Bioequivalence and Bioavailability Forum

Drug degrades in pH4.5 and HCl [Dissolution / BCS / IVIVC]

posted by Ken Peh – Malaysia, 2014-04-22 12:48 (4441 d 20:01 ago) – Posting: # 12871
Views: 7,550

Dear All,

If a drug degrades in pH4.5 and pH1.2 (0.1 HCl), is comparative dissolution profile necessary to be run at these two pH values ? In cases like this, pH 6.8 is sufficient ? Is there any guideline addressing this ?

Appreciate your input.

Thank you.

Regards,
Ken

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Please don’t write “RE: ” in the subject line; removed. [Helmut]

Complete thread:

• Drug degrades in pH4.5 and HClKen Peh 2014-04-22 10:48 
  • Drug degrades in pH4.5 and HCl Dr_Dan 2014-04-22 12:42
    • Drug degrades in pH4.5 and HCl Ken Peh 2014-04-27 20:43
  • Drug degrades… Helmut 2014-05-26 19:18