For procurement professionals and R&D scientists in the pharmaceutical industry, a deep understanding of API specifications is crucial for successful product development and manufacturing. Hydrocortisone powder, a fundamental corticosteroid, is no exception. Its therapeutic efficacy and safety are directly tied to its adherence to strict quality parameters. This guide aims to demystify the essential specifications of Hydrocortisone powder, helping you make informed purchasing decisions.

The primary identification of Hydrocortisone is often by its CAS number, 50-23-7, and its molecular formula, C21H30O5. Beyond these identifiers, the physical appearance is the first observable specification. High-quality Hydrocortisone powder is typically described as a 'White or off-white crystalline powder'. Any significant deviation from this description can indicate potential issues with purity or degradation.

Purity is arguably the most critical specification. Pharmacopoeial standards, such as USP (United States Pharmacopeia), BP (British Pharmacopoeia), EP (European Pharmacopoeia), and CP (Chinese Pharmacopoeia), set the benchmarks for Hydrocortisone's purity and impurity profiles. Key parameters include the 'Assay (on dry basis)', which typically ranges from 98.0% to 102.0%, ensuring a potent active ingredient. 'Related Substances' limits, specifying individual and total impurities (e.g., Individual Impurities: ≤0.5%, Total Impurities: ≤1.0%), are vital for safety and regulatory compliance.

Water content is another important specification, often limited to around 3.0%~4.5% for Hydrocortisone powder. Excessive moisture can affect the stability and processability of the API. Similarly, the 'Melting Point', typically within a narrow range of 198.0~202.0ºC, serves as a verification of identity and purity. 'Residue on Ignition' and 'Heavy Metals' (e.g., ≤10ppm) are also critical tests to ensure the absence of inorganic contaminants.

For pharmaceutical manufacturers intending to buy Hydrocortisone powder, understanding 'Residual Solvents' is also essential, as these must be controlled within safe limits (e.g., Dichloromethane ≤0.06%, Acetone ≤0.5%). A reputable manufacturer will provide a Certificate of Analysis (CoA) detailing these specifications, along with TDS and MSDS. When you source Hydrocortisone powder from China, partnering with a supplier that clearly communicates these specifications and offers reliable documentation is paramount for ensuring the quality and success of your pharmaceutical formulations.