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Stability Storage
Stability Testing
QC Release
Method Development
Product Characterisation
Impurity Identification
Process and Cleaning
Pre-formulation Chemistry

Solid Dose
Liquid Dose
Inhaled Products
Biopharmaceuticals
APIs
Veterinary
Other Tests

Chromatography
Spectroscopy
Electrophoresis
Immunological Tests
Performance Tests
Wet Chemistry
Physicochemical
Microbiological
Mass Spectrometry

Contract Types
Project Initiation
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Services Provided

Stability Testing

NDA Analytics has more than 20 years' experience in stability testing and undertakes stability testing to provide data throughout a product's development life cycle and beyond. We can also provide expert advice and guidance to help you tailor your stability programme to meet the requirements of the appropriate regulations for your particular product.

Stability Trials for product licence applications (NDA & MAA)

ICH Q1A covers drug substances and products. ICH Q5C covers biotechnology and biological substances and products. The guidelines define the requirements for long-term and accelerated stability studies in support of product licence applications (NDA & MAA), defining the conditions, duration, number of batches, selection of batches, testing frequency, specification and evaluation. Annexes address declaration of storage conditions, sterile/multi-use product testing and bracketing and matrixing. NDA Analytics can provide storage stability studies at the ICH conditions and at WHO and customer-specific conditions.

For biotechnology and biological products and others with non-25/60 recommended storage (e.g. 4°C and frozen), different stability storage conditions, analogous to those specified in the main ICH guideline, must be defined. In addition, cycling (e.g. freeze-thaw) studies may be appropriate in some cases (e.g. inhalers). NDA analytics can work with a customer to develop a suitable protocol.

The ICH guidelines cover submissions for the US, Europe and Japan. For other markets and world-wide submissions, WHO stability storage conditions may be necessary and NDA Analytics can provide storage at conditions (e.g. 30/70 and 30/65) necessary to fulfil these requirements. With the release of the revised ICH Q1A guideline and support from other authorities, the 30/65 condition may now replace the 30/60 and 30/70 conditions, reducing the number of conditions needed to gain acceptance world-wide.

Photostability Testing

ICH Q1B defines the light characteristics (spectrum) for photostability testing. There are two options and NDA Analytics uses option 2, a cool white fluorescent light and a near UV light (exposure to each is consecutive). The guideline also describes the process for determining if a material is light-sensitive, the ability of the pack to protect it and the exposure (in terms of total flux) required for confirmatory photostability studies.

Photostability testing may be required at several points in the development cycle, i.e. to develop and validate methods of analysis, to stress a material and identify degradates, to develop formulations/packaging and, if a material is shown to be light-sensitive and will be exposed to light in use/storage, to evaluate shelf-life (i.e. confirmatory studies).

Stability trials for clinical trials applications (IND & CTA)

In general for CTA and IND (phase I/II), stability studies should demonstrate that the investigational material remains within acceptable limits for the duration of the trial. The extent of stability testing at this stage will depend upon information gathered to date and the toxicology aspects and should be defined on a case-specific basis. NDA Analytics can work with a sponsor to develop a suitable protocol.

Accelerated stability trials for formulation development/compatibility studies

NDA Analytics can undertake storage and analysis of materials/products at accelerated conditions, e.g. high temperature and humidity, to screen candidate formulations and evaluate compatibility with containers/packaging, thus enabling speedy evaluation and selection of formulation candidates for further development.

Post-approval stability trials

The ICH guidelines require that the first three batches of a material, manufactured after approval, are put on a stability testing programme to the same protocol as the batches for the approved drug application. In addition, annual batches may be necessary.

New dosage form stability trials

ICH Q1C covers the stability data needed for different dosage types containing an active ingredient from an already-licensed product. Essentially this guideline follows the parent guideline (ICH Q1A or ICH Q5C), but with reduced data at submission.