For pharmaceutical procurement professionals and research scientists, understanding the precise specifications of an Active Pharmaceutical Ingredient (API) like Doxylamine Succinate (CAS 562-10-7) is non-negotiable. This white powder, known for its antihistamine and sedative effects, requires stringent quality control to ensure the safety and efficacy of the final drug product. This article outlines the critical specifications that buyers should look for when considering a purchase of Doxylamine Succinate.

1. Purity (Assay)

The most crucial specification is the purity, often referred to as the assay. For Doxylamine Succinate, a high purity of ≥99% is the industry standard. This indicates the proportion of the active compound relative to impurities. Buyers should always request a Certificate of Analysis (CoA) that clearly states the assay value and the analytical method used (e.g., HPLC, titration). A reputable manufacturer or supplier will readily provide this documentation.

2. Appearance

The physical appearance is a primary indicator of quality. Doxylamine Succinate is characterized as a White powder. Any deviation from this description, such as discoloration or the presence of foreign particles, could suggest contamination or degradation. This visual inspection is the first line of defense for quality assurance.

3. CAS Number and Molecular Formula

The Chemical Abstracts Service (CAS) Registry Number, 562-10-7, is a unique identifier for Doxylamine Succinate. Its molecular formula is C21H28N2O5, and its molecular weight is approximately 388.46 g/mol. These identifiers are essential for accurate product identification and should be cross-referenced on all documentation and packaging.

4. Melting Point

The melting point provides valuable information about the compound's thermal properties and purity. The reported melting point for Doxylamine Succinate is typically in the range of 95-98°C (or 103-108°C as seen in some sources). Deviations outside this range can indicate the presence of impurities or polymorphism.

5. Water Content

The acceptable level of water content is usually specified as ≤0.5%. Excessive moisture can lead to degradation and affect the stability of the API. Karl Fischer titration is a common method for determining water content.

6. Pharmacopoeial Compliance

For pharmaceutical use, Doxylamine Succinate must comply with established pharmacopoeial standards, such as USP (United States Pharmacopeia), BP (British Pharmacopoeia), EP (European Pharmacopoeia), and FCC (Food Chemicals Codex). Compliance ensures the API meets rigorous safety, quality, and efficacy requirements. A trusted supplier will clearly state which pharmacopoeial standards their product meets.

7. Packaging

The standard packaging for bulk quantities of Doxylamine Succinate is typically a 25kg fiber drum. This packaging is designed to protect the product from contamination and environmental factors during transport and storage. When you purchase, confirm that the packaging meets your specific handling and storage requirements.

By meticulously reviewing these specifications, pharmaceutical buyers can confidently select high-quality Doxylamine Succinate, ensuring the integrity and regulatory compliance of their final pharmaceutical products. Always partner with reputable manufacturers and suppliers who prioritize quality assurance.