RANITIDINE

Ranitidine
Cas #:66357-35-5
MF:C13H22N4O3S
Use:H2-antagonist
Ranitidine API
Synonyms N'-[2-[[5-(Dimethylaminomethyl)-2-furyl]methylsulfanyl]ethyl]-N-methyl-2-nitro-ethene-1,1-diamine hydrochloride
Molecular Formula C13H22N4O3S.HCl
Molecular Weight 350.87
CAS Registry Number 66357-35-5
EINECS 266-332-5
Ceitificate:GMP and COS
Color:Off-yellow powder
Use:Treatment of peptic ulcer.

Ranitidine API:
PRODUCT: RANITIDINE HYDROCHLORIDE
Batch No:0802004

Quantity:1000kgs

ITEMS
SPECIFICATION
RESULTS
Identification
Positive reaction
Positive reaction
PH
4.5-6.0
5.2
Loss on drying
Not more than 0.75%
0.10%
Residue on ignition
Not more than 0.1%
Less than 0.5%
Chromatographic purity
Ranitidine Related Compound B not more than 0.5%
Less than 0.5%
Any other impurity not more than 0.3%
Less than 0.3%
The sum of all impurities not more than 1.0%
Less than 1.0%
Organic volatile impurities
Meets the requirements
Meets the requirements
Residual solvents
Meets the requirements
Meets the requirements
Assay(dry substance)
97.5%-102.0%
99.1%
Remarks
Bulk density: 0.4054g/ml
Conclusion:Complies with the requirement of USP29 standards.



General info:Ranitidine is a histamine H2-receptor antagonist that inhibits stomach acid production. It is commonly used in treatment of peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). Ranitidine is also used alongside fexofenadine and other antihistamines for the treatment of skin conditions such as hives.

Clinical uses:Certain preparations of ranitidine are available over the counter (OTC) in various countries. In the United States, 75 mg and 150 mg tablets are available OTC. Outside of the United States, ranitidine is combined with bismuth (which acts as a mild antibiotic) as a citrate salt, to treat Helicobacter pylori infections. This combination is usually given with clarithromycin, an antibiotic.