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API/Intermediates

Famotidine
CAS NO
HS Code
Molecular Formula C8H15N7O2S3
Molecular Weight ‎337.5 g/mol
Applications
Packing Available
TEST SPECIFICATION RESULT
Description White to pale yellowish white crystalline powder White crystalline powder
Solubility Freely soluble in dimethyl formamide,
galcial acetic acid, slightly soluble in
methanol, very slightly soluble in water,
practically insoluble in acetone, in
alcohol, in chloroform, in ether and in ethyl acetate.
Complies
Identification by IR The IR spectrum of hte test sample as KBr
pellet is concordant with IR spectrum of a
similar prepartion of Famotidine working standard
Complies
Loss on drying Not more than 0.5% 0.18%
Residue on ignition Not more than 0.1% 0.01%
Organic impurities (By HPLC)
Famotidine related compound-D Not more than 0.3% Not detected
Famotidine related compound-C Not more than 0.3% 0.009%
Famotidine cyanoamidine Not more than 0.2% Not detected
Famotidine related compound-F Not more than 0.1% 0.019%
Famotidine amidine Not more than 0.2% Not detected
Famotidine related compound-B Not more than 0.3% 0.029%
Famotidine related compound-E Not more than 0.3% Not detected
Any other individual impurity Not more than 0.1% 0.047%
Total impurities Not more than 1.0% 0.146%
Assay (By Potentiometry) Not less than 98.5% and Not more than 101.0% 100.06%
Residual solvents (By GC)
Acetone Not more than 5000 ppm Not detected
Acetic acid Not more than 5000 ppm Not detected
Benzene Not more than 2 ppm Not detected
Ethanol Not more than 5000 ppm Not detected
Hexane Not more than 290 ppm Not detected
Isopropyl alcohol Not more than 5000 ppm Not detected
Methanol Not more than 3000 ppm 529.13 ppm
Additional Test
Heavy metals Not more than 10 ppm Complies
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