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Drugs shelf life

Chow, S.-C., and Shao, J., Estimating Drug Shelf-Life with Random Batches, Biometrics 47, September 1991, 1071-1079. [Pg.415]

FIGURE 5 Normal probability plot of drug shelf life with 95% confidence interval. [Pg.292]

A. K. Kishore and J. B. Nagwekar, Influence of temperature and hydrophobic group-associated icebergs on the activation energy of drug decomposition and its implication in drug shelf-life prediction, Pharm. Res. 7, 730-735 (1990). [Pg.239]

The guideline on impurities in new medicinal products parallels the drug substance text, but the designated thresholds concern only degradation products. The thresholds should be applied to the product at the end of its shelf-life, as that is when the greatest level of degradation is expected to have occurred. [Pg.336]

CREAM.dat A batch of cream containing two drug substances was put on stability and tested for at f = 0, 3, 7, and 24 months. Active component 1 remains stable, while AC2 degrades so fast that a shelf-life of only 26 months can be demonstrated for SL = 90%. Use with SHELFLIFE. [Pg.388]

When configurational stability is truly low and results in half-lives of racemization or epimerization, which are on the order of minutes or hours, the phenomenon has pharmacological significance. On the other hand, when the half-lives are on the order of months or years, the phenomenon has pharmaceutical significance and may shorten the shelf life of drugs [47],... [Pg.151]

Various drugs are known to exist in different polymorphic forms (e.g., cortisone and prednisolone). The rate of conversion from a metastable into the stable form is an important criteria to be considered with respect to the shelf life of a pharmaceutical product. Polymorphic changes have also been observed during the manufacture of steroid suspensions. When steroid powders are subjected to dry heat sterilization, subsequent rehydration of anhydrous steroid in the presence of an aqueous vehicle results in the formation of large, needle-like crystals. A similar effect may be... [Pg.263]

It has now been established beyond any reasonable doubt that quality of a drug product cannot simply be ensured by inspection or analysis, but a control system has to be built into, from the very beginning of manufacture of a drug. Besides effective quality control measures exercised in every aspects of production including environment, screening of raw materials, process controls, intermediate shelf-life of finished products the most important aspect is to assess the bioavailability of the active principle. [Pg.10]


See other pages where Drugs shelf life is mentioned: [Pg.289]    [Pg.290]    [Pg.290]    [Pg.291]    [Pg.583]    [Pg.583]    [Pg.599]    [Pg.604]    [Pg.639]    [Pg.59]    [Pg.307]    [Pg.54]    [Pg.201]    [Pg.289]    [Pg.290]    [Pg.290]    [Pg.291]    [Pg.583]    [Pg.583]    [Pg.599]    [Pg.604]    [Pg.639]    [Pg.59]    [Pg.307]    [Pg.54]    [Pg.201]    [Pg.249]    [Pg.308]    [Pg.378]    [Pg.241]    [Pg.251]    [Pg.411]    [Pg.55]    [Pg.235]    [Pg.392]    [Pg.406]    [Pg.406]    [Pg.450]    [Pg.456]    [Pg.457]    [Pg.458]    [Pg.460]    [Pg.591]    [Pg.810]    [Pg.321]    [Pg.133]    [Pg.92]    [Pg.163]    [Pg.606]    [Pg.249]    [Pg.357]    [Pg.273]    [Pg.22]   
See also in sourсe #XX -- [ Pg.188 ]




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