Description

Famotidine Acid Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) famotidine. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract manufacturing organizations (CMOs) involved in the production of anti-ulcer medications.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify this specific acid-related impurity in famotidine API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurity levels throughout the manufacturing process.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of degradation products and establish shelf-life specifications.
• Quality Control and Batch Release: Serves as a primary standard in QC laboratories to ensure that every batch of famotidine meets stringent pharmacopeial limits (e.g., USP, EP, ICH Q3A/B) for related substances.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of famotidine under various environmental conditions.

Basic Information

Product Name	Famotidine Acid Impurity
CAS No.	107880-74-0
Molecular Formula	C8H15N7O2S3
Molecular Weight	337.44 g/mol
Synonyms	Famotidine Related Compound A; Famotidine Impurity A; 3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide; N-Sulfamoyl-3-[[2-(diaminomethylideneamino)-1,3-thiazol-4-yl]methylsulfanyl]propanimidamide; Famotidine Acid Degradant; Famotidine Process Impurity
EINECS	Contact for details

Quality Control

Our Famotidine Acid Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, mass spectrometry, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents, supporting compliance with ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an 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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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