Home » Active Pharmaceuticals Ingredients » 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 |
| 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 |
| 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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