Stability by Design - Live Online Training - Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

Stability by Design - Live Online Training

Course No 20367

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager". Learn more.

All times mentioned are CET.


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Dr Raphael Bar, BR Consulting, formerly with Teva, Israel
Dr Helmut Buschmann, AiCuris, Germany and RD&C, Vienna
Dr Norbert Handler, RD&C, Vienna


Forced degradations are the basis for development of analytical methods, for drug formulation development, for understanding the degradation mechanisms and for predicting the stability behavior of active ingredient and drug product. Stress testing is the basis for predicting the stability behavior during storage, shipping and distribution of active ingredient and marketed drug product. Both forced degradation and stress testing are regulatory requirements.


After an overview of the basic chemistry of the common degradation reactions, this course will teach you how they are practiced in the pharmaceutical industry, and how you can carry them out on your own, while ensuring that all degradation products are chromatographically detected and subjected to a mass balance.

Among the topics to be discussed will be:
  • An overview of the basic chemistry of the degradation reactions
  • Common practices of forced degradations in the pharmaceutical Industry
  • Practical aspects in carrying out forced degradation studies
  • How to ensure that all degradation products are detected
  • Set up a mass balance in degraded samples with guided exercises (A hand-held calculator is required!)
  • Comparing degradation rates to estimate impact of a process change on the drug Quality
  • Performing stability studies to support shipping/Distribution of medicines
  • Investigating an excursion from a label storage condition

Target Group

Personnel from the following departments will highly benefit from this course: ƒ
  • Stability Personnel ƒ
  • Analytical R&D ƒ
  • Quality Control Formulation Development ƒ
  • Quality Assurance and RA ƒ
  • CROs offering analytical services 
  • Qualified Persons (QP)

Technical Requirements

We use Webex for our live online training courses and webinars. At training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.


What is Stress Testing and what are Forced Degradations – Regulatory View
  • Regulations (ICH, EU and USFDA)
  • Chemical stress of drug substance and product
  • Physical stress of excipients and active pharmaceutical ingredient
  • Is a forced degradation study a GMP study?
  • Purposes of stress testing:
    a. development of stability-indicating Methods
    b. optimization of a formulation (API-Excipients compatibility study)
    c. Prediction of stability behavior (accelerated testing of pharmaceuticals)
    d. Evaluation of temperature excursions during shipment/distribution
Common Degradation Reactions of APIs and Excipients
  • Reactivity of common chemical functional Groups
  • Major mechanisms of chemical Degradation
  • Hydrolysis (alkaline, acidic)
  • Oxidation (Autoxidation, peroxide and metal-mediated)
  • Photolysis
  • Case studies for APIs and excipients
Forced Degradation Studies in the Pharmaceutical Industry
  • Common practices of forced degradations
  • Examples of forced degradations studies
  • Is there a general methodology for chemical stress?
How to Ensure Chromatographic Detection of all Degradation Products
  • Ensuring chromatographic elution of all Degradation products (Gradient mode, varying mobile phase solvents; various modes of chromatography)
  • Detecting all degradation products (LC-PDA, LC-MS, universal detector)
  • Techniques to confirm undetected degradation products (Flow injection analysis, UV spectrophotometric analysis)
  • Determining peak purity by LC-PDA (spectral and matching homogeneity)
Presentation and Workshop on Photostability of a Drug Product under Manufacturing Conditions

Design of Forced Degradation Studies/Experimental Units of Stress Testing
  • Heat (with and w/o humidity)
  • Acid and base
  • Oxidation
  • Mechanical stress factors (e.g. grinding, milling …)
Impurities and Degradation Products Resulting from Reactive APIs, Excipients and their Impurities
  • Reactivity of common chemical functional Groups
  • Major mechanisms of chemical Degradation
  • Hydrolysis (alkaline, acidic)
  • Oxidation (Autoxidation, peroxide and metal-mediated)
  • Photolysis
  • Case studies for excipients
Mass Balance in Degraded Samples of Pharmaceuticals
  • Definition and equations for mass balance
  • Determination from chromatographic analysis of degraded samples
  • Correction of mass balance for response factor
  • Correction of mass balance for molecular weights
  • Exercises of mass balance calculations
Workshop on Mass Balance

Compatibility Studies (Excipient/APIs)
  • Studies for Excipient/APIs
Workshop on Interaction and Incompatibilities
  • Part 1: Drug substance
  • Part 2: Drug product
Reactions and Forced Degradations in Solid State – Innovative Approach
  • Differences liquid phase – solid state
  • Reactions and degradation in solid state
  • Kinetics
  • Alternative approach to mimic and predict solid state degradation
Comparative Accelerated Degradation Rates
  • A quality control tool of pharmaceutical products – monitoring process changes
  • A development tool for optimizing drug formulations – Excipients-API compatibility studies
Mean Kinetic Temperature: Uses and Misuses
  • Mean Kinetic Temperature (MKT) and relative humidity
  • Interpretation of MKT
  • Temperature profile of a shipment of medicines
  • Global climatic zones by ICH and WHO
Thermal Stress Studies to Support Shipping/Distribution
  • Studies at elevated extreme temperatures
  • Studies at low extreme conditions
  • When, how and what?
  • Cyclic studies to support shipping/distribution

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