Aspirin IP
IMG_0021IMG_0026IMG_0027

Aspirin Starch Granules

Molecular Formula :C9H8O4(Aspirin)
Molecular weight     :180.16 (Aspirin)
Reference                   :In-house
Description                :White granular powder with characteristic odour
Category:

Product Description

Tests Specifications
Identification

A.A violet red color with ferric chloride on heating a solution in water.

B.Water slurry with iodine solution produces reddish violet colour.

Water (%w/w, by KF) 0.60 to 1.60
Heavy metals (ppm, as Pb) Not more than  10
Non Aspirin salicylates (%w/w) Not more than  0.1
Assay (%w/w, on as is basis) 89.00 to 91.00

 

Particle Size Distribution
Mesh No. Limit( % )
       -18 NLT 90.0
      + 50 NLT 90.0

 

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) & 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 

INSPECTIONS   

US FDA    23rd – 27th March 2015

EDQM       28th – 30th March 2011

WHO GMP 6th – 7th October 2015

APPLICATIONS

Blood thinning agent, Analgesic,

Cardiology, Cough & Cold.

Field of activity

  Consumer Health

Advantages

  • Audited and approved by USFDA & EDQM.  We also have  GMP Certifications from EU, TGA and  WHO
  • Dedicated plant for Aspirin.
  • All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.

Packing

  • For Indigenous: 25 kgs net laminated kraft paper bags inside LDPE Liner
  • For Export: 50 kgs net HDPE drums / 100 kgs net Fibre drums inside 2 LDPE Liners

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