For any pharmaceutical manufacturer or R&D scientist working with key intermediates, understanding and verifying critical quality specifications is non-negotiable. 3-Pyridylacetic Acid Hydrochloride (CAS 6419-36-9) is a prime example of such a compound, essential for the synthesis of Risedronate Sodium. Ensuring the quality of this intermediate directly impacts the purity, efficacy, and safety of the final active pharmaceutical ingredient (API). When you decide to buy, a clear grasp of its key specifications is vital.

The Paramount Importance of Purity (Assay)

The single most critical specification for 3-Pyridylacetic Acid Hydrochloride is its assay, or purity. For its primary application as an intermediate for Risedronate Sodium, a high assay is mandatory. Manufacturers typically guarantee a minimum purity of ≥99.0%. This high level of purity ensures that unwanted side reactions are minimized during subsequent synthetic steps, and critically, that the final Risedronate Sodium product meets stringent regulatory requirements for drug substances. Any deviation from this purity can lead to increased impurity profiles in the API, potentially requiring costly downstream purification or even rendering the batch unusable.

Appearance: A Visual Indicator of Quality

While purity is paramount, the physical appearance of 3-Pyridylacetic Acid Hydrochloride also provides valuable insights into its quality and consistency. It is typically described as an 'off-white crystalline powder' or sometimes 'white to beige crystalline powder'. Significant deviations from this description, such as a dark color, clumping, or the presence of foreign particles, could indicate issues during manufacturing, storage, or handling. A consistent, off-white crystalline appearance from a trusted supplier is a good first sign of a quality product.

Impurity Profiling and Control

Beyond the main compound's assay, understanding the impurity profile is crucial. While the source material might list common synonyms like 'Nicotine Impurity 3' or 'Risedronate Impurity D', a reputable manufacturer will have robust processes to control and quantify these and other process-related impurities. For buyers, requesting a Certificate of Analysis (CoA) that details the acceptable limits for known impurities is standard practice. This is especially important when buying in larger quantities, as batch-to-batch consistency in impurity profiles is essential for reproducible manufacturing processes.

Physical Properties: Melting Point and Stability

The melting point, typically cited between 161-163 °C, serves as another indicator of purity and identity. A melting point within this narrow range suggests a well-defined crystalline structure. Furthermore, the stability of the compound under normal conditions (stable under normal temperatures and pressures) and recommended storage conditions (e.g., in a tightly closed container, in a cool, dry, well-ventilated area) is vital. This ensures that the material's quality is maintained from the manufacturer's facility to the end-user's production line.

Making an Informed Purchase Decision

When you are ready to buy 3-Pyridylacetic Acid Hydrochloride, partner with suppliers who openly provide detailed specifications, Certificates of Analysis, and are transparent about their quality control procedures. Manufacturers like NINGBO INNO PHARMCHEM are committed to meeting these critical quality benchmarks, ensuring that the intermediates you purchase are of the highest standard for your pharmaceutical applications. Prioritizing these specifications guarantees that your investment in this essential intermediate will translate into successful and compliant Risedronate Sodium production.