Description

Metformin Impurity E Sulfate is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the widely used antidiabetic drug Metformin Hydrochloride, enabling accurate identification, quantification, and monitoring during drug development and manufacturing. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories to ensure product safety, efficacy, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity E in Metformin Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays, in compliance with ICH Q2(R1) guidelines.
• Quality Control & Stability Studies: Used in routine batch release testing and long-term stability studies to monitor impurity profiles and ensure the drug product remains within specification throughout its shelf life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data required for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Pharmacopeial Testing: Employed to verify compliance with impurity limits specified in major pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Indian Pharmacopoeia (IP).
• Research and Development: Facilitates impurity profiling and route scouting during the synthesis process development of Metformin and its related compounds.

Basic Information

Product Name	Metformin Impurity E Sulfate
CAS No.	36801-25-9
Molecular Formula	C4H11N5 • H2SO4
Molecular Weight	249.25 g/mol
Synonyms	1-Carbamimidamido-N,N-dimethylmethanimidamide Sulfate; N,N-Dimethylbiguanide Sulfate; Dimethylbiguanide Sulfate; Metformin Sulfate; Metformin Base Sulfate; Metformin Related Compound E; USP Metformin Related Compound E Sulfate; European Pharmacopoeia Metformin Impurity E
EINECS	Contact for details

Quality Control

Our Metformin Impurity E Sulfate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity, identity confirmation, and residual solvent analysis, to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against predefined specifications. Our quality commitment aligns with the needs of cGMP-compliant pharmaceutical operations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
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.