Baloxavir Impurity C149
Baloxavir Impurity C149 (CAS 2136287-68-6) is the 4-methylbenzenesulfonate salt form of a baloxavir marboxil related substance, described in reference-standard catalogues as related to Baloxavir Impurity 5. It is a white to off-white solid supplied as an analytical reference material in small quantities for pharmaceutical quality control, and it is not intended for human or veterinary use. As an impurity of the influenza antiviral baloxavir marboxil, its structure derives from the synthetic route to the drug, and it is monitored as a specified or unspecified impurity in the active substance and tablet specifications. The tosylate salt form improves crystallinity and weighing accuracy compared with the free base, making it convenient for preparing accurate volumetric stock solutions for chromatographic analysis. FLAG: listed by suppliers as a baloxavir marboxil related substance (tosylate form, C16H23N3O4) under this CAS; the exact structure was not independently confirmed in the references retrieved.
1. Impurity identification and quantification: a certified reference material for identifying and measuring this related substance in baloxavir marboxil drug substance and in the corresponding film-coated tablets.
2. Analytical development and validation: used to optimise chromatographic separation, determine relative response factors, establish resolution and validate impurity methods in accordance with regulatory expectations for the product.
3. Pharmaceutical quality control: supports stability studies, batch release testing, shelf-life determination and regulatory submissions concerning the influenza antiviral product and its manufacturing process.
4. Handling and storage: laboratory reference material only and not for human use; store sealed, dry, cool and protected from light, prepare fresh stock solutions as required, and dispose of all residues as regulated chemical waste.
5. Verification note: FLAG: listed by suppliers as a baloxavir marboxil related substance (tosylate form, C16H23N3O4) under this CAS; the exact structure was not independently confirmed in the references retrieved.
Product Name: Baloxavir Impurity C149
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