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babun ☆ 2009-08-21 16:28 (6151 d 12:28 ago) Posting: # 4088 Views: 3,742 |
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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 |
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Helmut ★★★ ![]() Vienna, Austria, 2009-08-21 17:19 (6151 d 11:36 ago) @ babun Posting: # 4090 Views: 3,036 |
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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! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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babun ☆ 2009-08-24 08:31 (6148 d 20:25 ago) @ Helmut Posting: # 4100 Views: 3,032 |
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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 |

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