Aspirin BP
IMG_0001IMG_0002IMG_0003IMG_0006IMG_0007IMG_0008

Aspirin USP

Molecular Formula   :C9H8O4
CAS Registry No       :[50 – 78 – 2]
Molecular weight       :180.16
Reference                  :USP – 34
Other names             :Benzoic acid, 2 – (Acetyloxy)-Salicylic acid acetate, Acetyl salicylic acid.
Category:

Product Description

Tests Specifications
Description White 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.
Solubility  Freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether. Slightly soluble in water.
Identification
A. Colour test Colour change to violet red by the addition of ferric chloride TS to a heated and cooled sample with water.
B. IR absorption The IR absorption spectrum of the sample exhibits maxima only at the same wavelengths as that of a similar preparation of  Aspirin WRS.
Loss on drying (% w/w) Not more than 0.5
Readily carbonizable substances  The solution of 500 mg sample dissolved in 5 mL of H2SO4 has no more color than Matching fluid Q.
Residue on ignition (% w/w) Not more than 0.05
Substances insoluble in Sodium carbonate TS

                 

A solution of 500 mg sample in 10 mL of warm sodium carbonate TS is clear.
Chloride (% w/w) Not more than 0.014
Sulfate (% w/w) Not more than 0.04
Heavy metals (mg per g) Not more than 10
Limit of free salicylic acid (% w/w)   Not more than  0.10
Assay (% w/w, On dried basis) Not less than 99.5 and Not more than 100.5.
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 3 Years
– 18 NLT 90.0
+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.

Customers' review

5 stars 0 0 %
4 stars 0 0 %
3 stars 0 0 %
2 stars 0 0 %
1 star 0 0 %

Reviews

There are no reviews yet.

Be the first to review “Aspirin USP”