Analytical methods terminology

ICH Guideline (1994) Validation of analytical methods (Definition and Terminology). IFPMA, Geneva. 

ICH (1994) ICH Topic Q2A (ICH Harmonised Tripartite Guideline) Validation of analytical methods Definitions and terminology (CPMP/ICH/381/95), ICH, London... 

Note that some organizations may not use the terminology used in this book and may not distinguish between SOPs and WIs. Standard Operating Procedures provide details of how a series of operations are carried out. An example of a SOP would be the detailed instruction for carrying out a particular analytical method. Work Instructions give details of how a specific operation is carried out. What might be classed as a WI is how to operate a particular instrument, how to estimate measurement uncertainty or how to calibrate a piece of equipment. 

APV (1981) International Association for Pharmaceutical Technology Praxis der Validierung (Validation in Practice), Symposium (1981-1982, Gelsenkirchen) [6] Terminology, sterile, semisolid, and solid dosage forms in development and production, analytical methods and stability evaluation, packaging development and packaging validation transfer, cost-effectiveness... 

One of the most important performance characteristics in residue analysis is certainly the detection capability of a method. Unfortunately, many different definitions with regard to the detection and quantifying capability of an analytical method are found in the literature. Attempts have been made to harmonize the definitions with regard to the limit of detection (LoD) and the limit of quantification (LoQ). For the sake of consistency, here reference is made only to the harmonized definitions of IUPAC and ISO for the detection decision (Lc, critical value), LoD (minimum detectable value) and LoQ (minimum quantifiable value) (45 -47). ISO terminology is given between brackets. 

Q2A Validation of Analytical Methods Definitions and Terminology CPMP/ICH/381/95 Step 5... 

Specifications for formulated or technical pesticides must be based on satisfactory analytical methods. Collaborative study methods that are acceptable to a number of international organizations are available through CIPAC-AOAC cooperation. Internationally, more effective use of current analytical methodology could result from increased efforts towards harmonization of methods and terminology. 

In practice an instrumental detection limit is of limited use because in analytical chemistry it is rare that no other procedural steps are involved. Normally a limit of detection for the whole analytical method is required. The terminology used in this area is confusing. In general, limit of detection and detection limit are synonymous. The detection limit will encompass factors such as (a) sample matrix effects (b) loss of the analyte during sample preparation etc. The detection limit for the analytical procedure is defined as The minimum single result which, with a stated prohahility, can be distinguished from a suitable blank value . ... 

ICH, Q2A Validation of analytical methods Definitions and terminology, October 1994. 

ICH Q2A Validation of Analytical Methods (Definitions and Terminology), October 1994, Implementation (Step 5) EU Adopted by CPMP, November 94, issued as CPMP/ICH/381/95 MHW Adopted July 95, PAB/PCD Notification No. 755 FDA Published in the Federal Register 1995, 60, 11,260. 

Implementation of the recommendations in the following section should take into account the ICH/VICH Guidelines Validation of analytical methods definitions and terminology" (CPMP/ICH/381/95 and CVMP/VICH/590/98) and "Validation of analytical procedures methodology" (CPMP/ICH/281/95 and CVMP/VICH/591/98). 

Terminology related to analytical methods based on flowing media, as well as terms describing the flow system and its components, is well documented [148,149], and a particular reference to process analytical chemistry is also available [150]. However, most of the proposed flow-based procedures and/or related instrumentation are not fully described in the literature or in commercial material. As a consequence, harmonisation of methods has not yet been achieved and adaptation of a given flow-based procedure to a different analyser is generally cumbersome. Some guidelines are therefore needed for the appropriate description of... 

With improved analytical methods there has been a large increase in the number of compounds identified in wines. Volatile compounds from different families (such as alcohols, esters, aldehydes, terpenes, etc.) play an important role in the organoleptic characteristics of wines. This wide variety of compwimds with different chemical properties and with different concentrations makes the flavour pa-ofile of wines very complex. Therefore, it is necessary to standardise the terminology so as to facilitate the knowledge of the aromatic profile of wines. 

Because chlorine-based disinfectants are widely used in water treatment, much effort has been invested in the development of analytical methods for their determination in municipal water samples over the concentration range from 0.001 to lOmgl (expressed as CI2). The overriding challenge in the development of these procedures has been the need to distinguish between the free and combined forms of residual chlorine. This terminology is highly specific and, in order to clarify the discussion that follows, the definitions of these and other relevant terms are listed below. 

The same terminology is also applied to a complete integrated analytical method for a target analyte in a particular type of matrix. If the distinction between instrumental and method dynamic ranges is not made explicit, the context usually makes clear which of the two is intended. 

As discussed previously in Section 6.2.1, the selectivity of an analytical method can be summarized as the ability of the method to measure and differentiate the analytes in the presence of components that may be expected to be present, e.g. metabohtes, impurities, degradants or matrix components. The terminology specificity is sometimes used in the hterature as a synonym for selectivity but more properly describes the property of an analytical method for which only the target analyte gives any response whatsoever, i.e. the extreme case of selectivity. (It seems unlikely that a truly specific method exists for any analyte.) One of... 

EDQM has issued an update of an early ICH document [14] on validatimi of analytical procedures [15]. EDQM has published a Technical Guide for elaborating monographs [16] that cmitains essential information for the characteristics of analytical methods. These documents contain definitions of the terminology used (accuracy, precision etcetera) in analytical validation and refer to pharmacopoeial mmiographs and pharmacopoeial methods. 

Perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) are the two most commonly measured PFASs however, analytical methods have been developed to determine other, shorter and longer chain PFSAs and PFCAs (see Table 13.2 for a list of common PFASs and abbreviations). Recommended terminology and abbreviations have been described by Buck et al, [146]. 

Every discipline has its own terminology. Your success in studying analytical chemistry will improve if you master the language used by analytical chemists. Be sure that you understand the difference between an analyte and its matrix, a technique and a method, a procedure and a protocol, and a total analysis technique and a concentration technique. 

Dietary fiber is the accepted terminology ia the United States for nutritional labeling. Total dietary fiber (I DF) and its subfractions, insoluble dietary fiber (IDF) and soluble dietary fiber (SDF), are defined analytically by official methods (3—5). 

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