Accelerated Impurity Profiling Workflow for Bulk Drugs and Formulations using an Accurate Mass Workhorse
نویسندگان
چکیده
Key Challenges of Impurity Profiling Workflow Identification and quantification of trace-level impurities in drug substances and drug products Laborious workflows for accurate characterization and confirmation of related impurities and other degradants which are present at or below 0.1% Manual and time consuming structure elucidation process for drug related impurities or unknown impurities and MS/MS fragment assignment
منابع مشابه
Impurity Profiling: Theory and Practice
There is an ever increasing interest in impurities present in APIs. Now days, not only purity profile but also impurity profile has become mandatory according to various regulatory authorities. In the pharmaceutical world, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arise out of synthesis or unwanted ...
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