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Belinostat Z-Isomer

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CAT NO

AQ-B001613

CAS NO

1884227-58-0

Mol.F

C15H14N2O4S

Mol.Wt

318.3

Availability

Custom Synthesis

Chemical name

(Z)-N-hydroxy-3-(3-(N-phenylsulfamoyl)phenyl)acrylamide

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Belinostat Z-Isomer

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Product Description

Belinostat Z-Isomer 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).

Belinostat Z-Isomer 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 Belinostat Z-Isomer:

1. Pharmaceutical Impurity Profiling

  • The Belinostat Z-Isomer is a stereoisomeric impurity of the active pharmaceutical ingredient (API) Belinostat.

  • Used to detect, identify, and quantify cis-trans (Z/E) isomerization that may occur during synthesis or storage.

  • Ensures isomeric purity, which is critical for drug efficacy and safety.

2. Analytical Method Development & Validation

  • Serves as a reference standard for the development of stereoselective and stability-indicating methods such as:

    • HPLC with chiral or stereospecific columns

    • LC-MS/MS

    • UPLC

  • Validates analytical parameters like:

    • Specificity

    • Resolution between E- and Z-isomers

    • Linearity, LOD, and LOQ

3. Regulatory Submissions & Compliance

  • Supports regulatory submissions under:

    • ICH Q3A/B guidelines for impurity profiling

    • FDA, EMA, and other agency requirements related to stereochemical characterization

  • Required in:

    • ANDA filings

    • DMF submissions

    • CTD dossiers

4. Stability & Forced Degradation Studies

  • Used in forced degradation and photostability studies to evaluate:

    • Potential Z-isomer formation under stress conditions (e.g., UV light, heat)

    • Isomeric stability during shelf-life and formulation storage

5. Quality Control & Batch Release

  • Implemented in routine QC testing to monitor levels of the Z-isomer in Belinostat bulk and dosage forms.

  • Ensures regulatory compliance by maintaining the Z-isomer within acceptable thresholds.

6. Pharmaceutical R&D and Synthesis Optimization

  • Used in synthetic chemistry and drug development labs to:

    • Study isomerization mechanisms

    • Optimize reaction conditions to minimize Z-isomer formation

    • Understand the structure-activity relationship (SAR) of stereoisomers

⚠️ Note: This isomeric impurity is intended strictly for research and analytical use only. Not for use in humans or animals.

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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