Description

Aspirin IP

Pharma

Molecular Formula	C₉H₈O₄
CAS Registry No.	[50 – 78 – 2]
Molecular weight	180.2
Reference	IP
Chemical Name	Acetylsalicylic acid
Other names	2 – Acetoxybenzoic acid.
	0 – Acetoxybenzoic acid
HSN :	2918 2200

MOLECULAR FORMULA

Product Description and Specifications

S.No.	Tests	Specifications
1	Description	Colourless crystals or white, crystalline powder: odourless or almost odourless.
2	Solubility	Freely soluble in ethanol (95%): soluble in chloroform and in ether: slightly soluble in water.
3	Identification	Test A may be omitted if tests B and C are carried out. Tests B and C may be omitted if Test A is carried out. A. IR spectrum of the sample is concordant with that of Aspirin WRS. B. A deep violet colour with ferric chloride solution. C. On heating with sulphuric acid, odour of ethyl acetate perceptible.
4	Appearance of solution	A 1% w/v solution in ethanol (95%) is clear and not more intensely coloured than reference solution BS₈.
5	Clarity of solution in alkali	A 5% w/v solution in warm 5% w/v solution of sodium carbonate is clear.
6	Related Substances (%w/w by HPLC)
	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
	Any other secondary Impurity	NMT 0.05
	Sum of Impurities	NMT 0.25
7	Arsenic	Sample stain shall not be more intense than Standard stain. (2 ppm)
8	Chlorides	Not more than 430 ppm
9	Sulphates	Not more than 650 ppm
10	Readily Carbonisable substances	A 10% solution in H₂SO₄(94.5 – 95.5%w/w); any colour produced is not more than that of reference solution BYS₄.
11	Sulphated Ash	Not more than 0.1%
12	Loss on drying	Not more than 0.5%
13	Assay (By HPLC)	NLT 98.0 % & NMT 102.0 %

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 46.0 & 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
8	ASL 230GS (Crystalline Powder)	Aspirin	-45	NLT 95.00	3 Years
			+60	NMT 3.00
			+230	NMT 60.00
9	ASL 25G (Granules)	Aspirin	+25	NMT 15.00	3 Years
			+60	NLT 70.00
			+120	NLT 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 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. CEP 2000-042-Rev05
ISO 9001:2015; ISO 14001:2015; and ISO 45001:2018 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 09^th – 13^th September 2024

EDQM 28^th – 30^th March 2011

WHO GMP 10^th – 11^th March 2025

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

25 kgs net laminated kraft paper bags inside LDPE Liner
50 kgs net HDPE drums inside 2 LDPE Liners
50 kgs net FIBRE drums inside 2 LDPE Liners
100 kgs net HDPE drums inside 2 LDPE liners and
1000 kgs net Super Sacks inside LDPE liner.

The Andhra Sugars Limited was established on the 11th of August, 1947. We have used locally available renewable resources to produce value-added products, generating employment for the rural population and helping in boosting the rural economy.

Description

Aspirin IP