Glycerol 85% Ph. Eur./JP LA/API/ parenteral grade

Glycerol 85% Ph. Eur./JP LA/API/ parenteral grade
Testing specification: Ph.Eur; JP; ChP: JF20130007
Assay: 83.5% ~ 88.5%
Registration-No.: F20180000410 | Status: A

HPLC Aldehyde Specification
Glyceraldehyde: ≤ 5 ppm
Dihydroxyacetone: ≤ 5 ppm
Hydroxyacetone: ≤ 5 ppm
Formaldehyde: ≤ 2 ppm
Total Aldehyde Content ≤ 10 ppm

Microbiological Tests
Endotoxins: ≤ 0.5 IU/mg
Bioburden (∑ Total aerobic microbial count + Total yeast mould count): ≤ 100 CFU/g

Impurity Tests
Heavy Metals: ≤ 2 ppm
Ethylene glycol: ≤ 0.025%
Diethylene glycol: ≤ 0.025%
Each impurity with Rt < Rt of glycerol: ≤ 0.1%
Total Impurities with Rt > Rt of glycerol: ≤ 0.5%

Residual solvents
Based on the process knowledge only one Class 3 solvent is likely to be present. The level of this Residual Solvent is less than 100 ppm.

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