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To pack the Cytotec (Misoprostol)- Multum, a plug of silanized glass wool is inserted into one end of the 6 mm pyrex tubing. Silanized Mvasi (Bevacizumab-awwb Solution for Intravenous Infusion)- Multum silica support (about 0.

The solvent treatment light then distilled Cytotec (Misoprostol)- Multum the column under reduced pressure. After loading the column draw water up through the column to remove entrapped air. Use the following procedure to collect and analyze Cytotec (Misoprostol)- Multum solute.

As soon as this occurs, place a 25 mL weighing bottle (weighed 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 two more times and determine Cytotec (Misoprostol)- Multum average ratio of peak area to grams of water collected. In the GC method, or any other analytical 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 Cytotec (Misoprostol)- Multum 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 quantity 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 and injected into a gas chromograph equipped with an appropriate detector. The Cytotec (Misoprostol)- Multum concentration in the 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 quantitatively the amount of solute present in the extraction solvent.

Select a column Cytotec (Misoprostol)- Multum optimum GC operating conditions for resolution between the solute and solvent and the solute and extracting solvent. Inject a known volume of each standard solution into the injection port Cytotec (Misoprostol)- Multum the GC.

For each standard solution determine the average of the ratio Cytotec (Misoprostol)- Multum 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 Cytotec (Misoprostol)- Multum manner as for the HPLC method described under paragraph (c)(3)(ii)(B)(3) Cytotec (Misoprostol)- Multum this section.

As shown in figure 2 in paragraph (c)(1)(i)(A)(2) 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 Gatifloxacin Ophthalmic Solution (Zymaxid )- FDA (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 water from the reservoir 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 tube 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 back pain asthma 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 solute as described above. Calculate the water solubility of the solute from the average solute concentration in the three vessels. If Cytotec (Misoprostol)- Multum 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 process.

For additional information on this Cytotec (Misoprostol)- Multum guideline, the following references should be consulted. Journal of Research, National Bureau of Standards, 86:361-366 (1981). Cytotec (Misoprostol)- Multum of Organic Chemistry 33:347-350 (1968). Analytical Chemistry 50:175-179 (1978). Determination of the solubility behavior of some polycyclic aromatic hydrocarbons in the water.

Analytical Chemistry, 50:997-1000 (1978a). Journal of Chemical and Engineering Data 29:184-190 (1984). Water solubility column elution-flask method (1981).



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