Compounding quality control

Part II, chemical, pharmaceutical and biological documentation describing the composition and method of preparation of the medicinal product (raw materials, manufacture, characteristics of the labeled compound, quality control, European Pharmacopeia standards), and the documentation of preclinical studies performed in animals to determine stability and the elimination kinetics (half-times of removal)... 

Complex environmental samples originate from diverse matrices (the predominant material of which the sample to be analyzed is composed). These matrices, usually either water or soil/sediment, can contain as many as 50 to 100 organic components at widely varying concentrations. The EPA approach to the analysis of these samples involves the analysis of specific (or target) compounds and the use of authentic standards for quality control. The current number of standards in the EPA repository is about 1500, and their analysis is covered by various approved methods. 

SEMCONDUCTORS - COMPOUND SEMICONDUCTORS] (Vol21) QC. See Quality control laboratories. 

Quality Control. Reproducible production of perfumes requires careful quality control of all materials used as well as the compounding process itself. The use of analytical tools has iacreased over the years with their availability, but there can be no substitute for organoleptic evaluation. The human nose is far more sensitive than any analytical instmment for certain materials, yet it is also quite limited as a quantitative tool and is subject to fatigue. There are also weU-documented examples of specific anosmias ia iadividuals, ie, iaability to smell certain odor types, which is somewhat analogous to color-blindness. 

The so-called flow temperature cannot be considered to be either the processing temperature or the maximum service temperature. It is obtained using the highly arbitrary Rossi-Peakes flow test (BS 1524) and is the temperature at which the compound is forced down a capillary of fixed dimensions by a fixed load at a specified rate. It is thus of use only for comparison and for quality control purposes. Since the rates of shear and temperatures used in processing are vastly different from those used in this test, extreme caution should be taken when assessing the result of flow temperature tests. 

The production of a rubber lining includes the preparation of the rubber compound followed by processing to form the lining sheet, substrate preparation, lining application, vulcanisation and inspection. All these stages require thorough quality control, especially compound manufacture and sheet preparation, as chemical resistance depends on satisfactory dispersion of the individual ingredients and undetected flaws in the sheet will cause problems in service. 

A quality control laboratory had a certain model of HPLC in operation. One of the products that was routinely run on the instrument contained two compounds, A and B, that were quantitated in one run at the same detector wavelength setting. At an injection volume of 20 /tL, both compounds showed linear response. The relatively low absorption for compound B resulted in an uncertainty that was just tolerable, but an improvement was sought. 

It Is now a relatively straightforward matter to analyze commercial pesticide mixtures for nitrosamlne contamination as part of the normal quality control process (2.18). and, as Illustrated above, some of the major contamination problems have begun to be solved by means of technological Improvements. If further research brings about the circumstance In which there Is no detectable N-nItroso compound In any pesticide sold an here, will that mean that pesticide use Is safe from nitrosamlne-formatlon problems I believe that considerably more research must be done before a responsible answer to this question can be given. To elaborate on this position, let me focus on the herbicides for a moment. 

All the analytical methods mentioned to separate, identify, and quantify chlorophylls and derivatives consume time, money, and samples. As alternatives, industries have been employing non-destructive methods for surface color measurements that are not only indirectly related to chlorophyll content, but may also estimate the pigments directly in tissues, leaving the sample intact and enabling serial analyses in a relatively short time. Eood color affects consumer acceptance and is an important criterion for quality control. Color vision is a complex phenomenon that depends on both the total content and number of pigments and also on absorption, reflectance and emission spectra of each compound present. 

Particularly for direct microanalytical techniques using <10 mg of sample for analysis, it is highly desirable to obtain quantitative information on element- and compound-specific homogeneity in the certificates for validation and quality control of measurements. As the mean concentration in a CRM is clearly material-related, the standard deviation of this mean value should represent the element s distribution in this matrix rather than differences in the analytical procedures used. 

Advances in quality control requirements for rubber compounds have demanded that special care is exercised in the weighing of the various fillers and critical small volume powders necessary for the formulation. Ingredient weighing systems are available which can be tailored to the specific requirements of individual factories. Additional components can include conveyors, bagging units and pneumatic conveyance systems. 

Hexavalent chromium is also a toxic compound (like lead, cadmium, mercury) and can be easily detected with UV spectrophotometry [20]. This system works for the quality control of electroplating treated wastewater with a detection limit of 5 pg It1. 

---