sodiumdiclofenac
diclofenac sodium
CAS: 15307-79-6
Molecular Formula: C14H10Cl2NNaO2
sodiumdiclofenac - Names and Identifiers
| Name | diclofenac sodium |
| Synonyms | tsudohmin AKOS B020028 sodiumdiclofenac diclofenac sodium Diclofenac sodium salt sodium(o-(2,6-dichloroanilino)phenyl)acetate {2-[(2,6-dichlorophenyl)amino]phenyl}acetic acid sodium(o-((2,6-dichlorophenyl)amino)phenyl)acetate sodium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate 2-(2,6-DICHLOROANILINO)PHENYLACETIC ACID SODIUM SALT 2[(2,6-dichlorophenyl)amino]-benzeneacetic aci monosodium 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid sodium salt N-(2,6-Dichlorophenyl)-o-aminophenylacetic acid sodium salt 2-[(2,6-DICHLOROPHENYL)AMINO]-BENZENEACETIC ACID MONOSODIUM SALT |
| CAS | 15307-79-6 |
| EINECS | 239-346-4 |
| InChI | InChI=1/C12H9Cl2N.C2H4O2.Na/c13-10-7-4-8-11(14)12(10)15-9-5-2-1-3-6-9;1-2(3)4;/h1-8,15H;1H3,(H,3,4);/q;;+1/p-1 |
| InChIKey | KPHWPUGNDIVLNH-UHFFFAOYSA-M |
sodiumdiclofenac - Physico-chemical Properties
| Molecular Formula | C14H10Cl2NNaO2 |
| Molar Mass | 318.13 |
| Density | 0.781 g/cm3 |
| Melting Point | 288-290°C |
| Boling Point | 412°C at 760 mmHg |
| Water Solubility | Soluble in water to 50mg/ml. |
| Solubility | H2O: 50 mg/mL |
| Appearance | White crystalline powder |
| Color | White to Almost white |
| Merck | 14,3081 |
| pKa | 4(at 25℃) |
| Storage Condition | room temp |
| Stability | Stable. |
| MDL | MFCD00082251 |
| Physical and Chemical Properties | Colorless crystalline powder. Melting point 283-285 °c, free acid melting point 156-158 °c. |
| Use | Used as an anti-inflammatory analgesic |
sodiumdiclofenac - Risk and Safety
| Risk Codes | R25 - Toxic if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R63 - Possible risk of harm to the unborn child |
| Safety Description | S22 - Do not breathe dust. 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. S60 - This material and its container must be disposed of as hazardous waste. S20 - When using, do not eat or drink. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | AG6330000 |
| HS Code | 29224999 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 in mice, rats (mg/kg): ~390, 150 orally (Krupp) |
sodiumdiclofenac - Upstream Downstream Industry
| Raw Materials | 2,5-Dichloroaniline 2,6-Dichlorophenol 2-Chlorobenzoic acid Aniline Chloroacetyl chloride Ethyl Alcohol |
sodiumdiclofenac - Reference
| Reference Show more | 1. Xue Xiaoxu, Chen Changze, Gu Guowei. Adsorption of Pharmaceutical Active by Polyacrylic Acid Modified Magnetic Chitosan Composite Microspheres [J]. Yunnan Chemical Industry, 2020,47(08):48-51. 2. Guo Rui, Li Yao, Wang Ping. Evaluation of Antioxidant and Anti-inflammatory Activities of Three Solanum nigrum Fruit Extracts in Vitro [J]. Modern Food Science and Technology, 2020, v.36;No.246(02):100-107. 3. Xue Xiaoxu, Chen Changze, Gu Guowei. Adsorption of Pharmaceutical Active by Polyacrylic Acid Modified Magnetic Chitosan Composite Microspheres [J]. Yunnan chemical industry, 2020,47(08):48-51. 4. [IF = 1.908] Hui Wang et al."Mechanism-based inactivation of CYP2C9 by linderane." Xenobiotica. 