handbook of process chromatography development manufacturing validation

... CHALLENGES OF HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF COMBINED DRUG PRODUCTS Éva Kalmár, Pharm.D Szeged 2014 Ph.D Thesis CHALLENGES OF HPLC METHOD DEVELOPMENT AND VALIDATION FOR ... and processing software The results were evaluated with LCSolution and Microsoft Office Excel 2007 software The log D vs pH function was predicted with Pallas intelligent chromatographic software ... times of the drugs Robustness Examinations were made of the effects of changing the organic:aqueous ratio in the isocratic phases of the gradient, the pH of the aqueous phase, the flow rate of the

Ngày tải lên: 10/12/2016, 13:40

... Determination of limit of determination and limit of quantification: The limit of detection and limit of quantification were estimated from signal to noise ratio Limit of detection and limit of quantification ... Journal of military pharmaco-medicine no9-2019 DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF NIFEDIPINE IN DRUG - EXCIPIENT ... Sample processing and chromatography carried out under selected conditions Figure 12: Chromatogram of blank sample 170 Journal of military pharmaco-medicine no9-2019 Figure 13: Chromatogram of NIF

Ngày tải lên: 14/01/2020, 21:45

... model library of the Apros process simulation software: an overview of development and validation work T Ari Sildea,∗, Jukka Ylijokia, Esa Ahtinenb a b VTT Technical Research Centre of Finland Ltd., ... example of applications is described Severe accident containment phenomena are out of the scope of this paper The results of the validation demonstrate that Apros can be used for analyses of containment ... Transfer Processes with Difference Method Thesis for the Degree of Licenciate of Technology Lappeenranta university of technology Hänninen, M., Silde, A., Eerikäinen, L., 2003 Basic Validation of Containment

Ngày tải lên: 24/12/2022, 22:29

... Journal of Chromatography A, 1600 (2019) 183–196 Contents lists available at ScienceDirect Journal of Chromatography A journal homepage: www.elsevier.com/locate/chroma Development and validation of ... the metabolic pathways of some emerging SARMs in various species to support the development of detection assays for these compounds [14,19,22,56] Moreover, the detection of SARMs and associated ... 183–196 Fig Overlay of UHPLC-MS/MS traces of equine urine fortified with 15 SARMs at 1/2/5 ng mL−1 standard solution of equivalent concentration was injected, divided by the signal of the latter [71]

Ngày tải lên: 25/12/2022, 00:41

... Quality of Life Outcomes 2011, 9:92 http://www.hqlo.com/content/9/1/92 Page 4 of 18 of Life Scale (EQ5D) [24] were used as a global mea- sures of mental health and health related quality of life ... Criteria for number of factors included the number of e igenvalues greater than 1.0, ratio of first to second eigenvalue, pattern of loadings on each factor (i. e., number of non-loading or double-loading ... pur- pose of the first stage was to carry out item reduction while the second aimed to establish the validity of the measure in t he local population. This paper describes the development of the

Ngày tải lên: 20/06/2014, 15:20

... decisions throughout the process of development and finalisation of the questionnaire They gave their approval at each of the milestones of the development and finalisation process The questionnaire ... properly cited Development and validation of the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on ... patient-reported outcomes guidelines The use of this questionnaire will provide assessment of the impact of dry eye on patient dry eye-related quality of life, impact of treatment on patient outcomes in

Ngày tải lên: 20/06/2014, 15:20

... approval of the version to be published MS: Preparation of the paper; analyses and interpretation of data; final approval of the version to be published PV: Preparation of the paper; acquisition of ... that successful aging is a life-long process of realizing and sustaining well-being, even in the face of declining resources Rather than being the process of neutralising losses and discrepancies, ... 0.955, near the cut-off value of 95, and SRMR was well below the cut-off value of 0.08 All indices indicated that the model not systematically linked to the five dimensions of well-being was acceptable,

Ngày tải lên: 20/06/2014, 16:20

... doctors. Materials and methods Development of FAS The development of a self-administered evaluation instrument usually follows a series of major steps: a) the identification of a specific patient population; ... cut-off values led to greater sensitivity but lower specificity, whereas a cut-off value of 4.6 gave a sensi- tivity of 58.7% with a specificity of 91.9%. Reliability analysis The reliability of ... ratios (or 1-specifi- city) of a particular cut-off value, and may help in selecting the optimal cut-off value for a new scale: i.e. assuming an optimal FAS cut-off value of 5.7, sensitivity was

Ngày tải lên: 09/08/2014, 14:22

... tasks — or processes — are done tend to propagate almost haphazardly. Such organizational growth, along with the lack of formal process development or analysis, leads to a vast number of processes ... it is. There are various definitions of Six Sigma. Table 2.1 presents some of the confusing array of descriptions. Each of these definitions contains an element of truth. Six Sigma includes quantitative ... bring profound improvements to an organization However, it is not easy It demands profound changes of an organization: first, on the part of its leaders, and eventually, on the part of everybody

Ngày tải lên: 11/08/2014, 13:22

... small. Such a process, often called a “point” process, may be indicative of high sensitivity to input parameters. Alternatively, it may indicate a lack of knowledge of the effect of process settings ... cover a range of possible settings; temperature is one example. Often these factors are continuous. A subset of this type of factor is one with an ordered set of levels. An example of this is high-medium-low ... result). To use one of these designs, the experimenter should consult one or more of the reference books listed at the end of this chapter or employ one of the enumerated software applications.

