Description

Famotidine Acid Impurity Methyl Ester CAS NO 76824-14-1 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) famotidine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific process-related impurity, ensuring drug safety and efficacy. It is an essential material for research and development, method validation, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the methyl ester impurity in famotidine API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC analytical methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of famotidine products.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and impurity formation mechanisms of famotidine.

Basic Information

Product Name	Famotidine Acid Impurity Methyl Ester
CAS No.	76824-14-1
Molecular Formula	C9H15N7O2S2
Molecular Weight	317.40 g/mol
Synonyms	Famotidine Methyl Ester; Famotidine Related Compound C; 3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidic Acid Methyl Ester; 2-[2-(Diaminomethylideneamino)-1,3-thiazol-4-ylmethylsulfanyl]-N-sulfamoylethanimidate; Famotidine EP Impurity C; Famotidine USP Related Compound C; Famotidine Acid Methyl Ester Impurity
EINECS	Contact for details

Quality Control

Every batch of Famotidine Acid Impurity Methyl Ester is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards (USP/EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters is provided with each shipment to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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