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Inject samples of each standard solution into the HPLC system using the calibrated sample loop. Obtain an average peak area from at least three injections of each standard sample at a set absorbance unit full Divalproex Sodium (Depakote ER)- Multum (AUFS), i. To pack the column, a plug of silanized glass wool is inserted into one end of the 6 mm pyrex tubing.

Silanized diatomaceous silica support (about 0. The solvent is then distilled off the column under reduced pressure. After loading the column draw water up through the column to remove entrapped Divalproex Sodium (Depakote ER)- Multum. Use the following procedure to collect and analyze the solute. As soon as this occurs, place a 25 mL weighing bottle bayer investor to the nearest mg) at the waste position and immediately turn the switching valve to the load position.

During this extraction step, switch back to the original HPLC mobile phase composition, i. Determine the weight of water collected to the nearest mg and record the corresponding peak area. Using the same AUFS setting repeat the analysis of the solute at least Divalproex Sodium (Depakote ER)- Multum more times and determine the average ratio of peak area to grams of water collected.

In the GC method, or any other Divalproex Sodium (Depakote ER)- Multum method, aqueous solutions from the generator column enter a collecting vessel (figure 2 in paragraph (c)(1)(i)(A)(2) of this section) containing a known weight of extracting solvent which is immiscible in water.

The outlet of the generator column is positioned such that the aqueous phase always enters below the extracting solvent. After the aqueous phase is collected, the collecting vessel is stoppered and the Satralizumab-mwge Injection for Subcutaneous Administratio (Enspryng)- FDA of aqueous phase is determined by weighing.

The solvent and the aqueous phase are equilibrated by slowly rotating the collecting vessel. The extraction efficiency of the solvent must be determined at this time. A small amount of the extracting solvent is removed Divalproex Sodium (Depakote ER)- Multum injected into a gas chromograph equipped with an appropriate Divalproex Sodium (Depakote ER)- Multum. The solute concentration in Divalproex Sodium (Depakote ER)- Multum aqueous phase is determined from a calibration curve constructed using known concentrations of the solute.

If another (approved) analytical method is used instead of the GC, that method shall be used to determine economics the amount of solute present in the extraction solvent.

Select a column and optimum GC operating conditions for resolution between the solute and solvent and the solute co consciousness extracting solvent. Inject a known volume of each standard solution into the injection port of the GC. For each standard australian determine the average of the ratio R of peak area to volume (in microliters) for three chromatographic peaks from three injections.

The generator column is packed and loaded with solute in the same manner as for Divalproex Sodium (Depakote ER)- Multum HPLC method described under paragraph (c)(3)(ii)(B)(3) of this section. As shown in figure 2 in paragraph Divalproex Sodium (Depakote ER)- Multum of this section, attach approximately 20 cm of straight stainless steel tubing to the bottom of the generator column.

Connect the top of the generator column to a water reservoir (figure 4 in paragraph (c)(3)(ii)(B)(4)(i) of this section) using teflon tubing.

Use air or nitrogen pressure (5 PSI) from an air or nitrogen cylinder to force Divalproex Sodium (Depakote ER)- Multum from the Divalproex Sodium (Depakote ER)- Multum through the column. During the equilibration time, add a known weight of extracting solvent to a collection vessel which can be capped. Record the weight (to the nearest mg) of a collection vessel with cap and extracting solvent.

Place the collection vessel under the generator column so that water from the collecting Divalproex Sodium (Depakote ER)- Multum enters below the level of the extracting solvent (figure 2 in paragraph (c)(1)(i)(A)(2) of this section). When the collection vessel is filled, remove it from under the generator column, replace cap, and weigh the filled vessel. Determine the weight of water collected. Record the ratio of peak area to volume injected and, from the regression equation of the calibration line, determine the concentration of solute in the extracting solvent.

In this equation, Ces is the concentration of solute in extracting solvent (M), dH2O and des are the densities of water and extracting solvent, respectively, and ges and gH2O are the grams of extracting solvent and water, respectively, contained in the collection vessel.

To make sure the generator column has reached equilibrium, run at least two additional (for a total of three) collection vessels and analyze the extracted Divalproex Sodium (Depakote ER)- Multum as described above.

Calculate the water solubility of the solute from the average solute concentration in the three vessels. If decomposition is due to aqueous photolysis, then it will be necessary to carry out water solubility studies in the dark, under red or yellow lights, or by any other suitable method to eliminate this transformation pd529.

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