The development and manufacturing of pharmaceutical products like Deferasirox involve intricate chemical processes, where the quality of starting materials and the control of impurities are of utmost importance. 4-Hydrazinobenzoic Acid (CAS 619-67-0) plays a dual role in this context: as a vital synthetic intermediate and as a potential genotoxic impurity that requires careful monitoring and control within the final drug formulation. Understanding its significance is key for R&D scientists and quality control professionals looking to buy or purchase this compound.

4-Hydrazinobenzoic Acid as a Deferasirox Intermediate
As previously discussed, 4-Hydrazinobenzoic Acid is a foundational component in the synthesis of Deferasirox. Its chemical structure, featuring both a hydrazine group and a carboxylic acid, makes it highly reactive and suitable for the specific chemical transformations required to build the complex Deferasirox molecule. Ensuring a high level of purity for this intermediate, typically ≥99.0%, is critical to prevent the introduction of extraneous substances into the final Active Pharmaceutical Ingredient (API).

The Significance of 4-Hydrazinobenzoic Acid as an Impurity
Regulatory bodies and pharmaceutical manufacturers are increasingly focused on identifying and quantifying potential genotoxic impurities (PGIs) in drug products. Research has highlighted 4-Hydrazinobenzoic Acid as a compound that can exhibit genotoxic properties. This means that even trace amounts present in the final Deferasirox formulation must be meticulously controlled. Consequently, 4-Hydrazinobenzoic Acid is also supplied as a high-purity reference standard. This standard is invaluable for:

  • Analytical Method Development: Establishing sensitive and specific analytical methods, such as High-Performance Liquid Chromatography (HPLC), to detect and quantify 4-Hydrazinobenzoic Acid in Deferasirox samples.
  • Quality Control (QC) and Quality Assurance (QA): Routine testing of Deferasirox batches to ensure that the levels of this impurity remain within acceptable regulatory limits.
  • Process Optimization: Identifying and mitigating steps in the synthesis that might lead to the formation or carry-over of 4-Hydrazinobenzoic Acid, thereby improving the overall purity of the API.

Sourcing Strategies for Pharmaceutical Companies
For organizations involved in Deferasirox manufacturing or quality testing, securing a reliable supplier for both the bulk intermediate and the high-purity impurity standard is essential. When seeking to purchase 4-Hydrazinobenzoic Acid, consider:

  • Supplier Specialization: Look for chemical suppliers who explicitly cater to the pharmaceutical industry and offer comprehensive documentation, including CoAs and potentially impurity profiling data.
  • Availability of Reference Standards: Ensure your chosen manufacturer or distributor also offers the compound in a highly purified form suitable for use as a reference standard.
  • Global Reach: Partnering with a supplier with a global presence can streamline logistics and ensure timely delivery, whether you are a domestic or international client.

The dual role of 4-Hydrazinobenzoic Acid underscores the complexity of pharmaceutical chemistry. By understanding its function as both a building block and a potential impurity, companies can implement robust quality control measures and ensure the safety and efficacy of Deferasirox. Engaging with experienced suppliers and manufacturers is key to navigating these challenges and maintaining product integrity.