Description

Cimetidine Hydrochloride is the hydrochloride salt form of cimetidine, a well-characterized 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 solid and liquid dosage forms for the treatment and management of gastric acid-related disorders.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of prescription and over-the-counter (OTC) anti-ulcer medications.
• Tablet Formulation: Used in the production of compressed and coated tablets for oral administration.
• Capsule Filling: Incorporated into hard gelatin or vegetarian capsules.
• Oral Suspensions/Syrups: Suitable for formulating liquid dosage forms, often for pediatric or geriatric use.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in laboratories.
• Research & Development: Used in preclinical and clinical studies for developing new therapeutic applications or generic formulations.

Basic Information

Product Name	Cimetidine Hydrochloride
CAS No.	70059-30-2
Molecular Formula	C10H16N6S • HCl
Molecular Weight	288.79 g/mol (as free base: 252.34 g/mol)
Synonyms	Cimetidine HCl; Cimetidine Monohydrochloride; SKF 92334; N''-Cyano-N-methyl-N'-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]guanidine Hydrochloride; 1-Cyano-2-methyl-3-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]guanidine Hydrochloride; Tagamet Hydrochloride (brand name salt form)
EINECS	Contact for details

Quality Control

Our Cimetidine Hydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to meet stringent pharmacopeial standards, including identification, purity assay, and impurity profiling. A Certificate of Analysis (COA) detailing results against relevant specifications (e.g., USP, EP, or in-house pharmacopeia) is provided with each batch to ensure traceability and compliance.

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). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White or almost white 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%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Microbial Enumeration	Meets Ph. Eur. / USP criteria

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