Analytical method. An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Analytical method. An analytical method should be used where relevant transactions are not available but information providing a reasonable basis for valuation is available, such as appraisals, analysts' reports, valuation models built on the market behavior of similar types of securities or assets that are readily marketable, or valuation models seeking to determine the inherent value of the streams of income and return of principal from a particular security or asset.
Analytical method. In the case of method transfer, the Sponsor has completed qualification or validation of product-specific methods to be used for cGMP purposes. Diosynth Fujifilm will review and analyze Sponsor provided method development/qualification/validation reports. Based upon the documentation, Fujifilm Diosynth will [*] each method to be transferred. In the case of method verification, Fujifilm Diosynth will [*] for each method to be verified. Fujifilm Diosynth expects that no more than [*] runs are sufficient to demonstrate that knowledgeable analysts can successfully execute a method [*]. [*] for each transfer/verification will be provided to the Sponsor and the transfer of a method [*]. If target acceptance criteria are not met during the execution of the [*] during or after the execution of the transfer protocol. Once the method transfer/verification protocol is successfully executed, [*] for verified methods) will be prepared to support cGMP activities. Definitions used in this section include: • Verify: Demonstrating that an USP compendial method, general Fujifilm Diosynth qualified or validated method or commercial testing kit (e.g., [*]) is suitable for use with the intended product. • Implement: Application of a Sponsor’s method at Fujifilm Diosynth [*]. Successful implementation of the method will be documented in a [*] at the completion of execution. • In-Process Control (IPC): Manufacturing decisions are based on the results of in-process control assays (e.g. methods used to determine protein concentration for column loading). • In-Process Test (IPT): [*]. This test provides a check that the process operates [*], as identified by transfer package.
Analytical method. Stock solutions of the analytical standards tebufenozide (purchased from ChemService 99.5% purity) and bupirimate a.s. (purchased from ChemService, 99.5% purity) were prepared in HPLC acetone (purchased from Xxxxxxxx Co.) for all trial sets of the study. Working solutions used for validation purposes (recovery spiking), quality control- and calibration standards solutions were prepared from the original stock solutions after solvent evaporation with initial and further dilutions of the appropriate stock solution aliquots with HPLC grade methanol (purchased from Xxxxxxxx Co.). All the aforementioned solutions were stored at -180C.
