell proliferation and apoptosis [J]. Journal of Chongqing Medical University 2019 044(006):716-721. 3. Determination of LC-MS of 25 characteristic components in danhe granules and analysis of consistency of preparations [J]. Chinese herbal medicine 2019 v.50;No.659(24):63-72. 4. Li Suli, Liu Guiqing. Preliminary Study on transdermal permeability of indomethacin gel in vitro [J]. World latest medical information abstracts 2016(52): -155. 5. Xie Weijie, Zhang Yongping, Xu Jian. Screening Matrix formulation of indomethacin hydrophilic gel patch by uniform design [J]. China Pharmacy, 2017(10). 6. Zhang Yongping, Xu Jian, Xie Weijie. Optimization of matrix formulation and molding process of indomethacin hydrophilic gel patch by Central composite design-response surface methodology [J]. Medical leads, 2018, 037(005):593-599. 7. Song Yanbo, Zhao Guishan, Ru Xiaofei, Hou Xiaolin, Mengzhou, Li Xinjie, Meng Qingrong, Wang Xiaodong. Preparation of artificial antigen and polyclonal antibody of indomethacin [J]. Animal husbandry and veterinary medicine 2019 51(10):44-48. 8. Bi ran Bai Rui Liu Zhiqiang Liu Huiliang. Comparison of biological characteristics between mesenchymal stem cells derived from human induced pluripotent stem cells and bone marrow mesenchymal stem cells [J]. Military Medicine, 2018, 42(12):941-948. 9. Cheng Youmin, Lin JingYu, Zhou Fan, Huang Peiwei, Chen Qi, Xu Kinson. Effect and mechanism of pre-acupuncture combined with acupoint injection on gastric mucosal injury in rats with gastric ulcer [J]. Chinese medical science, 2021,11(03):20-24. 10. [IF = 4.545] Hui Yang et al."Essential abuse mechanism of araloside A in situ single-pass essential perfusion and in vitro Caco-2 cell model." Biomed Pharmacother. 2018 Oct;106:1563 11. [IF = 3.343] Qian Kang et al."Transdermal delivery system of nanostructured lipid carriers loaded with Celastrol and Indomethacin: optimization, characterization and efficacy evaluation for rheumatoid arthritis."Artificial Cells Nanomedicine and Biotechnology. 2018 O 12. [IF=5.81] Huixia Feng et al."Exploring Multifunctional Bioactive Components from Podophyllum sinense Using Multi-Target Ultrafiltration."Front Pharmacol. 2021; 12: 749189 13. [IF=3.534] Jiuheng Ruan et al."A Systematic Quantitative Evaluation of Permeation Enhancement Window: Transdermal Permeation Enhancing Dynamics Establishment and Molecular Mechanisms Characterization of Permeation Enhancer."J Pharm Sci-Us. 2022 Jan ;: |
INDOMETACIN - Standard
Authoritative Data Verified Data
This product is 2-methyl-l-(4-benzoyl)-5-methoxy-1h-indole-3-acetic acid. Calculated as dried product, the content of C19H16C1N04 shall not be less than 99.0%.
Last Update：2024-01-02 23:10:35
INDOMETACIN - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Almost odorless.
- This product is dissolved in acetone, slightly soluble in methanol, ethanol, chloroform or ether, very slightly soluble in toluene, almost insoluble in water.
melting point
The melting point of this product (General 0612) is 158~162°C.
absorption coefficient
take 50mg of this product, weigh it accurately, put it in a 100ml measuring flask, add 50ml of methanol, shake it to dissolve, dilute it to the scale with phosphate buffer (pH 7.2), shake it well, take 5ml of precision, put in flask, add phosphate buffer (pH 7.2)-methanol (1:1) solution diluted to the scale, shake. The absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General Rule 185), and the absorption coefficient was 200.
Last Update：2022-01-01 11:57:14
INDOMETACIN - Introduction
This product is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic and analgesic effects. Its mechanism of action is to reduce the synthesis of prostaglandins by inhibiting cyclooxygenase. Stop the formation of pain nerve impulses in inflammatory tissues and inhibit inflammatory reactions, including inhibiting the chemotaxis of white blood cells and the release of lysosomal enzymes. As for the antipyretic effect, due to the effect on the hypothalamus thermoregulatory center, it causes peripheral vasodilation and sweating, which increases heat dissipation. This central antipyretic effect may also be related to the inhibition of prostaglandin synthesis in the hypothalamus.
