Ranitidine

CAS number:

Molecular formula: C13H22N4O3S

molecular weight: 314.404 g/mol

Chemical structure:

SR. NO.TESTSPECIFICATIONRESULT
1DescriptionWhite to pale yellow practically odourless crystalline powderWHITE, PRACTICALLY ODOURLESS CRYSTALLINE POWDER
2SolubilityVery soluble in water, sparingly soluble in alcohol.COMPLIES
3Identification (197M) (197U) (191)Infrared Absorption, Ultraviolet Absorption and A solution of it   meets the requirements of the tests for ChloridesCOMPLIES
4pH (1 in 100) (791)4.5  to 6.05.68
5Chromatographic purity ( By HPLC ) (621)
a) Ranitidine bis-compound(Imp-B)NMT 0.3%0.20%
b) Ranitidine simple nitroacetamideNMT 0.1%NOT DETECTED
c) Ranitidine oximeNMT 0.1%NOT DETECTED
d) Ranitidine amino alcohol hemifumarateNMT 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-oxideNMT 0.1%0.05%
h) Ranitidine complex nitroacetamideNMT 0.1%NOT DETECTED
i)    Ranitidine formaldehyde adductNMT 0.1%NOT DETECTED
j)    Major / Largest single unknown ImpurityNMT 0.1%BELOW DISREGARD LIMIT
k) Total impuritiesNMT 0.5%0.25%
6Loss on drying (731)NMT 0.75%0.23%
7Residue on ignition (281)NMT 0.10%0.05%
8Assay ( Dry basis ) (621)97.5 % - 102.0 %99.94%
9Residual solvents ( in ppm ) (467)1 Chloroform        NMT 60 ppm19 ppm
2. Isopropyl   alcohol   NMT 5000 ppm859 ppm


Melting range (In house)ABOUT 140 0C140 °C
2*Clarity: 10% Soln:430 nm (In house)NMT 0.20.071
3*Bulk density (In house) Untapped Tapped (1250)0.40 + 0.2   gm / ml
   
0.46 gm /   ml
     
   
0.55 + 0.2 gm / ml0.59 gm / ml
4*Particles % by weightNLT 90 % PASS THROUGH 80    mesh99.46 % PASS THROUGH 80 mesh