Hello Guest! Log In or Register now. Lost Password? Click Here to Reset

Ask About Validation

Results 1 to 5 of 5
  1. #1

    Default Refarence/working standard qualication

    can anyone have a relevt info on below topic and would greatly appreciate your help

    Rational for the qualification of referanced standard qualification by the following tests

    1. By Mass balance method
    2. Assay by HPLC on dried basis.

    Which is the more appropriate test parameters to quantify the reference standard
    Is it depends on product specific.
    Is there any relevent guidelines or info pertaining the above topic.


  2. #Ads
    AskaboutValidation sri4516 is offline

    Train your staff in GDP in 60 Minutes!

  3. #2

    Cool Reference / Working standard qualification

    Dear Sri,
    If reference standard available, working standard purity determined as %w/w on as is basis only whereas reference standard not available, working standard purity determined as mass balance.


  4. #3

    Default Reference/ working standard qualification

    Dear e-sanmail,

    Thanks for your lucid explination for the subjected topic

    besides could you clarify " when we can perform characterisation for working standard" i.e., each time we have to do or any criteria is there

  5. #4
    Validation Expert
    Join Date
    Mar 2012


    Whenever you prepare a new working standard (usually, once in a year), it should be characterized.

  6. #5

    Smile working standard characterisation.

    Dear Sri,
    I agree ramyaraj statement. But working standard "characterisation" and "qualification "are different.
    Qualification is your working standard qualify with pharmacopeial reference standard whereas characterisation is working standard (without pharmacopeial reference standard) characterised by using UV, IR & HPLCMS, NMR instruments to find the mass balance. Normally working standards are qualified once in a year.
    I hope you clarify.

Tags for this Thread


Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts

Get In Touch with AskaboutValidation

© 2006 - 2012 askaboutvalidation. All Rights Reserved
Single Sign On provided by vBSSO