A N A L Y T I C A L CH E M I S T R Y WALTER J. MURPHY, Editor
Salute to USP and NF
cists. Likewise, responsibility for the preparation of USP gradually passed from the physicians to leaders among the nation’s pharmaceutical chemists, to the extent that their aid and advice today are clearly indispensable. The drug standards of USP and N F achieved a rapid rise in status at the turn of the century, when they were adopted as official in many state laws controlling the practice of pharmacy and the quality of foods and drugs. The Federal Food and Drug Law of 1906 required that all drugs listed in U8P or N F comply with the standards set up by these two compendia. The Federal Food, Drug, and Cosmetic Act of 1938 defines the term “drug,’ as a product recognized by either USP or NF. I n both compendia, the official specifications for physical chemical tests and the assay of drug potency are critical and specific. The assay not only indicates the percentage of thp actual drug but furnishes added assurance of its quality, purity, and identity. Ordinarily, the analytical procedure involves either the isolation of the active principle of the drug or its identification by an entirely characteristic chemical IFaction. Where two or more methods of equal precision or specificity are available, the simplest procedure is adopted. Virtually every principle of analytical chemistry is used in the official assay of drugs. In recent years, increasing emphasis has been placed on instrumentation and spectrophotometric techniques. In the forthcoming revisions of USP and KF, use will be made for the fiist time of analyses involving titrations in nonaqueous media. Even with the best chemical methods available, difficulties are frequently encountered in the interpretation of enti points. As a partial answer to the problem, USP and S F provide high-purity reference standards that may be assayed in parallel with the drug under test. USP alone furnishes more than 50 such reference standards. The accuracy and sensitivity of official procedures are. of course, dependent on the purity of the reagents used. Thu-. both USP and N F have issued standards for reagent chemicals. Wherever possible, these standards are identical or at least very similar to those established by the AMERICA?; CHEMICAL SOCIETY. The creation of drug standards is a tremendous cooperative undertaking, enlisting the efforts of hundreds of technical specialists. Before a set of specifications is issued, it is critically reviewed in numerous scientific laboratories and colleges of pharmacy throughout the nation. At all times, these standards are arrived at democratically by processes of trial and criticism. The target date for the publication of the latest revisions of USP and NF is January 1955. We look forward with keen interest to the release of these newest compendia, which unquestionably will match if not exceed the high standards of the past.
ON
THE bookshelves of analytical chemists in the pharmaceutical industry, the most dog-eared reference works are likely to include the United States Pharmacopeia and the National Formulary. For decades, both of these volumes have been indispensable guides to standards of strength, quality, purity, and identity of hundreds of drugs widely used throughout the United States. I n fact, so valuable and authoritative are these standards that they also serve as drug specifications in many countries abroad. Thanks to the work of USP and NF, the public is given ample assurance that approved drugs are not only safe but also useful agents for the treatment or cure of human ills. Our appreciation of the work of USP and N F was further heightened recently a t a meeting of the Analytical Group of the AMERICANCHEMICAL SOCIETY’S North Jersey Section. Those attending had the opportunity to hear from two foremost leaders in this field, Lloyd C. hliller, director of pharmacopoeial revision of the United States Pharmacopeia, and Justin L. Powers, chairman of the Committee on National Formulary of the American Pharmaceutical Association. Their discussion of the work of USP and N F left no doubt whatever that these t y o compendia are not only of immense service to the physicians, pharmacists, clinicians, and drug manufacturers of the nation but also-and quite iniportantly-to the analytical chemists. Although both USP and K F serve the same function of establishing drug standards, each operates within its own sphere. There is no overlapping. In general, drugs described in USP are those considered the most effective forms of medical treatment. On the other hand, those described in N F are drugs which, although they may have long been widely used, are not considered the very best available today. Of course, K F is not merely a catchall for outmoded drugs. Khere a product has only very limited value or no value whatever, it is covered neither in USP nor in NF. The U. S. Pharmacopeia and the National Formulary both have had long and distinguished histories. The older of the two is USP, which first appeared in 1820, even though the sponsoring agency, the U. S. Pharmacopoeial Convention, was not formally incorporated until 1900. The National Formulary, sponsored by the American Pharmaceutical Association, was first issued in 1888. Although both were published once every 10 years until 1940, they are now issued once every 5 years. USP was founded by a group of physicians who felt an acute need for reliable drug standards. Lack of drug uniformity was one of the bugbears of the day. Those were the times when doctors, Iacking many of the conveniences of the present, were obliged to roll their own pills and perform other functions that, in later years, were turned over to the pharma-
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