Description

Meptazinol Bp Impurity D is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the analgesic drug Meptazinol. It serves as a key impurity marker for method development, validation, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Meptazinol active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, UPLC, GC) to monitor and control impurity profiles.
• Quality Control & Assurance: Used in routine QC testing to ensure Meptazinol batches comply with pharmacopoeial specifications (e.g., BP, USP, EP) and ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data for drug master files.
• Stability Studies: Employed to track the formation of degradation products in Meptazinol under various stress conditions.
• Research & Development: Used in academic and industrial R&D for studying the metabolism, degradation pathways, and synthesis of Meptazinol.

Basic Information

Product Name	Meptazinol Bp Impurity D
CAS No.	1883577-02-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Meptazinol Impurity D; Meptazinol Related Compound D; Meptazinol BP Impurity D; Meptazinol EP Impurity D; 3-(3-Ethylhexahydro-1-methyl-1H-azepin-3-yl)phenol Impurity D; (1R,3S,5S)-3-(3-Hydroxyphenyl)-1-methyl-8-azabicyclo[3.2.1]octane Impurity D; Meptazinol Process Impurity D; Meptazinol Degradant D
EINECS	Contact for details

Quality Control

Our Meptazinol Bp Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. Certificates of Analysis (COA) with detailed chromatographic data are provided, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support pharmaceutical-grade applications with a commitment to data integrity and regulatory readiness.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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