Reference standards description

Information on the analytical reference standard Description of the container/closure system Stability data... 

The denomination of odors was schematically related to two separate domains, both related to the memory stimulus of an event concomitant with the perception of the odor. One domain was based on an actual reference point that contains the odor vectors the other was associated with an odor stimulus based on imagination, ie, what image is evoked by the stimulus. With such a system, the final descriptive terminology used would more often than not be expressed in esoteric language, causing confusion and even communication breakdown. The work of Jaubert (1) was the origin of a more standardized descriptive system in the field of aroma description. 

Control All control points starting with the basic raw materials right through to the finished product must be identified. Descriptions of the specifications, test methods, reference standards, and methods validation data should be included. 

The purpose of this compilation is to tabulate the densities of compounds, hence only minimal description of experimental methods used to measure the density of liquids or solids appears. Detailed descriptions of methods for density determination of solids, liquids and gases, along with appropriate density reference standards, appear in a chapter by Davis and Koch in Physical Methods of Chemistry, Volume VI, Determination of Thermodynamic Properties [86-ros/bae],... 

The ENZYME database (Bairoch, 1996) is also used to generate standardized description lines for enzyme entries and to allow information such as catalytic activity, cofactors, and relevant keywords to be taken from ENZYME and to be added automatically to TrEMBL entries. Additionally, specialized databases such as FlyBase (FlyBase Consortium, 1999) and MGD (Blake et al., 1999) are used to transfer information such as the correct gene nomenclature and cross references to these databases into TrEMBL entries. The automatic analysis and annotation of TrEMBL entries are redone and updated every TrEMBL release. 

The dynamics of a generic linear, ideal Gaussian chain - as described in the Rouse model [38] - is the starting point and standard description for the Brownian dynamics in polymer melts. In this model the conformational entropy of a chain acts as a resource for restoring forces for chain conformations deviating from thermal equilibrium. First, we attempt to exemphfy the mathematical treatment of chain dynamics problems. Therefore, we have detailed the description such that it may be followed in all steps. In the discussion of further models we have given references to the relevant literature. 

A modem monograph is devoted to a drug substance and starts with a concise description of the product. This is followed by instructions for packaging and storage, relevant USP reference standards, identification, and procedures for the assay of the drag or the product components. There is sufficient information for those skilled in the arts to be able to analyze the drug and its components, making the compendium... 

A description and the results of all the analytical testing performed on the manufacturer s reference standard lot and qualifying lots to characterize the drug substance should be included. The section should provide information from specific tests regarding the identity, purity, stability, and consistency of manufacture of the drug substance. All test methods should be fully described and the results provided. 

A description and results of all relevant in vivo and in vitro biologic testing performed on the manufacturer s reference standard lot to show the potency and activity of the drug substance should be included. Results of relevant testing performed on lots other than the reference standard lot and that might have been used in establishing the product s biologic activity should also be provided. 

Reference Standard. If an international reference standard (WHO, NIBSC) or compendial reference standard (USP) is used, the applicant should submit the citation for the standard and a certificate of analysis. If an inhouse working reference standard is used, a description of the preparation, characterization, specifications, and testing and results should he provided. 

Describe how the reference standard used to perform the proof-of-structure studies was prepared and how new lots of reference standards will be qualified. If the method of synthesis is the same as that of the drug substance, a statement referencing this fact is sufficient, along with a detailed description of any addi-... 

For an unknown compound without a reference standard, important structural information can be obtained from the IR spectrum. Fig. 9 is a simplified illustration of the correlation between the absorption frequency incm and the functional groups (a more comprehensive description of this type of correlation chart is given in Ref. ). By observing the presence or absence of certain group frequencies, related to common functional groups such as -OH, -NH2, -CH3, -C=0, -CN, -C-O-C, -COOH, etc., the gross structural features of an unknown compound can be quickly determined. 

The analytical method or procedure is a detailed description of the steps necessary to perform each analytical test. This may include (but is not limited to) preparation of the sample, reference standard and reagent, use of apparatus, generation of the calibration curve, use of the formulae for calculation, etc. 

Standard test methods should be described in detail and should provide sufficient information to allow properly trained analysts to perform the analysis in a reliable manner. As a minimum, the description should include the chromatographic conditions (in the case of chromatographic tests), reagents needed, reference standards, the formulae for the calculation of results and system suitability tests. 

Although not an exhaustive list, a validation report should include a description of the bioanalytical method, the reference standard and critical reagents, the calibration standards and validation samples, the validation experiments, SOPs, and the validation testing results. Table 12.1 provides additional details for the suggested content of the validation report. 

Standards for software identification and traceability (e.g., for each software item—unique name/reference, version, project/ product reference, module description, list of build files, change history, traceability to design document) (see Appendix C, section 5, Item 1.2)... 

Commonly, the evaluation of the susceptibility Xzzzz related to a reference standard. A detailed description of both experimental techniques and data evaluation is given in the article by Singer et al. [20]. 

Reference standards very rarely require any sophisticated pretreatment before they are ready for use, unless they are to be derivatised in some way. In most cases, the reference standard is weighed and quantitatively transferred into a suitable volumetric flask with the aid of the solvent. Any dilutions that are required are performed in the same way as the sample descriptions given previously, again depending on the sample size. 

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