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Description Back to Top
Benzalkonium Chloride Solution, 50 Percent, NF is used as a solubilizing agent and wetting agent excipient. Spectrum Chemical NF 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 (w/v) | 47.5 | 52.5 % |
AVERAGE MOLECULAR WEIGHT | AS REPORTED | |
RATIO OF ALKYL COMPONENTS: | ||
C12 | 40.0 % | |
C14 | 20.0 % | |
C12 + C14 | 70.0 % | |
C16 | AS REPORTED | |
LIMITS OF AMINES AND AMINE SALTS | 0.1 mmol/g | |
ACIDITY OR ALKALINITY | 0.5 ml | |
ALCOHOL CONTENT (v/v) | AS REPORTED | |
BENZYL ALCOHOL | 0.5 % | |
BENZALDEHYDE | 0.15 % | |
(CHLOROMETHYL)BENZENE | 0.05 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
IDENTIFICATION A | WHITE PRECIPITATE FORMS DISSOLVES | |
IDENTIFICATION B | POSITIVE FOR CHLORIDE | |
IDENTIFICATION C | ORANGE-RED COLOR PRODUCED | |
IDENTIFICATION D | RETENTION TIME CORRESPONDS TO STANDARD | |
APPEARANCE | ||
RETEST DATE | ||
DATE OF MANUFACTURE | ||
RESIDUAL SOLVENTS | AS REPORTED | |
MONOGRAPH EDITION |
Shipping & Storage Back to Top