For any pharmaceutical manufacturer, the selection of chemical intermediates is a critical decision that impacts product quality, regulatory compliance, and cost-effectiveness. L-2-Aminobutanamide Hydrochloride (CAS 7682-20-4) is a prime example of such a vital compound, serving as an essential intermediate in the synthesis of Levetiracetam, a widely used medication for epilepsy. This article provides insights for procurement professionals and R&D chemists on how to approach the purchase of this crucial pharmaceutical raw material.

Understanding the Specifications of L-2-Aminobutanamide Hydrochloride

The quality of L-2-Aminobutanamide Hydrochloride directly influences the success of Levetiracetam synthesis. Key parameters that buyers should scrutinize include:

  • Purity: A minimum purity of 99.0% is typically required. This is often verified through methods like HPLC or titration.
  • Chiral Purity: As a chiral molecule, the presence of the incorrect enantiomer (R-isomer) must be minimized. Specifications usually limit the R-isomer to ≤0.5%.
  • Loss on Drying: This parameter indicates the moisture content, with a maximum of 0.5% being standard.
  • Related Substances: Limits on specific known impurities, such as L-(+)-2-Aminobutyric acid (≤0.5%) and maximum single or total impurities, are crucial for API quality.
  • Assay: The quantitative determination of the active compound, usually expressed as anhydrous assay, should fall within a specified range, often 98.0%~102.0%.
  • Physical Appearance: It is consistently described as a white or off-white crystalline powder.

The Importance of Reliable Suppliers

Securing a dependable supply chain for pharmaceutical intermediates is paramount. When seeking to buy L-2-Aminobutanamide Hydrochloride, it is advisable to partner with manufacturers who demonstrate:

  • Consistent Quality: A supplier with a robust quality management system and a history of delivering products that consistently meet specifications is essential.
  • Large-Scale Manufacturing Capability: Pharmaceutical production often requires significant quantities. Manufacturers capable of producing at scale ensure that your supply needs can be met reliably.
  • Technical Support: Access to technical experts who can provide detailed product information, assist with formulation challenges, and discuss impurity profiles adds significant value.
  • Competitive Pricing: Particularly for bulk purchases, negotiating favorable terms with a China-based manufacturer can offer substantial cost savings without compromising quality.
  • Regulatory Awareness: Suppliers familiar with international pharmaceutical regulations and documentation requirements can facilitate a smoother import and compliance process.

In conclusion, the procurement of L-2-Aminobutanamide Hydrochloride requires diligence. By focusing on quality parameters, understanding the supplier's capabilities, and establishing clear communication channels, pharmaceutical manufacturers can ensure they source a high-quality intermediate that underpins the production of effective and safe antiepileptic treatments like Levetiracetam.