Description

Famotidine Ep Impurity H CAS NO 106649-96-1 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 pharmaceutical products by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control of Famotidine-based drug substances and finished products.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Impurity H in Famotidine API and drug products during stability and release testing.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Batch Release: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches comply with pharmacopeial limits (e.g., EP, USP, ICH Q3A/B).
• Regulatory Compliance and Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product under various stress conditions.
• Research and Development: Used in R&D laboratories for studying the degradation pathways and chemistry of Famotidine.

Basic Information

Product Name	Famotidine Ep Impurity H
CAS No.	106649-96-1
Molecular Formula	C8H15N7O2S3
Molecular Weight	329.42 g/mol
Synonyms	Famotidine Impurity H; Famotidine Related Compound H; 3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide; N-Sulfamoyl-3-[[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]propanimidamide; Famotidine Sulfoxide; Famotidine EP Impurity H
EINECS	Contact for details

Quality Control

Our Famotidine Ep Impurity H is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) that detail purity, impurity profiles, and results from all specified tests, supporting compliance with ICH guidelines and major pharmacopeias (EP, USP).

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.