Ngày tải lên: 11/08/2014, 13:22

... design of a product by aiding the selection of (1) suppliers (parts), (2) manufacturing and assembly processes (process), (3) a system architecture and design (performance), and (4) a software process ... the requirement that the manufacturing engineer have full knowledge of the process capabilities of in-house equipment and processes, as well as supplier equipment and processes. SL3003Ch04Frame ... Press LLC 72 The Manufacturing Handbook of Best Practices 4.1.4 U SE OF C OMMON M ATERIALS The fifth design consideration is use of the materials most processed. This simply

Ngày tải lên: 11/08/2014, 13:22

... 88 The Manufacturing Handbook of Best Practices With IPPD, each process is still needed. It’s the sequencing, the sharing of knowledge, and the elimination of hand-offs that now offer a product ... REFERENCES Integrated Product and Process Development Handbook, Of ce of the Under Secretary of Defense, Washington, D.C Katzenbach, J and Smith, D K., The Wisdom of Teams, Harvard Business ... results from the interaction of product and process. SL3003Ch05Frame Page 91 Tuesday, November 6, 2001 6:10 PM © 2002 by CRC Press LLC 92 The Manufacturing Handbook of Best Practices Note:

Ngày tải lên: 11/08/2014, 13:22

... the “process approach” to management. The proposed new version of the international standard encourages the adoption of the process approach for the management of an organization and its processes, ... The Manufacturing Handbook of Best Practices Program audits should be conducted that consider the status and importance of the processes and areas to be audited and the results of ... philosophy of Quality Delivery. Any performance or operating process can be characterized as a sequence of input–process–output. Implementing a quality management system has the goal of ensuring

Ngày tải lên: 11/08/2014, 13:22

... 2002 by CRC Press LLC 176 The Manufacturing Handbook of Best Practices and lead to the loss of future business. Some of the causes of this waste may be weak process control, poor product design, ... Manufacturing Handbook of Best Practices 8. 5.1 POKA-YOKE DEVICE (MISTAKE PROOFING) Another... define the path of travel of a typical part Actually, drawing a spaghetti map of ... is one of the counterintuitive aspects of lean This leveling of the schedule accomplishes a steady demand of resources, shortens the lead time of individual product... types of kanban

Ngày tải lên: 11/08/2014, 14:20

... development of an as-is process flow chart. • Start the development of the as-is process flow chart with identification of the final step in the process and then a backward pass through the process, ... Press LLC 228 The Manufacturing Handbook of Best Practices • Process Map. A two-dimensional version of a process flow chart that also portrays handoffs and receipts of products or services ... (intangible). • Process Analysis. Examination of a process using tools or methods such as process flow charts, process maps, and annotation. The purposes of a process analysis are to expand the process

Ngày tải lên: 11/08/2014, 14:20

... management of about half of its C stock to others This means that by giving up control of the dollars on about 7.5% of your stock, you have relieved yourself of doing the work of managing ... minimize our manufacturing cost and called that tool inventory . Like the pharaohs, we now have our “pile of rocks” — the cheapest way to do it. From this point on in the development of manufacturing ... 262 The Manufacturing Handbook of Best Practices you open the restaurant door. This chapter identifies advanced and economically viable techniques that now involve the use of e-manufacturing,

Ngày tải lên: 11/08/2014, 14:20

... 286 The Manufacturing Handbook of Best Practices 13.1 THE SIGNIFICANCE OF ROBUST DESIGN Many studies have been performed demonstrating that the early design phase of a product or process ... LLC 292 The Manufacturing Handbook of Best Practices arrays, based on the design of experiments theory, to study a large number of decision variables with a small number of experiments. ... in manufacturing processes and operating conditions. As a result, development cycle time is shortened and development costs are reduced. An added benefit is the fact that a near-optimum choice of

Ngày tải lên: 11/08/2014, 14:20

... The Manufacturing Handbook of Best Practices • A detailed description of all problem-solving tools also is beyond the scope of a single chapter. Fortunately, the chapters of this handbook ... value of K . However, it takes a lot of work to do so. Also, process changes that reduce defect rates are likely to alter the value of K . As a rule of thumb, consider using a value of ... solving in manufacturing. TABLE 14.3 Steps in Effective Problem Solving Step Purpose(s) Signs of Success Project kick-off • Common understanding • Focus on process to fix instead of “Rules of Engagement”

Ngày tải lên: 11/08/2014, 14:20

... subgroup must be a “snapshot” of the process over a small window of time, and the order of the subgroups... 2001 6:02 PM 342 The Manufacturing Handbook of Best Practices 252.5 247.5 ... centerline (PCL, for process center line) of the individual-X chart is the average of the observations (18.6 days). It provides an indication of the process location. Most of the observations ... sequence of the points, we lack this information. Statistical process control (SPC) provides this context. 15.2 OVERVIEW OF SPC Statistical process control is a method of detecting changes to a process.

Ngày tải lên: 11/08/2014, 14:20