ICH Stability Testing

ICH stability testing for pharmaceutical drug substances or drug products with efficient study management, standard or bespoke storage conditions to meet your real-time, accelerated or forced degradation stability study requirements

ICH stability testing is an essential part of drug product development, in particular, supporting IND/NDA submission activities. Drug stability testing allows evaluation of active pharmaceutical ingredient (API) stability or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.

Selecting an experienced stability study service partner who offers efficient study management, flexible storage conditions and testing capabilities which satisfy all regulatory criteria for your real-time stability testing, long-term, intermediate, accelerated stability studies, forced-degradation, photo-stability, in use or follow-up stability testing trial requirements is key to success. Stability testing can present significant analytical hurdles and specialised knowledge is required to develop and validate stability indicating methods and perform analysis of leachable substances which migrate from pharmaceutical packaging into the product.

With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of ich stability zones including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability storage conditions. These are fully controlled and monitored with back up chambers at each site. All ICH stability testing sites have 24-hour alarm systems with dedicated on call teams to react to the excursions from storage conditions. Our stability teams provide professionally managed Good Manufacturing Practice (cGMP) ICH stability studies conducted according to ICH stability guidelines such as ICH Q1A (R2). We are experienced across all dosage forms product types such as orally inhaled and nasal drug products (OINDP), biopharmaceuticals, consumer healthcare, medical devices or vaccines. We also offer stability storage outsourcing and stability contingency storage services to help you mitigate risks associated with costly stability trials.

GMP Stability Services:

cGMP registration stability programs
ICH stability protocol design and program management
Development and validation of stability indicating methods
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, clinical trial materials, formulated products
Tailored reporting (timepoint and final reports)
Temperature cycling, freeze-thaw study and shipping studies
Stability contingency storage
Stability storage outsourcing
Forced degradation testing
Real time stability testing
Long term stability testing
Intermediate stability testing
Accelerated stability testing
In use stability testing
Follow-up stability trials
Formulation stability testing
Biologics stability studies
Specialist expertise for OINDP stability programs
Extractables / leachables

ICH Stability Storage Conditions

We have an extensive range of ICH stability storage conditions spanning the ICH climatic zones and also bespoke storage capabilities:

21ºC / 45% RH
25ºC / 40% RH
25ºC / 60% RH
30ºC / 25% RH
30ºC / 35% RH
30ºC / 65% RH
30ºC / 75% RH
40ºC / 75% RH
40ºC / NMT 25%RH
Cabinets 50 ºC, 57 ºC, 60 ºC
Storage at 2-8ºC
ULT storage -20ºC, -40ºC, -80ºC
ICH Photostability (ICH Q1B Photostability Options 1 & 2)
Specialised conditions
Freeze/thaw temperature cycling tests

Stability Testing of Pharmaceutical Products
Stability testing can present significant analytical hurdles and specialised knowledge is required to develop and validate stability indicating assay methods and perform analysis of leachable substances which migrate from pharmaceutical packaging into the product. Following ICH stability testing guidelines, our analytical laboratory network provides development and validation of stability-indicating methods utilizing a range of technologies to identify and quantify degradation products. Routine time point testing includes the usual tests such as assay and impurity analysis, dissolution, moisture, hardness, friability and disintegration. Intertek’s scientists have specialist expertise in OINDP testing for stability including particle or droplet size to provide data to drive understanding of the delivered formulation and delivery of the drug from the inhalation device. Our know-how in extractables and leachables studies means that we can ensure that the product container/packaging system demonstrates sufficient stability over the relevant lifecycle of your product.

Your Pharmaceutical Stability Program Partner
With nearly 30 years’ experience in conducting stability studies integrated with a comprehensive understanding of the latest developments in regional, country and ICH guidelines for stability studies, we offer a truly flexible stability outsourcing partnership. With integrated storage and testing capability, our expertise allows you to focus on your core business objectives. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards for your pharmaceutical products.