Drugs Compendia

Guo JJ, Wigle PR, Lammers K, Vu O. Comparison of potentially hepatotoxic drugs among major US drug compendia. Res Social Adm Pharm. 2005 l(3) 460-479. 

The use of drugs to treat disease antedates modem science ly 21 good many millenia. Every culture sooner or later developed I i own pharmacopeia. These compendia of natural products and... 

The 2000 U.S. Pharmacopoeia and National Formulary, USP 24-NF 19, was published in October 1999. It became official on 01.01.2000. USP-NF is one of, if not the most, widely recognized of the world s pharmacopoeial compendia of standards for drug strength, quality, purity, packaging, labelling and storage. USP-NF also provides standards for devices and diagnostics, as well as nutritional supplements. 

Trade associations and the compendia also played an important role in drug product control and quality during the nineteenth and twentieth centuries. The United States Pharmacopeia (USP) and National Formulary (NF) established standards of potency and... 

HPLC methods have been widely used for the analysis of OTC in different samples. As described above in the Section 2.3, the HPLC method is described in most of compendia [1,2,4,7] for determination of OTC in bulk drug substances and in some pharmaceutical preparations. The application of HPLC methods for the analysis of antibiotics including oxytetracycline has been recently reviewed by Diaz-Cruz et al. [37] and Lunn [38], A summary of HPLC method for the analysis of OTC is presented in Table 3. 

A large number of miscellaneous characteristics are usually included in many official compendia to ascertain the purity, authenticity and identification of drugs—including sulphated ash, loss on drying, clarity and colour of solution, presence of heavy metals and specific tests. 

Discuss the miscellaneous characteristic features included in official compendia to establish the purity, authenticity and identification of drugs. Give examples in support of your answer. 

Known amount of H2S04 consumed = Known amount of NaOH + Unknown amount of ZnO Most official compendia usually record the results of drug assays in terms of % w/v, % w/w and % v/v. 

A plethora of official drugs are assayed by the potentiometric method in various official compendia, and a few selected examples are given in Table 16.3, which may be assayed potentiometrically ... 

A plethora of pure drugs, their respective combinations and their dosage forms have been assayed by NMR-spectroscopy quantitatively by various researchers and the result(s) thus obtained were duly verified and compared with the standard methods prescribed in various official compendia. A few typical examples of such drugs shall be described briefly here ... 

The various modem techniques involved in Pharmaceutical Drug Analysis mostly covered in the official compendia have been adequately dealt with in Part II through Part VI and systematically spread over from Chapter 4 through Chapter 32 in the present textual compilation. 

Topical corticosteroids produce anti-inflammatory, anti-itching, and vasoconstricting effects. A wide variety is available (described in detail in Drug Information 2004 and other references and compendia). Such steroids are classified into five categories that reflect a... 

The tests for microbial limits and recommendations for microbial quality criteria of raw materials, excipients, drug substances, and pharmaceutical products have been established in pharmacopoeial compendia for over 30 years. These tests are listed in the USP 24 Chapter (61) Microbial Limits Tests and in the Ph. Eur. 3rd ed.. Biological Tests 2.6.12 and 2.6.13, Microbial Contamination of Products Not Required to Comply with the Test for Sterility (total viable count, tests for specified microorganisms) and the JP XIII 30 Microbial Limit Test. 

The format of the modem pharmacopeia remains roughly similar to those early medieval compendia that effectively listed drugs or the crude galenicals made from them in individuals monographs. Of course, these early documents were written in Latin but nowadays about the only remaining traces of Latin are in the titles of occasional botanical descriptions, which have recently made a return to official pharmacy under the mbric of Nutritional Supplements. 

Compendia that describe excipients used for various formulations such as parent-erals, vaginal formulations, and antibiotics are offered in a number of publications (7-9). The FDA publishes on its internet site, www.fda.gov, the downloadable Inactive Ingredient Database. The components of proprietary inactive ingredients are not always included. All inactive ingredients that are present in currently approved final dosage form in drug products are listed. Whenever included, one may need to search for such data under individual component entries. 

Several officially recognized compendia describe specifications for components and finished product (e.g., U.S. Pharmacopeia, Food Chemicals Codex, British Pharmacopeia, and European Pharmacopeia). These specifications have been established by an advisory board to each compendium and represent the views of many manufacturers and government based on a history of the component or product. Such specifications are reviewed and updated as the need arises when new information becomes available. These compendia are very useful and should always be used as a guide whenever possible. In the case of the USP, for example, if a monograph exists for a component or product, U.S. drug manufacturers are required to satisfy those specifications as a minimum requirement. 

Delayed release product In appli-cation/compendial release requirements plus dissolution tests in 0.1 N HC1 for 2 hr (acid stage) followed by testing in USP buffer media (pH 4.5-7.5) under application/compendia test conditions and two additional agitation speeds. Application/compen-dial method may be either apparatus 1 or apparatus 2.1 Adequate sampling should be performed (15, 30, 45, 60, and 120 min until either 80% of drug is released or asymptote is reached). Testing should be performed on changed product and biobatch or marketed product. 

Identification methods of rocuronium bromide in compendias only specify an identification method for its bulk drug substance, and none of these mention identification of rocuronium bromide in any of its pharmaceutical dosage forms. 

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