Rapamycin CAS:53123-88-9 99%

Rapamycin

CAS:53123-88-9 

ITEMS                              SPECIFICATION                         RESULTS

Appearance               White to off-white crystalline powder             White crystalline powder                     

Identification           A: IR,The infrared absorption spectrum

corresponds to that of sirolimus CRS.                  Conforms

B:HPLC,The retention time of sirolimus peak of

the sample solution corresponds to that of the

standard solution,as obtained in the assay.             Conforms

Isomer A                 ≤1.0%                                              0.01%

Isomer C                 ≤5.0%                                              2.51%

Related Substances       RRT0.86 ≤0.4%                                      0.23%

RRT0.94 ≤0.15%                                     0.06%

RRT1.06 ≤0.15%                                     0.03%

Any other Impurity ≤0.15%                             0.06%

Total of other impurities  ≤2.0%                        0.43%

Redidual Solvents         Methanol ≤0.3%                                      0.004%

Acetone ≤0.5%                                       N.D

Dichloromethane ≤0.06%                              N.D

N-hexane ≤0.029%                                   0.00006%

Ethyl acetate ≤0.5%                                   N.D

N-Heptane ≤0.5%                                     0.04%

2-Dichloroethylene≤0.5%                              N.D

Butyl acetate≤0.5%                                   N.D

Water                    ≤1.0%                                               0.17%

Residue on Ignition        ≤0.2%                                               0.06%

Heavy Metals             ≤20 ppm                                             <20 ppm

Assay                   Calculate isomer B & C of rapamycin

on anhydrous basis,98% ~102%                        99.1%                                     

 

Storage : Preserve in tight, light-resistant containers

Conclusion : The product conforms to the In-house specifications

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