Aspirin BP

Acetyl Salicylicacid ph. Eur.

Molecular Formula : C9H8O4
CAS Registry No. : [50 – 78 – 2]
Molecular weight : 180.2
Reference : EP 7.0
Other names : 2 – (Acetyloxy) benzoic acid.
Categories: ,

Product Description

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 143 ºC (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 156 º to 161 º C
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
11 Heavy metals Maximum 20
12 Loss on drying  (%, w/w)

(Determined on 1g by drying in vacuo) 

Maximum 0.5
13 Sulphated Ash (%, w/w, determined on 1g) Maximum 0.1
13 Assay (%, w/w, dried substance) 99.5 to 101.0
DETAILS OF STANDARD ASL GRADES

SPECIFICATIONS ( PARTICLE SIZE )

S.NO. Grade ASL Code Particle size Analysis Expiry Period
Mesh No. Limit( % )
1 20 Mesh Crystals ASL 20C + 20 NMT  4. 0 3 Years
+ 80 NLT 70. 0
2 40 Mesh Crystalline Powder ASL 40CP + 40 NMT 1. 0 3 Years
+ 50 NMT  26. 0
– 140 NMT  15.0
3 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
4 80 Mesh Crystalline Powder ASL 80CP +60 NMT 0. 6 3 Years
+80 NMT 5.0
5 18 Mesh Granules ASL 18G -18 NLT 90.0 3 Years
+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.

Advantages:

  • Audited and approved by USFDA & EDQM.  We also have  GMP Certifications from EU, TGA and  WHO.
  • 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
  • For Export: 50 kgs net HDPE drums / 100 kgs net Fibre drums inside 2 LDPE Liners

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