Stability, storage, packaging

Crospovidone has a shelf life of more than three years, after which the different types still meet the specifications given in Table 115, when they are stored in the original, sealed containers at room temperature (20-25 °C). 

Crospovidone also demonstrates excellent stability after processing into tablets, granules, capsules or suspensions, so that no changes are to be expected over many years. However, it should be borne in mind that the products are hygroscopic, so that if there are any leaks in the packaging, through which atmospheric humidity can enter, the crospovidone particles may swell. Tablets made from such product have a rough surface. 

The peroxide formation in placebo tablets (400 mg microcrystalline cellulose, 20 mg crospovidone, 3 mg magnesium stearate) was studied at room temperature over a storage period of 2 years. The results given in Table 122 show that no significant amounts of peroxides was formed in the tablets during this storage period. 

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The outer packaging must protect the tea from light and moisture absorption. Polypropylene or coated cellophane outer wraps for paper board tea packages provide a barrier to loss of tea aroma and retard permeation of oxygen and foreign flavors. Low temperature improves storage stability. Properly packaged and stored teas retain acceptable flavor for about a year. 

Many factors can influence the choice of solvent for topical preparations, ranging from chemical considerations such as drug solvent compatibility or solvent stability to packaging, storage and handling issues. Some critical concerns are discussed below. 

External factors affecting colour stability during packaging and storage... 

The nurse must read thoroughly the package insert supplied with the drug before the drag is prepared and administered. The manufacturer s recommendations may include information such as storage of the drag, reconstitution procedures, stability of the drag after reconstitution, the rate of administration, and the technique of administration. 

Data to demonstrate the stability characteristics of both the drug substance and the drug product must be collected. Studies using three different batches of both substance and product in their respective containers/packaging must be conducted. Real-time data should be collected under conditions of temperature and relative humidity in line with the recommended storage. Conditions in different world climatic zones must be taken into consideration for cases where normal environmental... 

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