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HOME >> API >> API List1 >> Alendronate sodium

Alendronate sodium Ph. Eur. CAS Registry Number: 121268-17-5



Alendronate sodium pdf api
structural formula:

Alendronate sodium Molecular formula: C4H12NNaO7P2, 3H2OAlendronate sodium Ph. Eur.
Specification: USP, Ph. Eur.

chemical name: (4-amino-1-hydroxybutylidene)
bisphosphonic acid monosodium salt

Molecular formula: C4H12NNaO7P2, 3H2O

molecular weight: 325.1
CAS No: 121268-17-5

General requirements
Sodium alendronate is white or almost white crystalline powder, soluble in water, practically insoluble in methanol and methylene chloride.

TESTS

REQUIREMENTS

METHODS

Identification:

A. IR spectrum

 

B. chemical reaction

 

corresponds to sodium alendronate CRS

gives reaction of sodium

Ph. Eur.

Appearance of solution

clear and not more intensely coloured than reference solution B7 or BY7

Ph. Eur.

pH

4.0 to 5.0

Ph. Eur.

Related substances (HPLC):

- impurity A

- other single impurity

- total impurities

 

not more than 0.1%

not more than 0.10%

not more than 0.5%

Ph. Eur.

Phosphate and Phosphite (HPLC):

- phosphate

- phosphite

 

not more than 0.5%

not more than 0.5%

Ph. Eur.

Heavy metals

not more than 20 ppm

Ph. Eur.

Loss on drying

16.1% to 17.1%

Ph. Eur.

Content of alendronate sodium calculated on the dried substance (HPLC)

98.0% - 102.0%

Ph. Eur.

Residual solvents:

- methanol

 

not more than 500 ppm

Information Associated with Product:
DRUG DESCRIPTION:
  USES:
  HOW TO USE:
SIDE EFFECTS:
  Pharmacology:
  Mechanism Of Action:
 
 
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