N-Nitroso Belumosudil Impurity 1

N-Nitroso Belumosudil Impurity 1 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).

N-Nitroso Belumosudil Impurity 1 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 N-Nitroso Belumosudil Impurity 1:

1. Nitrosamine Risk Assessment in Pharmaceuticals

• N-Nitroso Belumosudil Impurity 1 is a potential genotoxic impurity formed during the synthesis or degradation of Belumosudil.

• Used in nitrosamine risk assessment studies to:

  • Identify and evaluate possible contamination risks

  • Support impurity profiling under ICH M7 and regulatory guidance on nitrosamines

2. Analytical Method Development & Validation

• Used as a reference standard to develop ultra-sensitive detection methods for nitrosamines, including:

  • LC-MS/MS

  • GC-MS

  • UPLC with UV or MS detection

• Enables validation of:

  • Specificity between Belumosudil and nitroso impurities

  • LOD/LOQ at parts-per-billion (ppb) level

  • Accuracy and robustness for trace-level impurity detection

3. Regulatory Compliance & Submissions

• Required in regulatory filings to demonstrate nitrosamine control for:

  • USFDA, EMA, MHRA, and CDSCO

  • Included in ANDA, DMF, and CTD Module 3

• Supports documentation for:

  • Acceptable intake (AI) limits

  • Control strategies and risk mitigation

4. Stability Studies & Forced Degradation Analysis

• Utilized in stress testing and forced degradation studies to:

  • Evaluate the formation of N-Nitroso Belumosudil Impurity 1

  • Understand degradation pathways under conditions like high heat, nitrite exposure, or low pH

• Assists in defining shelf-life stability and packaging requirements

5. Quality Control Testing in GMP Environments

• Used in routine QC labs to:

  • Monitor and ensure the impurity is below regulatory thresholds (often <18 ng/day intake)

  • Maintain product safety, purity, and compliance across production batches

6. Toxicological and Carcinogenic Risk Evaluation

• Involved in genotoxicity studies and QSAR modeling to assess:

  • Potential carcinogenicity

  • DNA-reactivity profiles

• Helps in determining if impurity qualifies for threshold of toxicological concern (TTC) exemption or requires further toxicological qualification

⚠️ Note: N-Nitroso Belumosudil Impurity 1 is strictly for laboratory, analytical, and regulatory use. It is not for human or veterinary use and must be handled with appropriate safety measures due to its potential mutagenic nature.