Description

Famotidine Ep Impurity A CAS NO 88061-72-7 is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of the active pharmaceutical ingredient (API) Famotidine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by serving as a benchmark in analytical testing. It is an essential material for analytical laboratories, quality assurance departments, and research & development teams within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the accurate identification and quantification of Famotidine Ep Impurity A in drug substances and finished products.
• Method Development and Validation: Serves as a critical standard in developing and validating analytical methods, such as HPLC and UPLC, for impurity detection in compliance with ICH guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC testing of Famotidine API to monitor and control impurity levels, ensuring batches meet pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Used to assess the degradation pathways of Famotidine under various stress conditions, helping to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research on Synthesis Pathways: Aids in chemical research to understand and optimize Famotidine synthesis, minimizing the formation of this specific impurity.

Basic Information

Product Name	Famotidine Ep Impurity A
CAS No.	88061-72-7
Molecular Formula	C8H15N7O2S3
Molecular Weight	337.44 g/mol
Synonyms	Famotidine Related Compound A; 3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide; Famotidine Impurity A; EP Impurity A of Famotidine; USP Related Compound A of Famotidine; 1,1-Diamino-3-[[2-(diaminomethylideneamino)-1,3-thiazol-4-yl]methylsulfanyl]-2-nitroso-2-sulfanylidenepropane; Guanidine, N-[2-[[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]ethyl]-N'-sulfonyl-
EINECS	Contact for details

Quality Control

Our Famotidine Ep Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopoeial guidelines. Our quality commitment ensures reliability for your most critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term stability, consider storage under inert atmosphere.

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.