2015;45(12):1037-1046 5. [IF = 7.514] Nan Zhang et al."Hydrophilic carboxyl supported immobilization of UiO-66 for novel bar sorptive extraction of non-steroidal anti-inflammatory drugs in food samples." Food Chem. 2021 Sep;355:129623 6. [IF = 4.759] Yan Gao et al."Novel solid-phase extraction filter based on a zirconium meta-organic framework for determination of non-steroidal anti-inflammatory drugs residues." J Chromatogr A.2021 Aug;1652:462349 7. [IF = 5.909] Xi He et al."One-pot synthesis of C- doping and defects co-modified g-C3N4 for enhanced visible-light photocatalytic degradation of bisphenol A." J Environ Chem Eng. 2021 Dec;:106911 8. [IF = 7.312] Yunyun Li et al."Mass transfer enhancement for rapid, selective extraction of pharmaceuticals by enlarging the microporous on isostructural zeolitic imidazolate Framework-8." SEPARATION AND PURIFICATION TECHNOLOGY. 2022 Jul;293:121102 |
sodiumdiclofenac - Introduction
Open Data Unverified Data
diclofenac sodium name: Diclofenac sodium, atorvastatin, amirell, diverner; Orfen; Osok; Voltarine; Kevolan; Norfodine; Tianxinlide; Yingtaiqing capsules; white or white, odorless, easy to absorb the moisture of the crystalline powder, this product through the inhibition of cyclooxygenase to reduce the synthesis of prostaglandins. Indications are for the relief of mild to moderate pain in muscles, soft tissues and joints. Such as: relieve muscle, soft tissue sprain, strain, contusion, strain, low back injury caused by pain and joint pain. It can also be used for the symptomatic treatment of osteoarthritis. Adverse reactions were Abdominal Pain, Diarrhea, Nausea, indigestion, bloating, Vomit, gastritis, constipation, rash, dizziness, Head Pain, menorrhagia. Patients with liver disease can appear S-GPT, S-GOT and bilirubin increased. Occasionally, renal damage was noted.
Last Update：2022-01-01 08:51:03
sodiumdiclofenac - Trait
Open Data Unverified Data
white or white, odorless, easy to absorb the moisture of the crystalline powder, this product through the inhibition of cyclooxygenase to reduce the synthesis of prostaglandins. Commonly used its sodium salt, colorless crystals, odorless, soluble in water, ethanol and other polar organic solvents, aqueous solution pH = 7.68 , pKa = 4. Melting point 283-285 °c.
Last Update：2022-01-01 08:51:04
sodiumdiclofenac - Standard
Authoritative Data Verified Data
This product is 2-[(2, 6-dichlorophenyl) chloro]-phenylacetic acid sodium. Calculated as dry product, containing no less than 98.5% of C14H10Cl2NNaO2.
Last Update：2024-01-02 23:10:35
sodiumdiclofenac - Category
Authoritative Data Verified Data
antipyretic analgesic, non-steroidal anti-inflammatory drugs.
Last Update：2022-01-01 11:33:24
sodiumdiclofenac - Mechanism of Action
Open Data Unverified Data
-
li inhibits the arachidonic acid cyclooxygenase system, resulting in a decrease in prostaglandin and platelet production.
- inhibits the oxidase, which causes the formation of leukotrienes, and the inhibitory effect on leukotriene B4 is more pronounced in particular. li inhibits arachidonic acid release and stimulates re-uptake of arachidonic acid.
representative drug: Deffner (also known as Voltaren)
alias: Diclofenac sodium, diclofenac sodium, Betadine, amierel, diffner; Orfen; Oshok; Voltarine; Kevolan; Norfodine;
tianxinlide; Yingtaiqing capsule properties: This product is an enteric film-coated tablet, 25mg tablet is yellow.
