By Jens T. Carstensen, Christopher Rhodes

ISBN-10: 0824703766

ISBN-13: 9780824703769

Addressing matters for sufferer welfare whereas holding manufacturer acceptance, and delivering a database for formula of alternative items, this multiauthored reference blends primary concept and sensible recommendation on drug product balance in clinical, technical, and regulatory environments, protecting improvement of indicating assays, laptop use, medical trial fabrics, strategic making plans, and packaging. Describing the documentation required to lessen the alterations of regulatory citations, the e-book lists brands of photostability checking out chambers, balance method software program, and laboratory info administration platforms for pharmaceutical functions.

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Thus if the product is stored in accordance with label instructions, it is expectedthat the product will retain fitness for use up to that date. With the exception of products that have very short shelf lives, it is conventional in many parts of the world to give only the month and year of the expiration date. , May '03, the product should remain of acceptable quality until the end of the stated month. When products have a 5-year shelf life,the practice of only givingexpiration dates for the months of January or July seems to be becomingmore common.

G. testing at 3, 6, and 9 months at 55"C, if all the drug is lost after 3 months' storage. 10 100 80 10 0 20 30 40 50 Months Data from Table 5 treated by zero-order kinetics. 40 0 25 100 91 83 50 Time (months) Data from Table 5 treated by first-order kinetics. ate constants are, of course, a function of temperature, and the data shown in Table 5 are graphed in Figs. 10A and 10B. If rapid results are desired for a given product, it is at times a practice to store it at elevated temperatures. The purpose of this is to force sufficiently large degrees of decomposition in a short time, so that they may be assessed with accuracy.

However, a number of regulatory agencies, including FDA, are now showing much more reluctance than previously to approve such overages for drug products.? This reluctanceto approve the use of stability overages probably stems from a number of causes. First, there isconcern about the possibleincrease in toxicity that might accompany the use ofa stability overage. Ifa product for which compendia1 potency limits are 90-1 10% is released onto the market at 100% of label claim, then the ma~imumamount of any degradation product that could be present in the product up until the expiration date is 10%.

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Drug Stability by Jens T. Carstensen, Christopher Rhodes

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