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Belumosudil Metabolite KD025M2

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CAT NO

AQ-B001513

CAS NO

911417-62-4

Mol.F

C23H17N5O3

Mol.Wt

411.4

Availability

Custom Synthesis

Chemical name

2-(3-(4-((1H-indazol-5-yl)amino)quinazolin-2-yl)phenoxy)acetic acid

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Belumosudil Metabolite KD025M2


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single product

Product Description

Belumosudil Metabolite KD025M2 is a high-quality reference standard supplied with comprehensive characterization data, ensuring compliance with regulatory guidelines. This product is essential for analytical method development, method validation (AMV), quality control (QC) applications, and plays a crucial role in Abbreviated New Drug Applications (ANDA).

Belumosudil Metabolite KD025M2 can be used as a reference standard, with possible traceability to pharmacopeial standards such as USP or EP, based on feasibility. AquigenBio products are strictly for analytical purposes and is not intended for human use.

Applications of Belumosudil Metabolite KD025M2:

1. Drug Metabolism and Pharmacokinetic (DMPK) Studies

  • Belumosudil Metabolite KD025M2 is a primary in vivo metabolite of Belumosudil.

  • Used in ADME (Absorption, Distribution, Metabolism, and Excretion) studies to:

    • Investigate metabolic pathways

    • Understand bioavailability and systemic exposure

    • Evaluate metabolite-to-parent drug ratios

2. Bioanalytical Method Development

  • Serves as a reference standard in developing LC-MS/MS methods for quantifying KD025M2 in biological matrices (plasma, serum, urine).

  • Supports:

    • Pharmacokinetic profiling

    • Metabolite monitoring in clinical studies

    • Mass balance studies in drug trials

3. Toxicological Assessment

  • Assists in determining if KD025M2 requires qualification under ICH M3 and ICH M7 guidelines.

  • Helps evaluate:

    • Toxicological relevance of circulating metabolites

    • Safety thresholds for active or potentially reactive metabolites

4. Regulatory Compliance & IND/ANDA Filings

  • Used to meet global regulatory expectations in:

    • Investigational New Drug (IND) applications

    • Abbreviated New Drug Applications (ANDA)

    • Common Technical Documents (CTD Module 5)

  • Ensures that human metabolites are characterized and controlled appropriately

5. Stability and Degradation Studies

  • Employed in in vitro and in vivo degradation studies to:

    • Evaluate the stability of Belumosudil and its metabolic conversion

    • Identify potential transformation products during storage or metabolism

6. Clinical Research and Therapeutic Monitoring

  • Supports therapeutic drug monitoring (TDM) and biomarker studies in clinical trials.

  • Helps correlate exposure-response relationships between the metabolite and clinical outcomes (e.g., immune modulation).

⚠️ Note: Belumosudil Metabolite KD025M2 is intended strictly for laboratory, research, and analytical use only. Not for human or veterinary drug use.

Safety & Handling Information for Chemical Products

1. Read the Safety Data Sheet (SDS) : The SDS contains important safety information for handling procedures, first-aid measures, disposal instructions, etc. Read it carefully.

2. Wear Personal Protective Equipment (PPE) : Always wear PPE as indicated in the SDS and by the manufacturer. This may include safety goggles, gloves, lab coats, respirators, and protective clothing.

3. Handle with Care : Be careful with chemical products - prevent spills, splashes, or inhaling fumes or dust. Use secondary trays or spill kits during chemical transfer or dispensing.

4. Work in a Well-Ventilated Area : Use chemical products in well-ventilated spaces to reduce vapour or gas exposure. Indoors, ensure ample ventilation via mechanical systems, fume hoods, or open windows and doors.

5. Avoid Mixing Chemicals : Avoid mixing chemical products unless directed by the manufacturer or a qualified professional. Incompatible mixes can lead to hazardous reactions, toxic gas releases, or explosions.

6. Labeling and Storage : Label chemical containers with product names, hazards, and handling information. Store in original or approved containers.

7. Prevent Contamination : Prevent cross-contamination with dedicated equipment or thorough decontamination. Keep food, drinks, and personal items away from chemical storage or work zones.

8. Emergency Procedures : Learn emergency procedures for spills, leaks, fires, or exposure incidents. Keep spill control materials, fire extinguishers, and emergency eyewash/shower facilities accessible.

9. First Aid : Know first aid for chemical exposure (eye contact, skin contact, inhalation, and ingestion). Ensure accessible supplies and trained personnel for assistance.

10. Proper Waste Disposal : Ensure chemical waste disposal as per local regulations; segregate hazardous from non-hazardous waste for health and environmental protection.

11. Training and Education : Offer thorough training to chemical handlers, covering usage, hazards, safety, and emergency response.

12. Report Incidents and Near Misses : Report incidents, near misses, spills, or safety concerns promptly to authorities and supervisors for investigation and action. By following these safety and handling guidelines, you can minimize risks associated with chemical products and create a safer work environment for yourself and others.

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Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Avoid contact with eyes, skin, and clothing. Avoid ingestion and inhalation.

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