United States Pharmacopeia international

United States Pharmacopeia. Reference standards are requited in many USP and NF tests, and in a few FCC tests. The USPC distributes such standards domestically and has authorized international distribution by a number of organizations or companies. There are well over 1000 USP Reference Standards, including several for melting points, and also specimens of narcotics and other controlled substances. New standards are constantly under development as needed in various USP, NF, and FCC testing methods. 

All bioassays are comparative in nature, requiring parallel assay of a standard preparation against which the sample will be compared. Internationally accepted standard preparations of most biopharmaceuticals are available from organizations such as the World Health Organization (WHO) or the United States Pharmacopeia. 

Figure 5.19 The official logos of the United States Pharmacopeia (left), the American Society for Testing and Materials (center), and the AO AC International (right). 

Abbreviations. Ab, antibody SC, subcutaneous IV, intravenous CHO HSA, human serum albumin SC, subcutaneous USP, United States Pharmacopeia AHF IU, international unit NMT, not more than Ig, immunoglobulin BHK, baby hamster kidney PEG, polyethylene glycol hGH, human growth hoimone IM, intramuscular WFI, water for injection. 

This chapter will deal with the objective of manufacturing excipient ingredients to appropriate good manufacturing practices (GMP) requirements, as stipulated by the United States Pharmacopeia (USP) (1) and the International Pharmaceutical Excipients Council excipient GMP guide (2). It is beyond the scope to address the many quality techniques for minimizing variation in excipient quality. However this chapter will address the issues concerning assurance that all excipient material within each batch meets compendial or manufacturer s specification. 

FDA = United States Food and Drug Administration FEMA = Flavor and Extract Manufacturers Association INS = International Numbering System NIST = National Institute of Standards and Technology USP = United States Pharmacopeia... 

Seeking to establish dialogues with Central and South America, the USP, in 1905, responded to a request for a Spanish edition of the Pharmacopeia by contracting with Dr. Jose Guillermo Diaz, Dean and Professor of the College of Pharmacy of the University of Havana, Cuba. Support for this project may have come from a resolution adopted by the Second International Sanitary Convention of the American Republics in 1905, which read in part Resolved, that a translation of this United States Pharmacopeia into the Spanish language would prove of great benefit to the medical profession and pharmacists in each of the republics represented in this Convention. ... 

Some organizations, including the Canadian Health Protection Branch and the United States Pharmacopeia (USP), act as observers to the conference working committees, and their input is also influential in the guideline-setting process. In addition, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) acts as an umbrella organization and provides the ICH secretariat to coordinate the preparation of documentation. 

The current state of the art in clinical enzyme standardization has been extensively reviewed by Bergmeyer, and the information on various international organizations is compiled in the series Methods of Enzymatic Analysis. The World Health Organization (WHO) and the pharmacopeias on both national and international levels have to some extent been involved in enzyme standardization. A well-known example is the establishment of the international standard for hyaluronidase by WHO in cooperation with the Hyaluronidase Panel of the United States Pharmacopeia and the manufacturers in the United Kingdom, the United States, and France. 

The purposes of this book are to present the principles of operation of the most commonly used chemical separations, to describe the apparatus that is used, and to provide an experiment to illustrate the techniques required to perform each separation correctly. The samples used are commercial products and naturally occurring materials. The methods are, for the most part, official methods from the Association of Official Analytical Chemists, International (AOAC, Inti.) the United States Pharmacopeia (USP) the American Society for Testing and Materials (ASTM) and from university and industrial laboratories. 

Storage conditions should be specified on the label of API containers when it is critical to maintain such conditions to ensure the quality of the API. Where applicable, labeled storage conditions should comply with standard definitions for Freezer, Cold, or Controlled Room Temperature, as defined in the United States Pharmacopeia (USP) or guidelines of the International Conference on Harmonisation (ICH). Statements of specific storage conditions should be used instead of more general terms such as room temperature when it is critical for maintaining the quality of APIs. 

Schniepp, SJ, (2006) Understanding the united states pharmacopeia and the national formulary demystifying the standards-setting process. Davis Healthcare International Publishing, Moore, OK. 

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