Description

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Molecular Formula	C9H8O4
CAS Registry No	[50 – 78 – 2]
Molecular weight	180.2
Reference	I.P-Addendum 2015
Chemical Name	Acetylsalicylic acid
Other names	2 – Acetoxybenzoic acid.
	0 – Acetoxybenzoic acid
HSN :	2918 2200

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 Molecular Structure

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 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 (%)
	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
	Un Specified Impurity	NMT 0.05
	Total Impurities	NMT 0.25
7	Arsenic	Sample stain shall not be more intense than Standard stain. (2 ppm)
8	Heavy metals	Not more than 10 ppm
9	Chlorides	Not more than 430 ppm
10	Sulphates	Not more than 650 ppm
11	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.
12	Sulphated Ash	Not more than 0.1%
13	Loss on drying	Not more than 0.5%
14	Assay (By HPLC)	NLT 99.50 % & NMT 100.50 %

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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

* 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.

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 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

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APPLICATIONS

• Blood-thinning agent, Analgesic,
• Cardiology, Cough & Cold.

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INSPECTIONS

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FIELD OF ACTIVITY

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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.

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ADVANTAGES

• Dedicated plant for Aspirin
• All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.

[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_column_text][dt_button url=”https://theandhrasugars.com/wp-content/uploads/2016/12/SDS-Aspirin.pdf” style=”success” size=”btn-default” skin=”dark” target=”_blank” download]Material Safety Data[/dt_button][/vc_column_text][/vc_column][vc_column width=”1/4″ el_class=”download”][vc_column_text] Download Specifications[/vc_column_text][/vc_column][vc_column width=”1/4″][vc_column_text][dt_button url=”https://theandhrasugars.com/wp-content/uploads/2016/12/TREM-Card-ASPIRIN.pdf” style=”success” size=”btn-default” skin=”dark” target=”_blank”]Transport Emergency Card[/dt_button][/vc_column_text][/vc_column][vc_column width=”1/4″][vc_column_text][dt_button url=”https://theandhrasugars.com/wp-content/uploads/2016/12/IMS-cerificates.pdf” style=”success” size=”btn-default” skin=”dark” target=”_blank”]IMS Certificate[/dt_button][/vc_column_text][/vc_column][/vc_row]