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
Personnel from the following departments will highly benefit from this course:
Quality Control Formulation Development
Quality Assurance and RA
CROs offering analytical services
Qualified Persons (QP)
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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)
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)
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023