Description

Metformin Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Metformin hydrochloride, a first-line medication for type 2 diabetes. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this impurity standard for method development, validation, and routine quality control testing. Its availability supports the stringent impurity profiling mandated in modern pharmacopeial monographs.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Metformin API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Metformin formulations under various stress conditions.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Pharmacopeial Testing: Supports testing in compliance with USP, EP, BP, and other international pharmacopeia standards for Metformin.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Metformin.

Basic Information

Product Name	Metformin Impurity 9
CAS No.	786681-13-8
Molecular Formula	C4H11N5
Molecular Weight	129.16 g/mol
Synonyms	1-Carbamimidamido-N,N-dimethylmethanimidamide; Biguanide, N''-cyano-N,N-dimethyl-; N-Cyano-N',N'-dimethylbiguanide; Dimethylbiguanide cyanoguanidine derivative; Metformin Cyanoguanidine Impurity; Metformin Related Compound 9
EINECS	Contact for details

Quality Control

Every batch of Metformin Impurity 9 (CAS 786681-13-8) is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, listing batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at 2-8°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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