In the intricate world of pharmaceutical manufacturing, the quality of starting materials and intermediates directly dictates the efficacy and safety of the final drug product. For manufacturers of fluoroquinolone antibiotics, particularly those involved in producing Moxifloxacin and its hydrochloride salt, securing a high-purity intermediate like 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3-quinolinecarboxylic acid (CAS: 112811-72-0) is paramount. This article delves into why sourcing this specific intermediate is critical and what manufacturers should look for in a supplier.

Understanding the Importance of Purity

1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3-quinolinecarboxylic acid serves as a foundational building block in the synthesis of potent antibacterial agents. Its chemical structure, C14H11F2NO4, with a molecular weight of approximately 295.24 g/mol, is carefully engineered to facilitate the subsequent chemical transformations required to yield the active pharmaceutical ingredient (API). Any deviation in purity or presence of unwanted byproducts in this intermediate can lead to:

  • Reduced yield in the synthesis process.
  • Formation of impurities in the final API, potentially impacting safety and regulatory compliance.
  • Increased purification costs and processing time.
  • Suboptimal therapeutic outcomes for patients.

Therefore, when you buy this essential chemical, prioritizing a product with a guaranteed high assay (e.g., ≥98.0% or ≥99%) and minimal total impurities (e.g., ≤2.0%) is a non-negotiable aspect of procurement.

Key Specifications to Look For

When evaluating potential suppliers for 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3-quinolinecarboxylic acid, several key specifications should be scrutinized:

  • Appearance: Typically expected as a white to off-white crystalline powder.
  • Assay/Purity: A high purity level, often exceeding 98.5% or 99%, is crucial.
  • Loss on Drying/Water Content: Should be within acceptable limits (e.g., ≤0.5% or ≤3.0%) to ensure stability and accurate weighing.
  • Residue on Ignition: Low levels indicate minimal inorganic impurities.
  • Related Substances/Impurities: Strict control over individual and total impurities is essential for regulatory acceptance.

Reputable manufacturers will readily provide Certificates of Analysis (CoA) detailing these specifications, along with supporting documentation like MSDS.

Finding a Reliable Manufacturer and Supplier

The selection of a reliable manufacturer and supplier for pharmaceutical intermediates like this quinolinecarboxylic acid derivative is a strategic decision. Factors to consider include:

  • Manufacturing Capacity: Can the supplier meet your current and future demand?
  • Quality Control Systems: Are they compliant with international standards (e.g., ISO)?
  • Regulatory Support: Do they offer DMF (Drug Master File) or GMP certifications if required?
  • Technical Expertise: Do they possess in-depth knowledge of synthesis and impurity profiling?
  • Customer Service and Logistics: Is their communication responsive, and can they ensure timely delivery from their base, for example, in China?

By partnering with an established pharmaceutical intermediate supplier, you not only secure a critical raw material but also gain a partner dedicated to quality and reliability. We understand the demands of the pharmaceutical industry and are committed to providing high-quality 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3-quinolinecarboxylic acid. We encourage you to request a quote to discuss your specific procurement needs and experience the difference that quality sourcing makes.