Description

Delamanid Impurity 2 CAS NO 1202875-92-0 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anti-tuberculosis drug Delamanid. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Delamanid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during drug synthesis and quality control.
• Stability Studies: Employed in forced degradation and long-term stability studies of Delamanid to understand impurity formation pathways and establish shelf-life specifications.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Used as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to ensure product purity meets pharmacopeial standards.
• Research & Development: Supports synthetic chemistry research aimed at optimizing the Delamanid manufacturing process to minimize impurity formation.

Basic Information

Product Name	Delamanid Impurity 2
CAS No.	1202875-92-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Delamanid Related Compound 2; Delamanid Impurity B; (2R)-2-Methyl-6-nitro-2-{[4-(trifluoromethoxy)phenoxy]methyl}-2,3-dihydroimidazo[2,1-b][1,3]oxazole; OPC-67683 Impurity 2; Delamanid Process Impurity; Nitroimidazooxazole Impurity
EINECS	Contact for details

Quality Control

Our Delamanid Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment to support your regulatory and quality assurance needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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%

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