Description

Meptazinol Bp Impurity C is a designated impurity of the analgesic drug Meptazinol, referenced in pharmacopeial standards. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical laboratories, quality control departments, and regulatory affairs professionals in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Meptazinol.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to monitor impurity levels against regulatory limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Research on Degradation Pathways: Used in research settings to study the chemical stability and degradation mechanisms of Meptazinol.

Basic Information

Product Name	Meptazinol Bp Impurity C
CAS No.	1858268-92-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Meptazinol Impurity C; Meptazinol Related Compound C; Meptazinol EP Impurity C; Meptazinol BP Impurity C; 1,2,3,4,5,6-Hexahydro-8-hydroxy-3,6,11-trimethyl-2,6-methano-3-benzazocin-10-ol (Impurity C); Meptazinol Degradation Product C; Meptazinol Process Impurity C
EINECS	Contact for details

Quality Control

Every batch of Meptazinol Bp Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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