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Factors influencing stability of drugs and drug products

Factors Influencing Stability of Drugs and Drug Products... [Pg.641]

FACTORS INFLUENCING STABILITY OF DRUGS AND DRUG PRODUCTS... [Pg.644]

As with drugs and purified biomarkers, thermal- and photostability of botanical products are the factors that must be considered. Commercial dried extract and capsules of SJW were evaluated under harmonized test conditions (25). Photostability testing showed all the constituents to be photosensitive in the tested conditions. However, different opacity agents and pigments influenced the stability of the constituents. Amber containers had little effect on the photostability of the investigated constituents. Long-term thermal stability testing showed a shelf life of less than four months for hyperforins and hypericins, even when ascorbic and citric acids were added to the formulation. [Pg.61]

Stability Data Trending. Stability testing provides information about the quality of a drug product under the influence of a variety of environmental factors such as temperature, humidity, and light varying with time... [Pg.716]

Thus, biopharmaceutics involves factors that influence the I) protection and stability of the drug within the drug product 2) the rate of drug release from the... [Pg.82]

Chemical stability under a variety of macro- and microenvironmental conditions is a highly critical property determining the expected shelf life of products. The stability of the bulk solid and in solution must be studied, whereby the influence of environmental factors (pH, temperature, humidity, oxygen, light) and including the presence of various excipients on drug stability must be established. [Pg.613]

It is critical to understand that the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf-life for the drug product and recommended storage conditions [3]. [Pg.27]

See other pages where Factors influencing stability of drugs and drug products is mentioned: [Pg.251]    [Pg.337]    [Pg.674]    [Pg.34]    [Pg.256]    [Pg.344]    [Pg.434]    [Pg.292]    [Pg.208]    [Pg.354]    [Pg.383]    [Pg.388]    [Pg.560]    [Pg.561]    [Pg.566]    [Pg.580]    [Pg.590]    [Pg.658]    [Pg.7]    [Pg.122]    [Pg.347]    [Pg.219]    [Pg.103]    [Pg.286]    [Pg.76]    [Pg.187]    [Pg.2225]    [Pg.3598]    [Pg.471]    [Pg.473]    [Pg.334]    [Pg.375]    [Pg.242]    [Pg.249]   
See also in sourсe #XX -- [ Pg.644 , Pg.645 , Pg.646 , Pg.647 , Pg.648 , Pg.649 , Pg.650 , Pg.651 , Pg.652 , Pg.653 ]



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Drug stability

Drug stability product

Factors Influencing Stability

Factors influencing stability of drugs and

Factors of influence

Influence of Stabilizers

Influence of drug

Product Stabilization

Product stability

Product stability and

Stability factors

Stability of drug

Stability of product

Stabilizing Factors

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