Last Update：2022-10-16 17:25:57
INDOMETACIN - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, Add 10ml of water and 2 drops of 20% sodium hydroxide solution to dissolve; Take 1 ml of solution, add 0.03% potassium dichromate solution 0.3ml, heat to boiling, and cool, add 2~3 drops of sulfuric acid, put it on a water bath and slowly heat it, which should be purple; Take another 1 ml of solution, add 0.1% ml of 0.3 sodium nitrite solution, heat to boiling, let it cool, add 0.5ml of hydrochloric acid, should be green, placed after the gradient of yellow.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 193).
Last Update：2022-01-01 11:57:15
INDOMETACIN - Exam
Authoritative Data Verified Data
oxide
take 0.30g of this product, add 25ml of water, strongly shake for 3 minutes, filter, take the filtrate to check according to law (General rule 0801), and standard gasification sodium solution 6.0 ml of the control solution should not be more concentrated (0.02%).
Related substances
take about 50mg of this product, put it in a 100ml measuring flask, add an appropriate amount of methanol, shake to dissolve, dilute it with methanol to the scale, shake well, take 5ml, put it in a 25ml measuring flask, dilute with 50% methanol solution to the scale, shake, as a test solution; Take the precision of 1 ml, put in 50% flask, diluted with methanol solution to the scale, as a control solution. Test according to high performance liquid chromatography (General 0512). Silica gel bonded with eighteen alkyl silane was used as the filler; 0.1 mol/L glacial acetic acid solution-acetonitrile (50:50) was used as the mobile phase; The detection wavelength was 228mn. The number of theoretical plates shall not be less than 2000 calculated by the peak of indomethacin, and the separation degree between the peak of indomethacin and the adjacent impurity peaks shall meet the requirements. 50 u1 of the control solution and 50 u1 of the test solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main peak of the test solution. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (0.5%).
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
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 11:57:16
INDOMETACIN - Content determination
Authoritative Data Verified Data
take this product about 0.5g, precision weighing, add ethanol 30ml, slightly warm to dissolve, cool, add water 20ml, add phenolphthalein indicator solution 7~8 drops, quickly with sodium hydroxide titration solution (O. 1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 35.78mg of C19H16C1N04.
Last Update：2022-01-01 11:57:16
INDOMETACIN - Category
Authoritative Data Verified Data
antipyretic analgesic, non-steroidal anti-inflammatory drugs.
Last Update：2022-01-01 11:57:16
INDOMETACIN - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:57:16
INDOMETACIN - Indometacin Enteric-coated Tablets
Authoritative Data Verified Data
This product contains indomethacin (C19H16ClN04) should be 90.0% to 110.0% of the label amount.
trait
This product is an enteric coated tablet, White after removing the coating.
identification
- take this product, remove the coating, grind it, take an appropriate amount (about 10 mg equivalent to indomethacin), add 10ml of water, shake and saturate, add 2 drops of 20% sodium hydroxide solution, the indomethacin was dissolved by shaking, filtered, and the filtrate was taken. The same reaction was shown according to the indomethacin identification (1) test.
- 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
- appropriate amount of fine powder (about 50mg equivalent to indomethacin) under the content determination item, put it in a 100ml measuring flask, add appropriate amount of methanol, sonicate to dissolve indomethacin, and let it cool, dilute to the scale with methanol, shake, filter, take 2ml of filtrate accurately, put it in a 10ml measuring flask, dilute to the scale with 50% methanol, shake well, as a test solution; the sample solution (1ml) was accurately weighed, placed in a measuring flask (50% ml), diluted to a scale with methanol, and shaken to obtain a control solution. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution.
