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Description Back to Top
Benzalkonium Chloride Solution, 50 Percent, NF is used in the pharmaceutical industry as an antimicrobial preservative, antiseptic, disinfectant, solubilizing agent, and wetting agent. 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 | |
ALCOHOL CONTENT | As REPORTED | |
ACIDITY OR ALKALINITY | 0.5 ml | |
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 | |
RETEST DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |
Shipping & Storage Back to Top