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Home Active Pharmaceutical Ingredients amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Product Name : Amitriptyline Hydrochloride BP/EP/USP
Chemical Name : 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N dimethyl-,hydrochloride
CAS Number : 549-18-8
Chemical Formula : C20H23N.HCl
Molecular Mass : 313.86 g/mol
Therapeutic Category : Antidepressant

Test Specification
Description white or practically white, odorless or practically odorless, crystalline powder or small crystals
Identification

BY IR

BY UV

Test for Chloride

Solubility Freely soluble in water, in alcohol and in Chloroform, and in methanol, insoluble in ether.
Heavy Metals Not more than 0.001%
Ph (1% Solution) Between 5.0 and 6.0
Loss On Drying Not more than 0.5%
Assay on dried basis by HPLC Between 99 % w/w to 100.5 % w/w
Related Substances by TLC

Any secondary spot : NMT 0.5%

Sum of all secondary spots : NMT 1.0%

Melting Range Between 195.0°C to 199.0°C
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