- dissolution of this product, according to the dissolution and release determination method (General 0931 first method 2 ), to O. 1 mol/L hydrochloric acid solution 1000ml as the dissolution medium, the speed is 100 rpm, according to the law, after 2 hours, immediately raise the basket out of the liquid level, for the test piece shall not have cracks or disintegration phenomenon. The rotating basket was then immersed in 1000ml dissolution medium of human phosphate buffer (pH 6.8), and the rotating speed was unchanged. The rotating basket continued to operate according to law. After 45 minutes, the solution was taken and filtered, the absorbance was measured at a wavelength of 320mn according to UV-Vis spectrophotometry (General 0401), and the elution amount of each tablet was calculated as the absorption coefficient of C19H16C1N04 was 196. The limit is 70% 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).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica gel as filler; With acetonitrile -0.1 mol/L glacial acetic acid solution (50:50) is the mobile phase; The detection wavelength is 228nm; The number of theoretical plates is not less than 2000 according to the peak of indomethacin. The separation degree of indomethacin peak and adjacent impurity peaks should meet the requirements.
- determination of 10 tablets of this product, after removing the coating, precision calibration, fine grinding, precision weighing fine powder appropriate amount (equivalent to 50mg of indomethacin), 100ml flask, add the amount of methanol, ultrasonic dissolution of indomethacin, allowed to cool, diluted with methanol to the scale, shake well, filter, precision take the filtrate 2ml, put into a 10ml measuring flask, dilute with 50% methanol solution to the scale, shake well, as a test solution, accurately measure 20u1 and inject human liquid chromatograph, record the chromatogram; Additionally take indomethacin reference substance about 25mg, accurately weigh and set it in 50ml measuring flask, add appropriate amount of methanol, ultrasonic dissolution, cool, diluted with methanol to the scale, shake, precision take 2ml, put 10ml flask, diluted with 50% methanol solution to the scale, shake, the same method. According to the external standard method to calculate the peak area, that is.
category
Same as indomethacin.
specification
25mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:57:17
INDOMETACIN - Indomethacin cream
Authoritative Data Verified Data
This product contains indomethacin (C19H16C1N04) should be 90.0% to 110.0% of the label.
trait
This product is light yellow cream.
identification
take about 2.5g of this product, add 50ml of cyclohexane and 25ml of methanol, shake extraction, static stratification, take the lower methanol solution to test according to the following method.
- take 1ml of methanol solution and add 0. Add 0.03% of 0.5 potassium dichromate solution to 3-4 drops of 1 mol /L sodium hydroxide solution, heat to boiling, cool, add 4-5 drops of sulfuric acid, and slowly heat on a water bath to show purple color.
- take 1ml of methanol solution and add 0.1 mol /L sodium hydroxide solution 3~4 drops, add 0.1% of 0.5 sodium nitrite solution, heat to boiling, cool, add 0.5 of hydrochloric acid, should be green, after placed into yellow.
- 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
should comply with the relevant provisions under Cream (General rule 0109).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; 0.1 mol/L glacial acetic acid solution-acetonitrile (50:50) as mobile phase; The detection wavelength was 228nm; The number of theoretical plate according to indomethacin peak calculation is not less than 2000, the degree of separation of the indomethacin peak from the adjacent impurity peak should meet the requirements.
- determination method: take an appropriate amount of this product (about 10mg equivalent to indomethacin), weigh it accurately, put it in a 100ml measuring flask, add an appropriate amount of methanol, sonicate the indomethacin, and let it cool, dilute to the scale with methanol, shake well, place in an ice bath for 1 hour, filter, take and continue the filtrate to cool, as a test solution, take 20u1 and inject a human liquid chromatograph with precision, record the chromatogram; Take another indomethacin reference substance, precision weighing, plus methanol dissolution and quantitative dilution made in each lml containing 0.lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as indomethacin.
specification
10g:lOOmg
storage
shade, seal, and store in a cool place
Last Update：2022-01-01 11:57:18
INDOMETACIN - Indomethacin patch
Authoritative Data Verified Data
This product contains indomethacin (C19H16CIN04) should be labeled the amount of 80.0% to 120.0%.
trait
This product is a colorless transparent sheet polyacrylate patch.
identification
40ml of the impregnating solution (equivalent to 10mg of indomethacin) of the content determination item F is taken, and is evaporated to dryness on a water bath. The residue is added with 10ml of water and 2 drops of 20% sodium hydroxide solution, and stirred to dissolve indomethacin, filtration, filtrate to do the following test.
