In the complex world of pharmaceutical manufacturing, securing high-quality intermediates is paramount. For companies involved in the production of potent antibiotics like Tigecycline, understanding the role and sourcing of key components is essential. One such critical component is N-tert-Butylglycine Hydrochloride (CAS 6939-23-7). This article delves into why this specific intermediate is vital and how procurement managers and R&D scientists can effectively source it from reliable manufacturers.

Understanding N-tert-Butylglycine Hydrochloride

N-tert-Butylglycine Hydrochloride, a derivative of glycine, is a white powder with a molecular formula of C6H14ClNO2 and a molecular weight of 167.63. Its significance in the pharmaceutical sector stems primarily from its role as a key intermediate in the synthesis pathway of Tigecycline. Tigecycline, a glycylcycline antibiotic, is a powerful broad-spectrum agent used to treat complicated infections, particularly those caused by multi-drug resistant bacteria. The efficacy and safety of the final Tigecycline product are directly dependent on the purity and quality of its precursors, making N-tert-Butylglycine Hydrochloride a compound that demands rigorous quality control.

Purity Standards and Specifications for Tigecycline Intermediates

When sourcing pharmaceutical intermediates, purity is not just a desirable trait; it's a non-negotiable requirement. N-tert-Butylglycine Hydrochloride is typically expected to have a purity of ≥99%. Beyond overall purity, specific impurity profiles are critical. For instance, low levels of chloride (≤0.020%), ammonium (≤0.02%), and sulfate (≤0.020%) are commonly specified. Furthermore, stringent limits on heavy metals like lead (≤10 ppm), iron (≤10 ppm), and arsenic (≤1 ppm) are standard. Chromatographic analysis should ideally show no detectable other amino acids, ensuring the integrity of the synthesis process. Companies seeking to buy N-tert-Butylglycine hydrochloride must partner with suppliers who can consistently meet these demanding specifications. A reliable manufacturer will provide detailed Certificates of Analysis (CoA) to verify these parameters.

Why Source from a China Manufacturer?

China has emerged as a global hub for fine chemical and pharmaceutical intermediate manufacturing. For N-tert-Butylglycine Hydrochloride, sourcing from a reputable Chinese manufacturer offers several strategic advantages:

  • Cost-Effectiveness: Chinese manufacturers often provide highly competitive pricing due to economies of scale and efficient production processes. This allows for better cost management in the overall API production.
  • Robust Supply Chain: The established chemical infrastructure in China ensures a stable and scalable supply, crucial for meeting ongoing production demands. Buyers can secure a consistent stream of this essential intermediate.
  • Advanced Manufacturing Capabilities: Many Chinese chemical companies invest heavily in R&D and advanced manufacturing technologies, enabling them to produce intermediates with high purity and consistent quality.
  • Regulatory Compliance: Reputable suppliers are well-versed in international quality standards and regulatory requirements, often holding certifications that attest to their manufacturing practices.

When looking to purchase N-tert-Butylglycine Hydrochloride, it is advisable to engage with manufacturers who emphasize transparency, quality assurance, and strong customer support. Understanding the manufacturer's production capabilities and their commitment to quality control protocols is key to building a successful procurement strategy.

Key Considerations for Procurement

Procurement managers and R&D scientists seeking to buy N-tert-Butylglycine hydrochloride should consider the following:

  • Supplier Reputation: Vet potential suppliers thoroughly. Look for established companies with a proven track record in pharmaceutical intermediates.
  • Quality Documentation: Always request Certificates of Analysis (CoA) for each batch, detailing purity and impurity profiles.
  • Packaging and Storage: Ensure the product is appropriately packaged (e.g., 25kg cardboard drums) and that storage guidelines (cool, dry, away from moisture and light) are clear to maintain product integrity.
  • Lead Times and Delivery: Clarify delivery schedules and confirm that lead times align with your production planning.

By carefully evaluating these factors, businesses can secure a reliable supply of high-quality N-tert-Butylglycine Hydrochloride, ensuring the efficient and successful synthesis of Tigecycline and contributing to the availability of vital antibiotics in the global market. For inquiries about pricing, bulk orders, or specific technical requirements, do not hesitate to contact a trusted supplier.