Suitability testing

Ether solution (E,). This will contain any neutral compounds present. Dry with anhydrous magnesium sulphate, and distil ofi the ether. A residue indicates the presence of a neutral component. Determine the solubility of a portion in cone. HjS04. Apply any other suitable tests. 

The main criterion of acceptance for results of calculations of MWD for dextran 40 is validity of system suitability test (characteristics of MWD for dextran 40 standai d for system suitability test must be in prescribed intervals). 

It is found that the validity of system suitability test depends on loading of dextran standai d. Chai acteristics for loading 3 was close to the middle of prescribed interval, for loading 2 it is close to the upper limit, for loading 1 it is outside of the limit. 

Methods which ai e described in Phamiacopoeias (American, British, and European) ai e based on using narrow standai ds for calibration and broad standai d for system suitability test. Prescribed limits of system suitability ar e broad and therefore it may cause large uncertainty of results. But on the other side results ar e strongly influenced by par ameters of chromatographic system. 

In this work there is proposed approach which allows using broad standar ds for calibration and system suitability test. The approach is based on main principle of using of standards i.e. maximal closeness of tested sample and standar d. It has been shoved that the approach allows achieving essential improvement of robustness of method for determination of MWD of dextrans. 

Of the biomolecular force fields, AMBER [21] is considered to be transferable, whereas academic CHARMM [20] is not transferable. Considering the simplistic form of the potential energy functions used in these force fields, the extent of transferability should be considered to be minimal, as has been shown recently [52]. As stated above, the user should perform suitable tests on any novel compounds to ensure that the force field is treating the systems of interest with sufficient accuracy. 

The available range of plastics is very wide with a variety of compositions and related properties within any one type description. Even when physical properties and formulation are specified, minor variations in trace additives, release agents, moulding cycles, etc. may have a considerable influence on corrosivity. Table 18.18 can therefore be considered only as a guide and even in this sense much more experimentation is needed to provide the full picture. In the present state of technology precise information is only likely to result from tests carried out on the material of interest various suitable test methods have been described in the literature ... 

Where anticipated corrosion rates are moderate or low, ASTM 031 1972 (R198S) suggests that the following equation be used to estimate a suitable test duration ... 

For work of the highest precision, it is highly advisable to carry through an analysis of variance together with suitable tests of significance, not only to establish what the precision is, but also to uncover individual sources of error so that they can be made less serious. How this is done for instrumental and manipulative errors has been demonstrated in this chapter. 

R is the gas constant Dq and activation energy Eu are constants derived from an Arrhenius plot for diffusion coefficients applying at different temperatures, and solubility coefficient was obtained from a separate permeation test at TiK. Suitable testing using a specially constmcted permeation cell water-cooled at one end provided good validation data. 

A system suitability test prescribes a relative standard deviation of not more than 1% for the procedure to be valid with Xmean = 173.5 this translates into Vr - (1.735)2 because the limit is imposed, this is equivalent to having no uncertainty about the numerical value, or in other words,/r = Since Si was determined to be 2.43 for n, = 1 ... 

Assuming the 1% limit was set down in full cognizance of the statistics involved, the system suitability test must be regarded as failed because 2.43 > 1.74. This would be the legalistic interpretation under GMP rules. Statistically it would have made more sense to select the criterion as St <0.01 Xmean VFc 0.05,ft, °°) for acceptance and demanding, say, u > 5 in this particular case, s, could have been as large as 3.6. 

Acceptance Criteria System suitability tests are to be conducted, if necessary, every time an analysis method is installed, in order to ensure that meaningful results are generated. Criteria are in place to supply the necessary information for a go/no go decision. 

Use ofa hygienic hand rub, in which a suitable disinfectant or disinfectant-detergent is rubbed into dry hands for not more than 30 seconds. A suitable test method is to compare a product with a standard (70% ethanol or 60% isopropanol) the product must not be less effective than the standard. 

Solid disinfectants may be evaluated in vitro by applying them to suitable test organisms growing on solid medium. Discs may be cut from the agar and subcultured, observing the usual precautions. 

Obtain a group consensus on suitable test ranges for each factor by specifying a low and high level for each factor. 

Make a preliminary assessment of each of the combinations of low and high levels for the purpose of verifying that the individual combinations of levels are suitable for experimental implementation Some combinations may not be technically feasible If some combinations are not acceptable, revise the ranges of the factors until each combination of levels in the 2 factorial table can be accepted as a suitable test condition ... 

In case of reduced availability of an impurity a possible approach is to prepare a spiked sample , i.e. a known amount of impurity is added to the CRS and may serve in a system suitability test as well as for the control of the level of this impurity. An example is given in the monograph for chlorprothixene hydrochloride (Monograph 0815 1999) where the content of the E-isomer is controlled to a level of not more than 2 per cent, Figure 5.5. 

Rose U (1998) In situ degradation a new concept for system suitability tests in monographs of the European Pharmacopoeia. J Pharm Bio Anal 18 1-14. 

Once the targeted study regions, soil textures, space requirements, and other key aspects of study design have been determined, the search for suitable test sites... 

Establish detailed written protocols. A suitable test of the quality of the protocol is that a naive operator should be able to analyze accurately blind samples with no further instruction. 

It is being recognized increasingly that regulation can have a positive impact on laboratory productivity.36 System suitability testing has been proposed as superior to and supplemental to calibration in the UV-VIS detector.37 Large variations in both response factor and in relative response factors were observed on different instruments. Even on the same instrument, UV-VIS spectra can be extremely dependent on solution conditions, as was observed in a separation of hypericin, the antidepressant extract of St. John s wort.38... 

A number of recommendations have been made in the development of quantitative chromatographic methods. The American Society for Testing Materials — using as a benchmark the reversed phase separation of benzyl alcohol, acetophenone, benzaldehyde, benzene, and dimethylterephthalate — discovered substantial laboratory-to-laboratory differences in quantitative analysis.53 These compounds are routinely used to test column performance or for system suitability testing. A followup study, using benzyl alcohol, acetophenone, p-tolualdehyde, and anisole, showed that measurement of... 

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