In the meticulous world of chemical procurement, especially for materials used in pharmaceutical synthesis and research, quality assurance is paramount. N-(tert-Butoxycarbonyl)-L-phenylalanine, or Boc-L-Phenylalanine (CAS 13734-34-4), is a prime example of an intermediate where documentation and certifications are not just beneficial, but essential. For R&D scientists and purchasing managers, understanding these quality markers is key to ensuring product integrity and regulatory compliance.

The Foundation of Quality: Specifications and CoA

The most fundamental document accompanying any chemical purchase is the Certificate of Analysis (CoA). For Boc-L-Phenylalanine, a CoA should detail:

  • Product Identification: Name, CAS Number (13734-34-4), and lot number.
  • Appearance: Confirmation of its typical white powder form.
  • Purity: Usually measured by High-Performance Liquid Chromatography (HPLC), with standards often exceeding 99.0%.
  • Enantiomeric Purity: Critical for chiral compounds like Boc-L-Phenylalanine, ensuring the L-configuration is dominant.
  • Melting Point: A specific range indicating purity.
  • Moisture Content/Loss on Drying: Important for stability and reaction accuracy.
  • Impurity Profile: Identification and quantification of any significant impurities.

A reliable manufacturer or supplier will readily provide a comprehensive CoA for every batch, allowing buyers to verify that the material meets their exact specifications before use.

Beyond the CoA: Essential Certifications and Documentation

For pharmaceutical applications, particularly those involving drug manufacturing or clinical trials, additional certifications and documentation are often required:

  • ISO Certifications: Manufacturers adhering to ISO 9001 or similar quality management standards demonstrate a commitment to consistent processes and product quality.
  • Material Safety Data Sheets (MSDS/SDS): These documents provide critical information on handling, safety, storage, and emergency procedures, which are vital for workplace safety and regulatory compliance.
  • GMP Compliance: While not always required for early-stage intermediates, if your project is progressing towards Good Manufacturing Practice (GMP) standards, sourcing from suppliers who operate under GMP conditions or can provide GMP-compliant intermediates can be advantageous.
  • Regulatory Support: For API synthesis, manufacturers might offer support with regulatory filings, such as providing Drug Master Files (DMFs) or other necessary documentation.
  • Supplier Audits: Reputable companies may allow customer audits of their facilities to verify quality control and manufacturing practices.

When you decide to buy Boc-L-Phenylalanine (CAS 13734-34-4), prioritizing a supplier that provides robust documentation and holds relevant certifications significantly reduces risk. It ensures that the material is not only pure but also produced under controlled conditions, which is indispensable for developing safe and effective pharmaceutical products.

In summary, the quality of chemical intermediates like Boc-L-Phenylalanine is directly tied to the documentation and certifications provided by the manufacturer and supplier. Diligent review of these quality markers is an essential step in any strategic procurement process, especially within the highly regulated pharmaceutical sector.