required quality for water for pharmaceutical purposes

Ngày tải lên: 06/08/2012, 15:04

... goodwill and shared values such as quality, good service or innovation For example, in 2008, Facebook, the world’s largest social network, intended to buy Twitter for US$ 500 million; but Twitter ... development • When a forms wants achieve administrative benefits • To increased market share • To lower cost of operation and/or production • To gain higher competitiveness • For industry know how ... comfort in the idea that a merger will deliver enhanced market power M&A comes in all shapes and sizes, and investors need to consider the complex issues involved in M&A The most beneficial form...

Ngày tải lên: 12/08/2013, 12:00

Ngày tải lên: 09/09/2013, 12:24

Ngày tải lên: 01/11/2013, 16:20

Ngày tải lên: 01/11/2013, 16:20

Ngày tải lên: 01/11/2013, 16:20

Ngày tải lên: 01/11/2013, 16:20

Ngày tải lên: 01/11/2013, 16:20

Ngày tải lên: 01/11/2013, 16:20

... that must be given up, not quality! And it is increasing scope (not quality) that increases costs or schedules Quality vs Grade Where did people get the idea that quality costs more? It comes ... to grade, and not quality Once the requirements for the product have been agreed upon, its quality refers to the degree to which it meets those requirements Producing a poor -quality product does ... money In fact, as we will discuss later, quality problems actually cost us time and money Cost of Quality The confusion between grade and quality is reinforced (especially in software development),...

Ngày tải lên: 10/12/2013, 14:15

... ions Clearly, the ion formation process is separated from solvent evaporation process in APCI (in contrast to ESI), allowing the use of solvents unfavorable for ion formation For example, 290 APPLICATIONS ... of the most widely used systems for analysis of large biomolecules For a continuous ion source, the ions can be stored for a short period of time and pulsed out for analysis In the case of ESI, ... structures of analytes For basic compounds (i.e., amines), a positive ion mode can be used to form a protonated or cationized molecule For acidic compounds, a deprotonated molecule is formed in the negative...

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 ... was achieved for the exact mass measurements, using PEG sulfates as internal calibration substance Based on the high-resolution MS information, empirical formulae were obtained for all components ... might be the intermediates for formation of the keto acid, were also observed in the radiochromatogram of rat plasma (spectrum not shown) [131] Scheme 11 Mechanism for the formation of metabolite...

Ngày tải lên: 15/12/2013, 12:15

... sometimes the ACD prediction of the solubility for the ionized form of bases and acids shows greater deviation than for the solubility predicted for the neutral form of the molecules Reaction of the excipients ... the drug product Therefore, for the drug product formulations, as per the current ICH guidelines on impurities in new drug products [5], the reporting thresholds are 0.1% for drugs with maximum ... stability studies Therefore the stability-indicating methods should be rugged and robust and meet all validation requirements that will allow for determining the purity of the active pharmaceutical ingredient...

Ngày tải lên: 15/12/2013, 12:15

... in their ionic form or neutral form This may be dependent on the type of analysis that is required If fast analysis is required, then analysis of the component in its ionized form may be acceptable ... soluble in methanol /water than in acetonitrile /water or THF /water Some salt buffers are hygroscopic If an analyst makes a 20 mM buffer and the original buffer salt contains 20 w/w% water, then the ... column chosen for a particular separation depends on the compound and the aim of analysis Pharmaceutical companies may have a preferred list of columns that have good demonstrated performance in...

Ngày tải lên: 15/12/2013, 12:15

... peak 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 Rt for peak B must be 21 ± 1.0 The S/N of the LOQ solution (0.05%) for both actives ... acetonitrile The experiments for w pH 2–4 were performed on day w 1, and those for w pH 5–7 were performed on day (≈36 hr after initial prepaw ration) A further investigation was performed by preparing ... selectivities could be obtained for two components when using either methanol /water or acetonitrile /water eluents Varying the type of organic modifier in RPLC separations is recommended for the separation...

Ngày tải lên: 15/12/2013, 12:15

... analyte pKa shift) for both basic ionization centers Therefore this cors relates with a spKa of 2.7 for pyridinal nitrogen (i.e., 3.3 − 0.6 = 2.7) and with s a spKa of 4.7 for the morpholinal ... is in its neutral form No lower METHOD DEVELOPMENT APPROACHES 411 limit plateau is observed where the analyte would be in its fully ionized form Therefore, further analysis for this compound ... molecule in its neutral form The pKa shift of the ionizable analyte For this example, since the analyte is basic, the downward pKa shift for basic analytes must be accounted for The working pH should...

Ngày tải lên: 15/12/2013, 12:15

... isocratic conditions for determining the most suitable pH for the method The retention behavior of active as a function of pH (isocratic) was determined The best mobile-phase pH for further gradient ... AMDS/Dry Lab for method optimization and then use MS to confirm the separation of active species from possible co-eluting species MS/MS analysis can 426 METHOD DEVELOPMENT be performed for further ... Drylab, a forced degradation sample was run that was stressed at 50°C for week in pH diluent It was noted that a major impurity was formed (Figure 8-49) and was determined to be the carboxylic acid...

Ngày tải lên: 15/12/2013, 12:15

... Reversed-phase HPLC is the dominant method used for the majority of pharmaceutical applications (>95%) Normal-phase chromatography may be required for separations that are not compatible with reversed-phase ... crystals that will damage the seal over time Therefore it is recommended to wash the HPLC system with acetonitrile /water (20 : 80) for at least 30 before the system is shut down to remove any potential ... of analysis is critical to the success for fast and effective method development The general approach for the method development for the separation of pharmaceutical compounds was discussed,...

Ngày tải lên: 24/12/2013, 18:15

... three basic types of molecular forces: ionic forces, polar forces, and dispersive forces Each specific technique capitalizes on each of these specific forces: Polar forces are the dominant type of ... pharmokinetics, process research, preformulation, and formulation) At each phase of development the analyses of a myriad of samples are performed to adequately control and monitor the quality of the prospective ... process, the optimization of drug synthesis and formulation are performed which eventually lead to a sound and robust manufacturing process for the active pharmaceutical ingredient and drug product...

Ngày tải lên: 24/12/2013, 18:15

... expression for the retention factor (from Chapter 1) and expression (2-43) to get TABLE 2-1 Void Volume Values Measured with MeCN /Water, MeOH /Water, and THF /Water and a Deuterated Eluent Component for ... nonionic form of the analyte at conditions where protonation is completely suppressed Corresponding capacity factors for neutral and protonated forms of basic analyte could be written in the form ... general form of time-dependent interionic formation with the average lifetime on the level of 10−6 sec in water organic solution with dielectric constant between 30 and 40 With increase of the water...

Ngày tải lên: 24/12/2013, 18:15