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 Sphere Healthcare offers complete stability testing of all commercial products.
Stability trials are essential to determine the conformity to specification or label claim throughout the 'Shelf Life' of the product, and now the TGA are requesting sponsors to have evidence that their product is stable over the shelf life. To support all Sphere’s valued customers, Sphere has established state of the art Stability rooms, and can tailor a stability program and develop a protocol to suit your needs or store and analyze samples according to your program. These ovens are designed for long term stability, accelerated stability, and determining stability of products permeable to moisture. The stability program can cater for: - Analysis of vitamins and herbs by HPLC.
- Analysis of oils by Gas Chromatography.
- Analysis of minerals by Atomic Absorption Spectrophotometry.
- Herbal fingerprinting by HPTLC with digital photographic imaging.
- Microbiological analysis.
- Method development and Method validation.
- Physical testing, dissolution, viscosity, p-anisadine value, etc
Basic service
With your stability protocol listing your requirements we will store your products in our ICH stability ovens and analyze them and submit test results for each time interval. Add on services- Design a stability protocol to suit your needs compliant with TGA standards. This can vary from long term stability trials to accelerated stability trials.
- Provide a detailed report at each time point interpreting results and trends and make recommendations for your product.
- Develop stability indicating test methods to TGA standards to use in testing your product.
- Validate test methods to TGA guidelines.
- The advantage of Sphere is that it has experience not just in analysis but by being involved in the product development, manufacture, validation, and regulation of complementary medicines, gives Sphere superior knowledge into the understanding of complementary products and their stability.
For a quote or further information, please contact: Parthiv Mehta, Compliance & Stability Manager direct: 02 9733 4553 or customer service.
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