Description

Metformin Ep Impurity B Dinitrate is a high-purity reference standard and chemical intermediate critical for pharmaceutical research and development. This compound is essential for the quality control and analytical validation of Metformin hydrochloride, a first-line medication for type 2 diabetes. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Metformin API and finished dosage forms according to EP, USP, and ICH guidelines.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish system suitability, specificity, and detection limits.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in API manufacturing to monitor and control impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing data for impurity characterization and qualification.
• Research & Development: Employed in stability studies, degradation pathway elucidation, and formulation research to understand drug product behavior.
• Contract Research Organizations (CROs): Utilized by service laboratories offering analytical testing and method validation for clients in the pharmaceutical industry.

Basic Information

Product Name	Metformin Ep Impurity B Dinitrate
CAS No.	27369-26-2
Molecular Formula	C4H12N6O6
Molecular Weight	240.18 g/mol
Synonyms	1,1-Dimethylbiguanide Dinitrate; Metformin Dinitrate; Metformin Impurity B (EP); N,N-Dimethylimidodicarbonimidic diamide Dinitrate; Metformin Related Compound B; Biguanide, 1,1-dimethyl-, dinitrate; Guanylguanyldimethyldiamine Dinitrate
EINECS	Contact for details

Quality Control

Our Metformin Ep Impurity B Dinitrate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, IR and NMR for structural confirmation, and residual solvent analysis. We provide Certificates of Analysis (COA) with detailed results, ensuring traceability and compliance with relevant pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

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 must be kept in a desiccated environment to maintain 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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