Description

Ranitidine Hydrochloride is a histamine H2-receptor antagonist widely recognized for its therapeutic efficacy. This active pharmaceutical ingredient (API) is critical for the formulation of medications that effectively manage and treat gastric acid-related disorders. It is essential for pharmaceutical manufacturers, research institutions, and developers of generic drugs targeting the global healthcare market.

Application

• Pharmaceutical API: Primary active ingredient in prescription and over-the-counter formulations for treating ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome.
• Generic Drug Manufacturing: Core component for producing bioequivalent versions of branded ranitidine medications.
• Clinical Research: Used in pharmacological studies and the development of new dosage forms or combination therapies.
• Veterinary Medicine: Employed in formulations for treating acid-related disorders in animals.
• Reference Standard: Serves as a high-purity standard for quality control and analytical testing in laboratories.

Basic Information

Product Name	Ranitidine Hydrochloride
CAS No.	66357-59-3
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 (as hydrochloride salt); 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. We ensure compliance with major pharmacopoeial standards, including USP and EP monographs. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to guarantee it meets the stringent requirements for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to pale yellow, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Specific Rotation	Contact for details

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