Format of the report

Once the protocols have been completed, the test results and data need to be formally evaluated. The written evaluation needs to be presented clearly, in a manner that can be readily understood. The report should also address any nonconformances or deviations to the validation plan encountered during the qualification and their resolutions. The format of the report should be similar to the structure of the associated protocols. The qualification testing should be linked with the acceptance criteria in the relevant specification deliverable, so that the PQ will link with the requirements specification deliverable the OQ will link with the company system specification deliverable and the IQ will link with the technical design specification deliverable. 

The analytical development report is a documented summary and logic flow of all essential analytical information acquired during the R D phase of the project. In many cases, this report serves a variety of purposes it is a repository of all important analytical information pertaining to the project and is therefore a source document for the quality unit, and it is also used in the preparation of the site inspection at the time of product approval. All information contained in this report must be traceable to raw data and other reports, if applicable. Table 3 contains a summary of all information that should be contained in the analytical development report. The format of the report is not critical, but the information must be present. For further details on the various sections and chapters in this report, the reader is referred to other chapters in this text that describe the details therein. 

After completion of the validation experiments, a comprehensive report should be written. The format of the report may be dictated by internal policies of the laboratory however, such reports should summarize the assay performance data and deviations from the method SOP or validation plan and any other relevant information related to the conditions under which the assay can be used without infringing the acceptance criteria. 

The final attachment is a printout of the detailed timeline, along with the associated tables. This Attachment is shown last because it may require that the formatting of the report has to switch... 

Third, since the internet, including advances in search engines for scientific purposes, has made long lists of recent scientific studies within a well-defined smaller area obsolete, it is my plan to make a smaller change in the format of the reports. Each of these shall contain a short but self-contained introduction to the subject as well as a critical presentation of recent publications within the area of interest. Specialists with expertise in the given area will be asked not only to present their own results but also those of colleagues, thereby covering a broader area. 

Unfortunately not much work has yet been done on the solution properties of rod-coil systems in a concentration range spanning from micellar to liquid-crystal formation. In contrast to this many authors reported the bulk properties of their copolymer materials. Because of the complex nature of these systems it is not always easy to explain the observed bulk properties. The formation of the reported morphologies could certainly be better understood if there were a more thorough work on the solution properties of the related materials. 

Prepare an outline of a technical report. Compare the format of the report with that... 

Ketopregnan-21-oic Acids, the 17(3-Carboxy Androstanes, and the D-Homocorticoids. In the course of studies on the metabohsm of fluocoitolone (103) the formation of the water-soluble carboxyhc acid (105, R = H) was reported. As a free 21-hydroxyl is not necessary for antiinflammatory activity, it was concluded that the esters (105, R = alkyl) of the preceding metabohte would possess antiinflammatory activity on topical administration but would be devoid of systemic activity when hydrolysis to the free acid occurs followed by... 

Complex Formation. AH four Cg aromatic isomers have a strong tendency to form several different types of complexes. Complexes with electrophilic agents ate utilized in xylene separation. The formation of the HE-BF —MX complex is the basis of the Mitsubishi Gas—Chemical Company (MGCC) commercial process for MX recovery, discussed herein. Equimolar complexes of MX and HBr (mp — 77°C) and EB and HBr (mp — 103°C) have been reported (32,33). Similatly, HCl complexes undergo rapid formation and decomposition at —80°C (34). 

Hydration. Water adds to the triple bond to yield acetaldehyde via the formation of the unstable enol (see Acetaldehyde). The reaction has been carried out on a commercial scale using a solution process with HgS04/H2S04 catalyst (27,28). The vapor-phase reaction has been reported at... 

Two-step approaches based on cocatalysts or alternate catalysts and one-step approaches which circumvent the formation of the biscarbamate intermediates have also been reported (76—81). 

Monsanto has disclosed the use of carbon dioxide—amine complexes which are dehydrated, at low temperatures, with phosphoryl chloride [10025-87-3] or thionyl chloride [7719-09-7] as a viable route to a variety of aUphatic isocyanates. The process rehes on the facile formation of the intermediate salt (30).REPLACEVariations of this process, in which phosgene is used as a dehydrating agent, have been reported earlier (84). Table 2 Hsts commercially available aUphatic isocyanates. 

