MefenaMic Aicd (API)

MefenaMic Aicd (API) - Names and Identifiers

Name	mefenamic acid
Synonyms	ac.mefenamico mefenamic acid MefenaMic Aicd (API) Mefenamic Acid (200 mg) n-(2,3-xylyl)anthranilic acid Mefenamic acid Solution, 100ppm 2-(2,3-Dimethylanilino)benzoic acid N-(2,3-DIMETHYLPHENYL)ANTHRANILIC ACID 2-((2,3-dimethylphenyl)amino)-benzoicaci N-[(2,3-DIMETHYLPHENYL)AMINO]BENZOIC ACID 2-[(2,3-dimethylphenyl)amino]benzoic acid 2-((2,3-dimethyl(phenyl)amino)-benzoicaci 2',3'-dimethyl-2-diphenylaminecarboxylicaci 2',3'-dimethyl-2-diphenylaminecarboxylicaci o-(N,N-2,3-Dimethylphenyl) Amino Benzoic Acid 2-Diphenylaminecarboxylic acid, 2',3'-dimethyl- N-(2,3-Dimethylphenyl)anthranilic Acid2-(2,3-Dimethylphenylamino)benzoic Acid2-(2,3-Xylidino)benzoic Acid
CAS	61-68-7
EINECS	200-513-1
InChI	InChI=1/C15H15NO2/c1-10-6-5-9-13(11(10)2)16-14-8-4-3-7-12(14)15(17)18/h3-9,16H,1-2H3,(H,17,18)
InChIKey	HYYBABOKPJLUIN-UHFFFAOYSA-N

MefenaMic Aicd (API) - Physico-chemical Properties

Molecular Formula	C15H15NO2
Molar Mass	241.29
Density	1.0944 (rough estimate)
Melting Point	230 °C
Boling Point	384.06°C (rough estimate)
Flash Point	195°C
Water Solubility	It is soluble in acetone, chloroform, dichloromethane, methanol. Insoluble in water.
Solubility	Insoluble in water, slightly soluble in ethanol and chloroform, slightly soluble in ether.
Vapor Presure	4.45E-07mmHg at 25°C
Appearance	Crystalline powder
Color	White to Pale Yellow
Merck	14,5798
pKa	4.2(at 25℃)
Storage Condition	2-8°C
Refractive Index	1.5200 (estimate)
MDL	MFCD00051721
Use	For steroidal anti-inflammatory analgesics, for Arthralgia, Head Pain, foot pain, dental and other inflammatory pain

MefenaMic Aicd (API) - Risk and Safety

Hazard Symbols	Xn - Harmful
Risk Codes	R22 - Harmful if swallowed R40 - Limited evidence of a carcinogenic effect R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed.
Safety Description	S22 - Do not breathe dust. S36 - Wear suitable protective clothing.
WGK Germany	3
RTECS	CB4550000
HS Code	28142000
Toxicity	LD50 orally in mice, rats: 630, 790 mg/kg (Jahn, Adrian)

MefenaMic Aicd (API) - Upstream Downstream Industry

Raw Materials

2,3-Dimethylaniline

MefenaMic Aicd (API) - Standard

Authoritative Data Verified Data

This product is N-2, 3-dimethylanthranilic acid. Calculated as dried product, the content of C15H15N02 shall not be less than 99.0%.

Last Update：2024-01-02 23:10:35

MefenaMic Aicd (API) - Trait

Authoritative Data Verified Data

This product is white or off-white fine crystalline powder; Odorless.
This product is slightly soluble in ether, slightly soluble in ethanol or chloroform, and insoluble in water.

Last Update：2022-01-01 11:37:34

MefenaMic Aicd (API) - Differential diagnosis

Authoritative Data Verified Data

take about 25mg of this product, add chloroform 15ml to dissolve, put the UV light (254nm) under the inspection, show green fluorescence.
take about 5mg of this product, add 2ml sulfuric acid to dissolve, add 0.5% potassium dichromate solution 0.05, that is dark blue, then turn brown green.
take this product, add 1 mol /L hydrochloric acid solution-methanol (1:99) mixture solution and dilute to prepare 20% solution per 1 ml, according to the ultraviolet-visible spectrophotometry (General rule 0401), there is the maximum absorption at the wavelength of 279nm and 350mn, and the absorbance is 0.69~0.74 and 0.56~0.60 respectively.
The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 730).

Last Update：2022-01-01 11:37:34

MefenaMic Aicd (API) - Exam

Authoritative Data Verified Data

copper

take L. 0g of this product, put it in a quartz crucible, add sulfuric acid to wet it, burn it once the ash is complete, and use 0.1 mol/L nitric acid solution was dissolved and quantitatively transferred to a 25ml measuring flask, diluted to the scale, and shaken to serve as a test solution; precision measure standard copper solution (precision weigh 0.393g of copper sulfate, put it in 1000ml measuring flask, add 0.1 mol/L nitric acid solution dissolved and diluted to the scale, shake, precision take 10ml, 100ml flask, with 0. Dilute 1 mol/L nitric acid solution to the scale, Shake 1.0ml, put 25ml measuring flask, use 0.1 mol/L nitric acid solution was diluted to the scale, and shaken as a reference solution. The above two kinds of solutions were taken and each measured at a wavelength of 0406. 8nm by atomic absorption spectrophotometry (general). The absorbance of the test solution shall not be greater than that of the reference solution (0.001%).

