O-Dealkylated Belumosudil

O-Dealkylated Belumosudil 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).

O-Dealkylated Belumosudil 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 O-Dealkylated Belumosudil:

1. Pharmaceutical Impurity Profiling

• O-Dealkylated Belumosudil is a process-related or degradation impurity of the ROCK2 inhibitor Belumosudil.

• Used to identify and quantify this impurity in the active pharmaceutical ingredient (API) and its formulations.

• Ensures product purity and safety according to regulatory standards.

2. Analytical Method Development & Validation

• Serves as a reference standard in the development of stability-indicating analytical methods, including:

  • HPLC

  • UPLC

  • LC-MS/MS

• Enables validation of key method parameters like:

  • Specificity

  • LOD (Limit of Detection) and LOQ (Limit of Quantification)

  • Linearity, precision, and accuracy

3. Regulatory Compliance (ICH Q3A/B)

• Supports documentation required for:

  • ICH Q3A/B impurity qualification

  • ANDA, DMF, and CTD submissions to regulatory authorities like FDA, EMA, etc.

• Ensures impurity levels are within acceptable daily intake (ADI) thresholds.

4. Stability and Forced Degradation Studies

• Used in forced degradation testing to understand how Belumosudil degrades under:

  • Acidic/basic pH

  • Oxidative stress

  • Light and thermal exposure

• Helps map the degradation pathway and determine shelf life of the drug product.

5. Routine Quality Control (QC) Testing

• Applied in routine batch analysis and in-process quality checks to ensure:

  • Consistent impurity profiles

  • Compliance with established specifications

6. Research and Development

• Utilized in R&D for:

  • Synthesis optimization to reduce impurity formation

  • Structural characterization studies

  • Supporting impurity identification during drug formulation development

⚠️ Note: O-Dealkylated Belumosudil is intended only for analytical, research, and laboratory use. It is not suitable for human or veterinary consumption.