Analytical Sample Clauses
Analytical o Draft release Specifications for API, raw materials, and bulk packaging components for Client approval. o Conduct API, raw material, and bulk packaging component release testing; execute API ID test method (HPLC) transfer protocol from Client. o Draft equipment procedure documents using Client supplied analytical method and equipment protocols and procedures for Client approval. o Conduct Sterility and Endotoxin (LAL) testing of the Product. o Supply Certificate of Testing for Sterility and Endotoxin testing of Product to Client. o Qualify Endotoxin (LAL) method on one (1) batch of AI-850.
Analytical. Analytical disputes must be based upon laboratory analysis utilizing the appropriate Enterprise methodology. Analytical disputes must be made within forty-five
Analytical. Analytical disputes must be based upon laboratory analysis, using the Carrier-specified test method, of both the Carrier sample and the Shipper sample from the custody sampler (as described above). After analyzing their respective samples according to the Carrier-specified test method, if Shipper and Carrier are in disagreement, then they shall each send the other a copy of their respective sample results, and if the sample results differ by more than the GPA 2186/2177 reproducibility limits for one or more components, then the referee sample shall be taken to Coastal Flow Measurement, which shall analyze the sample in accordance with the Carrier-specified test method. If the third-party laboratory and Carrier analyses disagree by more than the GPA 2186/2177 reproducibility limits for one or more Components, then the third-party lab results shall be accepted by Shipper and Carrier as final and conclusive for the composition of the stream. If the third-party laboratory and Carrier analyses agree within the reproducibility limits of GPA 2186/2177, then the Carrier analysis shall be accepted by Shipper and Carrier as final and conclusive for the composition of the stream.
Analytical. Internal quality control was done and well trained technologists performed the test according to the SOP.
Analytical. Methods will be developed by [ * ] for QC release, characterization, subidentification, potency, and activity prior to the IND submission. [ * ] will [ * ] the release assays for both bulk and product to [ * ].
Analytical. A report summarizing available data describing the physical properties of the drug substance, including MW, solubility, pI, etc as applicable.
Analytical. Contractor shall have access to State certified analytical facilities capable of performing chemical analyses on 24-hour turnaround bases. Standard turnaround time for laboratory analysis shall be 48 hours or less. Laboratories performing chemical analyses for the Contractor shall be certified by the California State Water Resources Control Board, Environmental Laboratory Accreditation Program (SWRCB-ELAP) for the specific required cleanup analyses. Mobile laboratory units shall be certified by SWRCB, for the specific cleanup analyses. Laboratory methods not certified by SWRCB may be performed by laboratories only if recognized by SWRCB for comparable test methods or if the laboratory is certified as a US EPA Contract laboratory.
Analytical. Analytical test methods, qualification or validation protocols and reports for the methods to be transferred, and list of reagents required within [*] of the effective date of the Agreement.
Analytical. Analytical disputes must be based upon laboratory analysis, using the Enterprise-specified test method, of both the Enterprise sample and the Customer sample from the custody sampler (as described above). After analyzing their respective samples according to the Enterprise-specified test method, if Customer and Enterprise are in disagreement, then they shall each send the other a copy of their respective sample results, and if the sample results differ by more than the GPA 2186/2177 reproducibility limits for one or more components, then the referee sample shall be taken to a mutually agreed upon third-party laboratory, which shall analyze the sample in accordance with the Enterprise-specified test method. If the third-party laboratory and Enterprise analyses disagree by more than the GPA 2186/2177 reproducibility limits for one or more components, then the third-party lab results shall be accepted by Customer and Enterprise as final and conclusive for the composition of the stream. If the third-party laboratory and Enterprise analyses agree within the reproducibility limits of GPA 2186/2177, then the Enterprise analysis shall be accepted by Customer and Enterprise as final and conclusive for the composition of the stream. Section