53123-88-9 Rapammune Rapamycin
Sirolimus (INN/USAN), also known as rapamycin, is a macrolide produced by the bacteria Streptomyces hygroscopicus. It has immunosuppressant functions in humans and is used to prevent rejection in organ transplantation; it is especially useful in kidney transplants. It prevents activation of T cells and B cells by inhibiting their response to interleukin-2 (IL-2). Sirolimus is also used as a coronary stent coating. Sirolimus works, in part, by eliminating old and abnormal white blood cells.[citation needed] Sirolimus is effective in mice with autoimmunity and in children with a rare condition called autoimmune lymphoproliferative syndrome (ALPS).
Item |
Specification |
|
Appearance |
Odorless,off-white or yellow crystalline powder |
|
Identification A |
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 |
|
Identification B |
The UV spectrum of 95% Ethanol preparation of the sample exhibits maxima at 267nm,277nm,288nm as that of a similar preparation of in-house reference standard |
|
Identification C |
The retention time 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 |
|
Loss on drying |
≤ 0.5% |
|
Heavy metals |
≤ 0.002% |
|
Chromatographic purity |
||
Individual impurity |
≤ 1.0% |
|
Total impurities |
≤ 2.0% |
|
Cis-stereoisomer of sirolimus |
≤ 5.0% |
|
Assay |
98.0-102.0% calculated trans-and cis-stereoisomers of sirolimus on the dried basis |
|
Residual organic solvents |
||
Ethanol |
≤ 5000ppm |
|
Ethyl acetate |
≤ 5000ppm |
|
Acetone |
≤ 5000ppm |
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