CAS number:
Molecular formula: C13H22N4O3S
molecular weight: 314.404 g/mol
Chemical structure:
SR. NO. | TEST | SPECIFICATION | RESULT | |||||||||||
1 | Description | White to pale yellow practically odourless crystalline powder | WHITE, PRACTICALLY ODOURLESS CRYSTALLINE POWDER | |||||||||||
2 | Solubility | Very soluble in water, sparingly soluble in alcohol. | COMPLIES | |||||||||||
3 | Identification (197M) (197U) (191) | Infrared Absorption, Ultraviolet Absorption and A solution of it meets the requirements of the tests for Chlorides | COMPLIES | |||||||||||
4 | pH (1 in 100) (791) | 4.5 to 6.0 | 5.68 | |||||||||||
5 | Chromatographic purity ( By HPLC ) (621) | |||||||||||||
a) Ranitidine bis-compound(Imp-B) | NMT 0.3% | 0.20% | ||||||||||||
b) Ranitidine simple nitroacetamide | NMT 0.1% | NOT DETECTED | ||||||||||||
c) Ranitidine oxime | NMT 0.1% | NOT DETECTED | ||||||||||||
d) Ranitidine amino alcohol hemifumarate | NMT 0.1% | NOT DETECTED | ||||||||||||
e) Ranitidine diamine hemifumarate (Imp-A) | NMT 0.1% | NOT DETECTED | ||||||||||||
f) Ranitidine S-oxide (Imp-C) | NMT 0.1% | NOT DETECTED | ||||||||||||
g) Ranitidine N-oxide | NMT 0.1% | 0.05% | ||||||||||||
h) Ranitidine complex nitroacetamide | NMT 0.1% | NOT DETECTED | ||||||||||||
i) Ranitidine formaldehyde adduct | NMT 0.1% | NOT DETECTED | ||||||||||||
j) Major / Largest single unknown Impurity | NMT 0.1% | BELOW DISREGARD LIMIT | ||||||||||||
k) Total impurities | NMT 0.5% | 0.25% | ||||||||||||
6 | Loss on drying (731) | NMT 0.75% | 0.23% | |||||||||||
7 | Residue on ignition (281) | NMT 0.10% | 0.05% | |||||||||||
8 | Assay ( Dry basis ) (621) | 97.5 % - 102.0 % | 99.94% | |||||||||||
9 | Residual solvents ( in ppm ) (467) | 1 Chloroform NMT 60 ppm | 19 ppm | |||||||||||
2. Isopropyl alcohol NMT 5000 ppm | 859 ppm | |||||||||||||
Melting range (In house) | ABOUT 140 0C | 140 °C | ||||||||||||
2* | Clarity: 10% Soln:430 nm (In house) | NMT 0.2 | 0.071 | |||||||||||
3* | Bulk density (In house) Untapped Tapped (1250) | 0.40 + 0.2 gm / ml | 0.46 gm / ml | |||||||||||
0.55 + 0.2 gm / ml | 0.59 gm / ml | |||||||||||||
4* | Particles % by weight | NLT 90 % PASS THROUGH 80 mesh | 99.46 % PASS THROUGH 80 mesh |