Liter, definition

The validation process begins in method development in that the documentation reporting the validation data must include a record of the method development process, giving details of the conditions explored and the rationale of the progression of the process. The validation proper consists of a series of tests for which there are acceptance criteria which vary depending on the type of assay being carried out. Literal definitions of the parameters for which tests must be carried out are discussed elsewhere in this book but are repeated here as a reminder. 

We must first indicate exactly what is meant by tire term organic add in the context of this Chapter. Inevitably it will be far more restricted in scope than foe literal definition, which essentially means any oiganic compound which is addid. 

Basically, the term refers to what we might call a balance of forces . In the case of mechanical equilibrium, this is its literal definition. A book sitting on a table top remains at rest because the downward force exerted by the earth s gravity acting on the book s mass (this is what is meant by the weight of the book) is exactly balanced by the repulsive force between... 

For larger masses, the possibilities increase enormously. At mass 100, there would be literally thousands of possible elemental compositions so that, although integer mass can be measured mass spectromet-rically, attempts to obtain elemental compositions will not lead to a definite answer. 

Returning to the standard, this clause also only addresses the correction and prevention of nonconformities, i.e. departures from the specified requirements. It does not address the correction of defects, of inconsistencies, of errors, or in fact any deviations from your internal specifications or requirements. As explained in Part 2 Chapter 13, if we apply the definition of nonconformity literally, a departure from a requirement that is not included in the Specified Requirements is not a nonconformity and hence the standard is not requiring corrective action for such deviations. Clearly this was not the intention of the requirement because preventing the recurrence of any problem is a sensible course of action to take, providing it is economical. Economics is, however, the crux of the matter. If you include every requirement in the Specified Requirements , you not only overcomplicate the nonconformity controls but the corrective and preventive action controls as well. 

Remember that the CCPS definitions may not fit all companies or situations however, they provide a useful set of guidelines for considering how a management system like PSM can work within your company. Some companies have adopted these guidelines very literally and use a highly documented, checklist approach. Others follow them conceptually, in a less structured manner. 

The direct synthetic process is described in U.S. Patent 2,772,280. A solution of 73.3 g (0.332 mol) of (3-aminoxyalanine ethyl ester dihydrochloride in 100 ml of water was stirred in a 500 ml 3-necked round-bottomed flask cooled in an ice-bath. To the above solution was added over a 30-minute period 65.6 g (1.17 mols) of potassium hydroxide dissolved in 100 ml of water. While the pH of the reaction mixture was 7 to 10.5, a red color appeared which disappeared when the pH reached 11 to 11.5. The light yellow solution was allowed to stand at room temperature for 14 hour and then added to 1,800 ml of 1 1 ethanol-isopropanol. The reaction flask was washed twice with 10 ml portions of water and the washings added to the alcohol solution. The precipitated salts were filtered out of the alcohol solution and the filtrate cooled to 5°C in a 5 liter 3-necked round-bottomed flask. To the cold, well-stirred solution was added dropwise over a 35-minute period sufficient glacial acetic acid to bring the pH of the alcohol solution to 6.0. When the pH of the solution had reached 7 to 7.5, the solution was seeded and no further acetic acid added until Crystallization of the oil already precipitated had definitely begun. The crystalline precipitate was collected on a filter, washed twice with 1 1 ethanol-isopropanol and twice with ether. The yield of 4-amino-3-isoxazolidone was 22.7 g. 

Chemists often indicate the concentration of a substance in water solution in terms of the number of moles of the substance dissolved per liter of solution. This is called the molar concentration. A one-molar solution (1 M) contains one mole of the solute per liter of total solution. a two-molar solution (2 M) contains two moles of solute per liter, and a 0.1-molar solution (0.1 M) contains one-tenth mole of solute per liter. Notice that the concentration of water is not specified, though we must add definite amounts of water to make the solutions. 

Isotonic solutions, by definition, exert equal osmotic pressure. Therefore, for blood is the same as I I for the glucose solution. We can calculate from Equation after converting the concentration moles per liter —MRT and... 

Note particularly that it is liters of solution that is used, not liters of solvent. Chemists often abbreviate the definition to merely moles per liter, but the shortening does not change the way the unit is actually defined. The unit of molarity is molar, symbolized M. Special care must be taken with abbreviations in this chapter. M stands for molar mol for mole(s). (Some authors use M to stand for molarity as well as molar. They may use italics for one and not the other. Check your text and follow its convention.)... 

Molarity is defined in moles per liter. We convert each of the quantities given to those used in the definition ... 

Am. By definition, normality is the number of equivalents per liter. Then... 

A In determining total [Cl ], we recall the definition of molarity moles of solute per liter of solution. 

By definition, the mole fraction of NaCl in this solution is = 0 2 35 2 = 0.0036. (Note the number of significant figures [see Section 13.4] reported here taking the density of the solution as 1, and calculating the weight of water therefore as 1000 g would not have affected this calculation. The density correction could, therefore, have been omitted. Also, as a rule of thumb, 1 liter of water can be approximated as 55 mol F O.)... 

These steps give us the moles of calcium hydroxide. To get the molarity of calcium hydroxide, we use the definition of molarity, which tells us we need to divide these moles by the volume, in liters, of the calcium hydroxide solution. In order to finish the problem, we must add one more step ... 

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