Description

Famotidine Ep Impurity A CAS NO 124646-10-2 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient (API) Famotidine. This compound is critical for ensuring the quality, safety, and efficacy of Famotidine-based drug products by serving as a benchmark in analytical testing. It is an essential material for pharmaceutical manufacturers, quality control (QC) laboratories, and regulatory affairs departments engaged in the development, production, and compliance monitoring of generic and branded pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Famotidine Ep Impurity A in Famotidine API and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure Famotidine batches comply with pharmacopeial specifications (e.g., EP, USP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CEP) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports impurity fate and tolerance studies during the synthetic route development and process optimization of Famotidine API.

Basic Information

Product Name	Famotidine Ep Impurity A
CAS No.	124646-10-2
Molecular Formula	C8H15N7O2S3
Molecular Weight	337.44 g/mol
Synonyms	Famotidine Impurity A; Famotidine Related Compound A; 3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide; N-Sulfamoyl-3-[[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]propanimidamide; Famotidine EP Impurity A; Famotidine USP Related Compound A
EINECS	Contact for details

Quality Control

Our Famotidine Ep Impurity A is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial monographs (EP, USP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

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

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