chemical name:sirolimus off-white to yellow crystalline powdercas no: 53123-88-9
specification:
item |
specifications |
results |
description |
off-white to yellow crystalline powder |
complies |
identification |
the ir spectrum of potassium bromide preparation of the sample exhibits maxima at the same wavelengths as that of a similar preparation of in-house reference standard |
complies
|
the uv spectrum of 95% ethanol preparation of the sample exhibits maxima at 267nm, 277nm, 288nm that of similar preparation of in-house reference standard. |
complies |
|
the retention times of the peaks for the trans- and cis-stereoisomers in the chromatogram of assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay |
complies |
|
loss on drying |
≤0.5% |
0.16% |
heavy metal |
≤0.002% |
complies |
total impurity |
≤2.0% |
0.76% |
single impurity |
≤1.0% |
0.67% |
cis-stereoisomer of sirolimus |
≤5.0% |
2.4% |
assay |
≥98.0% |
99.2% |
conclusion |
the production complies with enterprise standard |