Description

Meptazinol Impurity 2 (Meptazinol BP Impurity B HCl) is a high-purity reference standard critical for pharmaceutical analysis and quality control. This compound is essential for the accurate identification, quantification, and monitoring of related substances in Meptazinol drug substances and finished products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with pharmacopeial standards such as the British Pharmacopoeia (BP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Meptazinol.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic techniques for the identification and quantification of Meptazinol BP Impurity B.
• Regulatory Compliance: Critical for demonstrating compliance with stringent pharmacopeial specifications (e.g., BP, EP) and regulatory filings (e.g., ANDA, NDA).
• Stability Studies: Employed to track the formation and levels of this specific impurity in Meptazinol formulations under various storage conditions.
• Process Chemistry: Used to optimize synthesis and purification processes by monitoring and controlling the levels of this impurity in the active pharmaceutical ingredient (API).

Basic Information

Product Name	Meptazinol Impurity 2 (Meptazinol BP Impurity B HCl)
CAS No.	112269-41-7
Molecular Formula	C15H23NO•HCl
Molecular Weight	269.81 g/mol (Free base: 233.35 g/mol)
Synonyms	Meptazinol Impurity B; Meptazinol Related Compound B; 3-(3-Ethylhexahydro-1-methyl-1H-azepin-3-yl)phenol hydrochloride; (±)-m-(3-Ethylhexahydro-1-methyl-1H-azepin-3-yl)phenol hydrochloride; Meptazinol EP Impurity B; Meptazinol Hydrochloride Impurity B
EINECS	Contact for details

Quality Control

Every batch of Meptazinol Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified purity criteria.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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%
Residue on Ignition	≤ 0.1%

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