P-AMINOSALICYLIC ACID SODIUM SALT
4-Aminosalicylic Acid Sodium Salt
CAS: 8031-28-5
Molecular Formula: C7H6NNaO3
P-AMINOSALICYLIC ACID SODIUM SALT - Names and Identifiers
| Name | 4-Aminosalicylic Acid Sodium Salt |
| Synonyms | PAS-SODIUM PAS SODIUM SALT Sodium Aminosalicylate SODIUM AMINOSALICYLATE SODIUM P-AMINOSALICYLATE SODIUM 4-AMINOSALICYLATE P-AMINOSALICYLIC ACID SODIUM P-Amino Salicylic Acid Sodium P-AMINOSALICYLIC ACID SODIUM SALT SODIUM 4-AMINO-2-HYDROXY-BENZOATE 4-Aminosalicylic Acid Sodium Salt 4-AMINO-2-HYDROXYBENZOIC ACID SODIUM SALT |
| CAS | 8031-28-5 |
| EINECS | 1312995-182-4 |
| InChI | InChI=1S/C7H7NO3.Na/c8-4-1-2-5(7(10)11)6(9)3-4;/h1-3,9H,8H2,(H,10,11);/q;+1/p-1 |
P-AMINOSALICYLIC ACID SODIUM SALT - Physico-chemical Properties
| Molecular Formula | C7H6NNaO3 |
| Molar Mass | 175.12 |
| Melting Point | 150-151℃, with efferve℃e℃e |
| Boling Point | 380.8℃ at 760 mmHg |
| Appearance | Crystallization |
| Storage Condition | Room Temprature |
| MDL | MFCD00064392 |
P-AMINOSALICYLIC ACID SODIUM SALT - Standard
Authoritative Data Verified Data
This product is 4-amino-2-hydroxybenzoate sodium salt dihydrate. The content of C7H6NNa03 shall not be less than 98.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
P-AMINOSALICYLIC ACID SODIUM SALT - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline or crystalline powder.
- This product is soluble in water, slightly soluble in ethanol.
Last Update：2022-01-01 11:43:08
P-AMINOSALICYLIC ACID SODIUM SALT - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 10ml of water to dissolve, add 2 drops of dilute hydrochloric acid to make it acidic, add 1 drop of ferric chloride test solution, which should be purplish red; Place for 3 hours, no precipitation (differentiated from sodium 5-aminosalicylate) should occur.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 132).
- identification reaction of sodium salt of this product (General rule 0301).
Last Update：2022-01-01 11:43:09
P-AMINOSALICYLIC ACID SODIUM SALT - Exam
Authoritative Data Verified Data
pH
take 0.40g of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 6.5~8.50.
clarity and color of solution
take a sample l.Og (for oral use) or 2.0g (for injection), after adding 0902 of water to dissolve, the solution should be clear and colorless; In case of turbidity, compare with No. 1 turbidity standard solution (General rule method 1), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow 6th Standard Colorimetric solution (General Principles 0901 first method).
chloride
take 1.0g of this product, add 25ml of water to dissolve, add 2ml of nitric acid, filter if necessary, and check the filtrate according to law (General rule 0801), and compare with the control solution made of 5.0ml of standard sodium chloride solution, no more concentrated (0.005%).
sulfate
take 1.0g of this product, add 25ml of water to dissolve, add 2ml of dilute hydrochloric acid, filter, and check the filtrate according to law (General rule 0802), and compare with the control solution made of 5.0ml of standard potassium sulfate solution, no more concentrated (0.05%).
sulfide
take 0.50g of this product, add 5ml of water to dissolve, add 5ml of potassium iodide test solution and 2g of zinc particles, and add 5mh of 1.6% stannous chloride hydrochloric acid solution to check according to law (General rule 0803) should meet the requirements (0.001%).
Related substances
operation in the dark; New system in use. Take an appropriate amount of this product, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about lmg per lml, as a test solution; Take an appropriate amount of test solution for precision, dilute with mobile phase to prepare a solution containing lug per lml, as a control solution; Take an appropriate amount of M-aminophenol reference substance, precisely weigh, add mobile phase to dissolve and quantitatively dilute to prepare a solution containing 1ug per lml, as a control solution. The mobile phase consisted of acetonitrile-10% tetrabutylammonium hydroxide solution -0.05mol/L sodium dihydrogen phosphate (100:2:900). The detection wavelength was 220nm. Take the appropriate amount of M-aminophenol, 5-aminosalicylic acid (mesalazine) and sodium p-aminosalicylate respectively, and dissolve them with mobile phase to prepare 5ug of M-aminophenol and 5-aminosalicylic acid for each lml, the mixed solution of sodium para-aminosalicylate 10ug was used as the system applicable solution, and the system applicable solution 20 u1 was taken. The liquid chromatograph was injected and the chromatogram was recorded. The order of peaks was M-aminophenol, 5-aminosalicylic acid and sodium para-aminosalicylate, the degree of separation between adjacent chromatographic peaks shall meet the requirements. The sample solution, the control solution and the reference solution are respectively injected with 20 u1, and the chromatogram is recorded to 3.5 times of the retention time of the main component peak. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the main peak of the reference solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.1%, Other single impurity peak area shall not be greater than the main peak area of the control solution (0.1% ) , and the sum of each impurity peak area shall not be greater than 5 times (0.5%) of the main peak area of the control solution. Any peak less than 0.1 times (0.01%) the area of the main peak of the control solution in the chromatogram of the test solution is ignored.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 16.0% ~ 18.0%.