indications rheumatoid arthritis and osteoarthritis, ankylosing spondylitis
Last Update：2022-01-01 08:51:04
sodiumdiclofenac - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:33:24
sodiumdiclofenac - Precautions
Open Data Unverified Data
contraindication
Gastrointestinal bleeding in pregnant women and women planning to become pregnant. Use with caution in lactating women.adverse reactions
Abdominal Pain, Diarrhea, Nausea, dyspepsia, bloating, Vomit, gastritis, constipation, rash, dizziness, Head Pain, menorrhagia. Patients with liver disease can appear S-GPT, S-GOT and bilirubin increased. Occasionally renal damageLast Update：2022-01-01 08:51:05
sodiumdiclofenac - Indication
Open Data Unverified Data
-
li relieved rheumatoid arthritis and osteoarthritis. Acute attack or persistent joint swelling and pain symptoms of various chronic arthritis such as spondyloarthropathy, gouty arthritis and rheumatoid arthritis;
- a variety of soft tissue rheumatic pain, such as shoulder pain, tenosynovitis, bursitis myalgia and post-exercise injury pain;
- Acute mild to moderate pain such as: pain after surgery, trauma, strain, etc.;
- primary dysmenorrhea, toothache, Head Pain, etc.
Last Update：2022-01-01 08:51:06
sodiumdiclofenac - Differential diagnosis
Open Data Unverified Data
- take this product and add water to make a solution containing 20 μg per 1ml. Measure the absorbance at the wavelength range of 240 ~ 340nm by spectrophotometry, there is an absorption maximum at a wavelength of 276nm.
- The infrared absorption spectrum of this product should be consistent with that of the control.
- take about 50mg of this product, add 0.2g of sodium carbonate, mix well, burn to charring, let it cool, add 5ml of water, boil, filter, filtrate shows chloride identification reaction.
Last Update：2022-01-01 08:51:08
sodiumdiclofenac - Exam
Open Data Unverified Data
pH
take 0.5g of this product, add 50ml of water to dissolve, according to the pH measurement method, the pH value should be 6.5~7.5.
clarity and color of ethanol solution
take 0.5g of this product and add 10ml of ethanol to dissolve it. If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution, not deeper.
chloride
take 0.5g of this product, add 48ml of water to dissolve, add 2ml of dilute nitric acid Dropwise, stir well, filter, take 25ml of filtrate, check according to chloride test method, if there is turbidity, not more concentrated (0.02%) than the control solution made of 5ml of standard sodium chloride solution.
Related substances
take this product, add methanol to dissolve and dilute the solution containing 1mg per 1ml as the test solution; Take the appropriate amount of precision, A solution containing 2 μg per 1ml was diluted with methanol as a control solution. In addition, an appropriate amount of ethylparaben, hydroxyphenylpropyl Ester and diclofenac sodium reference substance was dissolved in methanol and diluted to prepare a mixed solution containing 2.8 μg, 4.0 μg and 2.0 μg per 1ml as a system suitability test solution. According to the high performance liquid chromatography test, silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-0.12% glacial acetic acid solution (60:40) was used as the mobile phase; The detection wavelength was 240nm. The system suitability test solution is injected into the liquid chromatograph to adjust the detection sensitivity so that the peak height of diclofenac sodium is about 20% of the full scale and the retention time of diclofenac sodium peak is about 20 minutes, the resolution of the peak of ethylparaben should be greater than 5.0. Then 20 μl of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 2 times of the retention time of the main peak. 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 (0.2%), and the sum of the areas of each impurity peak shall not be greater than 2.5 times the area of the main peak of the control solution (0. 5%).
loss on drying
take this product, dry to constant weight at 105°C, and lose no more than 1.0% of weight.
Heavy metals
take 2.0g of this product, add 45ml of water, dissolve with slight heat, slowly add 5ml of dilute hydrochloric acid, stir with addition, filter, take 25ml of filtrate, check according to heavy metal inspection method, heavy metals should not be more than 10 parts per million.
Last Update：2022-01-01 08:51:09
sodiumdiclofenac - Preparation
Open Data Unverified Data
- Diclofenac SodiumEnteric-coated Tablets
- Diclofenac Sodium Suppositories
- diclofenac sodium liniment
Last Update：2022-01-01 08:51:09
sodiumdiclofenac - Diclofenac SodiumEnteric-coated Tablets
Authoritative Data Verified Data
This product contains diclofenac sodium (C14H10Cl2NNa02) should be 90.0% to 110.0% of the label amount.
trait
This product is enteric-coated tablets, white or white after removing the coating.
identification
- 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.