Related substances

take an appropriate amount of this product, add the mobile phase to dissolve and dilute to prepare a solution containing lmg per lml as a test solution; Take an appropriate amount for precision measurement, A solution containing 5ug per 1 ml was prepared by dilution with the mobile phase as a control solution. According to high performance liquid chromatography (General 0512) determination. Silica gel bonded with eighteen alkyl silane was used as the filler, and 0.05mol/L ammonium dihydrogen phosphate solution (adjusted to pH 5.0 with ammonia solution)-acetonitrile-tetrahydrofuran (40:46:14) was used as the mobile phase; the detection wavelength was 254mn. The number of theoretical plates is not less than 5000 based on the peak of mefenamic acid. The control solution and the test solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 2.5 times of the retention time of the main component 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 0.2 times (0.1%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (0.5%).

2, 3-dimethylaniline

take an appropriate amount of this product, precision weighing, add dichloromethane-methanol (3:1) solution to dissolve and quantitatively dilute to make a solution containing about 25mg per 1 ml as a test solution; in addition, an appropriate amount of 2, 3-dimethylaniline was accurately weighed, dissolved and quantitatively diluted with dichloromethane-methanol (3:1) to prepare a solution containing about 2.5ug per 1 ml as a reference solution. According to the test of gas chromatography (General rule 0521), the capillary column with polyethylene glycol (PEG-20M) as stationary liquid is used as the chromatographic column, the reference solution is at a constant temperature of 150°C, and the test solution is heated by program, the initial temperature is 150°C, and after the peak of 2, 3-dimethylaniline is maintained, the temperature is raised to 220°C at a rate of 70°C per minute for 20 minutes; The temperature of the sample inlet is 250°C; the detector temperature was 260°C. 1 u1 of each of the reference solution and the test solution was accurately measured and injected into the human gas chromatograph respectively, and the chromatogram was recorded. If there are chromatographic peaks consistent with the retention time of 2, 3-dimethylaniline in the test solution, the peak area shall not be greater than the peak area of 2, 3-dimethylaniline in the control solution (0.01%).

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 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).

Last Update：2022-01-01 11:37:35

MefenaMic Aicd (API) - Content determination

Authoritative Data Verified Data

take about 0.5g of this product, weigh it precisely, add 100ml of anhydrous neutral ethanol (neutral to phenolsulfonphthalein indicator solution) at a slight temperature, shake to dissolve, add 3 drops of phenolsulfonphthalein indicator solution, with sodium hydroxide titration solution (0.lmol/L) titration. Each ltnl sodium hydroxide titration solution (0.1 mol/L) corresponds to 24.13mg of Cl5H15N02.

Last Update：2022-01-01 11:37:36

MefenaMic Aicd (API) - Category

Authoritative Data Verified Data

antipyretic analgesic, non-steroidal anti-inflammatory drugs.

Last Update：2022-01-01 11:37:36

MefenaMic Aicd (API) - Storage

Authoritative Data Verified Data

sealed and stored in a dry place.

Last Update：2022-01-01 11:37:36

MefenaMic Aicd (API) - Mefenamic acid tablets

Authoritative Data Verified Data

This product contains mefenamic acid (C15H15N02) should be labeled the amount of 93.0% ~ 107.0%.

trait

This product is white or off-white.

identification

take an appropriate amount of fine powder of this product (about 25mg of mefenamic acid), add 15ml of chloroform, shake to dissolve mefenamic acid, and the solution is tested according to item (1) of identification under mefenamic acid, the same results are 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. (3) take an appropriate amount of fine powder of this product (about 20mg equivalent to mefenamic acid), add 100ml of lmol/L hydrochloric acid solution-methanol (1:99) mixture, sonicate to dissolve mefenamic acid, filter, the appropriate amount of continued filtrate was taken and diluted with the above mixed solution to prepare a solution containing 20ug mefenamic acid per 1 ml, which was determined by UV-Vis spectrophotometry (General rule 0401); there is a maximum absorption at a wavelength of 279nm and 350Nm.

