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Description Back to Top
Acetaminophen, Granular, USP, also known as paracetamol, is a widely used antipyretic and mild analgesic that is available over-the-counter. All Spectrum Chemical USP products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Specifications Back to Top
Test | Specification | |
---|---|---|
Min | Max | |
ASSAY (DRIED BASIS) | 98.0 | 102.0 % |
RESIDUE ON IGNITION | 0.1 % | |
ELEMENTAL IMPURITIES: | ||
PLATINUM (Pt) | AS REPORTED | |
FREE p-AMINOPHENOL | 0.005 % | |
ORGANIC IMPURITIES: | ||
ACETAMINOPHEN RELATED COMPOUND B | 0.05 % | |
ACETAMINOPHEN RELATED COMPOUND C | 0.05 % | |
ACETAMINOPHEN RELATED COMPOUND D | 0.05 % | |
ACETAMINOPHEN RELATED COMPOUND J | 0.001 % | |
ANY UNSPECIFIED IMPURITY | 0.05 % | |
TOTAL IMPURITIES | 0.1 % | |
LOSS ON DRYING | 0.5 % | |
IDENTIFICATION A (FTIR) | SPECTRUM MATCHES REFERENCE | |
IDENTIFICATION (B) | RETENTION TIME MATCHES STANDARD | |
EXPIRATION DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |
Shipping & Storage Back to Top