Description

Acetylsalicylic acid Ph.Eur.

Pharma

Molecular Formula	C₉H₈O₄
CAS Registry No.	[50 – 78 – 2]
Molecular weight	180.2
Reference	EP
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 Spectrophotometry	The Transmission minima (or absorption maxima) in the spectrum obtained with the sample corresponds in position and relative size to those in the spectrum obtained with Acetylsalicylic acid 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 (%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
	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	NMT 15.00	3 Years
			+60	NLT 70.00
			+120	NLT 90.00
8	ASL 230GS (Crystalline Powder)	Aspirin	-45	NLT 95.00	3 Years
			+60	NMT 3.00
			+230	NMT 60.00
* 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. 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

Acetylsalicylic acid Ph.Eur.