For pharmaceutical manufacturers, the quality and specifications of chemical intermediates are paramount to the success of their final products. D-(-)-4-Hydroxyphenylglycine Dane Salt, known by its CAS number 69416-61-1, is a prime example of such a critical component, particularly in the synthesis of Amoxicillin. Understanding its detailed specifications is key to ensuring an efficient and compliant manufacturing process.

The primary specification for D-(-)-4-Hydroxyphenylglycine Dane Salt is its purity, typically guaranteed to be a minimum of 99.5%. This high assay is essential for pharmaceutical applications to minimize impurities that could affect the efficacy or safety of the final Amoxicillin product. The physical appearance of the compound is consistently described as a white powder, a characteristic that aids in its handling and identification during production.

Furthermore, adherence to international quality standards such as USP (United States Pharmacopeia), BP (British Pharmacopoeia), EP (European Pharmacopoeia), and FCC (Food Chemicals Codex) is a significant indicator of the intermediate's suitability for pharmaceutical use. Meeting these benchmarks means that D-(-)-4-Hydroxyphenylglycine Dane Salt has undergone rigorous testing and validation, assuring manufacturers of its reliability and consistency. This focus on quality is vital when producing drugs for global markets.

The role of D-(-)-4-Hydroxyphenylglycine Dane Salt as an Amoxicillin synthesis intermediate means that its properties directly influence the outcome of complex chemical reactions. Manufacturers looking to buy D-(-)-4-Hydroxyphenylglycine Dane Salt often prioritize suppliers who can provide comprehensive Certificates of Analysis (CoA) detailing these critical specifications. This documentation is crucial for regulatory compliance and internal quality control procedures.

In essence, the detailed specifications of D-(-)-4-Hydroxyphenylglycine Dane Salt, from its purity and appearance to its compliance with pharmacopoeial standards, are what make it an indispensable intermediate in the production of Amoxicillin. For any pharmaceutical company engaged in antibiotic manufacturing, a thorough understanding and verification of these specifications are fundamental steps in their quality assurance process.