Overview of USP-NF Requirements for Stability Purposes
This chapter discusses how companies can apply compendial procedures to monitor the stability of their product through product expiry. When companies are able to employ compendial procedures for stability monitoring purposes they may save time and money because they will not need to validate new procedures. In addition, the drug approval process may be quickened by referencing methods already approved and familiar to the regulatory authorities.
KeywordsDrug Substance Solid Oral Dosage Form Injectable Product Drug Approval Process General Chapter
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