For professionals in the pharmaceutical and fine chemical industries, understanding the detailed specifications of chemical intermediates is fundamental to ensuring product quality and process efficiency. When it comes to 3-Isobutylglutaric Anhydride (CAS: 185815-59-2), a critical intermediate in Pregabalin synthesis, specific parameters are crucial for procurement decisions. Whether you intend to buy small research quantities or purchase bulk industrial volumes, clarity on these specifications is vital.

Essential Specifications for 3-Isobutylglutaric Anhydride

The primary source of information for chemical specifications comes from the manufacturer's product data sheet and Certificate of Analysis (CoA). For 3-Isobutylglutaric Anhydride, key specifications typically include:

  1. Chemical Name and Synonyms: While 3-Isobutylglutaric Anhydride is the common name, understanding synonyms like 4-(2-methylpropyl)oxane-2,6-dione or Dihydro-4-(2-methylpropyl)-2H-pyran-2,6(3H)-dione helps in cross-referencing and accurate identification.
  2. CAS Number: 185815-59-2 is the unique identifier, essential for regulatory compliance and precise ordering.
  3. Molecular Formula and Weight: C9H14O3 and 170.206 g/mol are fundamental chemical properties that define the compound.
  4. Appearance: This is one of the most immediate indicators of quality. For 3-Isobutylglutaric Anhydride, the typical appearance is a White crystalline powder. Any deviation from this, such as discoloration or inconsistent particle size, could indicate contamination or improper storage.
  5. Assay (Purity): This is perhaps the most critical specification for pharmaceutical applications. A high assay, such as ≥98.0%, is required to ensure the intermediate does not introduce detrimental impurities into the final API. Pharmaceutical manufacturers must ensure their chosen manufacturer consistently meets this purity level.
  6. Melting Point: While not always explicitly stated in every listing, the melting point is a key indicator of purity. A sharp melting point within a narrow range signifies a purer compound.
  7. Solubility: Understanding the compound's solubility in various common solvents is crucial for process development and formulation.
  8. Packaging and Storage: Information on how the product is packaged (e.g., 25 kg/drum) and recommended storage conditions (e.g., cool, ventilated place) is essential for maintaining quality post-delivery.

Why These Specifications Matter to Buyers

For procurement managers and R&D scientists looking to purchase 3-Isobutylglutaric Anhydride, these specifications directly impact:

  • Product Quality: Ensuring the final Pregabalin API meets regulatory requirements and exhibits desired therapeutic effects.
  • Process Efficiency: Consistent purity and physical form can lead to predictable reaction kinetics and higher yields.
  • Regulatory Submissions: Accurate documentation of intermediate specifications is vital for Drug Master Files (DMFs) and other regulatory filings.
  • Cost-Effectiveness: While striving for the best price, sacrificing quality due to overlooked specifications can lead to much higher costs in terms of batch failures and rework.

When engaging with a 3-isobutylglutaric anhydride supplier or manufacturer, it is always recommended to request a detailed specification sheet and a sample for internal testing before committing to a large order. This due diligence ensures you are acquiring a product that meets your exact needs and contributes to the successful synthesis of high-quality pharmaceuticals.