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 |