Description

Proguanil Related Compound D (25 Mg) (1,5-Bis(1-Methylethyl)Biguanide Hydrochloride) is a high-purity analytical reference standard used for pharmaceutical research and quality control. This compound is critical for ensuring the accuracy and reliability of analytical methods, particularly in the development and monitoring of antimalarial drugs. It is primarily utilized by research scientists, analytical laboratories, and quality assurance professionals in the pharmaceutical and life sciences industries.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification, purity assessment, and quantification of Proguanil and its related substances in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH and pharmacopeial guidelines.
• Impurity Profiling & Control: Used to identify, characterize, and monitor specified impurities and degradation products in Proguanil-based formulations to ensure drug safety and efficacy.
• Quality Control & Assurance (QC/QA): A key component in routine quality control testing within pharmaceutical manufacturing to comply with strict regulatory standards (e.g., USP, EP).
• Metabolism and Pharmacokinetic Studies: Employed in research to study the metabolic pathways, stability, and pharmacokinetic profile of Proguanil and its derivatives.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and analytical procedure suitability.

Basic Information

Product Name	Proguanil Related Compound D (25 Mg) (1,5-Bis(1-Methylethyl)Biguanide Hydrochloride)
CAS No.	35708-82-8
Molecular Formula	C9H22ClN5
Molecular Weight	235.76 g/mol
Synonyms	1,5-Diisopropylbiguanide Hydrochloride; N1,N5-Diisopropylbiguanide Hydrochloride; Proguanil Impurity D; Chloroguanide Related Compound D; 1,5-Bis(isopropyl)biguanide Hydrochloride; Biguanide, 1,5-bis(1-methylethyl)-, hydrochloride; Paludrine Impurity D
EINECS	Contact for details

Quality Control

Our Proguanil Related Compound D is manufactured under strict quality management systems to ensure it meets the exacting requirements of analytical reference standards. Each batch undergoes comprehensive testing, including identification, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry. A Certificate of Analysis (COA) is provided, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines. We are committed to supplying materials that support your regulatory and research needs with uncompromised traceability and reliability.

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 low-humidity environment to prevent degradation. For long-term stability, consider storage under inert atmosphere.

Specification

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