examination

dissolution: according to the dissolution and release determination method (General rule 0931 second method), 40ml of ethanol was used, and phosphate buffer (pH 8.0) was added to ML as the dissolution medium, after 45 minutes, take the solution and filter it. Take 3ml of the continuous filtrate and put it in a 100ml measuring flask and dilute it to the scale with phosphate buffer solution (pH 8.0), another 20mg mefenamic acid reference product was weighed accurately, put in a 100ml measuring flask, added with 5ml ethanol to dissolve, and diluted to the scale with phosphate buffer solution (pH 8.0), shake well, take an appropriate amount of precision, and dilute with phosphate buffer (pH 8.0) to make a solution containing about 10ug per 1 ml. The absorbance of each of the above two Solutions was measured at a wavelength of 0401 Mn by ultraviolet-visible spectrophotometry (general), and the elution amount of each tablet was calculated. The limit is 60% 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 using eighteen alkyl silane bonded silica gel as filler; 0.05mol/L ammonium dihydrogen phosphate solution (with ammonia test solution to adjust the pH value to 5.0)-Acetonitrile-tetrahydrofuran (40:46:14) as mobile phase; The detection wavelength was 254nm. The theoretical plate number should not be 5000 lower than the mefenamic acid peak, and the tailing factor should not be more than 2.0.
determination Method: Take 20 tablets of this product, precise weighing, fine grinding, precise weighing appropriate amount (about 0.lg of mefenamic acid), put it in a 100ml measuring flask, add mobile phase to dissolve and dilute to the scale, shake well, filter, Take 5ml of continuous filtrate accurately, put it in a 25ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as a test solution, take 10u1 injection liquid chromatograph, record chromatogram; Another mefenamic acid reference substance, same method for determination. According to the external standard method to calculate the peak area, that is.

specification

0.25g

storage

sealed and stored in a dry place.

Last Update：2022-01-01 11:37:37

MefenaMic Aicd (API) - Mefenamic Acid Capsules

Authoritative Data Verified Data

This product contains mefenamic acid (C15H15N02) should be labeled the amount of 90.0% ~ 110.0%.

identification

taking the appropriate amount of the contents of this product, the same results were shown according to the test of item (1) under the item of mefenamic acid.
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 an appropriate amount of fine powder of this product (about 20mg equivalent to mefenamic acid), add 100ml of 1 mol/L hydrochloric acid solution-methanol (1:99) mixture, sonicate to dissolve mefenamic acid, filter, take an appropriate amount of filtrate, dilute with the above mixture to make a solution containing 20% mefenamic acid per 1 ml, and measure by UV-Vis spectrophotometry (General 0401); there is a maximum absorption at a wavelength of 279nm and 350Nm.

examination

dissolution: according to the dissolution and release determination method (General rule 0931 second method), 40ml of ethanol was used, and phosphate buffer (pH 8.0) was added to ML as the dissolution medium, after 45 minutes, the solution is filtered, and the filtrate 3ml is accurately measured, placed in a 100ml measuring flask, diluted to the scale with dissolution medium, and shaken, as a test solution; Take 20mg of mefenamic acid reference substance with precision, put it in a 100ml measuring flask, add 5ml of ethanol to dissolve, dilute to the scale with dissolution medium, shake well, and take an appropriate amount with precision, A solution containing about 10% per 1 ml was prepared as a control solution by dilution with a dissolution medium. The absorbance of each of the above two Solutions was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general), and the elution amount of each particle was calculated. 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; 0.05mol/L ammonium dihydrogen phosphate solution (with ammonia test solution to adjust the pH value to 5.0)-Acetonitrile-tetrahydrofuran (40:46:14) as mobile phase; The detection wavelength was 254nm. The number of theoretical plates shall not be less than 5000 based on the peak of mefenamic acid, and the tailing factor shall not be more than 2.0.
the contents under the item of difference in loading amount were measured, mixed evenly, ground finely, and accurately weighed to take an appropriate amount (about 0.lg of mefenamic acid), and placed in a 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, filter, Take 5ml of the filtrate accurately, put it in a 25ml measuring flask, dilute to the scale with the mobile phase, shake well, and use it as a test solution, take 10u1 injection liquid chromatograph, record chromatogram; Another mefenamic acid reference substance, same method for determination. According to the external standard method to calculate the peak area, that is.

specification

0.25g

storage

sealed and stored in a dry place.

Last Update：2022-01-01 11:37:38

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MefenaMic Aicd (API) Request for Quotation

mefenamic acid

CAS: 61-68-7

Molecular Formula: C15H15NO2

MefenaMic Aicd (API) - Names and Identifiers

MefenaMic Aicd (API) - Physico-chemical Properties

MefenaMic Aicd (API) - Risk and Safety

MefenaMic Aicd (API) - Upstream Downstream Industry

MefenaMic Aicd (API) - Standard

Authoritative Data Verified Data

MefenaMic Aicd (API) - Trait

Authoritative Data Verified Data

MefenaMic Aicd (API) - Differential diagnosis

Authoritative Data Verified Data

MefenaMic Aicd (API) - Exam

Authoritative Data Verified Data

copper

Related substances

2, 3-dimethylaniline

loss on drying

ignition residue

Heavy metals

MefenaMic Aicd (API) - Content determination

Authoritative Data Verified Data

MefenaMic Aicd (API) - Category

Authoritative Data Verified Data

MefenaMic Aicd (API) - Storage

Authoritative Data Verified Data

MefenaMic Aicd (API) - Mefenamic acid tablets

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

MefenaMic Aicd (API) - Mefenamic Acid Capsules

Authoritative Data Verified Data

identification

examination

Content determination

category

specification

storage

Supplier List

MefenaMic Aicd (API)