Description

Cimetidine Impurity 12 is a specified impurity of the widely used pharmaceutical Cimetidine, an H2-receptor antagonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and ensuring the purity and safety of Cimetidine drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cimetidine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels against ICH Q3A/B guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (heat, light, humidity) as per ICH Q1A stability testing protocols.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to agencies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Cimetidine.

Basic Information

Product Name	Cimetidine Impurity 12
CAS No.	75850-09-8
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 Metabolite; Cimetidine Related Compound; Cimetidine Degradant; Cimetidine Process Impurity; Guanidine, 1-cyano-2-methyl-3-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]-; 1-Cyano-2-methyl-3-(2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl)guanidine
EINECS	Contact for details

Quality Control

Every batch of Cimetidine Impurity 12 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, GC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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