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Description Back to Top
Povidone K-30, USP is used as a binder in pharmaceutical tablets. 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.
Poly[1-(2-oxo-1-pyrrolidinyl)ethylene] ; Polyvinylpyrrolidone ; Povidone ; PVP;
Specifications Back to Top
Test | Specification | |
---|---|---|
Min | Max | |
K VALUE | 27.0 | 32.4 |
pH OF A 5% SOLUTION | 3.0 | 5.0 |
ASSAY, NITROGEN CONTENT | 11.5 | 12.8 % |
ALDEHYDE | 0.05 % | |
FORMIC ACID | 0.5 % | |
HYDRAZINE | 1 ppm | |
LEAD (Pb) | 10 ppm | |
PEROXIDE (H2O2) | 400 ppm | |
2-PYRROLIDONE | 3.0 % | |
RESIDUE ON IGNITION | 0.1 % | |
VINYLPYRROLIDONE | 0.001 % | |
WATER DETERMINATION | 5.0 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
IDENTIFICATION (A) | SPECTRUM MATCHES REFERENCE | |
IDENTIFICATION (B) | ORANGE-YELLOW PRECIPITATE | |
IDENTIFICATION (C) | PALE BLUE PRECIPITATE | |
IDENTIFICATION (D) | DEEP RED COLOR | |
IDENTIFICATION (E) | SUBSTANCE DISSOLVES | |
CERTIFIED HALAL | ||
RETEST DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |
Shipping & Storage Back to Top