White paper on Stability Studies Published in LCGC
Michael Dong
Subject matter expert in HPLC, CMC, and pharm analysis. PhD in analytical chemistry. Author of bestseller HPLC book and 130 articles.
This white paper on stability studies was just published in LCGC North America’s June issue. Here is the reference, a link to download the entire June Issue, and the Abstract/Introduction of the article.
, Stability Studies and Testing of Pharmaceuticals: An Overview, LCGC North Am. 38(6), 325-336, 2020.
To download the paper just follow the link.
or send me a request.
Stability Studies and Testing of Pharmaceuticals: An Overview
K. Huynh-Ba and M. W. Dong
If you're in pharmaceutical development and spend anything in stability studies and testing, don't miss this upcoming article in LCGC North American to be published near June 10, 2020 – a single white paper on this mundane and very important subject.
Kim Huynh-Ba and I have spent 100+ hours each in this challenging writing project to provide a single white paper to overview studies and testing for analytical chemists. Whether you are a novice or an experienced practitioner, you are likely to find something useful in this first overview installment on stability testing – such as regulatory expectation, best practice in the workflow, modern tools and software, science- and risk-based approaches, time-saving strategies, and forced degradation studies.
White paper #2 and #3 will be on method development and validation of stability-indicating analytical procedure. I will broadcast in early June when the article is printed and ready for a free download. Or you can just contact me for me to send you a pdf file for your record of the three paper series on stability.
Here is the abstract and introduction to the white paper.
Stability Studies and Testing of Pharmaceuticals: An Overview
Kim Huynh-Ba and Michael W. Dong
ABSTRACT
This installment is the first of a series of three white papers on stability studies and testing of pharmaceuticals, and the development and validation of stability-indicating HPLC methods. The series is co-authored by Kim Huynh-Ba, a subject matter expert on stability testing and regulatory compliance, and Michael Dong, the columnist on “Perspectives in Modern HPLC.” The first installment provides a comprehensive and updated overview of stability studies and testing of small molecule drugs, current regulatory requirements, and industry practices for forced degradation, as well as possible approaches for reduced testing and data evaluation to expedite stability study timelines.
introduction
Determining the product shelf life is a regulatory requirement for pharmaceuticals and many other regulated consumer products on the market. The shelf life of life-saving medicines is set following more stringent rules where efficient applications of stability science are critical. Stability studies and testing are used to determine the shelf life of medicinal products, providing the length of time and storage conditions that the medicines can be safely used and stored by patients. The shelf life (expiration dating or expiry) is displayed on labels of pharmaceutical products to assure the integrity, quality, and potency of the product when used within that time period. Shelf lives are established using data that are generated to verify the label claim and approved by the regulatory agencies. An expiration date is required by regional laws to ensure the safety, efficacy, and quality of the drug products, and that these criteria are maintained throughout the labeled shelf life of the pharmaceutical product.
Most companies have established standard operating procedures (SOPs) to supplement regulatory guidelines to provide more specific details so that the studies are more appropriate for their product types. Nevertheless, stability programs and their practices can vary widely, particularly between large and small pharmaceutical companies, often due to the depth of knowledge and available resources. The primary aim of this paper is to increase the understanding of the science, best practices, and regulatory expectations of stability programs.
The stability profile, a critical quality attribute (CQA) of a pharmaceutical entity, is based primarily on the physicochemical properties of the drug substance (DS) and drug product (DP). The DS is the active pharmaceutical ingredient (API), with small amounts of allowable impurities and degradation products. A DP typically contains a single DS; when the DP formulation has more than one DS, it is referred to as a combination product. For example, many over-the-counter (OTC) products contain multiple active ingredients. For small-molecule orally-delivered DP such as tablets or capsules, a typical expiration period is two to five years under room temperature storage. Table 1 summarizes the characteristics of stability studies and testing. Each will be discussed further in this paper.
Posted by Michael Dong on 6/16/2020 after the web edition of LCGC June issue was published.
Congrats