Description

Tolperisone Impurity A CAS NO 91625-73-9 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Tolperisone. This compound is critical for ensuring the purity, safety, and efficacy of Tolperisone-based pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolperisone Impurity A in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Tolperisone API.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for establishing impurity limits in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Tolperisone.

Basic Information

Product Name	Tolperisone Impurity A
CAS No.	91625-73-9
Molecular Formula	C16H23NO
Molecular Weight	245.36 g/mol
Synonyms	2-Methyl-1-(4-methylphenyl)-3-piperidin-1-ylpropan-1-one; 1-(4-Methylphenyl)-2-methyl-3-(1-piperidinyl)-1-propanone; Mydocalm Impurity A; Mydetone Impurity A; Eperisone Impurity A (related compound); 3-Piperidino-2-methylpropiophenone derivative
EINECS	Contact for details

Quality Control

Every batch of Tolperisone Impurity A is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be kept under inert conditions if the container is opened frequently to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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