In the precise world of pharmaceutical synthesis, understanding the exact specifications of intermediates is non-negotiable. For Lamivudine, a vital component in antiviral medications, its intermediate must meet stringent quality and purity standards to ensure the safety and efficacy of the final drug product. Pharmaceutical formulators and procurement specialists need to be well-versed in these parameters to make informed sourcing decisions, particularly when buying from manufacturers or suppliers in China.

The most critical specification for Lamivudine intermediate is its purity, typically required to be greater than 99%. This high level of purity is essential because even small amounts of impurities can potentially lead to side reactions during synthesis, affect the stability of the final Active Pharmaceutical Ingredient (API), or introduce unwanted toxicological profiles. Manufacturers must employ rigorous quality control processes to achieve and maintain this purity.

Beyond assay (purity), several other specifications are vital for Lamivudine intermediate. These include:

  • Appearance: The intermediate is generally expected to be a White Powder, a visual confirmation of its form and consistency. Any deviation from this can indicate potential contamination or degradation.
  • Loss on Drying (LOD): This measures the amount of volatile matter, primarily water or residual solvents, present in the intermediate. A low LOD, typically ≤ 5.0%, is crucial for accurate dosing and stability.
  • Residue on Ignition (ROI): Also known as sulfated ash, this test indicates the level of inorganic impurities remaining after ignition. A low ROI, usually ≤ 0.1%, signifies minimal inorganic contamination.
  • Heavy Metals: Limits for heavy metals like lead (Pb) and arsenic (often indirectly tested or specified as total heavy metals) are critical due to their toxicity. Strict adherence to ppm levels (e.g., Pb ≤ 3 ppm) is mandatory.
  • Residual Solvents: Solvents used during synthesis must be controlled to acceptable levels, often specified according to ICH guidelines. For example, residual ethanol limits are typically ≤ 0.5%.
  • Particle Size: While not always explicitly stated for intermediates, consistent particle size can influence dissolution rates and handling during subsequent manufacturing steps. For Lamivudine, particle size specifications like '100% pass 80 mesh' might be relevant.

Furthermore, compliance with pharmaceutical quality management systems is paramount. Manufacturers should ideally be certified with GMP, ISO 9001, and adhere to pharmacopeial standards such as USP and BP. These certifications provide assurance that the Lamivudine intermediate is produced under controlled conditions, ensuring traceability, safety, and consistency.

When sourcing Lamivudine intermediate, buyers should always request a detailed Certificate of Analysis (CoA) from the supplier. This document should clearly list all the tested specifications and their corresponding results, confirming that the batch meets the agreed-upon standards. Comparing the CAS number, 134678-17-4, with the supplier's documentation is also a critical step to ensure you are procuring the correct chemical.

By meticulously reviewing these specifications and partnering with reputable manufacturers who can consistently deliver intermediates that meet these demanding requirements, pharmaceutical companies can ensure the integrity of their drug development and manufacturing processes.