Quality Control and Analytical Methodology
In addition to our vertically integrated control of the whole process, each batch of POMELLA® Extract must undergo rigorous analyses in-house and at independent labs, as detailed on our product and manufacturing specifications. Selected analyses follow:
In addition to our vertically integrated control of the whole process, each batch of POMELLA® Extract must undergo rigorous analyses in-house and at independent labs, as detailed on our product and manufacturing specifications. Selected analyses follow:
- Multiple standardization fingerprint of several polyphenolic compounds, particularly punicalagins, using validated HPLC methodology and purified, validated standards
- Non-specific colorimetric methods such as UV
- Impurities performed by USP and other recognized pharmacopoeial methodologies
- Enhanced battery of physico-chemical analyses performed at multiple labs
We have a saying that goes, “The product is only as good as the methodology used to analyze it.” Because without appropriate methodology, how do we know our product meets rigorous specifications? This is why we we use the recognized, repeatable methods that are published in peer-reviewed literature, and the most advanced instruments including:
- Atomic absorption spectroscopy (AAS), inductively coupled plasma-mass spectrometry (ICP/MS), gas chromatography/mass spectrometry (GC/MS), high-performance liquid chromatography (HPLC) and High Performance Thin Layer Chromatography for impurities
- HPLC and HPTLC for identity and purity, in addition to other non-specific colorimetric methods such as UV-Vis spectrometry
- Liquid Chromatography/Mass Spectrometry (LC/MS or LC/MS/MS) for trace compounds and pharmacokinetic analyses
- Bioactivity analyses using cell cultures and detection methods such as enzyme-linked immunoassays, polymerase chain reaction (PCR) techniques, and immunofluorescence imaging
- Clinical endpoint analyses using imaging tools such as positron emission tomography and magnetic resonance imaging
