Description

Metformin Related Compound B (25 Mg) (1-Methylbiguanide Hydrochloride) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound is critical for the accurate identification and quantification of impurities in metformin hydrochloride drug substances and finished products. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in method development, validation, and compliance testing. The material is supplied as a precisely weighed 25 mg quantity to ensure convenience and accuracy in laboratory use.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of 1-methylbiguanide, a known impurity and degradation product of metformin.
• Analytical Method Development & Validation: Used as a critical standard in developing and validating HPLC, UPLC, or LC-MS methods for metformin assay and related substances testing.
• Quality Control (QC) & Quality Assurance (QA): Enables in-house QC laboratories to perform system suitability tests and ensure the accuracy and precision of their analytical procedures for metformin-based formulations.
• Stability Studies: Employed in forced degradation and long-term stability studies of metformin to monitor the formation of related compounds and establish shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing traceable data for impurity characterization as required by ICH guidelines Q3A(R2) and Q3B(R2).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of metformin.

Basic Information

Product Name	Metformin Related Compound B (25 Mg) (1-Methylbiguanide Hydrochloride)
CAS No.	1674-62-0
Molecular Formula	C3H10ClN5
Molecular Weight	151.60 g/mol
Synonyms	1-Methylbiguanide Hydrochloride; N-Methylbiguanide Hydrochloride; 1-Methylbiguanidine Hydrochloride; Metformin Impurity B; Metformin Related Substance B; European Pharmacopoeia (EP) Metformin Impurity B; United States Pharmacopeia (USP) Metformin Related Compound B; Dimethylbiguanide Impurity B
EINECS	Contact for details

Quality Control

Every batch of Metformin Related Compound B is manufactured and controlled to meet the stringent requirements for pharmaceutical reference standards. Our products undergo rigorous quality testing, including chromatographic purity and spectroscopic identification, to ensure compliance with relevant pharmacopoeial standards (e.g., USP, EP). Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, assay, purity, and related substances. The COA includes traceability information and is available upon request.

Storage

Preserve in the original 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); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

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% (on dried basis)
Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Loss on Drying	≤ 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.