Understanding Azithromycin Impurities: The Role of CAS 76801-85-9
The pharmaceutical industry places immense importance on controlling impurities within drug substances and products. For widely used antibiotics like Azithromycin, understanding and managing related compounds, including intermediates and potential impurities, is crucial for safety and efficacy. One such related compound, often discussed in the context of Azithromycin synthesis and quality control, is 9-Deoxo-9a-aza-9a-homo Erythromycin A Desmethyl Azithromycin (CAS 76801-85-9).
While CAS 76801-85-9 is primarily recognized as a key intermediate in the synthesis of Azithromycin, it's important for manufacturers to be aware of its presence and control throughout the production process. Regulatory bodies like the FDA and EMA have strict guidelines regarding the identification, quantification, and control of impurities in pharmaceutical products. Therefore, a reliable manufacturer and supplier of this intermediate must also provide comprehensive data on its characterization and potential for carry-over into the final API.
Research literature and pharmacopeial standards (such as USP and EP) often detail various related substances of Azithromycin. 9-Deoxo-9a-aza-9a-homo Erythromycin A Desmethyl Azithromycin, also known by synonyms like Azaerythromycin A or Desmethyl Azithromycin, is structurally very similar to Azithromycin. Its proper synthesis and purification are vital to minimize its presence in the final drug product. Pharmaceutical companies often purchase this compound as a reference standard for analytical method development and validation to accurately detect and quantify it within their Azithromycin batches.
As a supplier, we understand the critical need for impurity control. We ensure that our 9-Deoxo-9a-aza-9a-homo Erythromycin A Desmethyl Azithromycin product, with its guaranteed purity of 98%, is produced under strict quality management systems. This allows our clients to confidently buy this compound from us, knowing it meets the high standards required for pharmaceutical applications. We provide detailed documentation to support their quality assurance efforts.
For companies seeking to buy CAS 76801-85-9 for use as a reference standard or as a part of their ongoing R&D, selecting a reputable supplier in China or globally is essential. The focus should always be on obtaining materials that have been thoroughly characterized and manufactured in controlled environments. By diligently managing intermediates and related substances, the pharmaceutical industry can continue to deliver safe and effective Azithromycin to patients.
Perspectives & Insights
Alpha Spark Labs
“By diligently managing intermediates and related substances, the pharmaceutical industry can continue to deliver safe and effective Azithromycin to patients.”
Future Pioneer 88
“The pharmaceutical industry places immense importance on controlling impurities within drug substances and products.”
Core Explorer Pro
“For widely used antibiotics like Azithromycin, understanding and managing related compounds, including intermediates and potential impurities, is crucial for safety and efficacy.”