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kiranActimus ☆ India, 2010-01-29 07:56 (5993 d 11:36 ago) (edited on 2010-01-29 09:53) Posting: # 4656 Views: 4,082 |
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Dear All We are using the Sodium bicarbonate buffer (1 buffer : 20 plasma) for stability of plasma samples in the clinical phase but Diethylamine is used as a stabilizer in bioanalytical method development. Does it have an impact on the stability of plasma samples? Is there any issue with the regulatory? Kindly advise us in this regard Regards KK -- Edit: category changed [Ohlbe] |
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Ohlbe ★★★ France, 2010-01-29 10:52 (5993 d 08:40 ago) @ kiranActimus Posting: # 4657 Views: 3,368 |
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Dear Kiran, ❝ Diethylamine is used as a ❝ stabilizer in bioanalytical method development. (My emphasis) ❝ Is there any issue with the regulatory? As long as you are using the same stabiliser for method validation as for the clinical phase, and demonstrate long term stability with that stabiliser, there should be no regulatory issue. Regards Ohlbe — Regards Ohlbe |
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kiranActimus ☆ India, 2010-01-29 13:55 (5993 d 05:37 ago) @ Ohlbe Posting: # 4658 Views: 3,252 |
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Dear Mr Ohlbe Thanks for the reply. We will go ahead as per your suggestion Thanks & Regards KK |
Ing. Helmut Schütz