Description

Mianserin Ep Impurity D CAS NO 157994-98-4 is a high-purity chemical reference standard specifically identified as a known impurity of the antidepressant drug Mianserin. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance and product manufacturing. It is an essential material for analytical method development, validation, and quality assurance in pharmaceutical laboratories. This impurity standard is primarily used by researchers, quality control scientists, and regulatory affairs professionals in the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify Mianserin Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure product safety and efficacy.
• Stability Studies and Forced Degradation Testing: Acts as a marker to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Pharmacopoeial Standards (EP/BP/USP): Supports compliance with monographs and impurity limits specified in European Pharmacopoeia (EP), British Pharmacopoeia (BP), or other pharmacopoeias.

Basic Information

Product Name	Mianserin Ep Impurity D
CAS No.	157994-98-4
Molecular Formula	C18H20N2
Molecular Weight	264.37 g/mol
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methyldibenzo[c,f]pyrazino[1,2-a]azepine; Mianserin Related Compound D; Mianserin Impurity D; Mianserin EP Impurity D; 2-Methyl-1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine; Mianserin Metabolite 8-Hydroxy Derivative (potential); Nor-Mianserin (structural analog)
EINECS	Contact for details

Quality Control

Every batch of Mianserin Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support GMP-oriented applications and can supply materials suitable for regulatory submissions.

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 minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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
Residual Solvents (GC)	Complies with ICH Q3C

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