Lanospharma Laboratory Co.,Ltd

Appearance	Odorless , off-white to yellow crystalline powder	Complies
Identification A	The IR spectrum of Potassium Bromidepreparation of the sample exhibits maxima atthe same wavelength at that of a similar preparation of in house reference standard	Complies
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	Complies
Identification C	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	Not more than 0.5%	0.1%
Heavy metals	Not more than 0.002%	Complies
Chromatographic purity	Individual impurity: not more than 1.0% Total impurities: not more than 2.0%	0.1% 0.2%
Cis-steroisomer of Sirolimus	Not more than 5.0%	3.1%
Residual organic solvents	Ethanol :max 5000ppm Ethyl acetate :max 5000ppm Petroleum ether : max 1000ppm Acetone :max 5000ppm	Not detected 77ppm Not detected Not detected
Assay(on dry basis)	98.0% to 102.0%	99.5%