What are the requirements for USP/EP and JP protocol?

Dokument-ID

Dokument-ID TE2430

Veröffentlichungsdatum

Veröffentlichungsdatum 21.09.2016
Frage
What are the requirements for USP/EP and JP protocol?
Zusammenfassung
PAT700 and USP/EP and JP requirements
Antwort
PAT700 USP/EP and JP requirements are listed below.

Summary of requirements:

USP requirements: system suitability must pass on a calibrated system (they do not specify what solutions need to be used for calibration).

JP requirements: must be calibrated with KHP & must pass validation with SDBS with at least a 90% recovery.

If both USP/EP and JP requirements need to be met the following steps must be taken:
Part number FG7025700  must be ordered, this is for the JP license key. The license key will unlock the JP capability on the
system.
Once this function has been unlocked, an additional menu option will be available to select: setup > system > pharmacopeia > JP or USP/EP
• Choose JP in your setup menu
• Run a KHP calibration  - PN: FG7021701
• Run a SDBS validation – PN: FG7021601
• Choose USP/EP in your setup menu
• Run a system suitability test  - PN: FG7018402
• Please note:  DO NOT run a USP/EP calibration using sucrose.  If this is done it will invalidate the JP calibration performed with the KHP and you are no longer adhering to the JP requirements.

 

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