In the pharmaceutical industry, the quality of raw materials and intermediates directly dictates the efficacy, safety, and regulatory compliance of the final drug product. For (R)-9-(2-hydroxypropyl)adenine (CAS 14047-28-0), a vital intermediate in the synthesis of potent antiviral medications like tenofovir, adhering to stringent quality specifications is non-negotiable. This guide outlines the key parameters that R&D scientists and procurement specialists must consider when sourcing this critical compound.

The Importance of Purity and Assay

The most critical specification for any pharmaceutical intermediate is its purity, often quantified by the assay value. For (R)-9-(2-hydroxypropyl)adenine, suppliers typically guarantee an assay of NLT 98.0% & NMT 102.0% (anhydrous substance), determined by methods like High-Performance Liquid Chromatography (HPLC). This high assay ensures that the bulk of the material is the desired compound, minimizing the presence of inactive or potentially harmful impurities.

Understanding Key Impurities and Limits

Beyond the overall assay, specific impurities must be controlled within defined limits. The provided specifications often include:

  • Impurity G: NMT 0.15%
  • Impurity A: NMT 1.0%
  • Impurity B: NMT 5 PPM

These limits are established based on toxicological data and their potential impact on the final drug substance. A reliable (R)-9-(2-hydroxypropyl)adenine manufacturer will have robust analytical methods to detect and quantify these impurities accurately.

Other Critical Parameters

Several other specifications are vital for the successful synthesis and handling of (R)-9-(2-hydroxypropyl)adenine:

  • Appearance: White to off white crystalline powder – This visual characteristic helps in initial quality assessment.
  • Water Content (KF): NMT 1.0% – Moisture can affect the stability and reactivity of the intermediate during synthesis.
  • Heavy Metals: NMT 20 ppm – Essential for ensuring the safety of the final pharmaceutical product.
  • Fumaric Acid (by HPLC): 17.5%~19.0% (anhydrous substance) – This indicates a specific related compound or formulation component, requiring precise measurement.

Sourcing with Confidence

When you buy (R)-9-(2-hydroxypropyl)adenine, always partner with a reputable supplier or manufacturer that can provide comprehensive documentation and consistently meet these specifications. Understanding these quality parameters is crucial for R&D scientists to validate synthesis routes and for procurement managers to ensure they are acquiring a material fit for purpose. Always request the latest Certificate of Analysis (CoA) from your chosen vendor for CAS 14047-28-0.