Storage alternatives, long-term

Long-Term Storage Alternatives. How and where should the salt cake and fission product capsules generated in the present Hanford Waste Management Program be stored to ensure positive protection of the public and environment over the long time the radioactivity in these... 

Table V. Long-Term Storage Alternatives for Hanford High-Level Wastes...

Figure 16 Conjugation of an amine and a carboxylic acid via the (V-hydroxysuccinimide (NHS)-activated ester method. NHS esters may be isolated and characterized and are stable to long term storage as the powder. Alternatively, the NHS esters may be used immediately upon formation without isolation. Details of the reaction are given in Table 4...

In yams, an important crop in tropical climates, neither chemical sprout inhibitors nor cool storage are effective for long-term storage. On the other hand, irradiation would provide an effective alternative for postharvest treatment. 

These enzymes must have a large activity spectrum, and ideally enantioselectivity for toxic stereoisomers. Their mass production under GMP conditions must be realizable at a reasonable cost. Long-term storage without activity loss (in solution, lyophilized, or adsorbed/bound on a matrix) must be possible under field conditions. Conformational stability can be optimized by chemical modification or addition of stabihzers such as polyols. Thermostable enzymes from thermophilic bacteria (Merone et al., 2005) or mutated/ evolved highly stable enzymes from mesophilic bacteria (Elias et al., 2008) are promising alternatives. 

Products without an Approved Stability Protocol For applications that do not contain an approved stability protocol as defined above, a new or revised stability protocol may be submitted in a Prior Approval Supplement marked expedited review requested. This protocol should encompass 25°C/ambient humidity as the primary long-term storage conditions, and the ICH long-term conditions as the alternate, as well as accelerated stability storage conditions as defined by the ICH Guidance and above, in addition to other recommendations described in this guidance. On approval of the protocol, stability studies may be initiated on annual batches and on batches intended to support supplemental changes. 

Dissolve NHS-LC-biotin (Pierce) in DMF at a concentration of 40 mg/ml. This stock solution is stable for reasonable periods, although long-term storage is not recommended. For use of the water-soluble sulfo-NHS-LC-biotin, a stock solution may be prepared in water, or the solid reagent may be directly added to the reaction mixture. If a solution in water is made to facilitate the addition of a small quantity of reagent to a reaction, then the solution should be prepared quickly and used immediately to prevent hydrolysis of the NHS ester. Sulfo-NHS-LC-biotin may be dissolved in water at a concentration of 20 mg/ml. Add 5 0 xl of the NHS-LC-biotin solution in DMF to each milliliter of the protein solution in two aliquots apportioned 10 min apart. Alternatively, add a quantity of the sulfo-NHS-biotin solution prepared in water to the protein solution to obtain a 12- to 20-fold molar excess of biotinylation reagent over the quantity of... 

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