Description

Metformin Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antidiabetic drug Metformin. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for ensuring drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Metformin API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Assurance & Control (QA/QC): Serves as a system suitability standard in routine quality control testing to ensure the accuracy and precision of impurity assays.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing data for impurity characterization and establishing specification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies of Metformin to track the formation and levels of this specific impurity over time.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic profiles of Metformin.

Basic Information

Item	Detail
Product Name	Metformin Impurity 7
CAS No.	4390-68-5
Molecular Formula	C4H11N5
Molecular Weight	129.16 g/mol
Synonyms	1-Carbamimidamido-3-methylguanidine; N''-(Diaminomethylidene)-1-methylbiguanide; 1-Methylbiguanide; Metformin Impurity G; Metformin Related Compound G; N-Methylbiguanide; Biguanide, 1-methyl-; 1-Methylbiguanidine
EINECS	Contact for details

Quality Control

Every batch of Metformin Impurity 7 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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