Acetylsalicylic acid Ph.Eur.
|CAS Registry No.||[50 – 78 – 2]|
|Chemical Name||Acetylsalicylic acid|
|Other names||2 – Acetoxybenzoic acid.|
|0 – Acetoxybenzoic acid|
|HSN :||2918 2200|
Product Description and Specifications
|1||Appearance||White or almost white, crystalline powder or colourless crystals.|
|2||Solubility||Slightly soluble in water, freely soluble in ethanol (96 percent).|
|3||Melting point||About 143ºC (Instantaneous Method)|
|4||Identification||First identification : A, B.|
Second identification : B, C, D.
|A. IR absorption spectrum||The absorption maxima in the spectrum of sample corresponds in position and relative size to similarly recorded spectrum of Aspirin WRS.|
|B. Melting point of precipitate||156º to 161ºC|
|C. Colour test.||The colour becomes blue.|
|D. Reaction of Salicylates||The solution gives reaction (a) of Salicylates.|
|5||Appearance of solution||The solution is clear and colourless.|
|6||Related Substances (%)|
|Impurity A||4- Hydroxybenzoic acid NMT 0.15|
|Impurity B||4- Hydroxyisophthalic acid NMT 0.15|
|Impurity C||Salicylic acid NMT 0.15|
|Impurity D||Acetylsalicylsalicylic acid NMT 0.15|
|Impurity E||Salicylsalicylic acid NMT 0.15|
|Impurity F||AcetylSalicylic anhydride NMT 0.15|
|Unspecified Impurity||NMT 0.05|
|Total Impurities||NMT 0.25|
|7||Heavy metals ( ppm )||Maximum 20|
|8||Loss on drying (%, w/w) (Determined on 1g by drying in vacuo)||Maximum 0.5|
|9||Sulphated Ash (%, w/w, determined on 1g)||Maximum 0.1|
|10||Assay (%, w/w, dried substance)||99.5 to 101.0|
CERTIFICATIONS AND ACCREDITATIONS
- US FDA inspected and approved
- EDQM inspected and approved
- WHO GMP
- Written Confirmation issued by CDSCO, New Delhi
- US DMF No. 16345 (Aspirin USP) & 17816 (Aspirin Starch Granules)
- CEP/COS No. R1-CEP 2000-042-Rev03
- ISO 9001:2015; ISO 14001:2015; and OHAS 18001:2007 Management System Standards
- GDUFA registered, and GDUFA Facility & DMF fees paid
- Toxic, Harmful if swallowed.
- If absorbed through skin, causes skin irritation.
- If inhaled, causes respiratory irritation.
- Causes serious eye irritation.
FIELD OF ACTIVITY
US FDA 23rd – 27th March 2015
EDQM 28th – 30th March 2011
WHO GMP 13th – 14th June 2018
- Dedicated plant for Aspirin
- All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.
- Blood-thinning agent, Analgesic,
- Cardiology, Cough & Cold.
- 25 kgs net laminated kraft paper bags inside LDPE Liner
- 50 kgs net HDPE drums inside 2 LDPE Liners
- 50 kgs net FIBRE drums inside 2 LDPE Liners
- 100 kgs net HDPE drums inside 2 LDPE liners and
- 1000 kgs net Super Sacks inside LDPE liner.