The newly developed QA-810V is an optional unit for the determination of five-part white blood cell differentials. It can be used together with the same manufacturer's haematology analyser which has been used in relatively small-sized laboratories. The present study evaluates the basic performance of the QA-810V and the MEK-8118 haematology analyser using routinely obtained blood specimens treated with ethylenedioaminetetraacetic acid-2K. In this evaluation, reproducibility was good and little carryover was found. Accurate measurements were possible for up to 24h of storage. Storage at 4&#xb0;C yielded more stable measurements of complete blood counts and five-part differentials than storage at room temperature. A good correlation between findings with the MEK-8118 haematology analyser and those with the SE-9000 haematology analyser was found for complete blood counts. The leukocyte differential obtained with the QA-810V correlated well with eye counts, with <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"><mml:mrow><mml:mi>r</mml:mi><mml:mo>&#x3E;</mml:mo><mml:mn>0.9</mml:mn></mml:mrow></mml:math> for percentages of neutrophils, lymphocytes and eosinophils. Scattergrams obtained with the QA-810V reflected the presence of abnormal cells. The performance of the QA-810V was excellent and it can improve the quality of testing in clinical laboratories.

Izumi Tsuda

Takayuki Takubo

Tomio Kamitani

Noriyuki Tatsumi

Evaluation of use of the optional unit QA-810V for the determination of five-part leukocyte differentials

g-hydroxybutyrate and acetoacetate as well as lactate and pyruvate are intermediary metabolites normally present in blood. The g-hydroxybutyrate/acetoacetate ratio is an expression of the mitochondrial oxido-reduction state. This ketone body ratio can provide a clue to diagnosis and metabolic status in congenital errors of the electron transport chain and pyruvate metabolism. The standardization of these analytical procedures improves the interpretation of the results helping in the difficult diagnosis of mitochondrial diseases in children. This study describes an adaptation to a Dimension R 2 L (Dade Behring, Newark, Delaware, USA) automatic analyser for a method to measure blood ketone bodies (g-hydroxybutyrate and acetoacetate). The method allows the metabolites to be measured directly in nondeproteinized plasma (fluoride/ethylenediaminetetraacetic acid). This adaptation simplifies the analytical procedure and limits the turnaround time to 20 minutes. With a sample volume of 200 &#x3BC; l metabolite concentrations ranging from 12 to 1300 &#x3BC; molL&#x2212;1 of g-hydroxybutyrate and from 10 to 450 &#x3BC; molL&#x2212;1 of acetoacetate may be measured with a reliable analytical response.

Amparo Gal&#xE1;n

Jos&#xE9;m. Hern&#xE1;ndez

Orlando Jimenez

Measurement of blood acetoacetate and &#x3B2;-hydroxybutyrate in an automatic analyser

Drug discovery today includes considerable focus of laboratory automation and other resources on both combinatorial chemistry and high-throughput screening, and computational chemistry has been a part of pharmaceutical research for many years. The real benefit of these technologies is beyond the exploitation of each individually. Only recently have significant efforts focused on effectively integrating these and other discovery disciplines to realize their larger potential. This technical note will describe one example of these integration efforts.

Charles J. Manly

Computational chemistry, data mining, high-throughput synthesis and screening - informatics and integration in drug discovery

Significant advances within the field of laboratory automation and instrumentation have greatly benefited the pharmaceutical industry in its quest to discover, develop and monitor the quality of its products. Necessitated by the need for efficiency and greater productivity, faster and more cost-effective means of analyses exist in the form of devices made up of complex electromechanical components, all logically controlled and most with the capability to interface with sophisticated information systems. This benefit does come with a price, a greater responsibility to ensure data quality while complying with increased regulatory requirements. Commitment to this responsibility presents a substantial challenge to scientists and managers throughout the industry. Due diligence must be demonstrated. A comprehensive evaluation of every laboratory system utilized, a solid plan of action for correcting any known deficiencies including upgrades or complete replacement, and an accurate monitoring procedure with the ability to measure progress are all absolute necessities to ensure success. Crossfunctional team effott and communication must transpire with full managerial support. Vendors need to be audited, made aware of any functional or quality inadequacies they possess as well as the pharmaceutical industry's expectation for these shortcomings to be rapidly corrected. Suppliers of these systems should also be encouraged to provide complete &#145;off-the-shelf solutions&#146; to eliminate the need for in-house customization. The requirements for regulatory compliance in today's electronic environment have been well publicized. The players involved are not only listening, but also taking the necessary steps to retain and improve efficiency without sacrificing quality. With the proper measures, planning and action, a highly automated, cost-effective and compliant laboratory operation can become a reality.

