Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 15) pptx

... addition, forced decomposition studies must also be performed for dif- ferent dosage forms (capsule, tablet, suspension, injectable, etc.) of the same drug substance. 688 ROLE OF HPLC DURING FORMULATION ... (capsule dosage form) of the development compound A with aspirin was proposed. The preformulation TEST METHODS FOR MOST COMMON DOSAGE FORMS 689 Figure 15-2. HPLC chromatogram obtai...

Ngày tải lên: 22/01/2014, 00:20

... ions on the basis of mass-to-charge ratios, 281 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. low-polarity ... the most widely used systems for analysis of large bio- molecules. For a continuous ion source, the ions can be stored for a short period of time and pulsed out for analysis. In the...

Ngày tải lên: 15/12/2013, 12:15

... metabolites are important biotransformation pathways for many drugs and xenobiotics [127, 132, 133]. For example, the formation of acyl glucuronide conjugate forced the withdrawal of four marketed ... intermediates for formation of the keto acid, were also observed in the radiochromatogram of rat plasma (spectrum not shown) [131]. PRACTICAL APPLICATIONS 335 Scheme 11. Mechanism for th...

Ngày tải lên: 15/12/2013, 12:15

... separa- tion efficiency in HPLC is more related to instrument optimization, column 25 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley ... longer than the standard deviation of the same peak, and the resulting formula for the number of the theoretical plates will be (2 -15) Efficiency is mainly a column-specific param...

Ngày tải lên: 24/12/2013, 18:15

... based on the forced transport of the polymer molecules through the porous stationary-phase media under the conditions of suppressed interactions of the 263 HPLC for Pharmaceutical Scientists, ... in reversed-phase chromatography applications for example, if the area% does not agree with the assay% value for pharmaceutical analysis of a particular active pharmaceutical ingredient...

Ngày tải lên: 24/12/2013, 18:15

... validated methods. 455 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. 9.4.1 Accuracy The test for accuracy is intended ... support for qualifying the pro- posed LOQ as the official LOQ for the method. 9.4.3.1 Linearity Example (Assay and Content Uniformity). An example for linearity for Assay...

Ngày tải lên: 24/12/2013, 18:15

... (17+,18+, 19+,20+) for the reduced form, indicating a more open form of protein struc- ture for protonations upon disulfide-bonds reduction. Furthermore, the mol- ecular weight information obtained ... cells. It not only interferes with foreign invaders that may cause infections, but also prevents the growth and spread of other diseased 837 HPLC for Pharmaceutical Scientists, Edited...

Ngày tải lên: 22/01/2014, 00:20

... development; these include speed 347 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. for these studies. Fast gradient ... the ACD prediction of the solubil- ity for the ionized form of bases and acids shows greater deviation than for the solubility predicted for the neutral form of the molecule...

Ngày tải lên: 15/12/2013, 12:15

... by the pressure limitation of the HPLC equipment. For more information on gradient separation and developing fast HPLC methods, see Chapter 17 and Practical HPLC Method Development from Synder ... 0.2- or 0.45-µm-pore-size filter is generally recommend for removal of particulates [15]. Filtration as a preventive maintenance tool for HPLC analyses is well-documented in the lit- er...

Ngày tải lên: 15/12/2013, 12:15

... The experiments for w w pH 2–4 were performed on day 1, and those for w w pH 5–7 were performed on day 2 (≈36 hr after initial prepa- ration).A further investigation was performed by preparing ... height) for peak B ≤ 1.5 • Tailing factor (5% peak height) for peak A ≤ 1.5 • Rt for peak A must be 12.0 ± 1.3 min • Rt for peak B must be 21 ± 1.0 min • The S/N of the LOQ solution (0...

Ngày tải lên: 15/12/2013, 12:15