- take 1ml of the filtrate, add 0.03% of 0.3 potassium dichromate solution, heat to boiling, let it cool, add 2-3 drops of sulfuric acid, and slowly heat it on a water bath, which should be purple.
- take 1ml of the filtrate, add 0.1% of sodium nitrite solution, heat to boiling, let it cool, add 0.5 of hydrochloric acid, which should be green, and gradually yellow after being placed.
examination
- Content uniformity: Take 1 piece of this product, cut it into small strips, remove the protective layer, place it in a dry plug Erlenmeyer flask, and add 50ml of methanol accurately, according to the method under the content determination item, from the "dark place", the content is determined according to law, and the limit is ± 20%, which shall comply with the regulations (General 0941).
- Other in addition to the release rate, should comply with the relevant provisions under the patch (General Principles 0121).
Content determination
take 5 pieces of this product, cut them into small strips respectively, remove the protective layer, put them in a dry plug Erlenmeyer flask, add 250ml of methanol precisely, place them in the dark, soak them for 2 hours, shake them well, take 5ml of dipping solution, put it in a 50ml measuring flask, dilute it to the scale with methanol, shake it well, and measure it by UV-Vis spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 320mn, and calculated as the absorption coefficient of C19H16C1N04 was 179.
category
Same as indomethacin.
specification
7.2cm X 7.2, containing indomethacin 12.5mg.
storage
sealed and stored in a dry place.
Last Update：2022-01-01 11:57:19
INDOMETACIN - Indometacin Suppositories
Authoritative Data Verified Data
This product contains indomethacin (C19H16CIN04) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a white to light yellow suppository made of fatty matrix.
identification
take an appropriate amount of this product (about 50mg equivalent to indomethacin), add 50ml of water and 20% ml of sodium hydroxide solution, heat and stir to dissolve indomethacin, cool, filter after the matrix solidifies, and take the filtrate, the same reaction was shown in the identification (1) Test under indomethacin.
examination
- for related substances, take the test solution under the content determination item as the test solution; Take 1ml of the test solution with precision and put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with 50% methanol solution. According to the chromatographic conditions under the content determination item, 50ul of each of the control solution and the test solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be more than 2 times (2.0%) of the main peak area of the control solution.
- others should comply with the relevant provisions under suppository (General 0107).
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; With 0.lmol/L glacial acetic acid solution-acetonitrile (50:50) as mobile phase; The detection wavelength was 228nm. The number of theoretical plates shall not be less than 2000 calculated by the peak of indomethacin, and the separation degree between the peak of indomethacin and the adjacent impurity peaks shall meet the requirements.
- determination of this product 10 capsules, precision weighing, carefully chopped, mixed evenly, precision weighing an appropriate amount (equivalent to indomethacin 25mg), put the 50ml flask, add the amount of methanol, dissolve indomethacin by heating in water bath, let it cool, dilute to scale with methanol, shake well, filter, Take 5ml of filtrate accurately and put it in 25ml measuring flask, dilute to scale with 50% methanol solution, shake well, inject 20u1 into human liquid chromatograph with precise volume, record chromatogram; Take indomethacin reference substance about 25mg, weigh precisely, put it into 50ml measuring flask, add an appropriate amount of methanol, shake to dissolve, dilute to the scale with methanol, shake well, take an appropriate amount of precision, dilute with 50% methanol solution to make 0.lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as indomethacin.
specification
(l)25mg (2)50mg (3)l00mg
storage
light shielding, sealing, and storage at 25°C or lower.
Last Update：2022-01-01 11:57:20
INDOMETACIN - Indometacin Capsules
Authoritative Data Verified Data
This product contains indomethacin (C19H16C1N04) should be 90.0% to 110.0% of the label amount.
identification
- take an appropriate amount of the content of this product (about 10mg equivalent to indomethacin), add 10ml of water, shake and saturate, then add 3 drops of 20% sodium hydroxide solution, shake to dissolve indomethacin, filter, the filtrate was taken, and the same reaction was shown according to the identification (1) Test under the item of indomethacin.
