Pharmaceutical test methods

Crowther, J. B., Validation of Pharmaceutical Test Methods, In Handbook of Modern Pharmaceutical Analysis, Vol. 3, (Ahuja, S. and Scypinski, S., Eds.), Separation Science and Technology, Academic Press, New York, pp. 415 43, 2001. 

Sweetness is often an important characteristic of sugar alcohols in food and pharmaceutical applications. The property of sweetness is measured in a variety of ways and has a corresponding variability in ratings (218). Based on one or more test methods, erythritol and xyfitol are similar to or sweeter than sucrose (218,219). Sorbitol is about 60% as sweet as sucrose, and mannitol, D-arabinitol, ribitol, maltitol, isomalt, and lactitol are generally comparable to sorbitol (see Sweeteners). 

Nutrients and diet supplements without claims of therapeutic effects are considered foods, and are thus regulated by the U.S. Food and Dmg Administration. These are further subject to specific food regulations. Specifications for pyridoxine hydrochloride (7) for foods are given in the Food Chemicals Codex (80) and for pharmaceuticals in the US. Pharmacopeia (81). General test methods have been summarized (82). 

Food and pharmaceutical grades of calcium carbonate are covered by the Food Chemicals Codex (7) and the United States Pharmacopeia (8) and subject to U.S. Food and Dmg Administration Good Manufacturing Practices (9). Both purity requirements and test methods are available (7,8). Calcium carbonate is listed in the U.S. Code of Federal Regulation as a food additive, and is authorized for use in both paper and plastic food contact appHcations. 

HEPA and ULPA filters have been developed. In the CEN EN 1822 1998 test method, the filter s efficiency is determined for the most penetrating particle size (MPPS). Depending on the filter s total level of separation and leakage, the filter is classified as HIO, Hll,.. ., H14 and U15, U16, or U17. HEPA filters are commonly used for inlet air in the pharmaceutical, optical, and food industries. 

Pharmaceutical sites will usually create a dedicated team of validation specialists to coordinate all validation activities. They should operate according to a validation master plan that has been developed using risk analysis to identify the most critical systems requiring validation/re-validation. Before validating a system or process, a written protocol should be prepared that describes the system, the critical aspects, the objectives, the test methods and the acceptance criteria that will be applied. A validation report should be prepared on completion of each protocol. 

Since the U.S. vs. Barr decision in 1993 (relevant to pharmaceuticals and related fields, rules applied by the Federal Food Drug Administration, FDA), outlier tests may no longer be applied to physicochemical tests, under the assumption that such test methods, having been optimized and validated for the particular set of circumstances, rarely produce outliers. These tests may not be applied to CU results at all. Good manufacturing practices mandate that operators work according to pre-set procedures and write down any observed irregularities as they... 

Gad, S.C. (1989b). A tier testing strategy incorporating in vitro testing methods for pharmaceutical safety assessment. Flumane Innovations and Alternatives in Animal Experimentation 3 75-79. 

Gad, S.C. (1989). A Tier Testing Strategy Incorporating In Vitro Testing Methods for Pharmaceutical Safety Assessment. Humane Innovations Alternatives Anim. Exp. 3 75-79. 

Can one make use of NMR-Spectroscopy as an identification testing method for pharmaceutical substances Explain with typical examples. 

Stippler E. Biorelevant Dissolution Test Methods to Asses Bioequivalence of Drug Products. Frankfurt Institute for Pharmaceutical Technology, J. W. Goethe University, 2004 414. 

Detection If a small capillary diameter is desired for efficiency purposes, the detection part of the capillary can be adapted for better detection sensitivity. Examples are the bubble cell capillary and the Z-cell. In the bubble cell capillary, the capillary diameter is enlarged at the detection window so that better concentration sensitivity is obtained. If you implement a bubble cell capillary in your pharmaceutical analysis method, it is important to test different batches. Test also whether you need a bubble cell capillary or whether you can gain similar sensitivity increase with a proper injection procedure. Also, check the effect of the bubble cell on band broadening. An approximately three-times sensitivity enhancement is possible. 

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