Category:
Ph Control Agents
CAS NO:
64-19-7
Standard:
USP,EP,JP,In-house Standards,
Acetic Acid,Glacial(99,9%)Ph.Eur./USP/JP parenteral grade
Assay: ≥99.99%
Registration-No.: N/A | (Eligible for Associated Review and Approval/Exempt from Registration)
Impurity Tests
Assay: ≥99.99%
Aluminum content: ≤0.5 ppm
Acetic anhydride: ≤100 ppm
Microbiological Tests
Endotoxins: ≤ 0.5 IU/mg
Bioburden (∑ Total aerobic microbial count + Total yeast mould count): ≤ 100 CFU/g
Residual solvents
(The Class 2 residual solvent, Methanol, is significantly below the specified limit. Trace amounts of Class 3 solvents are present, with residual levels ≤ 0.02%.)
Methanol: ≤ 10 ppm
Acetone: ≤ 10 ppm
Methyl acetate: ≤ 10 ppm
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