Description

Metformin Impurity 10 is a specified impurity and degradation product of the widely used antidiabetic drug, Metformin Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation, stability studies, and quality control of the active pharmaceutical ingredient (API). It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring drug safety, purity, and compliance with stringent pharmacopeial standards such as USP, EP, and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use 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): Crucial for developing, validating, and verifying chromatographic methods to ensure specificity, accuracy, and robustness in impurity profiling.
• Stability and Forced Degradation Studies: Used to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Quality Control & Batch Release Testing: Enables precise impurity monitoring during API manufacturing to ensure every batch meets predefined specification limits.
• Regulatory Submissions & Compliance: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research on Metformin Metabolism & Pharmacokinetics: Potential use in studies investigating the metabolic pathways and pharmacokinetic profile of Metformin.

Basic Information

Product Name	Metformin Impurity 10
CAS No.	26690-75-5
Molecular Formula	C4H11N5
Molecular Weight	129.16 g/mol
Synonyms	1-Carbamimidamido-2-(diaminomethylideneamino)ethane; N''-(Diaminomethylidene)-1,1-dimethylbiguanide; Biguanide, N-(aminoiminomethyl)-N'-(1,1-dimethylethyl)-; Metformin Impurity J; Metformin Related Compound J; 1,1-Dimethylbiguanide impurity; N-(Aminoiminomethyl)-N'-(1,1-dimethylethyl)biguanide
EINECS	Contact for details

Quality Control

Every batch of Metformin Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, traceability, and analytical methods. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.