Description

Proguanil Related Compound C (25 Mg) (1,5-Bis(4-Chlorophenyl)Biguanide Hydrochloride) is a high-purity reference standard and pharmaceutical intermediate. This compound is critical for analytical research, method development, and quality control processes in the pharmaceutical industry. It is primarily utilized by researchers, analytical laboratories, and manufacturers involved in the development and production of antimalarial drugs and related APIs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of Proguanil and its formulations.
• Analytical Research: Essential for developing and validating chromatographic methods (HPLC, LC-MS) in quality control laboratories.
• Impurity Control: Serves as a specified impurity marker to ensure the purity and safety of Proguanil Active Pharmaceutical Ingredients (APIs).
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research related to biguanide antimalarial compounds.
• Process Development: Used in the research and scale-up of synthetic routes for Proguanil and related chemical entities.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing a characterized impurity for drug master files (DMFs).

Basic Information

Product Name	Proguanil Related Compound C (25 Mg) (1,5-Bis(4-Chlorophenyl)Biguanide Hydrochloride)
CAS No.	13590-98-2
Molecular Formula	C15H15Cl2N5•HCl
Molecular Weight	372.68 g/mol
Synonyms	1,5-Bis(4-Chlorophenyl)biguanide Hydrochloride; N1-(4-Chlorophenyl)-N5-(4-chlorophenyl)biguanide Hydrochloride; Proguanil Impurity C; Chloroguanide Related Compound C; Chloroguanide Impurity C; Biguanide, 1,5-bis(p-chlorophenyl)-, monohydrochloride; NSC 3061
EINECS	Contact for details

Quality Control

Our Proguanil Related Compound C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for reference standards. A detailed Certificate of Analysis (COA) is provided, confirming specifications for identity, assay, and related substances. Our quality commitment supports compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.