Description

Ranitidine Hydrochloride is the hydrochloride salt form of ranitidine, a potent histamine H₂-receptor antagonist. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers in the production of medications for the treatment and prevention of gastric acid-related disorders.

Application

• Pharmaceutical API: Core active ingredient in prescription and over-the-counter anti-ulcer medications.
• Tablet Formulation: Used in the manufacture of solid oral dosage forms for the treatment of peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome.
• Capsule Production: Incorporated into capsule formulations for controlled and effective delivery.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical testing in pharmaceutical laboratories.
• Research & Development: Used in preclinical and clinical studies for developing new gastrointestinal therapeutics.
• Veterinary Pharmaceuticals: Applied in formulations for treating similar gastric conditions in animals.

Basic Information

Product Name	Ranitidine Hydrochloride
CAS No.	70956-04-6
Molecular Formula	C13H22N4O3S·HCl
Molecular Weight	350.86 g/mol
Synonyms	Ranitidine HCl; Ranitidine Hydrochloride; Zantac (trade name); AH 19065; N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine Hydrochloride; 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 under strict quality management systems. Each batch is tested to ensure compliance with major pharmacopoeial standards such as USP, EP, and BP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing parameters including assay, related substances, residual solvents, and microbiological quality.

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). 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 to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets EP/USP requirements

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