Description

n-Cyano-3-(Cyanoamino)-N'-Methyl-7,8-Dithia-2,4,11-Triazadodec-2-En-12-Imidamide (Cimetidine Impurity) is a structurally defined organic compound of significant importance in pharmaceutical quality control. It serves as a critical reference standard for the analysis and validation of the widely used H2-receptor antagonist, Cimetidine. This impurity is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Cimetidine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Cimetidine meets specified purity criteria as per USP, EP, ICH, or other regulatory guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) during drug shelf-life studies.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., Drug Master Files, ANDAs) by providing necessary impurity characterization data.
• Research & Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemistry of Cimetidine.

Basic Information

Product Name	n-Cyano-3-(Cyanoamino)-N'-Methyl-7,8-Dithia-2,4,11-Triazadodec-2-En-12-Imidamide (Cimetidine Impurity)
CAS No.	74886-59-2
Molecular Formula	C9H14N8S2
Molecular Weight	298.39 g/mol
Synonyms	Cimetidine Impurity; Cimetidine Related Compound; 1-Cyano-2-methyl-3-[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]-; 1-Cyano-2-methyl-3-[2-[(5-methylimidazol-4-ylmethyl)sulfanyl]ethyl]guanidine; C9H14N8S2 (CAS 74886-59-2); Cimetidine Degradant
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured and controlled under a strict quality management system. Each batch is characterized and tested using advanced analytical techniques including HPLC, NMR, and Mass Spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (CoA) is supplied, providing batch-specific data and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures reliability for your most demanding analytical and regulatory 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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (IR)	Conforms to Reference Spectrum
Identification (HPLC)	Retention time corresponds to Reference Standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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