Stability data

We have seen ( 6.2.3) hat there is a close relationship between the rates of electrophilic substitutions and the stabilities of tr-complexes, and facts already quoted above suggest that no such relationship exists between those rates and the stabilities of the 7r-complexes of the kind discussed here. These two contrasting situations are further illustrated by the data given in table 6.2. As noted earlier, the parallelism of rate data for substitutions with stability data for o"-complexes is not limited to chlorination ( 6.2.4). Clearly, rr-complexes have no general mechanistic or kinetic significance in electrophilic substitutions. 

Information pertaining to the hazards of the chemicals used in the process. This should contain at least the following information toxicity, flammability, permissible exposure limits, physical data, reactivity data, corrosivity data, thermal and chemical stability data, and hazardous effects of inadvertent mixing of different materials that could occur. 

A wide range of caibocation stability data has been obtained by measuring the heat of ionization of a series of chlorides and cafbinols in nonnucleophilic solvents in the presence of Lewis acids. Some representative data are given in Table 5.4 These data include the diarylmediyl and triarylmethyl systems for which pX R+ data are available (Table 5.1) and give some basis for comparison of the stabilities of secondary and tertiary alkyl carbocations with those of the more stable aryl-substituted ions. 

Decreases with increasing wettability of liquid on plate surface. Kerosene, hexane, carbon tetrachloride, butyl alcohol, glycerine-water mixtures all wet the test plates better than pure water. The critical tray stability data of Hunt et al., [33] is given in Table 8-21 for air-water, and hence the velocities for other systems that wet the tray better than water should be somewhat lower than those tabulated. The data of Zenz [78] are somewhat higher than these tabulated values by 10-60%. 

One of the factors that will affect the stability data is the temperature of storage the higher the temperature, the shorter the time that will elapse before the fat becomes rancid. 

Fig. 3.1.6 Effects of pH on the activity and stability of Cypridina luciferase (solid lines) and the quantum yield of Cypridina luciferin (dashed line). In the measurements of activity and quantum yield, luciferin (1 pg/ml) was luminesced in the presence of luciferase (a trace amount for the activity measurement 20 pg/ml for the quantum yield) in 20 mM buffer solutions of various pH containing 0.1M NaCl, at 20°C. In the stability measurement, luciferase (a trace amount) was left standing in 0.1 ml of the buffer solutions of various pH for 30 min at 20°C, then the activity was measured by adding 1 ml of 50 mM sodium phosphate buffer, pH 6.5, containing 0.1 M NaCl and 1 pg of luciferin, at 20°C. The activity and stability data are taken from Shimomura et al., 1961, with permission from John Wiley 8c Sons Ltd.

Listed below in tabular form are the available parameters found for over 43 selected PBX formulations, supported by unclassified refs. Table 3 presents the nomenclature and formulation of each compn Table 4, sensitivity and stability data and Table 5, performance parameters... 

Table 4 — PBX Type Explosives — Sensitivity and Stability Data (continuedI... 

In Figure 2 the solubility and speciation of plutonium have been calculated, using stability data for the hydroxy and carbonate complexes in Table III and standard potentials from Table IV, for the waters indicted in Figure 2. Here, the various carbonate concentrations would correspond to an open system in equilibrium with air (b) and closed systems with a total carbonate concentration of 30 mg/liter (c,e) and 485 mg/liter (d,f), respectively. The two redox potentials would roughly correspond to water in equilibrium wit air (a-d cf 50) and systems buffered by an Fe(III)(s)/Fe(II)(s)-equilibrium (e,f), respectively. Thus, the natural span of carbonate concentrations and redox conditions is illustrated. 

Stability Data Package for Registration Applications in Climatic Zones III and IV Analytical Validation... 

Hematological and Hemoglobin Stability Data on 22 Members of the Family with Hb-Atlanta... 

