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Scripts make working with the Command Line Client a lot easier and safer than typing them in by hand because they let you study the commands and check for mistakes before you execute them. For example, you can make darned sure that you don t have a DROP TABLE or DROP DATABASE statement where you don t want it. This technique also lets you test the commands a few at a time. For example, you can start with a script that creates a database and makes a table. Then you can write another script to create a second table and insert records into it. After you have each script debugged, you can glue them together in one huge master script if you like. Alternatively you can leave each script in a separate le so you can execute them separately, or you can make a master script that uses the SOURCE command to invoke the individual scripts. Writing scripts by hand and testing them can be somewhat tedious. Two MySQL tools that can make the process a bit easier are MySQL Query Browser and MySQL Workbench.

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Anisimov, Critical Phenomena in Liquids and Liquid Crystals, Nauka, Moscow (1987) (in Russian) 34 S T Wu, U Efron, and L D Hess, Appl Phys Lett 44, 1033 (1984) 35 O L Antipov, S I Belyaev, H A Pasmanik, Four-pass laser ampli er with PC-NLC mirror, Laser Phys 4(6), 1185 1189 (1994) 36 G J Linford, E R Peressini, W R Sooy, and M L Spaer, Very long lasers, Appl Opt 13, 379 390 (1974) 37 O L Antipov, D V Chausov, A S Kuzhelev, and A P Zinoviev, Self-starting laser oscillator with a nonlinear nematic liquid crystal mirror, J Opt Soc Am B 18(1), 13 20, (2001)..

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those used for the marketed product) should be similar to the packaging materials used for marketed products Storage time and conditions should support the conditions that are likely to prevail during the designated shelf life of the product A model approach can be used for excipients that are available in different grades such as various molecular weights of a polymer or different monomer ratios or mixtures or blends of other excipients Stability data available on model products can be used to determine the theoretical stability for similar products In addition, for excipients that have been on the market for a long time, historical data may be used to assign the shelf life, retest dates, and storage conditions [4] 7123 Active Pharmaceutical Ingredients GMPs for APIs [3] require a documented stability storage and testing program to monitor the stability characteristics of APIs against established stability speci cations.

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Figure 11-11: The Layer States Manager dialog box. 4. Click New and type a name for your layer state in the New Layer State Name text box of the New Layer State to Save dialog box. If you want, type a description. Click OK. 5. Back in the Layer States Manager, choose the layer states and properties that you want to save in the Layer Settings to Restore section.

The results from stability studies are used to establish storage conditions and retest or expiry dates For APIs, retest rather than expiration date terminology is commonly used The GMP guideline also emphasizes that the assay procedures (for drug substance and degradation products) in stability samples should be validated and it should be stability indicating A stability-indicating assay is de ned as a validated quantitative analytical procedure that can detect the changes with time in the pertinent properties of the drug substance and measures the active ingredient accurately without interference from degradation products, process impurities or other potential impurities [12; Section III C].

The GMP API guideline also emphasizes that stability samples should be stored in containers and closures (the sum of packaging components that together contain and protect API or drug product dosage forms) that simulate the market container and should be consistent with storage conditions speci ed in the FDA stability guidance [7] The GMP guideline requires that the rst three commercial production batches should be placed on the stability program to con rm the retest or expiry date If the API is expected to remain stable for at least two years, fewer than three batches are allowed The stability program should be ongoing with at least one batch of API manufactured each year tested annually to con rm stability, with testing done more frequently for APIs with shorter shelf lives.

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