- take the fine powder of this product, add water to dissolve and dilute to make a solution containing 20ul of diclofenac sodium per 1 ml, filter, and take the filtrate for determination by UV-Vis spectrophotometry (General 0401), there is an absorption maximum at a wavelength of 276nm.
examination
- Related Substances: take an appropriate amount of the fine powder of this product (about 50mg of diclofenac sodium), weigh it accurately, put it in a 50ml measuring flask, add an appropriate amount of methanol, and ultrasonic to dissolve diclofenac sodium, and let it cool, dilute to the scale with methanol, shake well, centrifuge, take the supernatant as the test solution; Take diethyl phthalate 5mg, put it in a 200ml measuring flask, and add 1ml of the test solution precisely, methanol was added to dissolve and dilute to the scale, and the solution was shaken as a control solution. Diclofenac sodium, yes. Regarding the chromatographic conditions under the substance item, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 2 times of the retention time of the main peak. If there are impurity peaks in the chromatogram of the test solution, the impurity peak (impurity E) at the relative retention time of 1.2~1.3, except the diethyl phthalate peak and its previous chromatographic peak, when its peak area is multiplied by 0.5, it shall not be greater than the peak area of diclofenac in the control solution (0.5% ), and the peak area of other individual impurities shall not be greater than the peak area of diclofenac in the control solution (0.5% ), the sum of the peak areas of each impurity (the impurity DI is based on the corrected peak area) shall not be greater than 2 times (1.0%) The Peak area of diclofenac in the control solution.
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 2) determination, with 0.1 mol/L hydrochloric acid solution 1000ml as the dissolution medium, the speed is 100 rpm, according to the law, after 2 hours, take the appropriate amount of solution, filtering, take the continued filtrate as the test solution (1 ); Immediately soak the basket in 1000ml of phosphate buffer solution (pH 37.0) preheated to 6.8°C, and continue to operate according to law at the same rotational speed, after 45 minutes, take the appropriate amount of solution, filter, take the filtrate 5ml, put 10ml(25mg specification) or 20ml(50mg specification) flask, with phosphate buffer (pH 6.8) dilute to the scale, shake, as a test solution (2); Take diclofenac sodium reference product 25mg, precision weighing, 100ml flask, add water to dissolve and dilute to the scale, shake, as a reference stock solution; Precision take the control stock solution 2ml, 100ml flask, with 0. Dilute the lmol/L hydrochloric acid solution to the scale, shake well, and use it as the reference solution for the Test Solution (1 ); Take another 5ml of the reference stock solution, and place 100 The ml measuring flask was diluted to the mark with phosphate buffer solution (pH 6.8), and then shaken to form a reference solution for the Test Solution (2). Take the test solution and the reference solution, according to the ultraviolet-visible spectrophotometry (General rule 0401), measure the absorbance at the wavelength of 276nm, calculate the dissolution of each piece, should comply with the regulations.
- 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; Methanol -4% glacial acetic acid solution (70:30) as mobile phase; The detection wavelength was 276nm. Take an appropriate amount of diclofenac sodium reference substance and make a solution containing about 1 mg per 1 ml of water. Take an appropriate amount of the solution and expose it to UV lamp (254nm) for 15 minutes, an impurity peak appears at a retention time of about 0.8 relative to the main peak, and the separation degree of the two should be greater than 40.
- determination 5 tablets of this product were placed in a 70% measuring flask, added with an appropriate amount of 70% methanol, sonicated to dissolve diclofenac sodium, allowed to cool, diluted to the scale with methanol, shaken and centrifuged, the appropriate amount of supernatant is accurately measured and diluted quantitatively with 70% methanol to make a solution containing about 0.25mg per lml, which is used as the test solution. The sample is accurately measured and 10ul is injected into the human liquid chromatograph, and the chromatogram is recorded; another diclofenac sodium reference substance, precision weighing, plus 70% methanol dissolved and quantitatively diluted into each 1 mL solution containing about 0.25mg, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as diclofenac sodium.
