NEWS & EVENTS

Stability: Top Testing Factors You Should Consider

Stability testing is a fundamental part of the drug development process— upholding the quality of active pharmaceutical ingredients (APIs) and drug products while also providing an accurate shelf life. Through stability testing, pharmaceutical companies are able to determine the most suitable packaging and/or container closure system for the storage and distribution of drug products.

“Stability storage and testing plays a big part in the drug development process from research and development up to commercialization and beyond,” said Alcami Senior Manager of Stability Services, Scott Jedrey. “Testing throughout each phase, whether it is physical or chemical, allows data to be gathered, trended, and reviewed. Based on the data, decisions are made on whether to move forward to the next phase, which includes more testing and more patients in several clinical trials. The product must possess the purity, potency, and safety throughout each phase of the drug development process in order to obtain that very important agency approval.”

Topics: Stability Analytical Testing Blogs

Editorial: Stability Testing Ensures Proper Packaging for Drug Storage

Alcami recently contributed to an article featured in BioPharm International titled "Stability Testing Ensures Proper Packaging for Drug Storage." 

Stability testing is essential for maintaining the integrity and quality of biopharmaceuticals and for assessing an accurate shelf-life. It is an important aspect of quality control and is an important step in evaluating product safety and efficacy. It is also important for examining how critical quality attributes (CQAs) of a drug substance vary with time under different environmental factors.

Topics: Stability Editorials

Stability: Back to the Basics - Part V

Part V: The Summation of Stability and Quality Attributes

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.

The final post in this series examines the summation of stability’s role in the drug formulation process. From molecule discovery through product release to market, quality attributes are carefully analyzed to support product success and protect patients.

In the first step of the drug formulation process, drug discovery or the non-clinical phase, researchers investigate new understandings about a disease and design a product to stop or reverse its effects. Advanced technologies are explored, often to either target drug substances/active pharmaceutical ingredients (APIs) to specific locations within the body or to manipulate genetic material. During this phase, extensive research and development on how the finished product will be formulated also occurs.

Topics: Stability Blogs

Stability: Back to the Basics - Part IV

Part IV: Stability and the Importance of Storage Conditions

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.


After expounding on the importance of efficacy and degradation in the previous blog, this fourth edition of the stability series will answer the most common questions people have about storing medicines and explain how storage plays a direct role on a product’s efficacy, along with which studies are used to measure efficacy.

Is it necessary to read the storage conditions listed on the label? Could where I keep my medicine damage it?

Yes! How medicine is stored influences its efficacy and safety. Remember to always follow the recommended storage conditions for the best use of a finished pharmaceutical product.

Topics: Stability Blogs

Stability: Back to the Basics - Part III

Part III: Measuring Shelf Life— Product Efficacy of API and Finished Drug Products

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.

The Federal Drug and Food Administration (FDA) states that “Stability studies should include testing of those attributes of the active substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The justification of individual and total upper limits for degradation products should be based on safety and/or efficacy consideration.”

Safety, quality and product efficacy work together in stability studies of Active Pharmaceutical Ingredients (APIs) and finished drug products. Through stability testing, pharmaceutical companies like Alcami have the ability to identify and trend shelf life and their affects on efficacy as samples are exposed to time, light and temperature.

Topics: Stability Blogs

Stability: Back to the Basics - Part II

Part II: The Impact of Stability on the Safety of API and Drug Products

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.

Can you answer any of these questions?
- Exactly how safe are your drugs?
- Do you know the active ingredients in the pills that you are taking?
- What is the purpose of your medication?

Let’s be honest. Most people take these questions for granted. One quality attribute that all companies in the pharmaceutical fields strive for is the safety of drug products.

Topics: Stability Blogs

Stability: Back to the Basics - Part I

Part I: The Importance of Stability in the Evaluation of Quality Attributes of Pharmaceutical Drug Products

In this five-part blog series, Alcami subject matter experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals, beginning with quality attributes.

Exactly how important is stability testing in the life of the active pharmaceutical ingredient (API) or drug product?

The quality attributes that everyone strives for are safety, product efficacy and integrity, appropriate storage conditions, and shelf life.

Topics: Stability Blogs

In-Use Stability Testing: Providing the Right Instructions

In the WHO Technical Report Series, No. 953, 2009 Annex 2 Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products section 2.2.10, In-use Stability Testing is defined as:

“The purpose of in-use stability testing is to provide information for the labelling on the preparation, storage conditions and utilization period of multi-dose products after opening, reconstitution or dilution of a solution, e.g. an antibiotic injection supplied as a powder for reconstitution.” 

Like many guidance statements, it appears simple enough to understand, but then reality sets in.  How can a laboratory study be designed to execute potential real world uses of a product for a hospital or clinic?  How many lots of product are needed to meet expectations of the regulatory authorities?  Which batch(es) should be used in the in-use stability testing studies?  What analytical testing should be performed and at what time points should the testing be performed? 

Topics: Stability Blogs

Bringing the Light to Photostability in Three Parts - Part Three

Part 1: Basic Requirements – Setting the Stage

Part 2: Forced Degradation Studies to Support Photostability

Part 3: The Protocol Generation - Execution and Reporting of a Photostability Study

In this third and final section of our photostability series, the protocol design, execution, and reporting of the confirmatory photostability for API and pharmaceutical products will be discussed.  ICH guidance Q1B presents a straight-forward flowchart that initiates with the direct exposure of the dosage form. To initiate a study, a protocol should be written based on the steps outlined in the flowchart. However, not every step in the flowchart is needed. 

At this point in product development, it is very likely that the photo-sensitivity of the API is known. If the API is photo-labile, a prudent step would be to write the protocol to direct exposure of product and exposure of the product in its immediate packaging would occur simultaneously. Not only would this save time, but would demonstrate the effect of the immediate pack has in protecting the product from photo-degradation. On the other hand, if the API is photo-inert, the direct exposure of the product may be the only exposure required. As stated in the guidance, each exposed foil-wrapped dark control sample should be exposed and tested. 

Topics: Stability Blogs

Bringing the Light to Photostability in Three Parts - Part Two

Part II: Forced Degradation Studies to Support Photostability  

In Part One of this photostability blog series, a high level review on the background of photostability was presented.  In this second part, work leading up to the execution of a photostability study on Active Pharmaceutical Ingredient (API) and pharmaceutical products will be discussed. 

Prior to execution of a photostability study, the analytical test procedures (TP) must demonstrate the ability to detect degradants caused by photolysis (photodegradation).  Not all compounds are susceptible to photolysis; a molecule must absorb the UV or visible light energy to be susceptible to this phenomenon.  For example, if the absorption spectrum of a molecule has a maximum of ~254 nm and with minimal or no absorption above 300 nm, this molecule would not be susceptible to photodegradation during an ICH photostability study as the lowest wavelength of exposure is ~320 nm. 

Topics: Stability Blogs