Description

Famotidine Related Compound B is a high-purity chemical reference standard, essential for analytical and quality control processes in pharmaceutical development. Its primary value lies in its use as a well-characterized impurity for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Famotidine. This compound is critically needed by pharmaceutical manufacturers and contract research organizations (CROs) engaged in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify related substances in Famotidine API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, or GC analytical methods.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Famotidine formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research and Development: Facilitates synthetic route optimization and process chemistry studies by characterizing synthetic intermediates or by-products.

Basic Information

Product Name	Famotidine Related Compound B
CAS No.	89268-62-2
Molecular Formula	C8H15N7O2S3
Molecular Weight	337.44 g/mol
Synonyms	3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N-(aminosulfonyl)propanimidamide; Famotidine Impurity B; Famotidine EP Impurity B; Famotidine USP Related Compound B; 1,3-Bis(N-amidino-3-aminopropyl)-2-thiourea derivative; Guanidine, N-[2-[[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]ethyl]-N'-cyano- (9CI); Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Our Famotidine Related Compound B is manufactured and tested under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and residual solvent analysis, to ensure it meets high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.