New methods, adapted methods and validation for products that don’t fit a standard test
A lot of products don’t fit a published method. A new peptide, a blend of botanicals, an active in a thick cream, a gummy, an oil or a powder with an unusual excipient can all throw off a standard test. We develop methods for these products on HPLC, LC-MS/MS, high-resolution LC-MS, GC-MS and ICP-MS, validate them, and then use them for your routine testing or hand them over to your own lab.
Projects are quoted to the work.
A new method for an analyte or matrix with no published method, or a published method that doesn’t work on your product.
Validation to ICH Q2 and USP 1225: specificity, linearity, range, accuracy, precision, detection and quantitation limits, and robustness.
Showing that a USP or other compendial method works on your product, as USP 1226 describes.
Methods proven by forced degradation to separate the active from its breakdown products. See pharmaceutical stability testing.
Extraction and cleanup for gummies, softgels, creams, oils, chocolate, high-sugar and high-fat products, and other samples that interfere with a standard method.
Moving a validated method to or from your lab or another lab, with a transfer protocol and comparison data.
Products with several actives can be harder than any single one. Peaks can overlap, one ingredient can suppress another’s signal, and excipients can show up where an active should be. We work out separation and detection for each analyte, and when HPLC alone can’t tell two compounds apart, mass spectrometry usually can.
Analyte, matrix, range, limits and what the results will be used for.
Quick trials to pick the instrument, column and sample preparation.
The method is optimized on your product.
The tests and acceptance criteria, agreed with you before validation starts.
All of the data against the protocol.
We test your batches with the method, or transfer it to your lab.
Validation proves a new or changed method works for its purpose. Verification shows that an already validated method, such as a USP method, works on your product in our lab.
Verifying a compendial method usually takes a few weeks. Developing and fully validating a new method takes longer and depends on the analyte and matrix. We give you a timeline with the quote.
Methods developed for your product and paid for by you are yours. We can write them up as an SOP and transfer them to your lab or another lab.
Yes, if the instrument is the same type. Differences in equipment are handled in the transfer protocol.
Yes. Matrix interference and the wrong sample preparation are common causes. We can look at the method and the product and find out whether the result is real.
Tell us what you need to measure and in what, and we’ll send back a quote. You can also email [email protected].
