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Postion:Product Catalog >Pretomanid Impurity
Pretomanid Impurity
  • Pretomanid Impurity
  • Pretomanid Impurity
  • Pretomanid Impurity
  • Pretomanid Impurity
  • Pretomanid Impurity

Pretomanid Impurity NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-06-18

Product Details

Product Name: Pretomanid Impurity CAS No.: 1353753-57-7
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/06/18

Pretomanid Impurity1353753-57-7

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WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

    • Product Number: P109003
      English Name: Pretomanid Impurity 3
      English Alias: (S)-2-nitro-6-((3-(trifluoromethoxy)benzyl)oxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazine
      CAS Number: 1353753-57-7
      Molecular Formula: C??H??F?N?O?
      Molecular Weight: 359.26

    • Product Advantages

    • High purity and structural confirmation:HPLC purity ≥99.0%, confirmed by multiple methods including 1H NMR, 13C NMR, HRMS, and single-crystal X-ray diffraction, ensuring impurity structure accuracy and meeting ICH Q2(R1) standards.

    • Extreme condition stability:Stable for 36 months when stored at -20°C in the dark, with a degradation rate <0.5% after 10 days at room temperature in solution (e.g., dichloromethane), suitable for long-term storage and complex analytical scenarios.

    • Regioisomeric specificity:Clearly defined regioisomeric structure with a benzyloxy group at the 3-position of the benzene ring, enabling precise tracking of impurity risks caused by incorrect arylation reagent positioning in Pretomanid synthesis.


    • Applications

    • Pharmaceutical impurity screening:Used for LC-MS/MS detection of Impurity 3 in Pretomanid APIs and formulations, controlling its content ≤0.1% in accordance with ICH Q3A standards to ensure global quality regulatory compliance.

    • Synthesis process optimization:In benzylation reactions, monitoring impurity content (e.g., reducing impurity from 1.1% to 0.1% when using para-substituted benzaldehyde derivatives) optimizes the substitution position and reaction conditions of arylation reagents to reduce regioisomeric by-products.

    • Analytical method validation:Serves as a regioisomeric impurity reference standard for developing specific detection methods, such as ultra-performance liquid chromatography-fluorescence detection (UPLC-FLD), leveraging benzene ring substituent differences to achieve efficient separation from the main peak.

    • Toxicological risk assessment:Provides standard samples for evaluating the potential toxicity of aryl positional isomer impurities, supporting in vitro cytotoxicity tests and in vivo pharmacokinetic studies to facilitate the establishment of safe exposure limits.


    • Background Description
      Pretomanid Impurity 3 is a regioisomeric impurity introduced during Pretomanid synthesis due to insufficient regioselectivity in benzylation reactions. The benzyloxy group at the 3-position of the benzene ring (instead of the 4-position in the parent drug) may alter the drug's lipophilicity and target binding ability, increasing off-target effect risks. According to the ICH M7(R1) guideline, such structurally similar impurities require toxicological evaluation, making their content control an important aspect of Pretomanid process development. Currently, the industry generally sets individual impurity limits at ≤0.1% with reference to ICH Q3B.

    • Research Status

    • Advances in detection technology:UPLC-MS/MS is employed using a C18 column (1.8μm, 2.1×50mm) with 0.1% formic acid aqueous solution-acetonitrile (gradient elution) as the mobile phase, achieving a detection limit (LOD) of 0.005ppm in selected ion monitoring (SIM) mode for precise quantification of nanogram-level impurities.

    • Formation mechanism analysis:This impurity mainly originates from non-selective nucleophilic substitution of benzylation reagents (e.g., 3-(trifluoromethoxy)benzyl chloride). The proportion of regioisomeric products increases significantly under strongly basic conditions (e.g., NaH) or high temperatures (>60°C). Using weak bases (e.g., potassium carbonate) and low-temperature (25°C) reactions can reduce impurity formation by over 90%.

    • Safety evaluation:In vitro enzyme inhibition assays show that the impurity inhibits CYP450 3A4 enzyme activity twice as much as the parent drug, but rat acute toxicity tests (LD50 >2000mg/kg) indicate low toxicity. Combined risk assessment suggests a limit of ≤0.12%.

NOTE!

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com


NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery! 







Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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