Strontium Ranelate
 

MOLECULAR WEIGHT: 513.49 MOLECULAR FORMULA: C12H6N2O8S Sr2 .8H2O

alendronate sodium

Tests In House Specifications
Description Pale yellow to yellow powder
Solubility Sparingly soluble in 1% Hydrochloric acid.
IDENTIFICATION
IR
 TLC
Infrared absorption spectrophotometry to compare with the spectrum obtained with Reference Standard In test for assay, retention time of principal peak from sample should match that of working standard sample
pH 6.5-7.8
Loss on drying 20.0% to 24.0% w/w
Related Substance by HPLC)
Single impurity
Total Impurity

NMT 0.50%
NMT 1.00%
Assay.By HPL ( On dried basis) Between 97.0% and 101.0% w/w
Strontium content Between 25.0-28.0%w/w

 

 

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