Sentence examples for impurity specifications from inspiring English sources

Establishing appropriate impurity specifications for active pharmaceutical ingredient (API) starting materials is an important component of the commercialization and registration of an API.

The optimum process design is the one that minimize the Total Annual Cost (TAC) of this process while satisfying the stringent product impurity specifications.

This proposed control scheme is based on a override control framework and can manage a non-key trace ethanol product impurity specification while maintaining high product recovery.

It is fully algorithmic and insensitive to impurities in product specifications.

As an essential part of the entire control strategy for Pazopanib hydrochloride, analytical control of impurities with 'meaningful' specifications and the 'right' analytical methods is addressed.

There was a widespread but groundless belief that many generic drugs contain higher impurities, while meeting specifications.

The process technologies employed in FPs have to be properly selected on the basis of fuel characteristics, impurity tolerances and operating specifications of FCs.

Categorization of 245 spot variables was determined on the basis of specification of maximal impurity decrease generating cut points.

Since it is frequently difficult, and at times impossible, to obtain as much as 0.1 to 1 gram of "clean" material for analysis, the results should be accompanied by specifications on the amount of impurities present.

Reporter ion intensities were adjusted to correct for the isotopic impurities of the different TMT reagents (manufacturer specifications).

If needed, control of the levels of these impurities or residual solvents would warrant incoming specifications to assure long-term drug product performance.