Description

Metamizole Impurity C (4-Methylaminoantipyrine) Hcl is a high-purity reference standard and analytical impurity crucial for pharmaceutical quality control. This compound is essential for the accurate identification, quantification, and monitoring of a key degradation product in Metamizole (Dipyrone) drug substances and finished products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of test methods in QC/QA laboratories.
• Impurity Profiling & Method Development: Critical for developing and validating stability-indicating HPLC/UPLC methods to track impurity levels in Metamizole APIs and formulations.
• Stability Studies: Used as a marker to assess the degradation pathways and shelf-life of Metamizole-containing drug products under various stress conditions.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity identification and characterization data.
• Research & Development: Employed in synthetic chemistry R&D to study the formation mechanism of this impurity and develop mitigation strategies during API synthesis.

Basic Information

Product Name	Metamizole Impurity C (4-Methylaminoantipyrine) Hcl
CAS No.	856307-27-2
Molecular Formula	C12H16N3O • HCl
Molecular Weight	253.74 g/mol
Synonyms	4-Methylaminoantipyrine Hydrochloride; 4-(Methylamino)-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one Hydrochloride; Dipyrone Impurity C HCl; Noramidopyrine Methanesulfonate Impurity C; Analgin Impurity C; 1-Phenyl-2,3-dimethyl-4-methylaminopyrazolone-5 Hydrochloride; Metamizole Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Metamizole Impurity C HCl is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results against stringent in-house specifications. Our quality commitment ensures the material is suitable for its intended use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. After opening, seal the container tightly under an inert atmosphere if possible.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 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.