John A. Potter

Laboratory 2000 - The challenge of achieving efficiency and compliance

A renewed focus has been given to the 3-year-old regulation 21 CFR Part 11, Electronic Records and Electronic Signatures. This paper gives a chronology of the process of an equipment vendor, Zymark Corporation, validating laboratory automation equipment for compliance to the regulation 21 CFR Part 11. Zymark's Tablet Processing Workstation II&#153; (TPW&#153;) and Prelude&#153; are the instruments chronicled. The first instrument, the TPW&#153;, was developed before Zymark defined its strategy on how to meet its customer's need for 21 CFR Part 11 compliant equipment. The TPW&#153; has been available for several years, and in the summer of 1999 it received a major software upgrade to improve its security. The second instrument, the Prelude&#153;, is a new product. It had a design requirement to meet the regulation. Zymark's Part 11 strategy was already in place and used for this development project. This chronology will include all aspects of the exercise, including familiarization with the standard, development of the protocols, review of the protocols by industry experts, review of the protocols by pharmaceutical users, execution of the tests, preparation of the exception reports, and the release of any necessary product revisions.

Stephen M. Dobro

My continuing adventure with 21 CFR Part 11 - the evolution of Zymark's compliance

The need for a multiple-target compound selectivity programme led to the establishment of a single robotic system that produces a compound's serial dilution and its distribution to multiple replicate assay plates. A Genesis RSP 150 integrated into a Zymate Laboratory Automation System XP produced the serial dilutions, and the subsequent replicate assay plates were produced quickly and accurately by an efficient use of the carousels and rapid plate. Currently, this process allows for the production of over 200 serial dilution assay plates in a workday.

Cole O. Harris

Stephanie L. Schweiker

Optimizing production of serially diluted compounds and distribution to multiple targets

The development of drugs in the generic pharmaceutical industry is a highly competitive arena of companies vying for few drug products that are coming off patent. Companies that have been successful in this arena are those that have met or surpassed the critical timeline associated with trial formulation development, analytical method development, and submission batch manufacturing and testing. Barr Laboratories Inc., has been successful in the generic pharmaceutical industry for several reasons, one of which includes automation. The analytical research and development at Barr has employed the use of automated dissolution early in the lifecycle of a potential product. This approach has dramatically reduced the &#145;time to market&#146; on average for a number of products. The key to this approach is the network infrastructure of the formulation and analytical research and development departments. At Barr, the cooperative ability to work and communicate together has driven the departments to streamline and matrix their work efforts and optimize resources and time. The discussion will reference how Barr has been successful with automation and gives a case study of products that have moved with rapid pace through the development cycle

Jon P. Sadowitz

Expediting the formulation development process with the aid of automated dissolution in analytical research and development

For the on-line speciation of selenocystine (SeCys), selenomethionine (SeMet), selenoethionine (SeEt), selenite (Se(IV)) and selenate (Se(VI)), a high-performance liquid chromatography-UV irradiation-hydride generation-atomic fluorescence spectro- metric method is described. Separation was carried out on a conventional reversed-phase C18 column modified with didodecyl- dimethylammonium bromide with gradient elution applying two concentrations of ammonium acetate as the mobile phase. UV irradiation and hydride generation parameters were optimized. The obtained detection limits for SeCys, SeMet, SeEt, Se(IV) and Se(VI) were 0.31, 0.43, 0.7, 0.44 and 0.32 ng ml&#x2212;1, respectively, using a 100-wl loop. The method was tested with spiked mineral water and two volunteers' urine samples.

I. Ipolyi

W. Corns

P. Stockwell

P. Fodor

Speciation of inorganic selenium and selenoamino acids by an HPLC-UV-HG-AFS system

Margarete Assali

Ivo M. Raimundo, Jr

Ileana Facchin

Simultaneous multiple injection to perform titration and standard addition in mono-segmented flow analysis

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Journal of Analytical Methods in Chemistry publishes research into the methods and instrumentation used in chemical analysis, including spectroscopic, spectrometric and wet chemistry techniques, and their applications in real-world problems.

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Chief Editor, Dr. María José Trujillo-Rodríguez, is based in the Chemistry Department (Analytical Chemistry Division) at Universidad de La Laguna, Spain.

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Journal of Analytical Methods in Chemistry - Table of contents 2001

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Journal of Analytical Methods in Chemistry publishes research into the methods and instrumentation used in chemical analysis, including spectroscopic, spectrometric and wet chemistry techniques, and their applications in real-world problems.

Journal of Analytical Methods in Chemistry