Standard Operating Procedures Analytical Chemistry and Metabolism. Questo articolo non è disponibile.Standard Operating Procedures Analytical Chemistry and Metabolism

This is the fourth volume of Standard Operating Procedures (SOPs) compiled from documents prepared in these laboratories in part fulfilment of the requirements of various Good Laboratory Practice (GLP) regulations and guidelines. SOPs have now become an everyday feature of work in most industrial and contract toxicology laboratories. They provide a written definition of the mechanics of unit operations which together comprise the framework for experiments in safety evaluation. Metabolic studies and analytical chemistry are closely linked to toxicology since they embody essential aspects of the overall assessment of product safety. Some authorities consider certain parts of these subjects to be outwith the scope of the GLP requirements but for the reasons stated this is contrary to our own view. We have tried where possible to define in SOP format for use in our own laboratories the unit operations involved in these disciplines and they form the basis of this volume. Some relevant material from previous volumes has been brought together in updated form and is also presented here for completeness. Dr I P Sword Managing Director Inveresk Research International Musselburgh EH21 7UB Scotland ix Introduction GENERAL 1. The Food and Drug Administration of the US Government published its Good Laboratory Practice Regulations for Non-Clinical Laboratory Studies in the Federal Register (22 December 1978). The Regulations are the culmin­ ation of a number of years of investigation into the standards to which safety evaluation studies were performed in laboratories in the USA.

Standard Operating Procedures.- General procedures.- SOP/TSB/001 Chemical test sample reception.- SOP/TSB/002 Test substance formulation — general procedures.- SOP/TSB/004 Test substance handling and safety procedures.- SOP/TSB/005 Handling and safety procedures for operations involving hazardous materials or potentially hazardous materials.- SOP/TSB/020 The use of radioactive substances at IRI — a summary of operating procedures.- SOP/TSB/021 Swab monitoring procedure for radiochemical contamination.- SOP/TSB/042 General instructions for the preparation of treated diets for use in toxicity studies.- SOP/TSB/044 Formulated test substance sampling procedures.- Analytical chemistry.- SOP/ACH/001 Data collation and record keeping in analytical chemistry.- SOP/ACH/003 Procedure for the receipt and storage of test substances and analytical standards.- SOP/ACH/004 Procedure for the receipt and storage of biological samples prior to analysis.- SOP/ACH/005 Approval of final analytical methods in analytical chemistry.- SOP/ACH/007 Archiving procedures in analytical chemistry.- SOP/ACH/008 Tube labelling and data recording during pharmacokinetic studies in animals.- SOP/ACH/009 Oral administration of test substances to human volunteers.- SOP/REC/030 Studies involving human volunteers.- SOP/ACH/101 Use and maintenance of fixed volume pipettes.- SOP/ACH/102 Use and maintenance of “class A” pipettes and standard flasks.- SOP/ACH/103 The preparation of reference standards for the generation of standard curves during analysis of plasma and urine samples.- SOP/ACH/104 Processing of analytical data derived from liquid or gas chromatograms or from selected ion-monitoring computer output.- SOP/ACH/106 Preparation of reference standards and quality control samples during analysis of dietary formulations.- SOP/ACH/201 Instructions for using the Perkin Elmer F17 gas chromatograph.- SOP/ACH/204 Operation of HPLC systems in analytical chemistry.- SOP/ACH/205 Operation of the Finnigan 4000 GC-MS system.- SOP/ACH/207 Instructions for use and calibration of the Sartorius 2404 balance for critical weighings in analytical chemistry.- Metabolism.- SOP/MET/100 General record keeping and archiving procedures (amendment for metabolic studies).- SOP/MET/101 Quality control procedures.- SOP/MET/150 Procedure for the receipt, storage and distribution of non-radioactively labelled drugs and reference standard compounds.- SOP/MET/200 Authenticity, radiochemical purity and specific activity of supplied radiochemicals prior to administration to animals and/or man.- SOP/MET/201 The preparation and determination of a radiochemical dose.- SOP/MET/205 The receipt, randomisation and numbering of animals.- SOP/MET/210 The oral and parenteral administration of radiolabeled test substances to rats.- SOP/MET/213 The oral and parenteral administration of radiolabeled test substances to dogs.- SOP/MET/214 The oral and parenteral administration of radiolabeled test substances to non-human primates.- SOP/MET/220 Procedure for the withdrawal of blood samples from rats to which radiolabeled test substance has been administered.- SOP/MET/223 Procedure for the withdrawal of blood samples from dogs to which radiolabeled test substance has been administered.- SOP/MET/224 Procedure for the withdrawal of blood samples from non-human primates to which radiolabeled test substance has been administered.- SOP/MET/230 Collection of excreta from rats to which radiolabeled test substance has been administered.- SOP/MET/233 Collection of excreta from dogs to which radiolabeled test substance has been administered.- SOP/MET/234 Collection of excreta from non-human primates to which test substance has been administered.- SOP/MET/240 Sample collection at autopsy following administration of radiolabeled test substance.- SOP/MET/250 Procedure for the identification, receipt, storage and disposal of biological samples.- SOP/MET/255 Use of balances.- SOP/MET/260 Preparation of biological samples for analysis of radioactivity.- SOP/MET/300 Operation of the Packard 306 sample oxidiser.- SOP/MET/310 Routine use of the Philips PW 4510/01 automatic liquid scintillation analyser.- SOP/MET/320 Processing of data from the scintillation counter with particular reference to acceptance and rejection criteria.- SOP/MET/330 The topical administration of test substances to rats.- SOP/MET/340 Whole body autoradiography.- SOP/MET/350 The use of thin-layer chromatography.- SOP/MET/360 The use of HPLC systems in the operational area of metabolic studies.