Reconstitution design

The term bitumen is used in France to designate petroleum products, as in Great Britain and Germany. In the United States on the other hand, the equivalent material is designated by the expression asphalt-cement . In France, asphalt is a mastic, a mixture of bitumen and powdered minerals, poured in place. This mixture can be either natural or reconstituted by an industriai process. Asphait (French meaning) is utilized on roads, particularly in urban centers as well as for sidewalk surfacing. 

An SFE instrument can be designed as a single standalone instrument performing a range of manual processes extraction, fractionation, concentration, solvent exchange, reconstitution and derivatisation. 

The application should state the rationale for the design of the in-use stability tests performed. The procedures used should be fully validated. One key factor is that the test should simulate the use of the product as far as practicable. This should include any reconstitution or dilution prior to use. Aliquots should be removed in an appropriate manner following, as far as possible, the usage pattern that will be encountered in practice. Physical (color, clarity, closure integrity, particulate matter, and particulates/particle size), chemical (assays for active ingredient, antioxidants and... 

The wine industry in the United States has not seen even growth it has been characterized by periods of rapid expansion interspersed with times of little growth. Our nationwide experiment designed to prohibit production, transport, and sale of alcoholic beverages effectively destroyed the commercial wineries and fine varietal vineyards of this country. As a side effect, however, it introduced many people to the mysteries of making wine at home and the reconstitution of fine varietal grape vineyards... 

The design of the validation testing and the composition of the protocol reflect the circumstances under which the study is conducted. For retrospective validation the test may be statistical analysis of batch release data, such as assay, pH, physical appearance, residual moisture, reconstitution time, and constituted solution appearance. This retrospective process validation would be intended to demonstrate that the product is of consistent quality. A critical review of the processing conditions in a retrospective validation may consist of a test comparing actual processing conditions during lyophilization with ideal parameters. This not only shows adherence to the defined processing conditions, but also demonstrates process reproducibility. 

---