Description

Morinidazole Impurity 8 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Morinidazole during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of this specific impurity in Morinidazole API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Morinidazole batches meet stringent pharmacopeial (e.g., USP, EP, ChP) and internal purity specifications.
• Stability Studies and Degradation Pathway Analysis: Employed to monitor the formation of this impurity under various stress conditions to establish product shelf-life and storage requirements.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in R&D laboratories to study the chemical and metabolic pathways of Morinidazole.

Basic Information

Product Name	Morinidazole Impurity 8
CAS No.	1413431-46-5
Molecular Formula	C12H15N3O4S
Molecular Weight	297.33 g/mol
Synonyms	1-Methyl-2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethyl (2S)-2-(methylsulfinyl)acetate; Morinidazole Related Compound 8; Morinidazole EP Impurity H; Morinidazole Sulfoxide Ester Impurity; (S)-1-Methyl-2-((2-methyl-5-nitro-1H-imidazol-1-yl))ethyl 2-(methylsulfinyl)acetate; Morinidazole Sulfoxide Derivative
EINECS	Contact for details

Quality Control

Every batch of Morinidazole Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to maintain stability.

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 individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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