- 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
- for related substances, take the test solution under the content determination item as the test solution; Take 1ml of the test solution with precision and put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with 50% methanol solution. According to the chromatographic conditions under the content determination item, 50 u1 of the control solution and 50 u1 of the test solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be more than 2 times (2.0%) of the main peak area of the control solution.
- Content uniformity take 1 capsule of this product, pour the content into 50ml measuring flask, wash the capsule with 35ml methanol, wash the washing solution into the measuring flask, fully shake, dissolve indomethacin at a slight temperature, let it cool, dilute to the scale with methanol, shake well, and let stand; Precisely measure 5ml of the supernatant, put it in a 100ml measuring flask, and use phosphate buffer (pH 7.2).-Methanol (1:1) solution to the scale, shake. According to UV-visible spectrophotometry (General rule 0401), the absorbance is measured at the wavelength of 320nm, and the content is calculated according to the absorption coefficient of C19H16C1N04 as 193, which shall comply with the regulations (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with phosphate buffer (pH 7.2)-Water (1:4)900ml for the dissolution medium, speed of 100 rpm, according to the law, after 45 minutes, take the solution, filtering, UV-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 320nm, and the elution amount per particle was calculated as the absorption coefficient of C19H16C1N04 was 198. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
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; With 0.lmol /L glacial acetic acid solution-acetonitrile (50:50) as mobile phase; The detection wavelength was 228nm. The number of theoretical plates shall not be less than 2000 calculated by the peak of indomethacin, and the separation degree between the peak of indomethacin and the adjacent impurity peaks shall meet the requirements.
- determination Method: Take 20 capsules of this product, pour out the contents, accurately weigh the appropriate amount of the content (about 50mg equivalent to indomethacin), put it in a 100ml measuring flask, and add the appropriate amount of methanol, shake to dissolve indomethacin, dilute to scale with methanol, shake well, filter, Take 5ml of continued filtrate precisely, put it in a 25ml measuring flask, dilute to scale with 50% methanol solution, shake well, as the sample solution, 20ul was injected into the liquid chromatograph with precise quantity, and the chromatogram was recorded. Another reference substance of indomethacin, about 25mg, was accurately weighed and placed in a 50ml measuring flask, and an appropriate amount of methanol was added, shake to dissolve, dilute to the scale with methanol, shake well, take an appropriate amount of precision, dilute with 50% methanol solution to make 0.lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as indomethacin.
specification
25mg
storage
shading, sealed preservation,
Last Update：2022-01-01 11:57:21
INDOMETACIN - Indomethacin liniment
Authoritative Data Verified Data
This product contains indomethacin (C19H16C1N04) should be 90.0% to 110.0% of the label amount.
trait
This product is a yellow, slightly viscous, clear liquid.
identification
Take 2ml of this product (about 20mg equivalent to indomethacin), add water to 10ml, add 2~3 drops of 20% sodium hydroxide solution, shake, and test according to the following method.
- take 1ml of the solution, add 0.03% of 0.3 potassium dichromate solution, heat to boiling, let it cool, add 2-3 drops of sulfuric acid, and slowly heat it on a water bath, which should be red and purple.
- take 1ml of solution, add 0.1% of 0.3 sodium nitrite solution, heat to boiling, cool, add 0.5 of hydrochloric acid, should be green, after placement, gradient yellow.
examination
- the pH value should be 6.0 to 7.0 (General 0631).
- the amount of ethanol should be 52.0% to 62.0% (General 0711).
- others should comply with the relevant provisions under liniment (General rule 0117).
Content determination
take an appropriate amount of this product (about 50mg equivalent to indomethacin), put it in a 100ml measuring flask, dilute it to the scale with methanol, and shake it well, in another measuring flask, dilute to the mark with phosphate buffer (pH 7.2)-methanol (1:1) solution, shake, the absorbance was measured at a wavelength of 320mn according to UV-Vis spectrophotometry (General rule 0401), and the absorption coefficient of C19H16C1N04 was calculated as 193.
category
Same as indomethacin.
specification
(l)20ml:200mg (2)50ml:500mg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:57:21
INDOMETACIN - Indomethacin sustained-release tablets
Authoritative Data Verified Data
This product contains indomethacin (C19H16C1N04) should be 95.0% to 105.0% of the label amount.
trait
This product is a special-shaped film-coated tablet, White after removing the coating.
identification
- take 1 tablet of this product, remove the coating, grind, add 25ml of water and 5 drops of 20% sodium hydroxide solution, grind to dissolve, filter, take 1ml of filtrate, add 0.03% potassium dichromate solution 0.3, heat to boiling, cool, add 2~3 drops of sulfuric acid, slowly heat on a water bath, should be purple; Take another 1ml of filtrate, add 0.1% ml of 0.3 sodium nitrite solution, and heat to boiling, cool, add hydrochloric acid 0.5, should be green, after placement, gradient yellow.
