Description

Famotidine Related Compound A Hydrochloride is a high-purity chemical reference standard critical for analytical and quality control processes in the pharmaceutical industry. This compound serves as a key impurity marker for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Famotidine. It is an essential material for analytical chemists, quality assurance professionals, and researchers involved in pharmaceutical development and manufacturing. Precise identification and quantification of this related substance are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Famotidine Related Compound A in bulk drug substances and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for impurity analysis.
• Quality Control and Release Testing: A critical component in the routine QC testing of Famotidine API to ensure compliance with pharmacopeial monographs (e.g., USP, EP, JP).
• Stability Studies: Employed to monitor the formation of degradation impurities in Famotidine products under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to synthesize high-purity Famotidine.

Basic Information

Product Name	Famotidine Related Compound A Hydrochloride
CAS No.	76833-47-1
Molecular Formula	C8H15N7O2S2 • HCl
Molecular Weight	350.84 g/mol
Synonyms	N-(Aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide Hydrochloride; Famotidine Impurity A HCl; Famotidine EP Impurity A Hydrochloride; Famotidine USP Related Compound A Hydrochloride; 3-[[[2-[(Diaminomethylene)amino]-4-thiazolyl]methyl]thio]-N-(sulfamoyl)propanimidamide Hydrochloride; Famotidine Related Substance A HCl; GYH3Q2V4FV (UNII Code)
EINECS	Contact for details

Quality Control

Our Famotidine Related Compound A Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of specific impurities. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results, chromatograms, and traceability information. The product is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity during use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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