Mobile chat free sex - Developing validating dissolution procedures

The majority of the analysed elements could be measured with a satisfactory accuracy but determination of difficult-to-analyse elements, such as silicon and tungsten, requires a modified sample preparation and measurement procedure.

An alternative ‘non-destructive’ analytical method, such as XRF or laser ablation ICP-MS, can be applied for direct analysis of non-dissolved residues that remain in the digests.

This manuscript describes a Sector Field-Inductively Coupled Plasma-Mass Spectrometry (SF-ICP-MS) procedure for the determination of 67 minor and trace elements, including REE, in uranium ore concentrates (UOC) and related compounds without matrix separation.

Next, automated dissolution-profile testing is completed to screen several different dissolution media.

Profile sampling could be performed at 10, 20, 30, 45, and 60 min and the results compared.

Selecting the various dissolution media that are used in the evaluation depends upon the solubility and stability of the API in each media.

This process allows a dissolution chemist to determine quickly the media having the potential to provide the most discriminating dissolution performance for the product.

Automated dissolution instrumentation can help generate good manufacturing practice (GMP) data only when validated testing parameters can negate these influences, so the dissolution scientist can be confident that results do not differ between the manual and the automated methods.

In addition, all laboratory equipment used to support or generate GMP data about automated instrumentation must follow an instrument "chain of compliance." Proper documentation must exist that proves each piece of equipment has been properly qualified and calibrated for its intended use.The results generated at the earlier time points are the most significant because they have the highest potential for variation between the manual and automated methods.If comparable results are obtained between the two methods at the earlier time points, a dissolution chemist is more likely to be assured that accurate data are obtained at all time points of the automated dissolution-profile testing.At later time points, the percent drug released typically approaches 100%; therefore, not as much variation between the two tests would be expected at these later time points.The International Atomic Energy Agency (IAEA) uses information from characterization of uranium-bearing material samples to support the verification of states' declarations and to look for indications of possible undeclared materials and activities.And with additional validation efforts, an automated method can be extended to the testing of Phase IV stability batches.

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