- 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
- Related substances take an appropriate amount of this product's fine powder (about 50mg equivalent to indomethacin), weigh it accurately, place it in a 100ml measuring flask, add 10ml of tetrahydrofuran, shake it thoroughly, and dilute it to the scale with acetonitrile, shake well, filter, Take 5ml of the filtrate accurately, put it in a 25ml measuring flask, dilute it with acetonitrile to the scale, shake well, and use it as a test solution; Take 1ml accurately, set in a 200ml measuring flask, dilute to the scale with acetonitrile, and shake to serve as a control solution. The appropriate amounts of the reference substance for impurity I and the reference substance for impurity II were respectively taken, precisely weighed, dissolved and diluted with acetonitrile to prepare a solution containing about 0.5ug each in 1 ml, which was used as a reference solution. According to the method of indomethacin related substances, the sample solution, the reference solution and the control solution were respectively 20 u1, and the human liquid chromatograph was injected respectively, the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the contents of impurity I and impurity II shall be calculated by the peak area according to the external standard method, and neither shall exceed 0.5% of the labeled amount of indomethacin, other single impurity peak area shall not be greater than the main peak area of the control solution (0.5%), and the sum of each impurity peak area shall not be greater than 4 times (2.0%) of the main peak area of the control solution. The content uniformity of
- shall be calculated from the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931 second method), with phosphate buffer (pH 7.2)500ml as the dissolution medium, and the rotation speed was 100 rpm, operate according to law, take 5ml of the solution at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 20 hours respectively, and immediately supplement the dissolution medium with the same temperature and the same volume, filtration, 2 hours, 4 hours, 6 hours, 8 hours of the continued filtrate as the test solution (I); Precision measurement of 12 hours, 20 hours of the continued filtrate of 3ml, separately put into 10ml measuring flask, dilute to scale with dissolution medium, shake well, as test solution (II); Take about 25mg of indomethacin reference, weigh precisely, put into 100ml measuring flask, add 0.5ml of tetrahydrofuran to dissolve, dilute to scale with dissolution medium, shake well, take 5ml accurately, put it in 50ml measuring flask, dilute to scale with dissolution medium, shake well, as a control solution. Take the reference solution and the above test solution (I) and Test Solution (II), ultraviolet-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 320nm, and the elution amount of each tablet at different times was calculated. The dissolution of each tablet in 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 20 hours should be 15% to 30%, 30% to 50% of the label amount, respectively, 40% to 65%, 50% to 80%, 70% to 95%, and 80% or more shall comply with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-O.lmol/L glacial acetic acid solution (50:50) as mobile phase; The detection wavelength was 228mn. The number of theoretical plates is not less than 2000 calculated from the peak of indomethacin.
- determination method: 10 tablets of this product were placed in a mortar respectively, ground finely, triturated with about 35ml of methanol and quantitatively transferred to a 50ml measuring flask. The indomethacin was dissolved by ultrasound and allowed to cool, dilute to the scale with methanol, shake, filter, take 2ml of filtrate accurately, put it in a 10ml measuring flask, dilute to the scale with 50% methanol solution, shake well, as a test solution; 20u1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. Another reference substance of indomethacin, about 25mg, was accurately weighed and placed in a 50ml measuring flask, dilute with methanol to the scale, shake, take 2ml, put it in a 10ml measuring flask, dilute it with 50% methanol solution to the scale, shake well, and measure with the same method. The content of each tablet was calculated by the peak area according to the external standard method, and the average content of 10 tablets was obtained.
category
Same as indomethacin.
