For professionals in the pharmaceutical industry, the selection and procurement of raw materials are governed by strict quality standards and regulatory requirements. D-Tyrosine (CAS 556-02-5), a valuable amino acid derivative, serves as a key intermediate or component in various pharmaceutical syntheses. Ensuring that the D-Tyrosine purchased meets the precise specifications necessary for pharmaceutical applications is paramount for product efficacy, safety, and compliance. This guide, informed by leading D-Tyrosine manufacturers, outlines the critical specifications to consider.

The foremost specification for pharmaceutical-grade D-Tyrosine is its Assay, often expressed as a percentage purity. Typically, pharmaceutical applications demand an assay ranging from 98.5% to 101.0%. This high level of purity ensures that the active chemical entity is predominantly D-Tyrosine, minimizing the presence of unwanted by-products that could interfere with synthesis or affect the final drug product's performance. Manufacturers rigorously test for assay using methods like High-Performance Liquid Chromatography (HPLC) to meet these demanding standards.

Another critical aspect is Chiral Purity, specifically the control of the L-isomer. Since D-Tyrosine is an enantiomer of L-Tyrosine, its stereochemical integrity is vital. In pharmaceutical synthesis, using the incorrect isomer can lead to inactive compounds, altered pharmacological profiles, or even toxic side effects. Therefore, specifications usually stipulate that the L-isomer content must not exceed a very low threshold, often 0.5% or less. Reputable D-Tyrosine suppliers will clearly state this specification and provide supporting analytical data. When you buy D-Tyrosine, always verify the L-isomer content.

Beyond assay and isomer purity, several other parameters are crucial for pharmaceutical applications:

• Loss on Drying: This measures the volatile content, primarily water, and should be kept to a minimum (e.g., not more than 0.3%) to ensure product stability and accurate weighing.
• Residue on Ignition (as sulfate): This indicates the inorganic impurity content. For pharmaceutical use, this is typically limited to a very low percentage (e.g., not more than 0.1%).
• Heavy Metals: Limits for heavy metals (e.g., as lead, not more than 10ppm) are essential due to their potential toxicity.
• Other Impurities: Specifications often include limits for specific ions like chloride, sulfate, ammonium, and iron, as well as absence of other amino acids detectable by techniques like Thin-Layer Chromatography (TLC).

As a dedicated manufacturer of D-Tyrosine (CAS 556-02-5), we understand the stringent demands of the pharmaceutical sector. Our production processes are designed to consistently deliver D-Tyrosine that meets these critical specifications. We provide comprehensive documentation, including detailed Certificates of Analysis, to support your quality assurance and regulatory filings. For companies seeking a reliable supplier for pharmaceutical-grade D-Tyrosine, we offer a combination of high purity, consistent quality, and competitive pricing. Inquire about our D-Tyrosine for sale and request a quote to secure your supply chain.