|CAS Registry No.||[50 – 78 – 2]|
|Reference||USP – 39|
|Chemical Name||Acetylsalicylic acid|
|Other names||2 – Acetoxybenzoic acid.|
|0 – Acetoxybenzoic acid|
Product Description and Specifications
|1||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.|
|2||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.|
|4||Loss on drying (% w/w)||Not more than 0.5|
|5||Readily carbonizable substances||The solution of 500 mg sample dissolved in 5 mL of H2SO4 has no more color than Matching fluid Q.|
|6||Residue on ignition (% w/w)||Not more than 0.05|
|7||Substances insoluble in Sodium carbonate TS|
|A solution of 500 mg sample in 10 mL of warm sodium carbonate TS is clear.|
|8||Chloride (% w/w)||Not more than 0.014|
|9||Sulfate (% w/w)||Not more than 0.04|
|10||Heavy metals (mg per g)||Not more than 10|
|11||Limit of free salicylic acid (% w/w)||Not more than 0.10|
|12||Assay (% w/w, On dried basis)||Not less than 99.5 and Not more than 100.5.|
Details of Standard ASL Grades & Particle Size(PSD) Specifications
| * We are also producing as per customer specifications regarding Particle Size Distribution.|
Note:1. Sieve analysis is carried out on sieve shaker RETSCH AS-200 (Electromagnetic Sieve Shaker).
2. All retentions are cumulative.
CERTIFICATIONS AND ACCREDITATION
- 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.
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 and 1000 kgs net Super Sack inside LDPE liner.