babun
☆    

2009-08-21 16:28
(6151 d 12:28 ago)

Posting: # 4088
Views: 3,742
 

 Change of salt form [Bioanalytics]

Dear Members,

If clinical study has been performed with HCl salt of any analyte then can we prepare the calibration curve and quality control samples with sulfate form or free form of the same analyte ?

I mean if bioequivalence to be proved for metformin sulfate then can metformin hydrochloride be used for method validation ?

Regards,

bani
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2009-08-21 17:19
(6151 d 11:36 ago)

@ babun
Posting: # 4090
Views: 3,036
 

 only base/acid important

Dear Bani,

short answer: yes.
BTW concentrations for a BE study should always reported for the free base (or acid) - never the salt, in order to ease comparison between studies (e.g., the literature). Active in the body is always the free form, never any salt.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
babun
☆    

2009-08-24 08:31
(6148 d 20:25 ago)

@ Helmut
Posting: # 4100
Views: 3,032
 

 only base/acid important

Dear HS,

Thanks for the reply. Yes it is only the free analyte which we are quantifying, however for long term stability of bulk spiked sample is there any effect of different salt form in plasma ?

Please correct me if I am not right.


Regards

Bani
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
143 visitors (0 registered, 143 guests [including 15 identified bots]).
Forum time: 04:56 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5