Aspirin IP
IMG_0002IMG_0005IMG_0004

Aspirin BP

Molecular Formula   : C9H8O4
CAS Registry No.    : [50 – 78 – 2]
Molecular weight      : 180.2
Reference                 : BP 2011
Other names              : (Acetyloxy) benzoic acid
Category:

Product Description

Tests Specifications
Appearance White or almost white, crystalline powder or colourless crystals.
Solubility Slightly soluble in water, freely soluble in ethanol (96 percent).
Melting point About 143 ºC (Instantaneous Method)
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 156 º to 161 º C
C. Colour test. The colour becomes blue.
D. Reaction of Salicylates The solution gives reaction (a) of Salicylates.
Appearance of solution The solution is clear and colourless.
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
Heavy metals ( ppm ) Maximum 20
Loss on drying  (%, w/w) (Determined on 1g by drying in vacuo) Maximum 0.5
Sulphated Ash (%, w/w, determined on 1g) Maximum 0.1
Assay (%, w/w, dried substance) 99.5 to 101.0
DETAILS OF STANDARD ASL GRADES

SPECIFICATIONS ( PARTICLE SIZE )

S.NO. Grade ASL Code Particle size Analysis Expiry Period
Mesh No. Limit( % )
1 20 Mesh Crystals ASL 20C + 20 NMT 4. 0 3 Years
+ 80 NLT 70. 0
2 40 Mesh Crystalline Powder ASL 40CP + 40 NMT 1. 0 3 Years
+ 50 NMT  26. 0
– 140 NMT  15.0
3 60 Mesh Crystalline Powder ASL 60CP +60 NMT 5. 0 3 Years
+80 NLT 5. 0 & NMT 10. 0
+100 NLT 18. 0 & NMT 30. 0
+170 NLT 46. 0 & NMT 60. 0
4 80 Mesh Crystalline Powder ASL 80CP +60 NMT 0. 6 3 Years
+80 NMT 5.0
5 18 Mesh Granules ASL 18G -18 NLT 90.0 3 Years
+50 NLT  90.0
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 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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