Vial single vials

Technetium-99m mebrofenin is an iminodiacetic acid derivative used as a hepatobiliary agent. The kit is suppHed as a single vial containing lyopbilized mebrofenin. The reconstituted kit has 18-hour usage, owing to the preservative, propylparaben. 

Combine the test sample with the control sample in a single vial. Mix well. 

Upstream processing is deemed to commence when a single vial of the working cell bank system (see later) is taken from storage and the cells therein cultured in order to initiate the biosynthesis of a batch of product. The production process is deemed complete only when the final product is filled in its final containers and those containers have been labelled and placed in their final product packaging. 

Cells grow from a single vial (1-5 mL) to thousands of liters in bioreactors. Many generations of cell division and growth are involved. It is important that in this process, which may last from weeks to months, the cells do not mutate and faithfully express the intended protein. Cells at the completion of production are collected as samples and grown further as an end of production cell bank (EPCB). Analysis conducted on the products from the EPCB is to verify that the protein is produced properly, even after many generations of cell reproductions. 

In the single study performed using X ml vials, the vial washer should meet the acceptance criterion of NLT 90% reduction in particulate matter in each spiked vial after the completion of washing. 

When large sample volumes need to be analyzed, automation of the sample preparation should be considered by using pipette robots and a 96-well plate format as opposed to single vials. 

Cahill et al. [241] have developed a simple and sensitive analytical procedure for determining the concentration of trifluoroacetic acid in plant, soil, and water samples. The analysis involves extraction of trifluoroacetic acid by sulfuric acid and methanol followed by derivatisation to the methyl ester of trifluoroacetic acid. This is accomplished within a single vial without complex extraction procedures. The highly volatile methyl ester is then analysed using headspace gas chromatography. The spike recovery trials from all media ranged from a low of 86.7% to a high of 121.4%. The relative standard deviations were typically below 10%. The minimum detectable limit for the method was 34 ng/g for dry plant material, 0.20 ng/g for soil and 6.5 ng/1 for water. 

The stock solution (15 mg/ml) of luciferin can be transferred to smaller vials, each vial containing enough for a single day of in vivo measurements. These vials can be kept at —20°C for up to 6 months. 

When 1 ml of gas was injected seven times from a single vial of mixed standard and internal standard solution, the coefficients of variation of the peak heights were 3.18%, 2.96%, and 0.85% for 1-menthol, camophon, and methyl salicylate, respectively. 

Combining a mixture of reactants in the same reaction vessel to produce a library of products in a single vial and testing overlapping libraries to find those mixtures that contain active components... 

All of our existing calibrated methods were then modified to fit this new, smaller column, faster flow rate format and we ensured that there was, once again, total cross-correlation between the LC/MS analyses and the methods running on the autoprep systems. We effectively now had a system that could process 10 mg of a compound in 15 min with single peak/single vial fractionation or. as required, could process multiple hundreds of milligrams in an unattended fashion. In either case no specialist... 

This vial-to-vial variation occurs, even in the most carefully controlled laboratory conditions. Such behavior will also occur in routine manufacturing and is important to consider while establishing parameters when developing a process. It is therefore imperative that the process be sufficiently robust to accommodate the inherent variation within a single batch and that occurs from batch to batch. 

Commercial kits are usually supplied with calibration standard material. This may be in the form of a single vial of product from which a calibration curve can be constructed by serial dilution, or it may be a series of vials of ready-to-use standards with concentrations representative of the method s analytical range. For the purposes of assays used in drug development, it is often the case that the user will require a larger amount of calibration material, or a larger number of calibrator levels than is supplied. In the latter case, it is often possible to produce additional calibration standards from those provided either by dilution or by the mixing of those supplied. 

First, the batch size of products is often small, and in the case of a technetium product prepared in a hospital or clinic, may consist of only a single vial with a total volume of less than 10 ml. 

Agents which may be hazardous if the contents of a single vial are ingested or inhaled. Group III High risk... 

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