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Aspirin USP (2080B)

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Product Description

PRODUCT

Aspirin USP (2080B)

CAS #

50-78-2

SYNONYM

Aspirin; O-Acetylsalicylic acid; 2-acetoxybenzoic acid; Benzoic acid, 2-(acetyloxy)-

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FORMULA

C9H8O4

Typical Product Specifications

SUM OF RELATED SUBSTANCES(2)

0.25 % maximum

SUBSTANCES INSOLUBLE IN NA2CO3 TS

Clear solution

RELATED SUBSTANCES (USP GENERAL NOTICES)

0.10 % maximum

RESIDUAL SOLVENTS <467>

Must comply

FREE SALICYLIC ACID

0.1% maximum

CHLORIDE

0.014 % maximum

LOSS ON DRYING

0.5 % maximum

RESIDUE ON IGNITION

0.05 % maximum

HEAVY METALS

10 µg/g maximum

ASSAY, % DRY BASIS

99.5 – 100.5 %

READILY CARBONIZABLE SUBSTANCES

USP Fluid Q max.

SULFATE

0.04 % maximum

NOTES

Aspirin USP is sourced from a GDUFA registered manufacturer


Product: Aspirin USP (2080B)


Applications: Recommended for the manufacture of soluble, effervescent and dispersible acetylsalicylic acid tablets and for the manufacture of powder formulations and suppositories.


Further specifications: 


Screen Test, USSS:
Cumulative retained on 80 mesh(180 μm) 12.0% Max
Cumulative retained on 200 mesh( 75 μm) 50.0 - 75.0%
Cumulative retained on 325 mesh ( 45 μm) 75.0% Min


Method: Alpine


 

INDUSTRY

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