In the pharmaceutical industry, the purity of raw materials and intermediates is not just a specification; it's a fundamental requirement that directly impacts drug safety, efficacy, and regulatory compliance. For professionals involved in sourcing pharmaceutical intermediates, a clear understanding of product purity, such as for D-(+)-Cellobiose (CAS 528-50-7), is indispensable. This article addresses the critical aspects of D-cellobiose purity for buyers seeking to purchase this essential compound.

The Importance of Purity for D-Cellobiose
D-(+)-Cellobiose (CAS 528-50-7) is a disaccharide widely used as a pharmaceutical intermediate. Its purity level is typically defined by its assay, which indicates the percentage of the desired compound present. For most pharmaceutical applications, a high assay, often 98% or higher as determined by High-Performance Liquid Chromatography (HPLC), is expected. Impurities, even in trace amounts, can potentially interfere with downstream reactions, affect the physical properties of the final drug product, or even pose safety risks to patients.

Key Purity Parameters to Scrutinize
When evaluating D-cellobiose from a manufacturer or supplier, buyers should pay close attention to the following:

  • Assay (HPLC): This is the most critical parameter. An assay of ≥98% is a common benchmark, but specific projects might demand even higher purity. The method used (e.g., HPLC) should be stated.
  • Water Content: Moisture can affect stability and reactivity. Reputable suppliers will specify the maximum acceptable water content.
  • Ash Content: This indicates the level of inorganic impurities. For D-cellobiose, low sulfated ash content (e.g., <0.01%) is desirable.
  • Heavy Metals: Limits for heavy metals like lead (Pb) are crucial, typically specified in parts per million (ppm). Low heavy metal content is essential for pharmaceutical applications.
  • Appearance and Solubility: While not direct purity measures, the specified appearance (e.g., white crystalline powder) and solubility characteristics (e.g., clear colorless solution in water) can be early indicators of product quality.
  • Related Substances/Impurities: Some advanced specifications may detail limits for specific known impurities or a total limit for unknown related substances.

How to Ensure Purity When You Buy D-Cellobiose
To ensure you are buying high-purity D-(+)-Cellobiose, it is recommended to:

  • Request a Certificate of Analysis (CoA): Always demand a CoA for each batch you purchase. This document should detail all the purity parameters mentioned above, along with lot numbers and dates.
  • Source from Reputable Manufacturers/Suppliers: Partner with established companies that have a demonstrated commitment to quality control and regulatory compliance. Suppliers in China, like us, often have advanced manufacturing capabilities and adhere to international quality standards.
  • Ask for Samples: Before placing a large order, request samples to conduct your own in-house quality checks if necessary.

Conclusion
For pharmaceutical intermediate buyers, vigilance regarding purity is paramount. D-(+)-Cellobiose (CAS 528-50-7) is a critical material, and its quality directly influences the final pharmaceutical product. By understanding the key purity parameters and working with reliable suppliers, you can confidently buy D-cellobiose that meets the stringent requirements of the pharmaceutical industry. We, as a manufacturer and supplier in China, are dedicated to providing D-cellobiose with exceptional purity and reliable documentation to support your critical applications.