Aspirin IP
IMG_0002IMG_0001IMG_0002IMG_0004

Aspirin IP

Molecular Formula        :  <C9H8O4
CAS Registry No            :   [50 – 78 – 2]
Molecular weight             :   180.2
Reference                         :    I.P-2010(Addendum 2012)
Other names                     :    2 – Acetoxybenzoic acid.
HSN                                   : 2918

 

SKU: AIP Category:

Product Description

Tests Specifications
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 )

Grade ASL Code Particle Size Analysis Expiry Period
Mesh No. Limit( % )
20 Mesh Crystals ASL 20C + 20 NMT 4. 0 3 Years
+ 80 NLT 70. 0
40 Mesh Crystalline Powder ASL 40CP + 40 NMT 1. 0 3 Years
+ 50 NMT 26. 0
– 140 NMT 15. 0
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
80 Mesh Crystalline Powder ASL 80CP +60 NMT 0.6 3 Years
+80 NMT 5.0
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  

  • 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 / 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.

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