specification
(l)25mg (2)50mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:33:25
sodiumdiclofenac - Diclofenac sodium enteric-coated capsules
Authoritative Data Verified Data
This product contains diclofenac sodium (C11H10Cl2NNa02) should be the label amount of 90.0% ~ 110.0%.
trait
The content of this product is white or white spherical pellets.
identification
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 control solution.
examination
- for related substances, take an appropriate amount of fine powder under the content determination item (about equivalent to 0.lg of sodium diclofenac), weigh it accurately, put it in a 100ml measuring flask, and add an appropriate amount of methanol, diclofenac sodium was dissolved by ultrasound, allowed to cool, diluted to scale with methanol, shaken well, centrifuged, and the supernatant was taken as the test solution. Another 5mg of diethyl phthalate was taken and placed in a 200ml measuring flask, 1 ml of the test solution was added precisely, dissolved in methanol and diluted to the scale, and then shaken to serve as a control solution. According to the chromatographic conditions under the items of related substances of sodium dioxofenate, 20 u1 of the test solution and the control solution were accurately measured, and human liquid chromatograph was injected respectively, the chromatogram was recorded to 2 times the retention time of the main peak. If there are impurity peaks in the chromatogram of the test solution, except for the diethyl phthalate peak and its previous chromatographic peak, the impurity peak (impurity DI) at the relative retention time of 1.2~1.3, when its peak area is multiplied by 0.5, it shall not be greater than the peak area of diclofenac in the control solution (0.5% ) , and the peak area of other individual impurities shall not be greater than the peak area of diclofenac in the control solution (0.5% ) , the sum of each impurity peak area (calculated as the corrected Peak area of impurity melon) is not larger than 2 times (1.0%) of the peak area of bifenamic acid in the control solution.
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 1) determination, with 0.lmol/L hydrochloric acid solution 750tnl is the dissolution medium, the rotation speed is 100 rpm, the operation is carried out according to law, after 2 hours, take 10ml of the solution, filter, take the filtrate as Test Solution (1); Immediately add 0.5 mol/L sodium phosphate solution preheated to 37°C ± 0.2°C, mix well (if necessary, adjust the pH value to 6.8 with 2 mmol/L sodium hydroxide solution or 2mol/L hydrochloric acid solution). When the rotation speed is unchanged and the dissolution is continued for 45 minutes, take the appropriate amount of the solution and filter it, the filtrate was taken as the test solution (2). Separately, the reference substance diafenate sodium (lOmg) was accurately weighed, placed in a 50ml measuring flask, dissolved with water and diluted to the scale, and then shaken well to serve as a reference stock solution, and 5ml of the reference stock solution was accurately weighed, in a 200ml measuring flask, use 0.1 mol/L hydrochloric acid solution is diluted to the scale, shake, as a reference solution (1); Another precision take the reference stock solution 5ml, put in a 20ml measuring flask, use the dissolution medium (0.1 mol/L hydrochloric acid solution and 0.2mol/L sodium phosphate solution, mixed evenly according to 3:1, if necessary, adjust the pH value to 6.8 with 2mol/L sodium hydroxide solution or 2mol/L hydrochloric acid solution) to dilute to the scale, and shake to obtain the control solution (2). According to the chromatographic conditions under the content determination item, the sample solution (1)(2) and the reference solution (1), (2) each 500 were injected into the liquid chromatograph respectively, according to the external standard method to calculate the peak area, the dissolution of each particle in the acid should be less than 10% of the labeled amount, the amount of dissolution of each particle in the buffer solution, the limit is 80%, should meet the requirements.
- 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 applicability test using eighteen alkyl silane bonded silica gel as filler, methanol -4% glacial acetic acid solution (70:30) as mobile phase; The detection wavelength was 276nm. Take an appropriate amount of diclofenac sodium reference substance and make a solution containing about 1 mg per 1 ml of water. Take an appropriate amount of the solution and expose it to UV lamp (254nm) for 15 minutes, an impurity peak appears at a retention time of about 0.8 relative to the main peak, and the separation degree of the two should be greater than 4.0.
