The efficacy and safety of pharmaceutical products are intrinsically linked to the quality of their raw materials and intermediates. For D(-)-4-Hydroxyphenylglycine (CAS 22818-40-2), a crucial intermediate in the synthesis of important antibiotics like Amoxicillin, adherence to rigorous specification standards is non-negotiable. Pharmaceutical manufacturers and procurement specialists must understand these critical parameters to ensure they are sourcing a product that meets regulatory requirements and ensures reliable synthesis outcomes. This guide outlines the key specifications to consider when evaluating D(-)-4-Hydroxyphenylglycine from potential suppliers.

Key Quality Parameters for D(-)-4-Hydroxyphenylglycine

When considering purchasing D(-)-4-Hydroxyphenylglycine, the following specifications are typically of utmost importance:

1. Appearance: The product should consistently appear as a White or almost white crystalline powder, free from foreign matter. Deviations in appearance can indicate potential contamination or degradation.

2. Assay (Purity): This is arguably the most critical parameter. D(-)-4-Hydroxyphenylglycine is typically specified with a minimum purity of ≥99.00%. This high level of purity ensures minimal interference in subsequent synthesis steps and contributes to the overall quality of the final API.

3. Specific Rotation: As a chiral compound, its optical activity is a key indicator of its stereochemical integrity. A specific rotation within a defined range (e.g., -156.0° to -161.0°) confirms the presence of the desired D-enantiomer and the absence of significant amounts of the L-enantiomer.

4. Moisture Content: High moisture levels can affect the stability and reactivity of the intermediate. A typical specification for moisture content is ≤0.20% to ensure product integrity during storage and handling.

5. Iron Content: Trace amounts of metals like iron can act as catalysts for undesirable side reactions or can affect the color of the final product. Limits are usually very low, often ≤5mg/kg.

6. Absorbance: This parameter, often measured spectrophotometrically, can indicate the presence of colored impurities. A low absorbance value (e.g., ≤0.05) signifies higher purity.

Why Partner with a Quality-Focused D(-)-4-Hydroxyphenylglycine Manufacturer?

Sourcing D(-)-4-Hydroxyphenylglycine from a manufacturer that diligently controls these specifications is crucial. When you inquire about D(-)-4-Hydroxyphenylglycine price, remember that a slightly higher cost for a product that rigorously adheres to these standards offers far greater value than a cheaper alternative with questionable quality. A reputable D(-)-4-Hydroxyphenylglycine supplier, especially one based in China, will provide comprehensive Certificates of Analysis (CoA) that clearly document these parameters for each batch, ensuring transparency and traceability.

For pharmaceutical companies looking to buy D(-)-4-Hydroxyphenylglycine, choosing a supplier that prioritizes these quality control measures is a direct investment in the success and compliance of their manufacturing processes. This commitment to quality ensures that the D(-)-4-Hydroxyphenylglycine is fit for purpose, facilitating efficient and reliable production of essential antibiotics.