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Updated on August 25, 2023
QueriesQvents
Participant
August 25, 2023 at 11:01 pm
Q:

System suitability in UV Methods

What criteria can be defined for system suitability in UV Methods for Assay, Impurities (Limit test)

Methods, Validations

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  • Info_Qvents
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    August 25, 2023 at 11:01 pm
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      September 5, 2023 at 12:43 pm

      Pharmacopeia do not define specific system suitability tests for UV methods. However the following may be considered.

      1. A test of repeatability by measurement of response of a standard solution, for example response of standard in five replicates (with %RSD to be less than 2.0%)
      2. Resolution with a solution of toluene in hexane,  criteria – ratio between the minimum and maximum absorbance at respective wavelengths of 267 and 269 nm must exceed 1.3 (USP).

      Useful references:

    • Anonymous
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      August 25, 2023 at 11:01 pm
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