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Description

Acetylsalicylic acid Ph.Eur.

Acetylsalicylic acid Ph.Eur.

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

aspirin-ml-fm

Product Description and Specifications

S. No.TestsSpecifications
1AppearanceWhite or almost white, crystalline powder or colourless crystals.
2SolubilitySlightly soluble in water, freely soluble in ethanol (96 percent).
3Melting pointAbout 143ºC (Instantaneous Method)
4IdentificationFirst identification : A, B.

Second identification  : B, C, D.

A. IR absorption spectrumThe absorption maxima in the spectrum of sample corresponds in position and relative size to similarly recorded spectrum of Aspirin WRS.
B. Melting point of precipitate156º to 161ºC
C. Colour test.The colour becomes blue.
D. Reaction of SalicylatesThe solution gives reaction (a) of Salicylates.
5Appearance of solutionThe solution is clear and colourless.
6Related Substances (%) 
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
Unspecified ImpurityNMT 0.05
Total Impurities NMT 0.25
7Heavy metals ( ppm )Maximum 20
8Loss on drying  (%, w/w) (Determined on 1g by drying in vacuo)Maximum 0.5
9Sulphated Ash (%, w/w, determined on 1g)Maximum 0.1
10Assay (%, w/w, dried substance)99.5 to 101.0

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.