Pharmacopeial Forum

A guideline for evaluation of the photostability of new drug substances and dosage forms was published in 1997 [39]. Subsequently, a joint study was undertaken by the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America to evaluate the ICF1 guideline. A draft chapter for the United States Pharmacopeia, based on the guideline and the joint study, has been published in Pharmacopeial Forum [40]. 

Pharmacopeial Forum s list of in-process revision draft articles for consideration [31] include the following chapters relevant to pharmaceutical packaging ... 

C. Kotts, E. Gilkerson, D. Trinh, G. Hawker, A. Chen, H. Gazzano-Santoro, Assay validation report Cell proliferation test for human growth hormone, Pharmacopeial Forum, 25(3), 8313 (1999). 

Report of the Advisory Panel on Moisture Specifications (Chair G. Zografi), Pharmacopeial Forum, 17, 1459 (1991). 

The USP-NF is revised annually with two intervening supplements. As of the writing of this chapter, USP27-NF22 (2004) was official. Revision proposals are presented under authority of the Council of Experts in Pharmacopeial Forum, published bimonthly. 

Any proposal for harmonization must be presented for public comment in each of the pharmacopeial journals, Phar-meuropa (EP), Japanese Pharmacopoeial Forum (JP), and Pharmacopeial Forum (USP). This was accomplished early in 2003 (21-23). Comments were collated and further PDG discussions conducted. Any agreement will be presented again, prior to implementation. The PDG harmonization process can be found as General Information Chapter < 1196 > in USP 27 (24). 

Shangraw RF. Standards for vitamins and nutritional supplements who and when. Pharmacopeial Forum 1990 16 751-758. 

United States Pharmacopeial Convention Inc., <2091> Weight variation of nutritional supplements-proposed revisions to. Pharmacopeial Forum 2002 28(5) 1548-1554. 

Lang F, Keller K, Ihrig M, Oudtshoorn-Eckard J, Moller H, Srinivasan VS. Yu He-ci in FIP recommendations for biopharamceutical characterization of herbal medicinal products. Pharmacopeial Forum 2002 28(1) 173—181. 

Volpe, A.D., Faustino, P.J., and Yu, L.X., Towards standardization of an in vitro method of drug absorption, Pharmacopeial Forum, 27, July-August, 2001. 

Analytical Instrument Qualification, Pharmacopeial Forum 32(6), November 2006. 

Harmonization proposals do not have official status. The work of the PDG is finished at Stage 5B. The progress of the harmonization projects can and should be verified in the most recent number of Pharmacopeial Forum, Japanese Pharmaco-poeial Forum, and Pharmeuropa. For standards in force in USP24-NF19, see also the latest Supplement or Interim Revision Annoimcement. 

Drew, H. D., Brower, J. F., Juhl, W. E., and Thornton, L. K. (1998), Quinine photochemistry A proposed chemical actinometer system to monitor UV exposure in photostability studies of pharmaceutical drug substances and drug products, Pharmacopeial Forum, 24(3), 6334. 

Jomitz, M.W. and Meltzer, T.H. (2004). Sterilizing filtrations with microporous membranes. Pharmacopeial Forum, 30(5), 1903-1910. 

United States Pharmacopeial Convention, Inc., July 1988, In Vitro-In Vivo Correlation for Extended Release Oral Dosage Forms, Pharmacopeial Forum Stimuli Article, 4160-4161. 

Shah, V. P... 1. S. Elkins, and R. L. Williams, In Vitro Drug Release Measurement of Topical Glucocorticoid Creams." Pharmacopeial Forum, 19, 5048-5059, 1993. 

As part of the international harmonization of test methods, a proposed change to the USP <905> content uniformity test has been made [12]. This test is more restrictive than the current USP test, especially as the batch mean deviates from target. It is also more restrictive for capsules, since both the tablets and capsules are required to meet the same requirements. A number of USP Pharmacopeial Forum articles have been written by the Pharmaceutical Manufacturers Association (PhRMA) statistics expert team discussing the proposal and their characteristics. An approved version of the proposal is eventually expected. In anticipation of this happening, appropriate modifications to the CuDAL approach have been determined to evaluate the newly proposed test. 

Pharmacopeial Forum, Harmonization, General Chapter <905> Uniformity of Dosage Units. Pharm Forum 2001, May-June, 27 3) 2615—2619. 

Current concepts for the validation of compendial assays, Pharmacopeial Forum, 1241 (1986). 

R. J. Darnowski, Quantitative chromatographic system suitability tests revisited, Pharmacopeial Forum, 941 (1985). 

Uniformity of unit spray content, Pharmacopeial Forum, 73 3163 (1992). 

R. E. Graham and M. J. Uribe, Compendial monograph evaluation and development — prednisone, Pharmacopeial Forum, 1-2 2656(1983). 

W. F. Beyer, HPLC Assay for intact estrogenic sodium sulfate conjugates in bulk drug and tablets, Pharmacopeial Forum, 5-6 1955 (1991). 

M. J. Walters, Compendial monograph evaluation and develops ment Hydrocortisone, Pharmacopeial Forum, 5-4 2798 (1983). ... 

Comparison of three test methods for suppostories, Pharmacopeial Forum, 9/10 2427 (1991). 

D. M. Pearce, Critique of a proposal to use a common column and common mobile phase for USP high-performance liquid chromatographic steroid analyses in the normal-phase mode, Pharmacopeial Forum, 4821 (1984). 

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