For any manufacturer incorporating DL-Serine (CAS 302-84-1) into their products, understanding and ensuring its quality is non-negotiable. From pharmaceutical intermediates to nutritional supplements, the purity and consistency of DL-Serine directly impact product performance, safety, and regulatory compliance. As a leading manufacturer and supplier, NINGBO INNO PHARMCHEM CO.,LTD. emphasizes robust quality assurance throughout our production process.

The fundamental specification for DL-Serine is its assay, typically ranging from 98.5% to 101.5%. This high purity is essential, particularly for pharmaceutical applications where it serves as a key intermediate in complex syntheses. Manufacturers must scrutinize impurity profiles. Limits for chloride (NMT 500 ppm), sulfate (NMT 300 ppm), and heavy metals like lead (NMT 15 ppm) are critical benchmarks. These inorganic and metallic impurities can interfere with reactions, affect product stability, or pose safety risks, making stringent control a priority.

Beyond chemical purity, physical properties are also crucial. DL-Serine is typically supplied as a white crystalline powder. Its moisture content, measured by Loss on Drying (NMT 0.2%), and residual inorganic matter, indicated by Residue on Ignition (NMT 0.1%), are vital parameters. Low moisture content ensures product stability and shelf-life, while low residue indicates high overall purity. For applications where microbial contamination is a concern, such as in cell culture media or food products, microbiological testing is paramount. Manufacturers should confirm that suppliers provide DL-Serine meeting standards for total viable aerobic count (NMT 1000 CFU/g), moulds and yeasts (NMT 100 CFU/g), and the absence of specific pathogens like E. coli.

When partnering with a DL-Serine supplier, manufacturers should always request a comprehensive Certificate of Analysis (CoA) for each batch. This document details the specific test results against agreed-upon specifications. Establishing a reliable supply chain is also key. As a China-based manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. is committed to providing a consistent and dependable supply of high-quality DL-Serine. We understand the importance of competitive pricing for bulk purchases and encourage manufacturers to inquire about our offerings to ensure they secure a quality raw material that meets all their stringent requirements.