Description

Metformin Impurity 13 is a specified impurity of the widely prescribed antidiabetic drug, Metformin Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control testing. It is essential for manufacturers, contract research organizations (CROs), and regulatory bodies to ensure the purity, safety, and efficacy of Metformin API and its finished dosage forms.

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).
• Analytical Method Development & Validation: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing of Metformin API and finished drug products to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) dossiers with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Metformin to minimize the formation of this impurity.

Basic Information

Product Name	Metformin Impurity 13
CAS No.	847373-57-3
Molecular Formula	C4H11N5
Molecular Weight	129.16 g/mol
Synonyms	1-Carbamimidamido-2-(diaminomethylideneamino)ethane; N''-(Diaminomethylidene)-N-(diaminomethylidene)ethane-1,2-diamine; Biguanide, N-(aminoiminomethyl)-N'-(2-(aminoiminomethyl)amino)ethyl)-; Metformin Related Compound; Metformin EP Impurity; Metformin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Metformin Impurity 13 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, NMR, and Mass Spectrometry to confirm identity and ensure high purity, typically ≥95% (HPLC). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. We support compliance with ICH guidelines and major pharmacopeias (USP, EP).

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 Solid
Identification (IR)	Conforms to Reference Spectrum
Identification (HPLC)	Retention time matches CRS
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% 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.