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Aspirin USP (3080)

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Product Description

PRODUCT

Aspirin USP (3080)

CAS #

50-78-2

SYNONYM

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

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FORMULA

C9H8O4

Typical Product Specifications

FREE SALICYLIC ACID

0.1% maximum

SUBSTANCES INSOLUBLE IN NA2CO3 TS

Clear solution

SUM OF RELATED SUBSTANCES(2)

0.25 % maximum

RESIDUAL SOLVENTS

Must comply

RELATED SUBSTANCES (USP GENERAL NOTICES)

0.10 % maximum

ASSAY, % DRY BASIS

99.5 – 100.5 %

LOSS ON DRYING

0.5 % maximum

READILY CARBONIZABLE SUBSTANCES

USP Fluid Q max.

RESIDUE ON IGNITION

0.05 % maximum

SULFATE

0.04 % maximum

CHLORIDE

0.014 % maximum

HEAVY METALS

10 µg/g maximum

NOTES

Aspirin USP is sourced from a GDUFA registered manufacturer


Product: Aspirin USP (3080)


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 (RO-TAP Method):
Cumulative retained on 60 mesh (250μm) 2.0% Max
Cumulative retained on 80 mesh (180μm) 5.0% Max
Cumulative retained on 325 mesh (45μm) 70.0% Min

INDUSTRY

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