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Home Active Pharmaceutical Ingredients bromhexine hydrochloride
BROMHEXINE HYDROCHLORIDE
Product Name : Bromhexine Hydrochloride BP/EP/USP
Chemical Name : N-(2-Amino-3,5-dibromobenzyl)-N-methylcyclohexanamine hydrochloride
CAS Number : 611-75-6
Chemical Formula : C14H20Br2N2 HCL
Molecular Mass : 412.59 g/mol
Therapeutic Category : Antimucolytic

Test Specification
Identification

IR test : Complies with standard

Thin Layer Chromatography : Complies with standard

Chemical Test : Complies with test

Primary Aromatic Amine Test : Complies with amine test

Chloride test : Complies with chloride test

Solubility

Alcohol : 100 to 1000 parts

Methylene Dichloride : 100 to 1000 parts

Water : 1000 to 10000 parts

Appearance of Solution Complies with test
Loss On Drying Not More Than : 1.0 %
Related Substances by HPLC Identified impurity :

Impurity A : NMT 0.1 %

Impurity B : NMT 0.1 %

Impurity C : NMT 0.1 %

Impurity D : NMT 0.1 %

Impurity E : NMT 0.1 %

Unknown impurity :

Impurity 1 : NMT 0.1 %

Impurity 1 : NMT 0.1 %

Characteristics White crystalline powder
UV Test 208 to 211 nm
Foreign Particles Not detected
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