Strontium Ranelate In house

Product Name ：

Strontium Ranelate

Chemical Name：

Molecular Formula ：

C₁₂H₂₀N₂O₁₅SSr₂

Molecular Weight：

639.5966

Structurer：

CAS  RN.：

135459-87-9

Physical Character:

Off-white to yellowish crystalline powder

Functions and Usage ：

Mainly used for the treatment and prevention of osteoporosis in postmenopausal women, significantly reduce the risk of vertebral fractures and hip fractures.

Packing and Storage ：

1kg/bag   

Quality standard ：

pH     6.5～8.5   

Related Substances  Impurity Ａ≤0.5%  Single Impurity≤0.05%                    

                 Total Impurities≤1.0%

Strontium Ranelate Ethyl Ester   ≤0.2%                       

Residual Solvents    Acetone：≤0.05%      Ethanol：≤0.05%  

Loss on Drying   18.0% ～22.0%  

Heavy Metals    ≤0.002%         

Assay (Calculated on dried basis)   98.0% ～102.0%                                               

Strontium (Calculated on dried basis)         30.7～37.5%      

Executive standard：

Draft Specification of Strontium Ranelate for CFDA Submission