Pharmaceutical Dosage Forms: Tablets, Second Edition, by L. Augsburger Larry, Herbert Lieberman, Joseph B. Schwartz

By L. Augsburger Larry, Herbert Lieberman, Joseph B. Schwartz

Whole in three volumes. Pharmaceutical know-how. 14 participants.

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Extra resources for Pharmaceutical Dosage Forms: Tablets, Second Edition, --Volume 3

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7. Label the sample container, source of water, sample point location, and number, type of water, and time and date sampled. 8. Transfer the sample within 1 hr of sampling to the microbiology laboratory. 9. Refrigerate the sample in the microbiology lab until testing within 24 hr of sampling. 10. Follow USP total aerobic microbial count test. Figure 8 Water­sampling procedure.  coli. United States Public Health Services regulations describe the testing procedures and limits for each locality.  Public Health Services.

Monitoring should be at static and dynamic working conditions with all lights on in the aseptic areas.  Measure and record temperature at 30 minute intervals during dynamic and static working conditions. ACCEPTANCE The air conditioning system should be able to maintain the CRITERIA: temperature at 72 ± 20°F at static and dynamic working conditions with the specified occupancy and light generation levels. Figure 17 Temperature monitoring in aseptic areas.  An example of such a calibration method is given in Figure 19.

Table 6 lists USP physicochemical tests and requirements for plastics.  Nonvolatile residue Difference between sample and blank does not exceed 15 mg.  Residue on ignition Residue on ignition obtained from the sample and blank does not exceed 5 mg.  Heavy metals No more than 1 ppm. 0 ml, if acid was required for either the sample or the blank and alkali for the other.  Table 7 lists the classification of plastics for biological tests, as shown in the USP.  This unique combination of properties permits elastomeric closures to be used for vials, large volume parenteral bottles, and different types of cartridges in a variety of shapes, thicknesses, sizes, and chemical compositions.

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