Description

[3-[[[2-(Diaminomethyleneamino)-4-Thiazolyl]Methyl]Thio]Propionyl]Sulfamide Hydrochloride (Famotidine Impurity) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) famotidine by serving as a key impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial standards and regulatory filings.

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, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in the batch release testing of famotidine to ensure it meets pharmacopeial specifications (e.g., USP, EP, JP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation and levels of this specific degradation product during forced degradation and long-term stability studies of famotidine.
• Research & Development: Used in R&D laboratories to study the degradation pathways, synthesis impurities, and metabolism of famotidine.

Basic Information

Product Name	[3-[[[2-(Diaminomethyleneamino)-4-Thiazolyl]Methyl]Thio]Propionyl]Sulfamide Hydrochloride (Famotidine Impurity)
CAS No.	76824-17-4
Molecular Formula	C9H15ClN6O3S3
Molecular Weight	402.90 g/mol
Synonyms	Famotidine Impurity; Famotidine Related Compound; 3-(((2-((Diaminomethylene)amino)-4-thiazolyl)methyl)thio)-N-(aminosulfonyl)propanamide Hydrochloride; N-(Aminosulfonyl)-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)propanamide Hydrochloride; GYH-3-001 Hydrochloride; GYH 3-001 Hydrochloride
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality control conditions to ensure batch-to-batch consistency and reliability. Each lot is characterized using advanced analytical techniques including HPLC, NMR, and Mass Spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing the results of all specified tests. Our quality system is designed to support compliance with cGMP and relevant ICH guidelines for impurities in pharmaceutical substances.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

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%
Residue on Ignition	≤ 0.2%

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