Iron Salt
take this product l. Add anhydrous sodium carbonate (2g) into a platinum crucible, mix with it, flash at about 740 ° C., let it cool, dissolve the residue with 15ml of dilute hydrochloric acid, and check it according to law (General rule 0807), no deeper (O.0015%).
Heavy metals
take this product L. 0g, to the platinum crucible, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.
arsenic salt
take about lg of anhydrous sodium carbonate, spread on the bottom and around the platinum crucible, and take another l. Log, put it on anhydrous sodium carbonate, add a small amount of water to wet it, after drying, burn with small fire to carbonize it, then burn it at 500~600°C to make it ash completely, and let it cool, add hydrochloric acid 5ml and water 23ml to dissolve, check according to law (General Principles 0822 The first law), should comply with the provisions (0.0002%).
bacterial endotoxin
take this product, with bacterial endotoxin test water made per lml containing no more than 2.lmg solution, checked by law (General rule 1143), the amount of endotoxin per lmg of sodium aminosalicylate should be less than 0.030EU. (For aseptic dispensing)
sterile
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:43:10
P-AMINOSALICYLIC ACID SODIUM SALT - Content determination
Authoritative Data Verified Data
take this product about 0.15g, precision weighing, add water 20ml dissolved, add 50% sodium bromide solution 10ml and glacial acetic acid 25ml, according to the potential titration method (General rule 0701), after 5ml of sodium nitrite titration solution (0.1mol/L) was rapidly added, titration with the titration solution was continued to the end point. Each 1 ml of sodium nitrite titration solution (0.1 mol/L) corresponds to 17.52mg of C7H6NNa03.
Last Update：2022-01-01 11:43:10
P-AMINOSALICYLIC ACID SODIUM SALT - Category
Authoritative Data Verified Data
anti-tuberculosis drugs.
Last Update：2022-01-01 11:43:11
P-AMINOSALICYLIC ACID SODIUM SALT - Storage
Authoritative Data Verified Data
under shading, sealed and preserved.
Last Update：2022-01-01 11:43:11
P-AMINOSALICYLIC ACID SODIUM SALT - Sodium Aminosalicylate Enteric-coated Tablets
Authoritative Data Verified Data
This product contains sodium p-aminosalicylate (C7H6NNa03 • 2H20) should be 95.0% ~ 105.0% of label amount.
trait
This product is an enteric-coated tablet, white or off-white after removal of the coating.
identification
- take this product, remove the coating, grind, take an appropriate amount (about equivalent to 1g of sodium p-aminosalicylate), add 25ml of water, stir to dissolve sodium p-aminosalicylate, filter, and evaporate the filtrate to dryness, the same reaction was shown according to the tests of identification (1) and (3) under the item of sodium aminosalicylate.
- 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 are operated in the dark; New system is in use. Accurately weigh the appropriate amount of fine powder (equivalent to 100mg of sodium p-aminosalicylate) under the content determination item, put it in a 100ml measuring flask, add mobile phase to dissolve sodium p-aminosalicylate and dilute to the scale, shake well and filter, take the continued filtrate as the test solution; Take 1ml of the precise amount, put it in a 100ml measuring flask, dilute it to the scale with the mobile phase, shake it, and use it as the control solution, precision weighing, plus mobile phase dissolution and quantitative dilution to make a solution containing 5ug per 1ml, as a reference solution. If there is a peak in the chromatogram of the test solution with the same retention time as the main peak of the reference solution, the peak area shall be calculated according to the external standard method and shall not exceed 0.5%, other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%). The peaks in the chromatogram of the test solution which are 0.1 times (0.01%) smaller than the main peak area of the control solution are ignored.
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 2) determination, hydrochloric acid solution (9-1000)900ml as the dissolution medium, the rotating speed is 100 revolutions per minute, and the operation is carried out according to law. After 2 hours, the rotating basket is immediately raised out of the liquid surface, and the acid solution in each dissolution Cup is discarded. The test piece shall not have cracks or disintegration; then phosphate buffer solution (pH 371±0.51) preheated to 6.8 was added to each dissolution Cup as dissolution medium, and the rotation speed was unchanged, precisely take 1ml of continued filtrate, put it in a 100ml measuring flask, dilute it to scale with dissolution medium, shake it well, and use it as test solution, A solution containing 5.5ug of sodium p-aminosalicylate per 1ml was prepared by dissolving and quantitatively diluting with phosphate buffer (pH 6.8) as a control solution. The test solution and the reference solution were taken, and the absorbance at the wavelength of 0401 NM was measured by ultraviolet-visible spectrophotometry (general rule), and the elution amount of each tablet was calculated. 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 suitability test using eighteen alkyl silane bonded silica as filler; Acetonitrile-10% tetrabutylammonium hydroxide solution -0.05mol/L sodium dihydrogen phosphate (100:2:900) as mobile phase; the detection wavelength was 265nm. Take the appropriate amount of M-aminophenol, 5-aminosalicylic acid (mesalazine) and sodium p-aminosalicylate respectively, and dissolve them with mobile phase to prepare 5ug of M-aminophenol and 5-aminosalicylic acid for each lml, the mixed solution of sodium aminosalicylate (10ug) was used as the system applicable solution, and the system applicable solution 20 u1 was taken for injection into the human Liquid Chromatograph. The chromatogram was recorded, and the peak order was M-aminophenol, 5-aminosalicylic acid and sodium p-aminosalicylate, the degree of separation between adjacent chromatographic peaks shall meet the requirements.
