The pharmacist should communicate the deviations from the package insert to the manufacturer when requesting stability information. Many times the published references do not evaluate exactly the same formulation, israel matchmaking or the study did not examine the stability for a long enough period of time. There must be separate stability studies to support each expiration date.
Stress testing refers to testing the product after storage under exaggerated conditions. The requirement that stability testing be performed in the same container-closure system as that in which the drug product is marketed has been subject to interpretation. This also does not apply to repacking from bulk containers. Merely stating that a product was stored at room temperature is not sufficient for purposes of determining stability. Beyond use dates are different from expiration dates.
The major problem for pharmacists is that the stability of compounded formulations often is not known. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. Beyond use dates are used for compounded preparations and are generally in days or months. Once a minimally effective level of preservative is established, chemical testing for the preservative s may be performed.
Likewise, repackers who rely on stability studies performed by the manufacturer must have copies of all analytical data necessary to support the expiration dating period. Generally, the placing of three initial batches into the long term stability program is considered minimal to assure batch uniformity for establishing an expiration date. The expiration dating period used would then be the sum of that justified individually at each storage condition.
U.S. Food and Drug Administration
Most expiration dates are given in years for commercial products. This is in contrast to incompatibilities that can be visually observed. However, the repacker is subject to applicable current good manufacturing practices. Because of compelling patient-care needs, a pharmacist may be unable to stay within the approved labeling and product guidelines stated in the package insert.
Expiration Dating of USP Reference Standards
- Information obtained from old stock, not previously the subject of stability studies, may also be utilized.
- Beyond use dates should be in accordance with the manufacturer's approved labeling.
- Products sterilized in glass ampuls need not be subjected to sterility testing as part of the stability testing program.
- Pharmacists should obtain a letter from the manufacturer certifying the beyond use dating period provided.
Stability studies should be conducted on product stored under normal storage conditions or, preferably, under exaggerated conditions. When accelerated stability studies are performed, one batch may be adequate in order to establish a tentative expiration date. Although specific methods are critical to determine product stability, they do not have to employ any specific technique. However, more frequent testing near the end of the anticipated expiration date is often likely to give better information about the actual stability of the finished product.
Expiration Dating and Stability Testing for Human Drug Products
When the same product is marketed in more than one size, e. When this is not possible, a pharmacist ideally consults with the manufacturer to establish a beyond use date. The use of quantitative analysis, where limits are known, such as thin layer chromatography, christian perspective on high school may be satisfactory.
In these instances, pharmacists should consult with the drug's manufacturer to establish a beyond use date. The use of accelerated testing data to establish a tentative expiration dating period of greater than three years is discouraged when it is based solely on accelerated data. In other words, the evidence is not from a product-specific experiment. When qualifying the container-closure system, sterility testing should be performed initially and at the end of the expiration dating period. The preservative system should be monitored at the same stability testing times as other ingredients are monitored.
This can be done, as an example, by taking a sample product that has been at room temperature for one year and subjecting that sample to accelerated temperature conditions.
Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years. This is acceptable since it is not the purpose of an accelerated test to determine batch uniformity but rather to test for kinetic degradation. Satisfactory comparison of container-closure systems may be done by several methods, i. For example, a product liable to degrade by light need not be stored in a lit area if it is normally packaged and stored for use in an opaque container.
However, reliable, published stability information is sometimes lacking for many types of drugs. Some firms have chosen, for economical purposes, random dates to test all stability samples of a given product. This indicates that the smallest marketed container is the most critical in terms of the container properties contributing to product degradation. As long as there is at least one test performed annually, speed dating bailey's chocolate bar this approach can be quite satisfactory. The Pharmaceutics and Compounding Laboratory.
- If a product was stored under controlled conditions, those actual conditions temperature and humidity should be recorded.
- Most pharmacies have the name, address, and phone number of the pharmacy pre-printed on their prescription labels.
- The ability of the product to retain its sterile condition is a function of the container-closure system.
- It is commonly recommended that stability testing be performed initially, than every three months for the first year, then every six months for the second year, and then annually thereafter.
- Products formulated to contain preservatives to inhibit microbial growth should be monitored throughout their shelf life to assure the effectiveness of the preservative system.
Expiration dates are required on commercially manufactured products and are determined after extensive study of the product's stability. This will usually involve high temperature and high humidity. The stability indicating test does not have to be the assay method used to determine product strength. Based on published information, free it appears that C is a reasonable reference for thermal exposure at room temperature. It is not possible to use a manufacturer's expiration date and extrapolate or estimate a beyond use date for a compounded formulation.