CAS Registry No :[50 – 78 – 2]
Molecular weight :180.16
Reference :USP – 34
Other names :Benzoic acid, 2 – (Acetyloxy)-Salicylic acid acetate, Acetyl salicylic acid.
|Description||White crystals, commonly tabular or needle-like or white, crystalline powder. Is odorless or has a faint odor. Is stable in the dry air: in moist, air it gradually hydrolyzes to salicylic and acetic acids.|
|Solubility||Freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether. Slightly soluble in water.|
|A. Colour test||Colour change to violet red by the addition of ferric chloride TS to a heated and cooled sample with water.|
|B. IR absorption||The IR absorption spectrum of the sample exhibits maxima only at the same wavelengths as that of a similar preparation of Aspirin WRS.|
|Loss on drying (% w/w)||Not more than 0.5|
|Readily carbonizable substances||The solution of 500 mg sample dissolved in 5 mL of H2SO4 has no more color than Matching fluid Q.|
|Residue on ignition (% w/w)||Not more than 0.05|
|Substances insoluble in Sodium carbonate TS
|A solution of 500 mg sample in 10 mL of warm sodium carbonate TS is clear.|
|Chloride (% w/w)||Not more than 0.014|
|Sulfate (% w/w)||Not more than 0.04|
|Heavy metals (mg per g)||Not more than 10|
|Limit of free salicylic acid (% w/w)||Not more than 0.10|
|Assay (% w/w, On dried basis)||Not less than 99.5 and Not more than 100.5.|
|DETAILS OF STANDARD ASL GRADES
SPECIFICATIONS ( PARTICLE SIZE )
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) & 17816 (Aspirin Starch Granules)
- CEP/COS No. R1-CEP 2000-042-Rev02
- ISO 9001:2008; ISO 14001:2004; and OHAS 18001:2007 Management System Standards
- GDUFA registered, and GDUFA Facility & DMF fees paid
- US FDA 23rd – 27th March 2015
- EDQM 28th – 30th March 2011
- WHO GMP 6th – 7th October 2015
Blood thinning agent, Analgesic, Cardiology, Cough & Cold.
FIELD OF ACTIVITY:
- Dedicated plant for Aspirin
- All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.
- For Indigenous: 25 kgs net laminated kraft paper bags inside LDPE Liner / 50 kgs. net HDPE drums inside 2 LDPE Liners.
- For Export: 50 / 100 kgs net HDPE drums inside 2 LDPE Liners & 1,000 kgs. net Jumbo Bags / Super Sacks inside LDPE Liner.