Common use of Analytical Methods Clause in Contracts

Analytical Methods. DPC shall be responsible for providing the API standards for the assay and impurities for analytical methods validation, subject to written approval in advance by NovaCardia. DPC shall perform: (i) development and validation of all API analytical methods set forth on Schedule A hereto, (ii) Materials USP/NF monograph testing, and (iii) all analytical and microbiological testing for API and for release of Pre-Commercial Lots. All Materials supplied by DPC shall comply with USP/NF requirements. DPC shall conduct the stability work for the experimental and clinical batches of API as established in the stability protocol set forth in Schedule B.