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