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The guidance ICH Q1A (R2) [7] provides information on storage conditions and testing frequency for APIs under four intended storage conditions: (1) general cases, (2) Intended for storage in a refrigerator, (3) Intended for storage in a freezer, and (4) drug products intended for storage below 20 C (for this storage no speci c guidance is provided except to be treated on case-by-case basis). The storage conditions are summarized in Table 1. Marketed API Intended for Room Temperature Storage Conditions The storage conditions de ned in the guidance document [7] as a general case has no de nition assigned in the guidance. In this chapter, the author is interpreting this term as requiring room temperature storage (vs. storage in refrigerator and freezer) conditions for the marketed API. The storage conditions (temperature and humidity) and lengths of storage for stability studies should be suf cient to cover the following stages after manufacture: storage, shipment, and subsequent use. For submission of drug application, the data for long-term storage should cover a minimum of 12 months on three primary batches. The testing should, however, continue for the duration of the proposed shelf life and retest period. The accelerated and, when necessary, intermediate (storage condition designed to moderately increase rate of chemical degradation or physical change) storage conditions should be carried out for 6 months. In this scenario, long-term storage can be conducted at either at 25 C 2 C; 60% relative humidity (RH) 5% RH or 30 C 2 C, 65% RH 5% RH. If the long-term stability study is conducted at 30 C 2 C, 65% RH 5% RH, no intermediate condition storage is required. If long-term storage studies are conducted at 25 C 2 C, 60% RH 5% RH and a signi cant change occurs in the test

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You ll want something to store all your tools in. Big metal toolboxes aren t recommended. You re not going to have much in the way to tools anyway, so you re not going to need a lot of space. A small plastic toolbox is a good idea, but even these can be a bit big unless you can find a particularly small one. If you do take the plastic toolbox approach, then try to get one with little compartments to store small items in (such as screws, washers, jumpers, and bits of cable). Here are some other options for storing your tools: Tool roll. A roll of plastic or leather into which tools can be placed in a pouch. A zip-up folder. These are common among PC toolkits. Again, these are quite effective, but generally the range of tools you can store in it are quite limited and there is little room for your own additions. Also, these premade kits tend to be much more expensive than buying the parts individually. Plastic container. A cheap alternative is to store all your tools in a plastic container with a snap-on lid. For a free alternative, you might be able to recycle any suitably sized plastic tub you can find.

The risk analysis yielded a distribution of estimated capital cost in Figure 21.4, rather than the single value in Table 21.4. This enabled realistic figures to be given for the capital budget and contingency allowances, and it allowed the probabilities that the actual construction cost would be within these targets to be assessed. This is particularly important for projects that are unique in some way, are in new areas, or have special risks associated with them, where the use of a rule-of-thumb percentage contingency, based on experience in a stable environment, may not be appropriate. As Figure 21.4 indicates, the capital cost targets for this project were conservative, with a high probability of achievement, which is unusual.

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When you want to work on a file, and be absolutely certain that no one else replaces the file as you work on it, you can put an exclusive lock on the page. Be aware, though, that without Workgroup Support, other users can edit their own local copies. They cannot replace yours while it is locked, but they can replace it after you release the lock. To lock a file within the WebDAV tab of the Site Window or the WebDAV browser, point to the file you wish to lock and Control-click (Mac) or right-click (Windows) on that file. You can also do any one of the following: To lock a file or the selected files, choose Lock from the contextual menu. To lock an entire folder at once, choose Lock All from the contextual menu. (If you re running on a Microsoft IIS 5 server, you cannot lock folders. Instead, open the folder and lock the files within it.)

>>> f = open( read.txt , w+t ) # Create a file. >>> for i in range(3): ... f.write( Line #%d\n % i) >>> f.seek(0) >>> f.read(3) # Read 3 bytes from the file. Lin

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Mechanical Properties of Glass Fiber (GF) Filled PET/HDPE Blends [70] Heat Distortion Temperature ( C) 120 158 233 239

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