| 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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