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71130-06-8 Ranitidine hydrochloride Digestive system medication
Certain preparations of ranitidine are available (OTC) in various countries. In the United States, 75 mg and 150 mg tablets are available OTC. Zantac OTC is manufactured by . In Australia, packs containing 7 or 14 doses of the 150 mg tablet are available in supermarkets, small packs of 150 mg and 300 mg tablets are . Larger doses and pack sizes still require a prescription.
Outside of the United States, ranitidine is combined with (which acts as a mild ) as a salt (ranitidine bismuth citrate, Tritec), to treat infections. This combination is usually given with , an antibiotic.
Item |
Requirements |
Test Results |
Appcarance |
White Similar Yellow Crystalline Powder |
Complies |
Identification |
IR Should conform UV Should conform Water liquor show chloride |
Complies |
PH |
4.5~6.0 |
5.6 |
Loss on drying |
≤0.75% |
0.10% |
Related substances(TLC) |
Single Impurity ≤0.3% Total Impurity ≤1.0% |
Complies |
Appearance of solution |
The solution is clear and not more Intensely coloured than reference solution BY5 |
Complies |
Residue on ignition |
≤0.1% |
0.04% |
Organic volatile impurities |
≤0.5% |
0.07% |
Assay |
97.5~102% |
99.78% |
conclusion |
Meets the Requirements |
General Information:
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.
People often take prescription ranitidine to treat:
Duodenal ulcers
Gastric ulcers (stomach ulcers)
Over-the-counter ranitidine is approved for the following conditions:
Heartburn
Acid indigestion
Sour stomach.
Ranitidine comes in the form of a tablet and is taken one to four times a day, depending on the condition being treated. It belongs to a class of drugs known as H2 blockers
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