Product Portfolio with regulatory compliance

Residronate Sodium

Bulk Active : Residronate Sodiume
MOLECULAR FORMULA : C7H10NO7P2.Na
MOLECULAR WEIGHT : 305.10
Pharmacologic Activity : Anti-Osteoporosis
CAS No : 105462-24-6
Specifications : In-house
Regulatory compliance : Under preparation

TESTS SPECIFICATION
   
Appearance White to off- white powder
   
Solubility soluble in water and in aqueous solutions,insoluble in common organic solvents, freely soluble in ethanol (96%).
   

IDENTIFICATION
1] IR

2] test for sodium



IR absorbtion spectrum should be concordant with standard

Should test positive for reaction for sodium

   
water 11.9%-13.9%
   
Heavy metals
NMT 20ppm
   
Phosphite NMT 1.0%
   
Related Substance by HPLC
a) Risedronate related compound B
b) Any individual impurity
c) total impurities
d) 3-Pyridyl Acetic acid HCl
e) Related Compound A

NMT 0.1%
NMT 0.1%
NMT 0.5%
NMT 0.1%
NMT 0.1%
   
Assay by HPLC Between 98.0% to 102.0% calculated on anhydrous basis