Description

Metformin Impurity 16 is a high-purity 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 primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used 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: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to accurately detect and measure this specific impurity.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure drug substances and products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to monitor the formation of degradation products in Metformin formulations under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the FDA and EMA.
• Research & Development: Utilized in academic and industrial R&D to study the metabolism, degradation pathways, and toxicological profile of Metformin and its related substances.

Basic Information

Product Name	Metformin Impurity 16
CAS No.	35185-82-1
Molecular Formula	C4H11N5
Molecular Weight	129.16 g/mol
Synonyms	1-Carbamimidamido-3-methylguanidine; N-(Diaminomethylidene)-1-methylbiguanide; 1-Methylbiguanide; Metformin Impurity J; Metformin Related Compound J; Metformin EP Impurity J; Biguanide, 1-methyl-; 1-Methylbiguanidine
EINECS	Contact for details

Quality Control

Our Metformin Impurity 16 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

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
Residue on Ignition	≤ 0.1%

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