USP Chapter Emphasizes Problems With Revision Process - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

USP Chapter Emphasizes Problems With Revision Process
Inaccuracies in Chapter 91072: of the current USP 29 reveal problems in USP's revision and proofreading process.

Pharmaceutical Technology

Item No. 4: Table 4 lists two germicides that essentially have been banned or restricted since the 1970s: mercuric chloride, an environmental hazard, and hexachlorophene, a toxic antiseptic. The listing of these toxicants, even as informational material, should include a statement of their restricted status, lest someone in the future ascribe USP sanction to these agents. Better examples are available. Furthermore, mercurials are cited as attacking either "-SH groups" or "thiol" groups, but they are both the same. Any compound that contains a functional group consisting of a sulfur and hydrogen atom (R-SH) traditionally is known as mercaptan.

Item No. 5: Chapter ‹1072› in the section entitled "Theoretical Discussion of Disinfectant Activity" presents an intriguing but, in context, useless series of mathematical equations for the purpose of "... picking the use-dilution of different disinfectants." In legal and regulatory terms, the use-dilution is simply what the Environmental Protection Agency allows on the label after a manufacturer provides data or whatever the user decides to use based on in-house experiments with organisms isolated in the plant. Q-10 values, rate constants, and discussions of first-order reactions and linear or sigmoid plots are not required to sanitize, disinfect, or sterilize a pharmaceutical plant.

USP has at its service some of the finest microbiologists and chemists in the world. It has been honored by the scientific, regulatory, and legal communities. These comments on the work of a single chapter are not meant to diminish the classic writing in the chapters about sterility, antibiotics, microbial limits, or any others. We merely point out a series of questionable scientific statements in a USP chapter that reflect a proofreading or revision process that requires adjustment and that, if not corrected, could lead to serious problems in the future. There is an old saying: "What you tolerate becomes your standard." USP must not allow incorrect or misleading statements to become its standard.

Herbert Prince, PhD, is scientific director and founder, and Daniel Prince, PhD,* is president of Gibralter Laboratories, Inc., 122 Fairfield Rd., Fairfield, NJ 07004, tel. 973.227.6882 ext. 519, fax 973.227.0812,

*To whom all correspondence should be addressed.


1. United States Pharmacopeia 29—National Formulary 24, Chapter ‹1072› (US Pharmacopeial Convention, Rockville, MD, 2006).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here