In the competitive landscape of pharmaceutical manufacturing, the quality and availability of raw materials are critical differentiators. L-2-Aminobutanamide Hydrochloride (CAS 7682-20-4) is a high-value intermediate, indispensable for the synthesis of Levetiracetam, a leading antiepileptic drug. For procurement professionals and R&D scientists, understanding its key specifications and identifying reliable manufacturers is essential for successful operations.

Critical Specifications for L-2-Aminobutanamide Hydrochloride

When evaluating suppliers or preparing to buy L-2-Aminobutanamide Hydrochloride, attention to detail regarding its quality parameters is vital. Manufacturers must ensure:

  • High Chemical Purity: A typical requirement is a purity of ≥99.0%, verified through analytical methods like HPLC or titration. This ensures efficient conversion in subsequent synthetic steps.
  • Chiral Specificity: As a chiral intermediate for Levetiracetam, the enantiomeric purity is paramount. The content of the R-isomer must be strictly controlled, usually to ≤0.5%, to guarantee the therapeutic efficacy of the final API.
  • Low Impurity Profile: Beyond the R-isomer, other related substances like L-(+)-2-Aminobutyric acid should be within specified limits (e.g., ≤0.5%). Total impurities are also closely monitored.
  • Physical Properties: The product is consistently identified as a white or off-white crystalline powder, which is important for handling and formulation.
  • Standardized Testing: Adherence to established analytical standards for parameters like loss on drying (≤0.5%), residue on ignition (≤0.5%), and HCl content (23.0-28.0%) ensures product consistency.

Finding Reliable Manufacturers and Suppliers

The global market offers various sources for L-2-Aminobutanamide Hydrochloride. Identifying a trustworthy manufacturer involves a due diligence process:

  • Quality Certifications: Look for suppliers who hold relevant quality certifications (e.g., ISO 9001) and can provide detailed Certificates of Analysis (CoA) for each batch.
  • Manufacturing Expertise: Prioritize manufacturers with proven experience in chiral synthesis and pharmaceutical intermediate production.
  • Supply Chain Reliability: Ensure the manufacturer has the capacity to meet your volume requirements consistently and can provide assurance of stable supply.
  • Technical Support: A supplier that offers technical guidance and support for the application of their intermediates in pharmaceutical synthesis adds significant value.
  • Competitive Pricing for Bulk Orders: While quality is paramount, cost-effectiveness is also a key consideration for large-scale production. Comparing quotes from reputable suppliers is recommended.

By meticulously evaluating these factors, pharmaceutical companies can secure a dependable supply of high-quality L-2-Aminobutanamide Hydrochloride, thereby ensuring the efficient and compliant production of Levetiracetam and contributing to better patient care.