Description

Ranitidine Hydrochloride is the hydrochloride salt form of ranitidine, a histamine H2-receptor antagonist. This active pharmaceutical ingredient (API) is critical for the formulation of medications designed to reduce stomach acid production. It is primarily utilized by pharmaceutical manufacturers in the production of solid oral dosage forms for the treatment and prevention of peptic ulcers, gastroesophageal reflux disease (GERD), and other acid-related gastrointestinal conditions. Our supply meets the stringent quality standards required for global pharmaceutical applications.

Application

• Pharmaceutical API: Core active ingredient in prescription and over-the-counter anti-ulcer and acid-reflux medications.
• Tablet Formulation: Used in the manufacture of coated and uncoated oral tablets for precise dosing.
• Capsule Formulation: Incorporated into hard gelatin or vegetarian capsules.
• Generic Drug Production: Serves as a key component for manufacturers of generic ranitidine-based therapeutics.
• Clinical Research: Employed in R&D for developing new gastrointestinal treatments and comparative studies.
• Veterinary Pharmaceuticals: Used in formulations for treating acid-related disorders in animals.

Basic Information

Product Name	Ranitidine Hydrochloride
CAS No.	71130-06-8
Molecular Formula	C13H22N4O3S·HCl
Molecular Weight	350.86 g/mol
Synonyms	Ranitidine HCl; N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine Hydrochloride; Zantac Hydrochloride; AH 19065; Ranitidinium Chloride; 1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-, monohydrochloride
EINECS	Contact for details

Quality Control

Our Ranitidine Hydrochloride is manufactured and tested under a strict quality management system. It is produced to meet relevant pharmacopoeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia). Each batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting all test results and confirming compliance with specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to prevent degradation and clumping.

Specification

Item	Specification
Appearance	White to pale yellow crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (on dried basis)	98.0% - 102.0%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.