Assay. Upon initial delivery, a laboratory analysis of Customer Crude Oil that complies with regulations and industry recommended practice shall be submitted to Provider by Customer and shall include API gravity, Xxxx Vapor Pressure, pour point, sediment and water content, sulfur content, hydrogen sulfide, and other characteristics as may be required by Provider. After initial delivery, Provider reserves the right to require an assay to accommodate changes in regulations or changes in any characteristics of Customer Crude Oil.
Assay. The term “
Assay. The term "
Assay. An assay is performed using the reagents supplied in the Assay Kit plus any items not provided in the kit. Typically, the DNA from the blood sample is extracted using the commercial extraction kit. Some assays may be performed directly from whole blood. The genomic DNA is amplified, typically using polymerase chain reaction (PCR). If multiple DNA sequences are to be analyzed, the amplification is usually performed in a multiplex format. If the amplification procedure produces double stranded product then it is rendered single stranded by any of the several procedures. Typically, the DNA is digested with lambda exonuclease. In this case, one of the amplification primers in phosphorylated to facilitate digestion of the extension product of that primer. The DNA amplification is designed to produce target polynucleotides of from about 75 nucleotides up to several thousand nucleotides in length. A small volume of the single-stranded amplification product is mixed with a small volume of Assay Buffer and the mixture is loaded into a cartridge for analysis. The cartridge is inserted into a compartment of the Reader and the analysis is initiated on the Reader. The Assay Buffer contains electrolytes, denaturing agents, surfactants, an alkyl thiol, and signal probes. Signal probes are oligonucleotides of from about 12 to 25 nucleotides in length and are designed to bind to a region in the target polynucleotide which is adjacent (in the 3’ direction) to a second region of the target polynucleotide. The DNA on the electrode (capture probe) is designed to bind to the second region of the target polynucleotide. Signal probes are modified with electrochemical labels (ferrocene analogs) covalently attached to the sugar group. After the cartridge is inserted in the Reader, the Reader raises the temperature of the compartment to 35 to 45 degrees Celsius for a time sufficient for the target polynucleotide and the capture and signal probes to hybridize to one another. Following this hybridization period, the Reader analyzes each electrode in the cartridge. Genotyping assays are conducted as described, using two different signal probes, one having the expected wild-type sequence and the other having the expected mutation sequence. Each signal probe has an electrochemical label with a distinct electrochemical potential which allows independent recognition and quantitation. The preceding description applies to a series of DNA detection platforms which will incorporate improvement...
Assay. Blood samples are extracted using a commercial extraction kit (not supplied at present). The genomic DNA is amplified by multiplex PCR. One of the two primers for each amplicon is phosphorylated. The PCR amplicon is rendered single stranded by incubation with the supplied lambda exonuclease. A small volume of the single-stranded amplification product is mixed with a small volume of Assay Buffer and the mixture is loaded into either one or two cartridges for analysis. The cartridges are inserted into a compartment of the 4800 Reader and the analysis is initiated. Signal probes in the Generation 1.0 are oligonuclotides of from 14 to 20 nucleotides in length.
Assay. 4.1 Peptide *** amino-acid analysis NLT ***%
4.2 Assay by *** ***% to ***%
4.3 activity ***% to ***% inhibition METHODS, See Reference document. CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED, AND RULE 24B-2 PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS. WORK SCHEDULE *** Main activities foreseen before a cGMP production of bivalirudin, (TM-001) *** strategy at Lonza
1. Development program
1.1 R&D work (ca. *** months, *** of the *** to *** • Optimization of the *** on *** on laboratory scale (*** mmol); investigation of the following synthesis parameter: *** equiv. of incoming *** etc. • Optimization of the *** of the *** volume of the *** use of *** conditions, etc. • Isolation of the *** optimization of the *** step. • Optimization of the *** screening of *** (e.g., by *** of experiments) *** of the product *** , etc. • Optimization of the *** of *** etc. • Optimization of the *** screening of *** and *** etc.), study of the *** optimization of the *** of the *** and of the *** etc. • Investigation of different options for *** to be defined with TMC. • Optimization of the *** of the *** etc). • Progress report(s) CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED, AND RULE 24B-2 PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
1.2 work (ca. *** month *** of the process *** • *** synthesis on a ***), using the same *** and *** as the ones *** for the production. *** of the *** step. *** of the *** and *** investigation. • Progress report During this phase, the *** will be addressed: (i) Definition of *** of the different *** ; (ii) Study of *** on *** times; (iii) *** of the process *** and of the *** (iv) *** of the possible *** points; (v) *** (vi) ***
1.3 in the laboratory (ca. *** months) The goal of the qualification experiments is to provide *** to demonstrate the *** and *** of the *** and to set the *** • Development of *** methods allowing the *** to meet the *** it is required to produce *** to the *** process! • Identification of the *** (according to ***). • Establishment of the *** and *** of the process. Determination of the *** (proven *** and *** The e...
Assay. 4.1.1 Assay trospium chloride: [*] Number of determinations: [*] Number of measurements: [*] [*] Solvent mixture C: [*] Reference substance: [*] [*] [*] [*] Reference solution (RL) A: [*] Reference solution (RL) B: [*] *CONFIDENTIAL TREATMENT REQUESTED
Assay. SPECIFICATIONS
Assay the total weight of U-235 isotope per kilogram of Material divided by the total weight of all uranium isotopes per kilogram of Material, the quotient of which is multiplied by 100 and expressed as a weight percent.
Assay. Paclitaxel (API) 57 mg to 63 mg (95 – 105 % of 60 mg) HPLC AN-019 3.2. XR17 (Excipient) 72 mg to 88 mg (90 – 110 % of 80 mg) HPLC AN-006
