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5 Kilogram |
Negotiable |
Budesonide Budesonide ep Hormone
≥97.5% EP standard
Budesonide
Characteristics |
White or almost white crystalline powder |
Identification |
IR:Identical with budesonide WS |
Related substance |
A:≤0.2% D:≤0.2% K:≤0.2% L:≤0.2% Total impurities:≤0.5% Unspecified impurity:≤0.1% |
Epimer A |
40.0%~51.0% |
Residual solvents |
Methanol:≤3000ppm Acetonitrile:≤410ppm Methylene chloride:≤600ppm Ethanol:≤5000ppm Butyraldehyde:≤150ppm |
Loss on drying |
≤0.5% |
Particle size |
100%≤10um,95%≤5um |
Microbiological test |
Total viable microbial count:﹤1000CFU/g Fungi count:﹤100CFU/g |
Assay(HPLC) |
97.5%~102.0% |
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