Description

Famotidine Amide Impurity is a key chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Famotidine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Famotidine API and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity profiles as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Famotidine to monitor the formation of related substances.
• Pharmaceutical Research: Used in academic and industrial research to study the degradation pathways and metabolism of Famotidine.
• Quality Control Testing: Serves as a system suitability component in routine batch release testing of Famotidine to ensure analytical method performance.

Basic Information

Product Name	Famotidine Amide Impurity
CAS No.	76824-16-3
Molecular Formula	C8H15N7O2S2
Molecular Weight	305.38 g/mol
Synonyms	N-(Aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide; Famotidine Related Compound A; Famotidine Amide; 3-[[[2-[(Diaminomethylene)amino]-4-thiazolyl]methyl]thio]-N-(sulfamoyl)propanimidamide; 1-Amino-1-imino-N-(sulfamoyl)-3-[[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]propan-2-amine; GYH-209; Famotidine Impurity A
EINECS	Contact for details

Quality Control

Our Famotidine Amide Impurity is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch undergoes rigorous identity, purity, and assay testing via validated methods such as HPLC, NMR, and mass spectrometry to ensure compliance with pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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.