- determine the content under the item of loading difference, grind it finely, weigh the appropriate amount of fine powder accurately (about 25mg of diclofenac sodium), put it in a 100ml measuring flask, and add the appropriate amount of 70% methanol, diclofenac sodium was dissolved by ultrasound, allowed to cool, diluted to the scale with 70% methanol, mixed well, centrifuged, and the solution was taken as the test solution. L01 was accurately measured and injected into human liquid chromatograph, and the chromatogram was recorded. Another appropriate amount of diclofenac sodium reference substance was accurately weighed, dissolved with 70% methanol and quantitatively diluted to make a solution containing about 0.25mg per lml, same method determination. According to the external standard method to calculate the peak area, that is.
category
Same as diclofenac sodium.
specification
50mg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 11:33:26
sodiumdiclofenac - Diclofenac Sodium Suppositories
Authoritative Data Verified Data
This product contains diclofenac sodium (C14H10Cl2NNa02) should be 90.0% to 110.0% of the label amount.
trait
This product is white to light yellow suppository.
identification
- take an appropriate amount of this product (about 50mg of diclofenac sodium), add 2ml of ethanol, water bath heating to dissolve, let it cool, after the matrix solidifies, filter, evaporate the filtrate, take an appropriate amount of residue, add water to make a paste, dip a small amount of copper, burn in a colorless flame, the flame edge should be green.
- take the solution under the content determination item, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 282nm, there is minimal absorption at a wavelength of 250Nm.
- an appropriate amount of the residue under identification (1) was taken, and the identification reaction of the sodium salt was observed after ignition (General rule 0301).
examination
should comply with the relevant provisions under suppository (General rule 0107).
Content determination
Take 10 capsules of this product, precision weighing, water bath warm melting, under constant stirring and cooling, precision weighing appropriate amount (about 50mg equivalent to sodium diclofenac), add appropriate amount of water into a 100ml measuring flask, shake in a water bath at 50-60°C to dissolve the solution, then let it cool, add water to the scale, shake well, filter, and take 5ml of the continuous filtrate in a precise amount, add 20ml of water to the separating funnel, shake well, add 20ml of petroleum ether (60-90°C), shake, stand still, separate the water layer, filter, and take 5ml of filtrate accurately, in a 50ml measuring flask, dilute to the mark with 50% ethanol, and measure the absorbance at the wavelength of 282nm by UV-Vis spectrophotometry (General rule 0401), this was calculated as an absorption coefficient of C14H10Cl2NNa02 of 415.
category
Same as diclofenac sodium.
specification
(1)12.5mg (2)50mg
storage
protected from light, sealed, and stored at 30°C or less.
Last Update：2022-01-01 11:33:27
sodiumdiclofenac - Diclofenac sodium liniment
Authoritative Data Verified Data
This product contains diclofenac sodium (C14H10Cl2NNa02) should be 90.0%-110.0% of label.
trait
This product is colorless to light yellow clear liquid.
identification
- take the solution under the content determination item, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 284nm, there is minimal absorption at a wavelength of 251nm.
- take an appropriate amount of this product (about 50mg of diclofenac sodium), dry it on a water bath, add 0.2g of sodium carbonate, mix well, heat to complete carbonization, cool, add 5ml of water, boil, filtration, filtrate chloride identification (1) of the reaction (General 0301).
examination
- the color of this product, compared with the yellow No. 4 standard colorimetric liquid (General Principles 0901 first method), should not be deeper.
- the amount of ethanol should be 45.0% to 55.0% (General 0711).
- others should comply with the relevant provisions under liniment (General rule 0119).
Content determination
take an appropriate amount of this product (about 30mg of diclofenac sodium), put it in a 50ml volumetric flask, dilute it to the scale with ethanol, shake it, take 2ml for precision measurement, put it in a 100ml volumetric flask, dilute with ethanol to the scale, shake, according to UV-visible spectrophotometry (General rule 0401), measure absorbance at the wavelength of 284nm; Take appropriate amount of diclofenac sodium reference, ethanol was added to dissolve and diluted to prepare a solution containing about 12UG of diclofenac sodium per 1 ml, which was determined by the same method. It is obtained by calculation.
category
Same as diclofenac sodium.
specification
0.1%
storage
It should be kept in a sealed and cool place.
