Pharmaceutical products moisture

The authors concluded that water which cannot be removed at 100 °C is bound in such a way that it cannot jeopardize the pharmaceutical product. Only the free water can diffuse from the stopper to the product. The moisture content is measured by the Karl Fischer method with different temperatures in the oven, 100 °C to determine the free water content and up to 300 °C to measure the free and bound water. The authors suggested developing a similar program for other stoppers, since the time for such measurements is relatively short (1 week) instead of observing the RM in a product over long times. Table 1.15.2 summarizes the results with the stoppers described above. Table 1.15.3 lists the limits of the free moisture content in 2 types of stoppers and for different cake weights under the assumption that a maximum RM increase of 0.5% in the product is acceptable. 

Some general applications of TG-FTIR are evolved gas analysis, identification of polymeric materials, additive analysis, determination of residual solvents, degradation of polymers, sulphur components from oil shale and rubber, contaminants in catalysts, hydrocarbons in source rock, nitrogen species from waste oil, aldehydes in wood and lignins, nicotine in tobacco and related products, moisture in pharmaceuticals, characterisation of minerals and coal, determination of kinetic parameters and solid fuel analysis. 

Whatever the water requirement of a particular protein formulation, it is still important to maintain the residual moisture content of a pharmaceutical product within its stability specifications to maintain its quality. 

Gelatin capsules are also produced, which contain 5%i Polyethylene glycol (PEG) 4000 as an additional plasticizer. They have improved physical characteristics over standard gelatin capsules and can loose more moisture before they become brittle. They were first developed by Shionogi Qualicaps in Japan, where they are widely used for pharmaceutical products. 

In the area of moisture in pharmaceutical products, it is possible to identify three stages in the scientific and regulatory history. The first stage dealt more or less exclusively with the amount of water present in pharmaceuticals, most of which were products of natural origin, with regard to issues of potency and commerce. 

Moisture in Pharmaceutical Products Table 1 Definitions (Continued) 2371... 

Adjustment and control of moisture levels by drying, is important in the manufacture and development of pharmaceutical products. Apart from the obvious requirement of dry solids for many operations, drying may be carried out in order to ... 

Packaging material has a dual role and acts both to contain the product and to prevent the entry of microorganisms or moisture which may result in spoilage, and it is therefore important that the source of contamination is not the packaging itself. The microflora of packaging materials is dependent upon both its composition and storage conditions. This, and a consideration of the type of pharmaceutical product to be packed, determine whether a sterilization treatment is required. 

Because water provides the greatest extinction coefficient in the NIR for pharmaceutically relevant materials, it stands to reason that this is one of the most measured substances by the NIR technique. A recent application involves noninvasive measurement of water in freeze-dried samples. Derksen et al. [56], for instance, used NIR to determine water through the moisture content of samples with varying active content. Ka-met et al. applied NIR to moisture determination of lyophi-lized pharmaceutical products [57]. 

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