Description

Metamizole Impurity 7 is a specified impurity of the non-opioid analgesic drug Metamizole (Dipyrone). This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is essential for ensuring the purity, safety, and efficacy of Metamizole-based drug substances and products. This impurity is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Metamizole (Dipyrone) active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing of Metamizole batches to ensure they meet pharmacopoeial standards (e.g., USP, EP, BP) and internal specifications.
• Stability Studies: Used to track the formation of degradation products in Metamizole drug products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the synthesis, characterization, and toxicological profile of Metamizole-related substances.

Basic Information

Product Name	Metamizole Impurity 7
CAS No.	62902-13-0
Molecular Formula	C13H17N3O4S
Molecular Weight	311.36 g/mol
Synonyms	Dipyrone Impurity 7; 4-[(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)amino]-N-methylbenzenesulfonamide; 4-[(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)amino]-N-methylbenzenesulfonamide; Metamizole Related Compound 7; Noramidopyrine Methanesulfonate Impurity 7; 1-Phenyl-2,3-dimethyl-4-(N-methyl-p-aminobenzenesulfonamido)-5-pyrazolone; Analgin Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Metamizole Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods such as HPLC, NMR, and Mass Spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including purity, chromatographic data, and residual solvent analysis. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature between 15°C and 25°C (59°F and 77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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