Last Update：2022-01-01 11:33:28
sodiumdiclofenac - Diclofenac sodium eye drops
Authoritative Data Verified Data
This product contains diclofenac sodium (C14H10Cl2NNa02) should be 90.0% to 110.0% of the label amount.
trait
This product is colorless or yellowish clear liquid.
identification
- 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.
- This product is diluted with water to make a solution containing 20ug per 1 ml, which is determined by UV-visible spectrophotometry (General 0401). There is a maximum absorption at the wavelength of 276mn.
examination
- the pH value should be 7.0 to 9.0 (General 0631).
- the color of the solution of this product, according to UV-visible spectrophotometry (General 0401), measured at the wavelength of 420nm, absorbance should not exceed 0.06.
- Related substances this product was taken as a test solution; An appropriate amount was taken in a precise amount and diluted with methanol to prepare a solution containing about 5ug per 1 ml as a control solution. According to the chromatographic conditions under the items of related substances of digasenate sodium, 20ul of each of the control solution and the sample solution was accurately measured and injected into the liquid chromatograph respectively, record the chromatogram to 2 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the impurity peak at the relative retention time of 1.2~1.3 (diclofenac sodium impurity III ), the peak area multiplied by 0.5 shall not be greater than the main peak area of the control solution (0.5% ) , and the peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.5% ) , the sum of each impurity peak area (calculated as the corrected peak area for impurity III) shall not be greater than 2 times (1.0%) the area of the main peak of the control solution.
- benzalkonium chloride (when the prescription contains benzalkonium chloride, check this item) take 5 bottles of this product, mix them evenly, take 5ml for precise measurement, put it in 10ml measuring flask, and dilute it to the scale with mobile phase, shake, as a test solution; Another appropriate amount of benzalkonium chloride control, and mobile phase dissolution and quantitative dilution of prepared solution containing about 50ug per 1 ml, as a reference solution. According to the determination of high performance liquid chromatography (General 0512), with eighteen alkyl silane bonded silica gel as filler; Acetonitrile -5mmol/L ammonium acetate solution (containing 1% triethylamine, using glacial acetic acid to adjust the pH value to 5.0±0.5(65:35) as mobile phase; The detection wavelength was 214nm. The degree of separation between the C12 peak and the C14 peak of benzalkonium chloride shall meet the requirements. 20 u1 of each of the reference solution and the test solution were accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram was recorded. According to the external standard method to the peak area calculation, this product per lml containing benzalkonium chloride shall not exceed 0.12mg. Osmolality of this product, according to the law to check (General 0632), osmolality ratio should be 0.9~1.1.
- sterile take this product, dilute with pH 7.0 sterile sodium chloride-peptone buffer 200ml, after membrane filtration treatment, rinse with pH 7.0 sterile sodium chloride-peptone buffer (not less than 200ml per membrane), staphylococcus aureus as a positive control bacteria, according to law inspection (General 1101), should comply with the provisions.
- others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
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; Methanol -4% glacial acetic acid solution (70:30) as mobile phase; The detection wavelength was 276mn. Take an appropriate amount of diclofenac sodium, add water to dissolve and dilute to make a solution containing about 1 mg per 1 ml. Take an appropriate amount of the solution and expose it to UV lamp (254nm) for 15 minutes, A 20ul injection liquid chromatograph is taken and the chromatogram is recorded. An impurity peak appears at about 0.8 relative retention time to the main peak, and the separation degree of the two should be greater than 4.0.
- determination Method: Take 5 bottles of this product, mix well, take 5ml accurately, put it in a 25ml measuring flask, dilute it to the scale with 70% methanol, shake well, filter, the filtrate was continued as a test solution. Take 10ul accurately, inject human liquid chromatograph, record chromatogram; Take appropriate amount of diclofenac sodium reference substance, accurately weigh, add 70% methanol to dissolve and quantitatively dilute to make a solution containing about 0.2mg per lml, same method determination. According to the external standard method to calculate the peak area, that is.
category
Same as diclofenac sodium.
specification
5ml :5mg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 11:33:29
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Raw Materials for sodiumdiclofenac