Description

Metamizole Impurity CAS NO 106236-80-0 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, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Metamizole (Dipyrone) active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels throughout the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Metamizole batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Used to track the formation of degradation products in Metamizole formulations under various stress conditions (e.g., heat, light, humidity) as part of stability-indicating assays.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed characterization and control of potential impurities.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic byproducts of Metamizole.

Basic Information

Product Name	Metamizole Impurity
CAS No.	106236-80-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dipyrone Impurity; Metamizole Related Compound; [1,5-Dimethyl-3-oxo-2-phenyl-2,3-dihydro-1H-pyrazol-4-yl]methylamino]methanesulfonic acid (related compound); Noramidopyrine Methanesulfonate Impurity; Analgin Impurity; 4-[(Methylamino)methyl]-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one methanesulfonate derivative
EINECS	Contact for details

Quality Control

Our Metamizole Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, GC-MS, and NMR. We adhere to ICH guidelines for impurity characterization, supporting your compliance with global pharmacopeial standards (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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Complies with individual and total limits
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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