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Description Back to Top
Benzyl Alcohol, NF, EP, BP, JP, bioCertified is a commonly used low concentration bacteriostatic preservative, suitable for biopharmaceutical production. All Spectrum-labeled bioCertified products undergo additional testing for endotoxin, bioburden and other tests. Benzyl Alcohol, NF, EP 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 | 98.0 | 100.5 % |
CLARITY OF SOLUTION | NO MORE OPALESCENCE THAN STANDARD | |
COLOR OF SOLUTION | SAME COLOR AS WATER | |
Solubility (EP/BP/JP) | SOLUBLE IN WATER MISCIBLE WITH ETHANOL AND WITH FATTY AND ESSENTIAL OILS | |
Specific Gravity (JP)/Relative Density (EP/BP) | 1.043 | 1.049@20°C |
REFRACTIVE INDEX @ 20°C | 1.538 | 1.541 |
PEROXIDE VALUE | 5 | |
ACIDITY | 1 ml | |
RESIDUE ON EVAPORATION | 0.05 % | |
ORGANIC IMPURITIES: | ||
BENZALDEHYDE | 0.05 % | |
CYCLOHEXYLMETHANOL | 0.10 % | |
SUM OF ANY PEAK WITH A RELATIVE RETENTION TIME LESS THAN THAT OF BENYZL ALCOHOL | 0.02 % | |
SUM OF ANY PEAK WITH RELATIVE RETENTION TIME GREATER THAN BENZYL ALCOHOL | 0.2 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
BACTERIAL ENDOTOXIN | 2 EU/mL | |
IDENTIFICATION (A) FTIR | SPECTRUM MATCHES REFERENCE | |
APPEARANCE | ||
EXPIRATION DATE | ||
MANUFACTURE DATE | ||
RESIDUAL SOLVENTS | AS REPORTED |
Shipping & Storage Back to Top