The confirmatory procedure should be developed for the same tissues for which the determinative procedure was developed, preferably using the same extraction procedure as used for the determinative portion of the method. Storage and stability data are necessary for dried or liquid sample extracts if MS analyses of the confirmatory samples are to be conducted in a laboratory other than the laboratory of sample preparation. Analytes present in sample extracts must be stable long enough for the samples to be shipped to the MS laboratory and analyzed. 

OPPTS 860.1000 Background OPPTS 860.1100 Chemical Identity OPPTS 860.1200 Directions for Use OPPTS 860.1300 Nature of Residue - Plants, Livestock OPPTS 860.1340 Residue Analytical Method OPPTS 860.1360 Multiresidue Method OPPTS 860.1380 Storage Stability Data OPPTS 860.1400 Water, Fish, Irrigated Crops OPPTS 860.1460 Food Handling OPPTS 860.1480 Meat/Milk/Poultry/Eggs OPPTS 860.1500 Crop Field Trials OPPTS 860.1520 Processed Food/Feed OPPTS 860.1550 Proposed Tolerances... 

Stability is a critical variable that must be considered as part of method development. When considering stability within the method, reviewing the available stability data for the analyte is very helpful. Information on the stability of the analyte in aqueous... 

Many companies have developed or purchased computer software for the purpose of storing stability data for a large number of studies. Examples of commercially available systems are SLIM [147] and Stability System [148]. These systems can perform other functions as well, including work scheduling, preparation of summaries of selected or all studies in the system, tabulation of data for individual studies, label printing, statistical analysis and plotting, and search capabilities. Such systems should be validated to keep pace with current regulatory activity [149],... 

Once a product gains FDA approval for marketing, the sponsor should maintain a readily retrievable profile of commercial batches. This includes individual batch release data and stability data. These data should be compiled throughout the year and tabulated prior to the anniversary of NDA approval for submission in the annual product report to FDA. By maintaining an ongoing database, which is reviewed as new information is added, changing trends in the data can be observed and management notified if any of these trends are unfavorable. 

Chapter 661 of the USP provides criteria for the interchangeability of low- and high-density polyethylene for dry, oral dosage forms. In addition, there are standards for polyethylene terephthalate bottles and polyethylene terephthalate G bottles. USP criteria for interchangeability are listed in Table 17. These criteria allow usage of alternate materials in the same plastic class to be used prior to obtaining prior stability data. 

In addition to a description of the manufacturing method, packaging, and stability data, the ANDA requires only the following a description of the components and composition of the dosage form to be marketed brief statements that identify the place where the drug is to be manufactured the name of the supplier of the active ingredients assurance that the... 

Primary container-closure system-related data will need to cover storage, transportation, and use. The choice of materials of construction, their description, and the ability of the container-closure system to protect from moisture and/or light will need to be considered. The compatibility of the container-closure and its contents will need to consider sorption, leaching, and safety. The performance of the container-closure system will also need to be considered in terms of dose delivery from any associated device that is to be supplied as part of the product. Container-closure components will require adequate specifications covering description, identification, critical dimensional tolerances, and test methodology (including pharma-copeial and noncompendial methods). More data are likely to be required for liquid or semi-liquid products than for solid dosage forms. In the latter, product stability data and container-closure system specifications may suffice. 

Where antioxidants or antimicrobial preservatives are used, the finished product release specification will need to include identification tests and assays for these two types of excipient. The shelf life specification should also include a specification for assay for antimicrobial preservatives. Stability data will be required for both antioxidants and antimicrobial preservatives in the finished product, and in addition the preservative efficacy of the formulated product should be examined over its shelf life and by means of appropriate in-use stability tests. Preservative efficacy data should also be presented at the lower limit of the preservative assay. 

Blumenkrantz and Taborek (1971) applied the density effect model of Boure to predict instability in natural-circulation systems in thermosiphon reboil-ers used in the petrochemical industry. An important conclusion of their work was that similarity analysis in terms of the model s dimensionless groups can be used to extrapolate threshold stability data from one fluid to another. 

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