Glycerol Ph. Eur./USP/JP 99.7% (synth.) LA parenteral grade
Assay: ≥99.7%
Registration-No.: F20180000411 | Status: Active

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

Impurity Tests
Heavy Metals: ≤ 2 ppm
Residue on ignition: ≤ 0.01%
Each impurity with Rt < Rt of glycerol: ≤ 0.1%
Total Impurities with Rt > Rt of glycerol: ≤ 0.5%

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

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.

Contact
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Email: info@gencloud-pharma.com