- determination of 10 tablets of this product, remove the coating, precision weighing, fine grinding, precision weighing fine powder appropriate amount (about equivalent to sodium p-aminosalicylate lOOmg), 100ml measuring bottle, add mobile phase to dissolve sodium p-aminosalicylate and dilute to scale, shake well, filter, Take 5ml of continuous filtrate precisely, put it in a 100ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, the sample was accurately weighed by 20u1 injection into human liquid chromatograph, and the chromatogram was recorded. Another reference substance of sodium aminosalicylate was accurately weighed and determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as sodium p-aminosalicylate.
rule
0.5g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:43:12
P-AMINOSALICYLIC ACID SODIUM SALT - Sodium p-aminosalicylate for injection
Authoritative Data Verified Data
This product is a sterile crystalline powder of sodium aminosalicylate. The amount of sodium p-aminosalicylate (C7H6NNa03 • 2H20) shall be between 95.0% and 105.0% of the label amount, calculated as the average loading.
trait
This product is white or off-white crystalline or crystalline powder.
identification
- take this product, according to the identification of sodium aminosalicylate (1), (2), (3) test, showed the same results.
- 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
- pH value: take 0.40g of this product, add 20ml of water to dissolve it, and measure it according to law (General rule 0631). The pH value should be 6.5~8.5.
- clarity and color of solution take 1 bottle of this product, add water to dissolve and dilute to make a solution containing 0.2g of sodium p-aminosalicylate per 1 ml, the solution should be clear and colorless; If it is turbid, it shall not be more concentrated compared with No. 1 turbidity Standard Colorimetric solution (General rule 0902 method 1); If it is colored, it shall not be deeper compared with yellow No. 6 Standard Colorimetric solution (General rule 0901 method 1).
- Related substances are operated in the dark; New system is in use. Take an appropriate amount of this product, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about lmg per lml, as a test solution; Take an appropriate amount of test solution for precision, the solution containing lug in each lml was prepared by quantitative dilution with mobile phase and used as a control solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing lug per 1 ml as a control solution. According to the test method under the item of sodium aminosalicylate related substances, if there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of the main peak of the reference solution, the peak area shall be calculated according to the external standard method, the Peak area of other single impurities shall not be greater than the main peak area of the control solution (0.1% ) , and the sum of the peak areas of each impurity shall not be greater than 5 times (0.1%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are 0.1 times (0.01%) smaller than the main peak area of the control solution are ignored.
- moisture, bacterial endotoxin and sterility take this product, according to the method under the item of amino acid sodium salicylate inspection, should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; Acetonitrile-10% tetrabutylammonium hydroxide solution -0.05mol/L sodium dihydrogen phosphate solution (100:2:900) as mobile phase; the detection wavelength was 265nm. Take appropriate amount of M-aminophenol, 5-aminosalicylic acid mesalazine and p-aminosalicylic acid sodium respectively, add mobile phase to dissolve and prepare 5ug of M-aminophenol and 5-aminosalicylic acid in each lml, the mixed solution of sodium para-aminosalicylate 10 mesh is used as the system applicable solution, and 20ul of the system applicable solution is taken and injected into the liquid chromatograph. The chromatogram is recorded and the peaks are sequentially drawn according to M-aminophenol, 5-aminosalicylic acid and sodium para-aminosalicylic acid, the degree of separation between peaks shall meet the requirements.
- the appropriate amount of the content under the item of difference in loading amount was measured, accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing 50ug per 1 ml as a test solution, the chromatogram was recorded by injection of 20u1 into human liquid chromatograph, and the reference substance of sodium p-aminosalicylate was taken for determination by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as sodium p-aminosalicylate.
specification
(l)2g (2)4g (3)6g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:43:14
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Product Name: 4-Aminosalicylic Acid Sodium Salt Request for quotationCAS: 8031-28-5
Tel: +86-17551318830
Email: r@reformchem.com
Mobile: +86-17551318830
QQ: 3787852685
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Product Name: 4-Aminosalicylic Acid Sodium Salt Request for quotationCAS: 8031-28-5
Tel: +86-17551318830
Email: r@reformchem.com
Mobile: +86-17551318830
QQ: 3785839865
Product Name: 4-Aminosalicylic Acid Sodium Salt Request for quotation
CAS: 8031-28-5
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Email: pules.cn@gmail.com
Mobile: +86-17551318830
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CAS: 8031-28-5
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
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