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ASI provides support to manufacturers and distributors of nutraceuticals and dietary supplements. ASI uses more than 100 established methods for testing frequently used active ingredients in nutraceutical samples. These methods are designed for:
- Content / Potency determinations for organic, mineral and metal ingredients
- Identity confirmation of active ingredients and complex mixtures (such as botanical extracts)
- Release rate tests for active ingredients from formulated products
- Analysis of stability samples
For more information regarding the analytical techniques used for testing click here.
The established methods available have been used routinely over time, often for various types of products. For a new product, ASI initially attempts to analyze the product using established methods. For a list of the compounds for which established methods are available click here.
The standard turn-around time for analyses using established methods is 5 days. Shorter turn-around may be possible for an additional fee. Results are reported in a standard ASI format.
Method Validation
The established methods listed have not been formally validated. ASI can provide method validation services for specific products upon request. ASI provides method development services with emphasis on high-performance liquid chromatography (HPLC) ASI can provide SLV (Single Laboratory Validation) or can initiate or participate in MLV (Multi-Laboratory Collaborative Validation) studies. Method validation studies are performed according to USP and AOAC guidelines. For more information regarding method validation click here, or contact ASI.
Method Development
If no established method is available that is suitable for the testing required, ASI is able to provide method development services to customize a method for a specific product. After a suitable method has been developed, the resulting product-specific method will be used for routine testing or development support for that product only. ASI will use a method developed for a specific product for only analyses requested by the client who funded the method development work.
FDA GMP Compliance
Because compliance with FDA Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) is a critical part of performing analytical and bioanalytical testing for pharmaceutical and biotech clients, ASI has been performing GLP- and GMP-compliant analyses since being founded. For additional information regarding GMP Compliance for nutraceutical testing click here, or contact ASI.
Testing of nutraceutical samples may be used to support:
Product Development through
- Preformulation studies
- Solubility testing
- Excipient/vehicle compatibility
- Drug delivery method testing
- Cleaning method development and validation
- Assay/impurities method development and validation
- Product performance testing, including comparisons of various formulations
- Product performance test method development and validation
- Stability testing
Manufacturing through
- Raw materials testing
- In-process-testing
- Release testing
- Stability testing
- Cleaning validation testing
Distribution through
- Confirmation of identification testing
- Release/Re-release testing
- Stability testing
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