Description

Tolperisone Impurity C is a specified impurity and degradation product of the centrally acting muscle relaxant Tolperisone. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Tolperisone-based drug substances and products. The primary users are quality control units, R&D departments, and regulatory affairs teams within the global pharmaceutical and fine chemical industries.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Tolperisone-related impurities.
• Critical component in analytical method development and validation (HPLC, GC, LC-MS) for Tolperisone API and finished dosage forms.
• Used in stability studies to monitor degradation pathways and establish shelf-life specifications for Tolperisone products.
• Essential for regulatory compliance and submission, supporting ICH guidelines (Q3A, Q3B) on impurities in new drug substances and products.
• Employed in quality control laboratories for routine batch release testing of Tolperisone hydrochloride.
• Serves as a starting material or intermediate in the synthetic research of novel Tolperisone analogs or related pharmacological compounds.

Basic Information

Product Name	Tolperisone Impurity C
CAS No.	1023-20-7
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; Desmethyl Tolperisone; Tolperisone Desmethyl Impurity; Tolperisone Related Compound C; Tolperisone EP Impurity C; α-Methyl-4-methyl-β-piperidinopropiophenone
EINECS	Contact for details

Quality Control

Every batch of Tolperisone Impurity C is manufactured and tested under a strict quality management system. Our products undergo rigorous analytical testing to ensure high purity and consistency, meeting the exacting standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and related substances by validated methods such as HPLC. We support compliance with ICH, USP, and EP guidelines for impurities.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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