Physico-chemical testing

Klein, A.W., Harnish, M., Porenski, H.J., and Schmidt-Bleek, F. OECD chemicals testing programme physico-chemical tests, Chemosphere, 10(2) 153-207, 1981. 

Containers <661 > Physico-Chemical Tests Plastics. In USP24 2000 1933-1935. 

Often, for complex molecules, the physico-chemical information may be extensive but unable to confirm the higher-order structure which, however, can be inferred from the biological activity. In such cases, a biological assay, with wider confidence limits, may be acceptable when combined with a specific quantitative measure. Importantly, a biological assay to measure the biological activity of the product may be replaced by physico-chemical tests only in those instances where ... 

In-house primary reference material An appropriately characterized material prepared by the manufacturer from a representative lot(s) for the purpose of biological assay and physico-chemical testing of subsequent lots, and against which in-house working reference material is calibrated. 

For biopharmaceuticals, the complexity of analytical test approaches is also reflected in guidelines concerning reference standards and materials (see ICH Q6B [22]). In principle, it is desirable to use the same reference material for both biophar-maceutical assays and physico-chemical testing, but in some cases a separate reference material may be necessary. It may also be necessary to establish distinct reference materials for product-related substances, product-related impurities and process-related impurities. 

Apply physico-chemical tests (on plastic or extract) and biological tests (on extract). 

Parenterals—Biological and Physico-chemical tests. Ophthalmic preparations—Transparency and Neutrality. 

Biological (pyrogenicity, acute toxicity, haemolytic) and physico-chemical tests. 

Recipes which resulted in better quality precipitates were tried for further investigation and the samples were subjeeted to various physico chemical tests viz surface area determination, porosity, pore size distribution and CO-Conversion activity following techniques described in earlier communications [12] from this Laboratory. Details of such studies are given in Table-II. In a particular series, obtained by direct precipitation techniques, pore size distribution in the 4-60 A was found to increase with R values. Basing on these studies some 50 kg batches were prepared in Pilot Plant following reverse technique. Quality eis obtained in Laboratory... 

The physico-chemical tests required for Japanese MITI/MHW notification depend on the results of the ecotoxicological and toxicological studies, ie, in which class the substance is categorised. 

In the case of chemical and physico-chemical tests, unless otherwise specified, the technical inspection must start with at least two measured amounts, or two mutually corroborating determinations, in other tests, it is necessary to start with at least two parallel performed control determinations. 

Engel, G., and von Milczewski, K. E. (1977). Penicillium caseicolum, P. camemberti and P. roqueforti and their harmlessness to human health. I. Physico-chemical tests for the formation of known mycotoxins. Milchwissenschaft 32, 517-520. 

Quality control tests can be divided in physico-chemical tests (mainly radionuclidic and radiochemical piuity) and biological tests (sterility, endotoxins). 

Isseling, F. P., Electrochemical Methods in Crevice Corrosion Testing Report Prepared for the European Federation of Corrosion Working Party Physico-Chemical Testing Methods of Corrosion, British Corrosion Journal, Vol. 15, No. 2, 1980, pp. 51-69. 

Other relevant chemical and physico-chemical tests include ... 

The data sets are split into standard metal-to-metal tests, honeycomh sandwich tests, effect of multiple cures, fatigue and creep, thermal-oxidative testing, and, finally, immersion testing. Where necessary, an explanation of the tests being used is given with each individual table (Tables 13.8—13.13). Until recently, few physico-chemical tests were carried out for qualification purposes. Thus, for Redux 319, the only tests performed were Flow (53.7%) and Volatile Content (0.99%). 

The alternative methods in this field comprise isolate organs, chorioallantoic membrane (CAM) methods, tissue and cell culture systems and physico-chemical tests (Christian and Diener, 1996 Chamberlain et al, 1997 Spielmann, 1997). 

M] Physico-chemical tests Hydrogen absorption-desorption... 

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