Description

Metformin Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the widely used anti-diabetic drug, Metformin Hydrochloride, by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in the development and production of Metformin and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Metformin Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity detection and separation.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Metformin formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and toxicological profiling of Metformin-related substances.

Basic Information

Product Name	Metformin Impurity 11
CAS No.	32151-75-0
Molecular Formula	C4H11N5
Molecular Weight	129.16 g/mol
Synonyms	1-Carbamimidamido-1-iminomethanimidamide; Biguanide, N''-cyano-; Cyanoguanidine, polymer with biguanide; Metformin Related Compound; N-Cyanobiguanide; N-Cyanoguanidine, polymer with biguanide; Metformin Impurity G (EP); Metformin EP Impurity G
EINECS	Contact for details

Quality Control

Our Metformin Impurity 11 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (EP, USP) and ICH specifications.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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