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Home » Active Pharmaceuticals Ingredients » Nortriptyline Hydrochloride

Nortriptyline Hydrochloride

Product Name Nortriptyline Hydrochloride BP/EP/USP
Chemical Name 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-,hydrochloride
CAS Number 894-71-3
Chemical Formula C19H22ClN
Molecular Mass 294.84 g/mol
Therapeutic Category antidepressant

Specification of Nortriptyline Hydrochloride :

Test Specification
Appearance A white or almost white powder
solubility Sparingly soluble in water, soluble in alcohol and in methylene chloride.
Identification
First Identification


Second Identification

Infrared absorption Comparing with the spectrum (as KBr disk) obtained with Nortriptyline hydrochloride reference standard (working standard)
Test for chlorides Should be positive for chloridesTest for chlorides Should be positive for chlorides
A) Melting point (°c) Between 216 and 220
B) Specific Absorbance 465 to 495 at 239nm
C) Chemical test A red colour develops slowly
D) Test for chlorides Should be positive for chlorides
Tests
Appearance of the solution
Acidity (or) Alkalinity

Related substance (By TLC %)

The solution is clear and not more intensely coloured than reference solution B7
The solution is yellow
The solution is red
Dibenzosuberone NMT 0.05
Any other spot(other than Dibenzosuberone ) NMT 0.1
Heavy metals (ppm) NMT 20
Loss on drying (%w/w) NMT 0.5
Sulphated ash NMT 0.1
Assay (By titrimetry, %, w/w, on dried basis) NLT 98.0 and NMT the equivalent of 101.0

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Perindopril

Product Name Perindopril BP/EP/USP
Chemical Name (2S,3aS,7aS)-1-[(2S)-2-{[(2S)-1-ethoxy-1-oxopentan-2-yl]amino}propanoyl]-octahydro-1H-indole-2-carboxylic acid
CAS Number 82834-16-0
Chemical Formula C19H32N2O5 
Molecular Mass 368.47 g/mol
Therapeutic Category Antihypertensive





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Progunil HCL

Product Name Progunil HCL BP/EP/USP
Chemical Name 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride
CAS Number 637-32-1
Chemical Formula C11H17Cl2N5
Molecular Mass 290.19 g/mol
Therapeutic Category Antimalarial

Specification of Progunil :

Test Specification
Description White crystalline powder, odorless.
Solubility Practically insoluble in chloroform and ether, slightly soluble in water soluble in ethanol
Identification Test A,B,C & D should be comply
Acidity or Alkalinity NMT 0.2%
Sulphated Ash NMT 0.1% w/w
4-Chloro Aniline NMT 250 PPM
Loss on drying
@ 105oC for 3 hrs
NMT 0.5% w/w
Related Substances By HPLC 1. Single Impurity : NMT 0.7%
2. Total Impurity : NMT 1.0%
Assay NLT 98.5% w/w and NMT equivalent of 101.0% w/w of C11H16CLN5, HCL calculated with references to the dried substances

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