Description

Cimetidine Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Cimetidine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining drug efficacy and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cimetidine API batches.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Pharmacopeial Compliance: Supports testing to meet the specifications of USP, EP, BP, and other international pharmacopeias.
• Stability Studies: Employed in forced degradation and long-term stability studies of Cimetidine formulations to monitor impurity profiles.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Cimetidine.

Basic Information

Product Name	Cimetidine Impurity 3
CAS No.	208447-53-4
Molecular Formula	C10H16N6S
Molecular Weight	252.34 g/mol
Synonyms	1-Cyano-2-methyl-3-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]guanidine; Cimetidine Impurity C; Cimetidine Related Compound C; N-Cyano-N'-methyl-N''-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]guanidine; Guanidine, N-cyano-N'-methyl-N''-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]-
EINECS	Contact for details

Quality Control

Every batch of Cimetidine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and other relevant regulatory guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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