Guidance on analytical reagents and reference standard

GOOD LABORATORY PRACTICE (cGLP)
1

Hi All,
Do you have some references /guidances about handling, working, use and stability (setting of expiry date) of the analytical reagents and working standards.

Provide me some guidelines from your side also.

Prawan Dahal

2

hello~

below are the guidlines which mention about reference standard and reagent.

PIC/S GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I (chapter 6)

PIC/S GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART II ( 6.6)

I’ve been work on the guidline searching about reference standard management for a while, but there is not much guidlines mentioned about this, does anybody can supply their idea about standard grade definition and management?

thanks a lot
pat

3

Hi
PrAwAn DaHal
You may find some standard volumetric solutions stability in ASTM-E 200-97 “Standard Practice for Preparation, Standardization, and Storage of Standard and Reagent Solutions for Chemical Analysis” document.
Regards
T.Nageshwar