Category:

Description

Aspirin USP

Molecular Formula C9H8O4
CAS Registry No. [50 – 78 – 2]
Molecular weight 180.16
Reference USP – 39
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
1DescriptionWhite crystals, commonly tabular or needle-like or white, crystalline powder. Is odorless or has a faint odor. Is stable in the dry air: in moist, air it gradually hydrolyzes to salicylic and acetic acids.
2Solubility Freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether. Slightly soluble in water.
3Identification 
 A. Colour testColour change to violet red by the addition of ferric chloride TS to a heated and cooled sample with water.
 B. IR absorptionThe IR absorption spectrum of the sample exhibits maxima only at the same wavelengths as that of a similar preparation of  Aspirin WRS.
4Loss on drying (% w/w)Not more than 0.5
5Readily carbonizable substances The solution of 500 mg sample dissolved in 5 mL of H2SO4 has no more color than Matching fluid Q.
6Residue on ignition (% w/w)Not more than 0.05
7Substances insoluble in Sodium carbonate TS

                 

A solution of 500 mg sample in 10 mL of warm sodium carbonate TS is clear.
8Chloride (% w/w)Not more than 0.014
9Sulfate (% w/w)Not more than 0.04
10Heavy metals (mg per g)Not more than 10
11Limit of free salicylic acid (% w/w)  Not more than  0.10
12Assay (% w/w, On dried basis)Not less than 99.5 and Not more than 100.5.

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

S.No.GradeContentParticle Size AnalysisExpiry Period
Mesh No.Limit (%)
1ASL 20C (Crystals)Aspirin+ 20NMT 4. 003 Years
+ 80NLT 70. 00
2ASL 40CP (Crystalline Powder)Aspirin+ 40NMT 1. 003 Years
+ 50NMT  26. 00
– 140NMT  15.0
3ASL 60CP (Crystalline Powder)Aspirin+60NMT 5. 003 Years
+85NLT 5. 00 & NMT 10. 00
+100NLT 18. 00 & NMT 30. 00
+170NLT 46. 00 & NMT 60. 00
4ASL 60GS (Crystalline Powder)Aspirin+80NMT 12. 003 Years
+200NLT 50. 00 & NMT 75. 00
+325NLT 75.00
5ASL 80CP (Crystalline Powder)Aspirin+60NMT 0. 603 Years
+80NMT 5.00
6ASL 18G (Granules)Aspirin-18NLT 90.003 Years
+50NLT  90.00
    7ASL 25G (Granules)Aspirin+25NMT 15.003 Years
+60NLT  70.00
+120NLT  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 ACCREDITATION

  • 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. R1-CEP 2000-042-Rev03
  • ISO 9001:2015; ISO 14001:2015; and OHAS 18001:2007 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    23rd – 27th March 2015

EDQM       28th – 30th March 2011

WHO GMP 13th – 14th June 2018

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

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 and 1000 kgs net Super Sack inside LDPE liner.