Description

Metamizole Impurity 6 CAS NO 500880-95-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the analgesic drug Metamizole (Dipyrone). It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing of active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Metamizole (Dipyrone) API and its formulations.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to ensure drug substance and product purity meets pharmacopeial (e.g., USP, EP, BP) specifications.
• Stability Studies: Used to track the formation of degradation impurities in Metamizole under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A stability testing protocols.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a critical tool in pharmaceutical R&D for studying the metabolism, degradation pathways, and synthesis impurities of Metamizole.

Basic Information

Product Name	Metamizole Impurity 6
CAS No.	500880-95-5
Molecular Formula	C13H17N3O4S
Molecular Weight	311.36 g/mol
Synonyms	Dipyrone Impurity 6; [(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)methylamino]methanesulfonic Acid; 4-[(Methylamino)methyl]-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one methanesulfonate; Metamizole Related Compound 6; Noramidopyrine methanesulfonate sodium salt impurity; Sodium [(2,3-dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)methylamino]methanesulfonate impurity
EINECS	Contact for details

Quality Control

Our Metamizole Impurity 6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. The quality is controlled in alignment with ICH guidelines and current Good Manufacturing Practice (cGMP) principles for active pharmaceutical ingredients.

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. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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