Process-related impurities definition

Of these molecular variants, one is the desired product with the desired properties with respect to biological activity and efficacy. Some structurally related variants (referred to as product related ) exhibit similar properties to the desired product and are therefore not considered as impurities. However, there may also be structurally related variants with altered properties with respect to biological activity, efficacy and/ or safety, which must be considered as impurities. In addition to the molecular variants of the protein (or protein-like) product, additional process-related substances may be part of a biotechnological drug substance, e.g., cell culture media, host cell proteins, DNA residuals, solvents, bacteria and/or viruses. This suggests that the determination of purity of these products (which is referred to as purity estimation rather than purity determination ) is a complex analytical issue. A purity estimation consists of both the definition of the heterogeneity of the protein (or proteinlike) product, and the identification and quantitation of product- and process-re-... 

Since the final product is a pharmaceutical, high purity of the product is definitely required. Furthermore, the amount of any impurities in the final product has to be rigorously regulated under ICH guidelines. Rejection of impurities related to cyclopropylacetylene (37) was difficult throughout this whole process [28]. Thus, not only the isolated yield but the impurity profile of 37 was critical. 

The above definition is actually that for intrinsic semiconductors. What make semiconductors so useful in electronics, however, is that their electronic properties can be altered in a controllable manner by adding tiny amounts of an advisedly chosen impurity. This is the well-known process of doping, which is related to the notion of extrinsic semiconductors. 

In goal definition, the scope and purpose of the LCA is defined. The functional unit and system boundaries are also established. The functional unit is the reference point to which environmental impacts are attributed. The choice of functional unit depends on the application of the LCA. For a process it could be a tonne of product or feedstock, or a tonne of impurity removed. For a commodity product the functional unit could be a tonne of product, but for specialty chemicals and most consumer products performance properties are more important and the choice can become complex. For example, performance of a paint would be related to its surface coverage and durability hence a possible functional unit for the paint might be the quantity required to cover a square meter of surface over a time span of 20 years. 

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