Category:

Description

Aspirin IP

Molecular Formula  C9H8O4
CAS Registry No.  [50 – 78 – 2]
Molecular weight 180.2
ReferenceIP
Chemical Name Acetylsalicylic acid
Other names       2 – Acetoxybenzoic acid.
  0 – Acetoxybenzoic acid
HSN :2918 2200

MOLECULAR FORMULA

aspirin-ml-fm

Product Description and Specifications

 

S.No.TestsSpecifications
1DescriptionColourless crystals or white, crystalline powder: odourless or almost odourless.
2SolubilityFreely soluble in ethanol (95%): soluble in chloroform and in ether: slightly soluble in water.
3Identification

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.

4Appearance of solutionA 1% w/v solution in ethanol (95%) is clear and not more intensely coloured than reference solution BS8.
5Clarity of solution in alkaliA 5% w/v solution in warm 5% w/v solution of sodium carbonate is clear.
6Related Substances (%w/w by HPLC) 
 Impurity A4-Hydroxybenzoic acid NMT 0.15
 Impurity B4-Hydroxyisophthalic acid NMT 0.15
 Impurity CSalicylic acid NMT 0.15
 Impurity DAcetylsalicylsalicylic acid NMT 0.15
 Impurity ESalicylsalicylic acid NMT 0.15
 Impurity FAcetylSalicylic anhydride NMT 0.15
 Any other secondary ImpurityNMT 0.05
 Sum of ImpuritiesNMT 0.25
7ArsenicSample stain shall not be more intense than Standard stain. (2 ppm)
8Heavy metalsNot more than 10 ppm
9ChloridesNot more than 430 ppm
10SulphatesNot more than 650 ppm
11Readily Carbonisable substancesA 10% solution in H2SO4(94.5 – 95.5%w/w); any colour produced is not more than that of reference solution BYS4.
12Sulphated AshNot more than 0.1%
13Loss on dryingNot more than 0.5%
14Assay (By HPLC)NLT 99.50 % & NMT 100.50 %
 
 

Details of Standard ASL Grades & Particle Size(PSD) Specifications

S.No. Grade Content Particle Size Analysis Expiry Period
Mesh No. Limit (%)
1 ASL 20C (Crystals) Aspirin + 20 NMT 4.00 3 Years
+ 80 NLT 70.00
2 ASL 40CP (Crystalline Powder) Aspirin + 40 NMT 1.00 3 Years
+ 50 NMT 26.00
– 140 NMT 15.0
3 ASL 60CP (Crystalline Powder) Aspirin +60 NMT 5.00 3 Years
+85 NLT 5.00 & NMT 10.00
+100 NLT 18.00 & NMT 30.00
+170 NLT 46.0 & NMT 60.00
4 ASL 60GS (Crystalline Powder) Aspirin +80 NMT 12.00 3 Years
+200 NLT 50.00 & NMT 75.00
+325 NLT 75.00
5 ASL 80CP (Crystalline Powder) Aspirin +60 NMT 0.60 3 Years
+80 NMT 5.00
6 ASL 18G (Granules) Aspirin -18 NLT 90.00 3 Years
+50 NLT 90.00
7 ASL 25G (Granules) Aspirin -25 NLT 95.00 3 Years
+60 NLT 95.00
8 ASL 230GS (Crystalline Powder) Aspirin -45 NLT 95.00 3 Years
+60 NMT 3.00
+230 NMT 60.00
9 ASL 25G (Granules) Aspirin +25 NMT 15.00 3 Years
+60 NLT 70.00 
+120 NLT 90.00

 * 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 USP) & 17816 (Aspirin Starch Granules)
  • CEP/COS No. CEP 2000-042-Rev05
  • ISO 9001:2015; ISO 14001:2015; and ISO 45001:2018 Management System Standards
  • GDUFA registered, and GDUFA Facility & DMF fees paid

CAUTIONS

  • Toxic, Harmful if swallowed.
  • If absorbed through skin, causes skin irritation.
  • If inhaled, causes respiratory irritation.
  • Causes serious eye irritation.

FIELD OF ACTIVITY

Consumer Health

INSPECTIONS

US FDA    09th – 13th September 2024

EDQM       28th – 30th March 2011

WHO GMP 10th – 11th March 2025

ADVANTAGES

  • Dedicated plant for Aspirin
  • All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.

APPLICATIONS

  • Blood-thinning agent, Analgesic,
  • Cardiology, Cough & Cold.

PACKING

  • 25 kgs net laminated kraft paper bags inside LDPE Liner
  • 50 kgs net HDPE drums inside 2 LDPE Liners
  • 50 kgs net FIBRE drums inside 2 LDPE Liners
  • 100 kgs net HDPE drums inside 2 LDPE liners and
  • 1000 kgs net Super Sacks inside LDPE liner.