salicylic-acid-pure-edit
50 kgs. HDPE drums100 kgs. HDPE drums1000 kgs. Jumbo bags50 kgs. HDPE drums - Palletized25 kgs. kraft paper bags

Acetylsalicylic acid Ph.Eur.

  M.T
Category:

Product Description

Molecular Formula   C9H8O4
CAS Registry No.   [50 – 78 – 2]
Molecular weight  180.2
Reference  EP 8.0
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 Appearance White or almost white, crystalline powder or colourless crystals.
2 Solubility Slightly soluble in water, freely soluble in ethanol (96 percent).
3 Melting point About 143ºC (Instantaneous Method)
4 Identification First identification : A, B.

Second identification  : B, C, D.

A. IR absorption spectrum The absorption maxima in the spectrum of sample corresponds in position and relative size to similarly recorded spectrum of Aspirin WRS.
B. Melting point of precipitate 156º to 161ºC
C. Colour test. The colour becomes blue.
D. Reaction of Salicylates The solution gives reaction (a) of Salicylates.
5 Appearance of solution The solution is clear and colourless.
6 Related Substances (%)
Impurity A 4- Hydroxybenzoic acid   NMT 0.15
Impurity B 4- Hydroxyisophthalic acid  NMT 0.15
Impurity C Salicylic acid      NMT 0.15
Impurity D Acetylsalicylsalicylic acid   NMT 0.15
Impurity E Salicylsalicylic acid    NMT 0.15
Impurity F AcetylSalicylic anhydride  NMT 0.15
Unspecified Impurity NMT 0.05
Total Impurities  NMT 0.25
7 Heavy metals ( ppm ) Maximum 20
8 Loss on drying  (%, w/w) (Determined on 1g by drying in vacuo) Maximum 0.5
9 Sulphated Ash (%, w/w, determined on 1g) Maximum 0.1
10 Assay (%, w/w, dried substance) 99.5 to 101.0

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.