Description

Famotidine Impurity CAS NO 130463-35-3 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Famotidine. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Famotidine API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the purity and consistency of commercial Famotidine batches.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Famotidine Impurity
CAS No.	130463-35-3
Molecular Formula	C8H15N7O2S3
Molecular Weight	337.44 g/mol
Synonyms	Famotidine Related Compound; 3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide; Famotidine EP Impurity; Famotidine USP Impurity; Famotidine Process Impurity; Gaster Impurity; Pepcid Impurity
EINECS	Contact for details

Quality Control

Every batch of Famotidine Impurity (CAS 130463-35-3) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure compliance with pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.