Aspirin-USP
50 kgs. HDPE drums100 kgs. HDPE drums1000 kgs. Jumbo bags50 kgs. HDPE drums - Palletized25 kgs. kraft paper bags

Aspirin USP

  M.T
Category:

Product Description

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 Structure

 Product Description and Specifications

S.No. Tests Specifications
1 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.
2 Solubility  Freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether. Slightly soluble in water.
3 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.
4 Loss on drying (% w/w) Not more than 0.5
5 Readily carbonizable substances  The solution of 500 mg sample dissolved in 5 mL of H2SO4 has no more color than Matching fluid Q.
6 Residue on ignition (% w/w) Not more than 0.05
7 Substances insoluble in Sodium carbonate TS

                 

A solution of 500 mg sample in 10 mL of warm sodium carbonate TS is clear.
8 Chloride (% w/w) Not more than 0.014
9 Sulfate (% w/w) Not more than 0.04
10 Heavy metals (mg per g) Not more than 10
11 Limit of free salicylic acid (% w/w)   Not more than  0.10
12 Assay (% 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. 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. 00 & 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
 * 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. 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

INSPECTIONS

US FDA    23rd – 27th March 2015

EDQM       28th – 30th March 2011

WHO GMP 13th – 14th June 2018

APPLICATIONS

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

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

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 and 1000 kgs net Super Sack inside LDPE liner.