Category:
Other Excipients
CAS NO:
56-81-5
Standard:
ChP,USP,EP,JP,
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Glycerol Ph. Eur./USP/JP 99.7% (synth.) LA parenteral grade
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Aug. Hedinger GmbH & Co. KG
4
Years
Standard Member
Basic Info
CAS Number
56-81-5
Pharmacopoeia
ChP,USP,EP,JP
Grade
Injection Grade
Is Manufacturer
No
Packaging & Delivery
Packaging Specification
1L, 2.5L, 5L, 10L
Product Description
Glycerol Ph. Eur./USP/JP 99.7% (synth.) LA parenteral grade
Assay: ≥99.7%
Registration-No.: F20180000411 | Status: A
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.
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