Alendronate sodium,active api company in taj pharmaceuticals Ltd. manufacturer,importers,exporters, suppliers, manufacturing companies, traders, producers

Alendronate sodium Molecular formula: C4H12NNaO7P2, 3H2O

Alendronate 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 B₇or BY₇

Ph. Eur.

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%

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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Api Manufacturing At Taj

Acamprosate Calcium

Clomipramine Hcl [*]

Alendronate Sodium [#]

Clonazepam [$]

Amitriptyline [$]

Clopidogrel Bisulfate

Desmopressin Monoacetate

Dothiepin Hcl [*]

Escitalopram HBr

Cefuroxime Axetil [*]

Flurbiprofen [*]

Cisplatin [*]

Fluticasone Propionate [$

Citalopram Hbr. [$]

Fluvoxamine Maleate [$]

Fosphenytoin Sodium [$]

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