15307-81-0
Diclofenac Potassium
CAS: 15307-81-0
Molecular Formula: C14H10Cl2KNO2
15307-81-0 - Names and Identifiers
| Name | Diclofenac Potassium |
| Synonyms | ProSorb Diclofenac Potassium PotassiuM diclofenac Diclofenic potassiuM DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM SALT POTASSIUM [2-[(2,6-DICHLOROPHENYL)AMINO]PHENYL]ACETATE potassium 2-(2-(2,6-dichlorophenylamino)phenyl)acetate potassium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate 2[(2,6-dichlorophenyl)amino]benzeneacetic acid potassium salt 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid potassium salt |
| CAS | 15307-81-0 |
| EINECS | 630-422-6 |
| InChI | InChI=1/C14H11Cl2NO2.K/c15-10-5-3-6-11(16)14(10)17-12-7-2-1-4-9(12)8-13(18)19;/h1-7,17H,8H2,(H,18,19);/q;+1/p-1 |
15307-81-0 - Physico-chemical Properties
| Molecular Formula | C14H10Cl2KNO2 |
| Molar Mass | 334.24 |
| Melting Point | 300-330 °C |
| Boling Point | 412°C at 760 mmHg |
| Flash Point | 203°C |
| Solubility | DMSO 69 mg/mL; Water 10 mg/mL; Ethanol <1 mg/mL |
| Vapor Presure | 1.59E-07mmHg at 25°C |
| Appearance | White to pale yellow crystalline powder |
| Storage Condition | under inert gas (nitrogen or Argon) at 2-8°C |
| MDL | MFCD00082254 |
| Physical and Chemical Properties | White to yellowish crystalline powder; Pungent and hygroscopic. It is soluble in methanol, soluble in ethanol, glacial acetic acid, slightly soluble in acetone, insoluble in chloroform. |
| Use | Used as an anti-inflammatory analgesic |
15307-81-0 - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. |
| Safety Description | 61 - Avoid release to the environment. Refer to special instructions / safety data sheets. |
| UN IDs | UN 2811 6.1 / PGIII |
| WGK Germany | 3 |
| HS Code | 2922492050 |
15307-81-0 - Reference
| Reference Show more | 1. [IF=1.312] Xu Wang et al."Microwave-assisted ionic liquid microextraction combined with high performance liquid chromatography for the determination of naphthoquinones from Arnebia euchroma (Royle) Johnst."Journal Of Liquid Chromatography & Related Technologies. 20 |
15307-81-0 - Standard
Authoritative Data Verified Data
This product is potassium 2-[(2, 6-dichlorophenyl) amino] phenylacetate. Calculated as the dried product, the content of C14H10CL2KNO2 shall not be less than 99.0%.
Last Update：2024-01-02 23:10:35
15307-81-0 - Trait
Authoritative Data Verified Data
- This product is a white to yellowish crystalline powder; Has a sense of pungency and hygroscopicity.
- This product is soluble in methanol, soluble in ethanol, glacial acetic acid, slightly soluble in acetone, insoluble in chloroform.
Last Update：2022-01-01 11:33:30
15307-81-0 - Differential diagnosis
Authoritative Data Verified Data
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 698).
- take about 50mg of this product, add 0.2g of sodium carbonate, mix well, heat to carbonization, let it cool, add 5ml of water, stir, filter, filtrate chloride identification (1) response (General rule 0301).
- This product is the identification of potassium salt reaction (General 0301).
Last Update：2022-01-01 11:33:31
15307-81-0 - Exam
Authoritative Data Verified Data
pH
take 0.2g of this product, add 20ml of water to dissolve, check according to law (General rule 0631),pH value should be 6.5~8.0.
clarity and color of methanol solution
Take lg of this product and add 20ml of methanol to dissolve, the solution should be clear and colorless; If it is turbid, it should not be more concentrated than No. 1 turbidity standard solution (General rule 0902 first method). Take this solution, according to UV-visible spectrophotometry (General 0401), at the wavelength of 440nm absorbance, not more than 0.05.
chloride
take 0.5g of this product, add 48ml of water, dissolve at a slight temperature, let it cool, slowly add 2ml of dilute nitric acid, stir while adding, filter, take 25ml of filtrate, check according to law (General rule 0801), compared with the standard sodium chloride solution made of 0.02% of the control solution, not deeper ().
Related substances
take an appropriate amount of this product, accurately weigh it, add methanol to dissolve and dilute it to make a solution containing lmg per lml as a test solution; Take an appropriate amount of the test solution for precision measurement, A solution containing 2ug per 1 ml was prepared as a control solution by quantitative dilution with methanol. According to the high performance liquid chromatography (General 0512) test, silica gel bonded with eighteen alkyl silane was used as the filler; Methanol -4% glacial acetic acid solution (65:35) was used as the mobile phase; The detection wavelength was M. Take an appropriate amount of potassium bifenate reference substance and make a solution containing about 1 mg per 1 ml of water. Expose the solution to UV lamp (254nm) for 15 minutes and inject 20u1 into human liquid chromatograph, record the chromatogram, 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 6.0. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was 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 each impurity peak area shall not be greater than 2.5 times (0.5%) of the area of the main peak of the control solution..
loss on drying
take this product, dry to constant weight at 105°C, and lose no more than 0.5% of weight (General rule 0831).