Potassium removal is required because the presence of potassium during electrolysis reportedly promotes the formation of the a-Mn02 phase which is nonbattery active. Neutralization is continued to a pH of approximately 4.5, which results in the precipitation of additional trace elements and, along with the ore gangue, can be removed by filtration. Pinal purification of the electrolyte Hquor by the addition of sulfide salts results in the precipitation of all nonmanganese transition metals. 

Hydroxides. The hydrolysis of uranium has been recendy reviewed (154,165,166), yet as noted in these compilations, studies are ongoing to continue identifying all of the numerous solution species and soHd phases. The very hard uranium(IV) ion hydrolyzes even in fairly strong acid (- 0.1 Af) and the hydrolysis is compHcated by the precipitation of insoluble hydroxides or oxides. There is reasonably good experimental evidence for the formation of the initial hydrolysis product, U(OH) " however, there is no direct evidence for other hydrolysis products such as U(OH) " 2> U(OH)" 2> U(OH)4 (or UO2 2H20). There are substantial amounts of data, particulady from solubiUty experiments, which are consistent with the neutral species U(OH)4 (154,167). It is unknown whether this species is monomeric or polymeric. A new study under reducing conditions in NaCl solution confirms its importance and reports that it is monomeric (168). 8olubihty studies indicate that the anionic species U(OH) , if it exists, is only of minor importance (169). There is limited evidence for polymeric species such as Ug(OH) " 25 (1 4). 

P-D-Arabinofuranosylcytosine [147-94-4] (ara-C, 16), C H N O, reportedly has had significant therapeutic effects in patients with localized herpes zoster, herpes eye infections, and herpes encephaUtis (33), although several negative results have also been reported (34) (Fig. 2). Ara-C, also known as cytarabine, is quite toxic and is only recommended for very severe viral infections. It is rapidly deaminated in humans to the relatively inactive ara-U Ara-C is converted in the cell to the 5 -monophosphate by deoxycytidine kinase, followed by formation of the corresponding di- and triphosphate. The triphosphate has been shown to inhibit DNA polymerase. 

Diazophenols, ie, o-hydroxyaryldiazonium salts, couple to 1-naphthol in weaMy basic solution primarily in the para position, but as the hydroxyl ion concentration is increased, formation of the ortho isomer is favored and is frequentiy the sole product. Pyridine and pyridine derivatives, urea, and acetate, etc, used as buffers can also catalyze azo coupling reactions (28). l-amino-2-naphthol-4-sulfonic acid [116-63-2] (1,2,4-acid) and 1-naphthol yield the important Eriochrome Black A [3564-14-5] (18a, R = H) (Cl Mordant Black 3 Cl 14640) which is reportedly (20) a mixture of ortho and para isomers. 

Bromine is moderately soluble in water, 33.6 g/L at 25°C. It gives a crystalline hydrate having a formula of Br2 <7.9H2 O (6). The solubiUties of bromine in water at several temperatures are given in Table 2. Aqueous bromine solubiUty increases in the presence of bromides or chlorides because of complex ion formation. This increase in the presence of bromides is illustrated in Figure 1. Kquilibrium constants for the formation of the tribromide and pentabromide ions at 25°C have been reported (11). 

Ghlorohydrination with Nonaqueous Hypochlorous Acid. Because the presence of chloride ions has been shown to promote the formation of the dichloro by-product, it is desirable to perform the chlorohydrination in the absence of chloride ion. For this reason, methods have been reported to produce hypochlorous acid solutions free of chloride ions. A patented method (48) involves the extraction of hypochlorous acid with solvents such as methyl ethyl ketone [78-93-3J, acetonitrile, and ethyl acetate [141-78-6J. In one example hypochlorous acid was extracted from an aqueous brine with methyl ethyl ketone in a 98.9% yield based on the chlorine used. However, when propylene reacted with a 1 Af solution of hypochlorous acid in either methyl ethyl ketone or ethyl acetate, chlorohydrin yields of only 60—70% were obtained (10). 

The formation of ammonium bisulfate is strongly temperature dependent. Formation is favored at the lower temperatures. The temperature at which ammonium bisulfate is not formed depends strongly on the SO concentration in the exhaust gas. The temperature needed to minimize bisulfate formation has been reported to increase by about I5°C (around about 350°C) when the SO concentration increases from 5 to 15 ppm (23). The formation of the bisulfate is reversible, ie, if the temperature is raised to 20°C above the minimum temperature, the reaction is shifted to result in the decomposition of the bisulfate formed. When chlorides are present, ammonium chlorides can be formed ... 

---