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Ibuprofen, USP is a non-steroidal anti-inflammatory drug often used to treat and reduce fevers and swelling. 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.
Synonyms: Advil ; IBU ; 2-(4-Isobutylphenyl)propionic Acid
TEST | MIN | MAX |
---|---|---|
ASSAY (ANHYDROUS BASIS) | 97.0 | 103.0 % |
WATER DETERMINATION | 1.0 % | |
RESIDUE ON IGNITION | 0.5 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
CHROMATOGRAPHIC IMPURITIES | ||
INDIVIDUAL IMPURITY | 0.3 % | |
TOTAL IMPURITIES | 1.0 % | |
IBUPROFEN RELATED COMPOUND C | 0.1 % | |
IDENTIFICATION A ( FTIR) | SPECTRUM MATCHES REFERENCE | |
IDENTIFICATION (B) | 3.0% | |
IDENTIFICATION (C) | RETENTION TIME CORRESPONDS TO STANDARD | |
EXPIRATION DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |