MONOGRAPH SPECIFICATIONS

The Standard-Setting Process. Settiag USP-NF standards is a continuing, and by no means unilateral, process. The Committee of Revision not only develops monographs for new substances but also continually reviews the monographs, specifications, and testing methods for existing substances. Results are pubHshed in one or more supplements each year. A complete review is done every five years and a revision is pubHshed. 

The active ingredient specification may need to include specific relevant tests that relate to the use of the material in particular products. These may be in addition to any relevant pharmacopeial monograph specifications. 

The goal of harmonization is to bring the policies, standards, monograph specifications, analytical methods, and acceptance criteria of pharmacopoeias into agreement. Such imity may, however, not always be achievable. Where imity cannot be achieved, harmonization means agreement based upon objective comparability and a clear statement of any differences. The goal, therefore, is harmony, not imison. 

Accuracy. In the quantitative method that is used to measure the heavy metal quantity in the drug substance, the accuracy is usually represented by the recovery rate obtained from a spiked recovery test where lead is added to the samples. Since the heavy metals limit test specified in monograph specifications is a test where the intensity of coloring of the samples with sodium sulfide is compared with that of the control solution, it is necessary to confirm that heavy metal components can be detected fully in the process of test solution preparation. The Heavy Metals Limit Test in JP specifies four preparation methods for the test solutions. An appropriate method will be selected and used for further testing. The test method that gives the best recovery rate is to be adopted. The procedure is as follows ... 

Prospective, multisite, uncontrolled clinical studies were conducted to study the effectiveness of the formulations and the acceptability of the polym ethane delivery system. The formulation was imbibed into 2.5-in. hydrophilic polyurethane foam discs (LMI, St. Charles, MI). Each disc contained 2.4 g of the formulation. The method of application was developed in tests that limited the active ingredient to the same amount or less than the monograph specifications for the formulation ingredients. Fourteen volunteers were given boxes containing 42 individually wrapped foam pads impregnated with the fonnulation and were asked to complete the questionnaire weekly. 

The certificate, granted for 5 years, may include additional specifications (methods and limits) when monograph specifications do not fully control the purity of the substance (e.g., control of residual solvents, specific impurities, etc.). 

NMR basic principles and progress specialised monograph giving detailed descriptions of specific areas of solid state NMR. 

As mentioned in Chapter 14, it was my usual practice during my career that whenever I felt that I had substantially achieved my goals and interest in a specific field of my research, I wrote (or edited) a book or comprehensive monograph of the field. The interested reader may want to consult these for further details. They also contain extensive references to my 1200 original papers as well as to reviews and chapters. If not otherwise indicated, my books were all published by my longtime publisher, John Wiley Sons, Inc., in New York. 

A field of such importance and intrinsic difficulty should be made as readily accessible as possible, and the lack of a modern detailed and comprehensive presentation of heterocyclic chemistry is therefore keenly felt. It is the intention of the present senes to fill this gap by expert presentations of the various branches of heterocyclic chemistry. The subdivisions have been designed to cover the field in its entirety by monographs which reflect the importance and the interrelations of the various compounds, and accommodate the specific interests of the authors. 

An introduction to several of the more common methods of surface and interface analysis has been presented in this article. This treatment is certainly not comprehensive. An ever-expanding number of methods for the interrogation of surfaces and interfaces are available to the analyst. The ones chosen for discussion here were meant to be representative of methods that can answer the more general questions posed at the beginning of this article. The reader is encouraged to pursue further reading on other techniques for specific appHcations in the many excellent monographs on the subject of surface and interface analysis. 

The GeneralNlotices. These are the basic requirements for the appheation and interpretation of the tests and specifications that foUow in the USP-NF. Many of the terms used in the text are defined, and the majority of procedural questions that may arise within the monograph for each substance are answered. 

The objective of the FCC is to define food-grade chemicals in terms of the characteristics that estabUsh identity, strength, and quahty. It provides specifications in monograph form for some 900 food additives, together with analytical test procedures by which compliance with the specifications can be determined. The third edition was pubUshed in 1981 supplements followed in 1983, 1986, 1991, and 1993. The fourth edition is in preparation as of this writing and is to include monographs for almost 1000 food chemicals, including flavors. 

Specifications for hGH products are defined by the governmental licensing authorities, eg, the U.S. Pood and Dmg Administration. Draft monographs for hGH have been prepared by both the EnitedStates Pharmacopia and the European Pharmacopeia commissions and should be formally adopted by 1995. These specifications are suitable for biosynthetic hGH. The much less purified pituitary-derived hGH has virtually disappeared from commercial production. An international reference standard for pituitary-derived hGH (lot 80/505) has been used for caUbration, particularly for bioassay purposes. A highly purified biosynthetic hGH standard (lot 88/624) has been prepared and should be formally adopted by 1995, or before. 

The US. Pharmacopeia (USP XXII) or National Formula (NFXVII) (20) also provide a similar description however, the peroxide value is not defined (Table 9). These specifications are also given in the Handbook of Pharmaceutical Excipients (HPE), pubhshed jointiy by the American Pharmaceutical Association and The Pharmaceutical Society of Great Britain (21), which defines lecithins both from plants and eggs. The Merck Index (22) specifies a slightiy lower acid value. The Japanese Monograph (ISCI-II) (23) specifies a slightiy lower acetone-insoluble matter and a lower heavy-metal content. 

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