Description

Cimetidine Dihydrochloride Impurity D is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Cimetidine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development and production of H2-receptor antagonist drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Cimetidine API and finished dosage forms.
• Quality Control & Assurance: Essential for HPLC, UPLC, and GC method development and validation to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in Cimetidine formulations under various stress conditions.
• Research & Development: Utilized in synthetic chemistry and analytical research to study the degradation pathways and metabolism of Cimetidine.

Basic Information

Product Name	Cimetidine Dihydrochloride Impurity D
CAS No.	59660-24-1
Molecular Formula	C10H16N6S • 2HCl
Molecular Weight	345.27 g/mol
Synonyms	Cimetidine Dihydrochloride Related Compound D; Cimetidine Impurity D; 2-Cyano-1-methyl-3-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]guanidine Dihydrochloride; N''-Cyanomethyl-N-methyl-N'-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]guanidine Dihydrochloride; Guanidine, N-cyano-N'-methyl-N''-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]-, dihydrochloride; Cimetidine EP Impurity D; Cimetidine USP Related Compound D
EINECS	Contact for details

Quality Control

Our Cimetidine Dihydrochloride Impurity D is manufactured under strict quality systems to ensure high purity and batch-to-batch reproducibility, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, NMR, and MS. We support compliance with ICH guidelines and pharmacopeial standards (USP, EP).

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.10%
Total Impurities	≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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