Description

Pretomanid Impurity 6 is a specified impurity and degradation product associated with the anti-tuberculosis drug Pretomanid. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily required by researchers and quality assurance professionals in the pharmaceutical industry for method validation, stability studies, and ensuring batch-to-batch consistency of the active pharmaceutical ingredient.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pretomanid Impurity 6 in drug substance and drug product analysis.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to monitor impurity profiles in compliance with ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Pretomanid to understand degradation pathways and establish shelf-life.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC testing of Pretomanid API batches to ensure impurity levels are within specified limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the impurity profile of the drug substance.
• Research and Development: Used in R&D laboratories for synthesizing, isolating, and characterizing related substances to support process chemistry and impurity fate and tolerance studies.

Basic Information

Product Name	Pretomanid Impurity 6
CAS No.	1261679-35-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	PA-824 Impurity 6; (S)-2-Nitro-6-((4-(trifluoromethoxy)benzyl)oxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazine; Pretomanid Related Compound 6; Degradation Product of Pretomanid; Nitroimidazooxazine Impurity
EINECS	Contact for details

Quality Control

Every batch of Pretomanid Impurity 6 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality commitment includes comprehensive characterization by advanced techniques such as HPLC, GC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications and supporting its use as a reference standard.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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