Stability and Shelf Life of Pharmaceutical Products

Good manufacturing practice (GMP) regulations and guidelines allude to the importance of stability and shelf life of pharmaceutical products. The U.S. Food and... 

Ranga Velagaleti, BASF Corporation, Florham Park, New Jersey, Microbiology of Nonsterile Pharmaceutical Manufacturing Stability and Shelf Life of Pharmaceutical Products... 

S. Yoshioka, Y. Aso, and S. Kojima, Statistical evaluation of shelf-life of pharmaceutical products estimated by matrixing, Drug Stability 1,147-151 (1996). 

Topical preparations, like all other dosage forms, must be formulated, manufactured, and packaged in a manner that assures that they meet general standards of bioavailability, physical (physical system) stability, chemical (ingredient) stability, freedom from contamination, and elegance. Like all other pharmaceuticals, these factors must remain essentially invariant over the stated shelf life of the product and they must be reproducible from batch to batch. 

Applications of HPLC Of the bioanalytical separation technologies described in this book, arguably HPLC has the widest range of applications, being adopted for the purpose of clinical, environmental, forensic, industrial, pharmaceutical and research analyses. While there are literally thousands of different applications, a few indicators of how HPLC has been used are as follows (i) Clinical quantification of drugs in body fluids (ii) Environmental identification of chemicals in drinking water (iii) Forensic analysis of textile dyes (iv) Industrial stability of compounds in food products (v) Pharmaceutical quality control and shelf-life of a synthetic drug product (vi) Research separation and isolation of components from natural samples from animals and plants. 

Knowledge of the physical stability of a formulation is very important for two reasons. First, a pharmaceutical product must look fresh and elegant as long as it remains on the shelf. Second, the active ingredient must be available to the patient throughout the expected shelf life of the product. The causes of deterioration in quality of active ingredient could be due to incompatibility with excipients, oxidation, reduction, hydrolysis, and racemization to name a few. 

Many vitamins are quite stable under normal processing conditions and present little or no stability problems in finished pharmaceutical products. These include biotin, niacin, niacinamide, pyridoxine, riboflavin, and a-tocopheryl acetate. Others that can present problems are ascorbic acid, calciferol, calcium pantothenate, cyanocobalamin, fola-cin, and retinyl esters. Overages above label claim are customarily added to vitamin formulations as a means of maintaining the claimed level of each vitamin for the expected shelf life of the products. The percent overage for a particular vitamin such as L-ascorbic acid will vary... 

The so-called storage stability test is a standard test that is used across many different fields—e.g., the pharmaceutical, cosmetic, and food industries. The test is popular because it yields precise information about the long-term shelf life of emulsions. In this test, emulsions are stored under conditions that are applicable to those encountered in the actual production/consumption situation. It should be noted that the presented test protocol is time consuming and requires sampling over an extended period of time. In the... 

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