Heavy metals
take 2.0g of this product, add 45ml of water, dissolve at a slight temperature, let it cool, slowly add 5ml of dilute hydrochloric acid, stir while adding, filter, take 25ml of filtrate, inspection according to law (General Principles 0821, Law 1), containing heavy metals shall not exceed 10 parts per million.
Last Update：2022-01-01 11:33:32
15307-81-0 - Content determination
Authoritative Data Verified Data
take this product 0.25g, precision weighing, add glacial acetic acid 40ml dissolution, according to the potential titration method (General 0701 ), with high gas acid titration solution (0.lmol/L) titration, and the titration results were corrected by blank test. Each 1 ml of perchloric acid titration solution (0.1 mol /L) corresponds to 33.42mg of C14H10C12KNO2.
Last Update：2022-01-01 11:33:32
15307-81-0 - Category
Authoritative Data Verified Data
antipyretic analgesic, non-steroidal anti-inflammatory drugs.
Last Update：2022-01-01 11:33:32
15307-81-0 - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 11:33:32
15307-81-0 - Diclofenac potassium
Authoritative Data Verified Data
This product contains diclofenac potassium (C14H10CL2KNO2) should be 90.0% to 110.0% of the label amount.
trait
This product is white tablet or sugar-coated tablet or film-coated tablet, 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 control solution.
examination
- for related substances, take an appropriate amount of fine powder under the content determination item (about 25mg equivalent to potassium difenate), place it in a 25ml measuring flask, add an appropriate amount of methanol, and dissolve it by ultrasound, cool, dilute to the scale with methanol, shake well, centrifuge; Take the supernatant as the test solution; Take the appropriate amount of precision, A solution containing about 5% per 1 ml was prepared as a control solution by quantitative dilution with methanol. Determination according to the method of diclofenac potassium related substances. If there are impurity peaks in the chromatogram of the test solution, the impurity peak (impurity DI) at the relative retention time of 1.2~1.3, 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.
- Content uniformity (12.5mg specification) take 1 tablet of this product, put it in a 50ml measuring flask, add an appropriate amount of 70% methanol solution, sonicate to dissolve, cool, dilute to the scale with 70% methanol, as a test solution. Determination according to the method under the content determination item, should comply with the provisions (General 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 30 minutes, take 10ml of the solution, filter, and take the continued filtrate as the test solution (12.5mg specification); Or take 5ml of the continued filtrate with precision, and put 10ml(25mg specification) or 20ml(50mg specification) measuring flask, diluted with water to the scale, shake, as a test solution; Another appropriate amount of diclofenac potassium reference, precision weighing, water was added to dissolve and quantitatively diluted to prepare a solution containing 14ug of diclofenac potassium per 1 ml as a control solution. The elution amount of each tablet was calculated by measuring the absorbance at a wavelength of 276nm according to UV-visible spectrophotometry (General rule 0401). 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).
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 potassium 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.
- determination Method: Take 20 tablets of this product, remove the coating (film-coated tablets can not remove the coating), Precision weighing, fine grinding, precision weighing appropriate amount
category
Same as diclofenac potassium.
specification
(1)12. 5mg (2)25mg (3)50mg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 11:33:33
15307-81-0 - Diclofenac Potassium Capsules
Authoritative Data Verified Data
This product contains diclofenac potassium (C14H10Cl2KN02) should be 90.0% to 110.0% of the label amount.
trait
The content of this product is white to white particles or powder.
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
- appropriate amount of the content under the content determination item (about 25mg of diclofenac potassium) shall be accurately weighed, placed in a 25ml measuring flask, and the appropriate amount of methanol shall be added, and dissolved by ultrasound and allowed to cool, dilute to the scale with methanol, shake, centrifuge, take the supernatant as the test solution; Take an appropriate amount of precision and dilute quantitatively with methanol to make a solution containing about 5ug per lml, as a control solution. Determination according to the method of diclofenac potassium related substances. If there are impurity peaks in the chromatogram of the test solution, the impurity peak (impurity III) at the relative retention time of 1.2~1.3, the peak volume 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.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), water 900ml as the dissolution medium, the speed of 75 rpm, according to the law, after 30 minutes, take 10ml of the solution, filter, take 5ml of the filtrate accurately, put it in a 10ml(25mg specification) or 20ml(50mg specification) measuring flask, dilute it to the scale with water, shake it well, as a test solution; In addition, an appropriate amount of diclofenac potassium reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 14ug of diclofenac potassium per 1 ml, as a reference solution. The amount of elution of each particle was calculated by measuring the absorbance at a wavelength of 276nm according to UV-Vis spectrophotometry (General rule 0401). 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 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 276mn. Take an appropriate amount of potassium bifenate 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 (254mn) for 15 minutes, record the chromatogram, 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.
- determine the contents under the item of loading difference, mix evenly, weigh an appropriate amount (about 25mg of diclofenac potassium) accurately, put it in a 70% volumetric flask, and add an appropriate amount of methanol, ultrasonic dissolution of digasenate potassium, cool, dilute to the scale with 70% methanol, shake, filter, take the continued filtrate as the test solution, and take 10 u1 with precision, note human liquid chromatograph, record chromatogram; Take appropriate amount of potassium difenate reference substance, precisely weigh it, add 70% methanol to dissolve and quantitatively dilute to make a solution containing about 0.25mg per lml, and determine with the same method. According to the external standard method to calculate the peak area, that is.
category
Same as diclofenac potassium.
specification
(l)25mg (2)50mg
storage
sealed, stored in a dry place.
Last Update：2022-01-01 11:33:34
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View History
15307-81-0
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