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Various microorganisms, including molds and bacterial spores, were tested on stainless-steel coupons and demonstrated 2–6 log reductions with one-minute wet-contact times.

A Silver-Based Disinfectant—Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy Evaluations

Helen K. Gerardi is principal scientist at Ashland,

Paul Suszczynski is senior staff scientist at Ashland.

Zachary Digby is staff scientist at Ashland.

Fan Wu is technical director with Ashland.

In this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution. 

Determining Low PPB Levels of Nitrite in Polymeric Excipients

Donald Singer is principle microbiology global consultant at Ecolab Life Sciences.

Tony Cundell is principal consultant at Microbiological Consulting.

The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.

The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical Manufacturing

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

Determination of Shelf-Life from Stability Data: From Replicates or from Averages?

is quality unit lead and technical director, Bristol Myers Squibb, São Paulo, Brazil.

is director CMC Technical Advocacy and Policy, Merck Sharp and Dohme, LLC, Horsham, PA, USA.

is chief pharmaceutical officer, Sanofi Vaccines, Lyon, France.

is quality assurance director, Merck & Co. Inc., Rahway, NJ, USA.

is scientific director, Johnson & Johnson Innovative Medicine, Leiden, The Netherlands.

is head of External Affairs Europe, Amgen (Europe) GmbH, Rotkreuz, Switzerland.

is global SME Quality Advocacy, Vaccines Global Quality, GSK, Wavre, Belgium.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products

Gayatri C.Patel, M.Pharm, PhD, is associate professor in the Department of Pharmaceutics & Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy at the Charotar University of Science and Technology, Changa Campus, Changa- 388 421, Anand, Gujarat, India, gayatripatel.ph@charusat.ac.in, +91 2697 265162.

Divyangi Patel is a research scholar at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa-388421, Gujarat, India.

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.

Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release

Prasanth Sambaraju is an independent researcher based in Hyderabad, India. 

One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability. 

Pooling of Batches for Stability Data Analysis

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors. 

Peer-Reviewed Research