Quality Assurance / Quality Control
Recent high-impact research published in the Journal of the American Medical Association shows that most of the Nootropics products currently available online are either incorrectly labelled or low in purity.
In contrast, Umbrella Labs has implemented strict QA/QC protocols to ensure maximum purity of all our products. We employ industry-leading High Performance Liquid Chromatography and Liquid/Gas Chromatography-Mass Spectrometry in our manufacturing pipeline, and routine analyses are conducted in a CLIA environment using a flexible range of Thermo Scientific and Agilent modalities:
- 3D trap LC-MS (https://www.youtube.com/watch?v=zJagpUbnv-Y)
- Triple quadrupole GC-MS
- Linear ion trap LC-MS
- ESI and APCI ion sources
- UV detectors
- Nanoflow LC
Traditionally, chemical purity was determined using HPLC and UV detection. Unfortunately HPLC used in isolation can suffer from lack of sensitivity and specificity, which can lead to structural ambiguity. Today, the best way of performing mass spec quantitation is by using a mass spectrometer capable of MS/MS fragmentation, and this is commonly accomplished with a triple quadrupole or ion trap mass spectrometer. The reason MS/MS is required is because many compounds have the same intact mass. While many researchers use the first dimension of MS to perform quantitation, that technique again suffers from lack of specificity. The second dimension of MS fragmentation in the majority of cases resolves any ambiguity. The combination of specific parent mass and unique fragment ions is used to accurately interpret, annotate, and quantify the purity of virtually any compound.
Unfortunately for research scientists in academia and R&D, most manufacturers of Nootropics—including many large, multinational chemical companies—limit their analyses to HPLC-UV in order to save time and money on quality control. Take a look at their Certificates of Analysis and see for yourself…
At Umbrella Labs, however, we don’t take shortcuts.
By harnessing new-generation mass spectrometry analysis, we can augment our purity assessments by enhancing sensitivity and adding a new dimension of measurement. Without question, our LC/MS-MS approach offers better quality assurance and control than conventional HPLC-UV alone. This is especially crucial for analysis of Nootropics, many of which exist as diastereomeric mixtures. Quantitative resolution of these mixtures demands highly sensitive instrumentation, such as our triple-quadrupole spectrometer.
Purity assessment with LC/MS involves:
- Sample purity via measurement of peak area percentage of the target component.
- Target component identity confirmation with MS using isotope pattern, molecular ion, and adduct ions.
- Peak purity confirmation using 3D UV and MS data.
Method development, data acquisition/processing and report generation are performed using fully-licensed, comprehensive chromatography system software in order to comply with regulatory data integrity requirements.