specification
25mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:57:22
INDOMETACIN - Indomethacin sustained-release capsules
Authoritative Data Verified Data
This product contains indomethacin (C19H16C1N04) should be 90.0% to 110.0% of the label amount.
trait
The contents of this product are white to yellowish pellets.
identification
- take an appropriate amount of the content of this product (about 10mg equivalent to indomethacin), grind it finely, add 10ml of water, shake, add 3 drops of 20% sodium hydroxide solution, fully shake, filter, take 1ml of filtrate, add 0.03% potassium dichromate solution (0.3ml), heat to boiling, cool, add 2-3 drops of sulfuric acid, slowly heat on a water bath, should be purple; Take another 1ml of filtrate, add 0.1% 0.3 sodium nitrite solution, heat to boiling, cool, add 0.5 hydrochloric acid, should be green, after placement, gradient yellow.
- 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
- for related substances, take the test sample solution under the content determination item as the test sample solution; Take 1ml of the test sample solution for precise measurement and put it in a 200ml measuring flask, as a control solution, it was diluted to the scale with 50% methanol solution and shaken. According to the method of indomethacin related substances. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.5% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (1.0%).
- Content uniformity take 1 capsule of this product, pour the content into a mortar, grind it finely, and use about 35ml(25mg specification) or 70ml(75mg specification) of methanol. Transfer to 50ml(25mg specification) or 100ml(75mg specification) measuring flask, ultrasonic dissolution of indomethacin, let cool, dilute to the scale with methanol, shake, filter, take 5ml(25mg specification) or 3ml(75mg specification) of the continuous filtrate, put it in a 25ml measuring flask, dilute it to the mark with 50% methanol, shake it well, determination according to the method under the content determination item, should comply with the provisions (General 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with phosphate buffer (pH 7.2)-Water (1:4)750ml(25mg specification) or 1000mK75mg specification) is the dissolution medium, the rotation speed is 150 rpm, the operation is carried out according to law, and 10ml of the solution is taken at 3 hours, 6 hours and 12 hours respectively, immediately supplement the dissolution medium of the same temperature and the same volume, filter, take the continued filtrate (25mg specification) or take 5ml of the continued filtrate with precision, and put it in a 10ml measuring flask, dilute to scale with dissolution medium, shake well (75mg specification), measure absorbance at the wavelength of 320mn by UV-Vis spectrophotometry (General rule 0401); in addition, an appropriate amount of indomethacin reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to make a solution containing about 30ug per 1 ml. The absorbance was measured by the same method, and the dissolution amount of each particle at different times was calculated respectively. The dissolution amount of each capsule of this product in 3 hours, 6 hours and 12 hours shall be 25% ~ 55%, 45% ~ 85% and more than 70% of the labeled amount, and shall comply with the regulations.
- others shall comply with the relevant provisions under the capsule (General 0103).
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; Acetonitrile -0.lmol/ L glacial acetic acid solution (50:50) as mobile phase; The detection wavelength was 228nm. The number of theoretical plates is not less than 2000 calculated from the peak of indomethacin.
- determination Method: Take 20 capsules of this product, accurately weigh, mix evenly, grind finely, accurately weigh an appropriate amount (about 50mg equivalent to indomethacin), put it in a 100ml measuring flask, and add an appropriate amount of methanol, sonicate indomethacin, cool, dilute to the scale with methanol, shake well, filter, Take 5ml of continued filtrate precisely, put it in a 25ml measuring flask, dilute to the scale with 50% methanol solution, shake well, as a test solution, take 20 u1 for precise measurement, inject human liquid chromatograph, record chromatogram; Take about 25mg of indomethacin reference, weigh precisely, put it in 50ml measuring flask, add an appropriate amount of methanol, ultrasonic to dissolve, cool, dilute to the scale with methanol, shake well, take an appropriate amount of precision, quantitatively dilute with 50% methanol solution 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 indomethacin.
specification
(l)25mg (2)75mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:57:23
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Product Name: Indomethacin Visit Supplier Webpage Request for quotationCAS: 53-86-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Product Name: Indomethacin Request for quotation
CAS: 53-86-1
Tel: 0086-13605431940
Email: xuli678323@126.com
Mobile: +86-13605431940
QQ: 56860987
Wechat: 13605431940
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Raw Materials for INDOMETACIN