Cder guidance validating chromatographic methods

cder guidance validating chromatographic methods-46
The Genentech authors ran their process at 400-L scale because of space constraints in the manufacturing facility.

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An HPLC system using a simple liquid–liquid extraction and HPLC with UV detection has been validated to determine tramadol concentration in human plasma.

The method developed was selective and linear for concentrations ranging from 10 to 2000 ng/ml with average recovery of 98.63%.

Good precision (5.32 and 6.67% for intra- and inter-day, respectively) was obtained at LOQ.

The method has been applied to determine tramadol concentrations in human plasma samples for a pharmacokinetic study.

Companies invest in projects to improve product quality assurance, safety, and yield as well as production efficiency (1).

Such changes may come at any process stage, from early cell-growth methods through final-product packaging improvements.

Moreover, when a production unit is devoted to a validation study for a proposed process change, the resulting drug product manufactured often must not be released but rather kept on hold until stability and all predetermined acceptance criteria have been met and verified.

Putting product release at risk has multiple implications, including patient supply, operational, logistical, and financial consequences.

Implementing continuous process improvements is increasing in priority for the biopharmaceutical industry.

Such implementation can be driven by product safety, purity, and stability enhancement opportunities as well as by cost-reduction pressures.

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