Category:
Preservative
CAS NO:
108-39-4
Standard:
ChP,USP,EP,In-house Standards,
Metacresol (m-Cresol) Ph. Eur. / USP parenteral grade
Assay: 98.0 % – 102.0 %
Registration-No.: F20170000422 | Status: A
Related substances / Organic impurities
p-Cresol: ≤ 0.5 %
o-Cresol: ≤ 0.5 %
Any other impurity: each ≤ 0.1 %
Total: ≤ 1.0 %
Microbiological Tests
Endotoxins ≤ 0.5 IU/mg
Impurity Tests
Residue on evaporation ≤ 0.1 %
Absorption (400 - 700 nm) ≤ 0.05
Residual solvents
Solvents of class 1 – 3 except toluene are excluded because of the manufacturing process. Toluene content complies with the ICH Q3C* limit of 890 ppm and the additional stricter limit of 100 ppm. Typical content: < 10 ppm.
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