CAS Registry No : [50 – 78 – 2]
Molecular weight : 180.2
Reference : I.P-2010(Addendum 2012)
Other names : 2 – Acetoxybenzoic acid.
HSN : 2918
|Identification||Test A may be omitted if tests B and C are carried out. Tests B and C may be omitted if Test A is carried out.
A. IR spectrum of the sample is concordant with that of Aspirin WRS.
B. A deep violet colour with ferric chloride solution.
C. On heating with sulphuric acid, odour of ethyl acetate perceptible.
|Appearance of solution||A 1% w/v solution in ethanol (95%) is clear and not more intensely coloured than reference solution BS8.|
|Clarity of solution in alkali||A 5% w/v solution in warm 5% w/v solution of sodium carbonate is clear.|
|Related Substances (%)|
|Impurity A||– 4-Hydroxybenzoic acid NMT 0.10|
|Impurity B||– 4-Hydroxyisophthalic acid NMT 0.10|
|Impurity C||–Salicylic acid NMT 0.10|
|Impurity D||–Acetylsalicylsalicylic acid NMT 0.10|
|Impurity E||–Salicylsalicylic acid NMT 0.10|
|Impurity F||–AcetylSalicylic anhydride NMT 0.10|
|Total Impurities||NMT 0.25|
|Arsenic||Sample stain shall not be more intense than Standard stain. (2 ppm)|
|Heavy metals||Not more than 10 ppm|
|Chlorides||Not more than 430 ppm|
|Sulphates||Not more than 600 ppm|
|Readily Carbonisable substances||A 10% solution in H2SO4(94.5 – 95.5%w/w); any colour produced is not more than that of reference solution BYS4.|
|Salicylic Acid||Not more than 0.10%|
|Sulphated Ash||Not more than 0.10%|
|Loss on drying||Not more than 0.50%|
|Assay (On dry basis)||NLT 99.50 % & NMT 100.50 %|
| DETAILS OF STANDARD ASL GRADES
SPECIFICATIONS ( PARTICLE SIZE )
| We are also producing as per customer specifications regarding Particle Size Distribution.
1. Sieve analysis is carried out on sieve shaker RETSCH AS-200 (Electromagnetic Sieve Shaker).
2. All retentions are cumulative.
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.