Quality Control is at the heart of Bio-Botanica. Each and every product is subjected to a number of rigorous quality control tests everyday. Products that we manufacture must match specifications such as refraction, melting point, pH, specfic gravity, density and water levels.
Bio-Botanica incorporates highly sophisticated and analytical equipment such as High Performance Liquid Chromatography (HPLC), Infrared Spectrometer (IR), Ultra Violet Sepctromenter (UV), Gas Chromatography and Total Organic Carbon Analyzer. (TOC).
TOC allows us to check our water for any contamination, chemical or microbiological down to parts per billion. This ensures that the water we use in production is pure and free of any undesirable contaminants. TOC is the only FDA recognized method for United States Pharmacopeia (USP) Grade water testing.
Finally, the QC Department has a fully equipped
Microbiological-testing laboratory, which follows the appropriate testing methods as defined by the U.S. Pharmacopeia (USP). The microbiological laboratory is used to fully test all botanical extracts for any micro-activity. This guarantees a botanical extract free of any unwanted and potentially unhealthy microorganisms.
High Performance Liquid Chromatography (HPLC)
HPLC is used to accurately separate and measure components (constituents) in a mixture (extract) when compared to a retained standard. We can, for example, determine accurately the level of Resveratrol (constituent) present in our Muscadine Grape Extract by HPLC testing, ensuring that we are meeting consistent levels of a specific constituent or constituents time after time by employing specific production procedures. A Micromass Spectrometer is used in conjunction with the HPLC to analyze non-volatile constituents.
Gas Chromatograph (GC)
GC uses the same principles as HPLC except that it is used to analyze volatile constituents. GC uses a carrier gas instead of eluting liquid. Substances to be analyzed can be easily turned into gas and then determined. One example of a volatile constituent is alliin, found in garlic. Our GC is coupled with a Mass Spectrometer, which allows us to compare samples to a library of over 134,000 spectra standards for positive identification of unknown constituents. GC detects various volatile constituents in herbal products (ie. pesticide residues, fragrances, essential oils, contaminants); also used to measure alcohol level in a fluid extract. Useful tool for producing “profiles” or “fingerprints” of fixed oils, such as Saw Palmetto Oil, as well as volatile essential oils such as Peppermint.
Dual Wavelength Flying Spot Scanning Densitometer
Equipment used to detect and semi quantify constituents.
Infrared Spectrometer (IR)
IR measures different types of vibrations (of substituents and bondings in the molecule) in the Infra red region of light. Each substance has a characteristic pattern of vibrations at specific wavelengths, thereby creating a “fingerprint”. This is useful in not only identifying constituents but also their purity. Quantitative measurements can also be done. IR Measurements however, must be performed in absence of any humidity.
Our Microscopy Laboratory contains a group of simple and compound microscopes, digital T.V. camera, computer equipment and software which aid our chemists in the macro and micromorphology of various botanicals:
Atomic Absorption (AA):
AA can detect and quantitate any metallic element (ie. lead, mercury, arsenic, cadmium) which may be present in the herbs and finished products. If toxic metallic elements are present, the herb will be quarantined and rejected. AA coupled with MS is also available for testing multiple elements at the same time.
Karl Fischer Titrator:
Karl Fischer Titration instrument determines the amount of water present in a sample. Conventional methods for determining water are to simply dry an herbal sample in an oven (105°C) for a set amount of time. This method is not very accurate because it measures a total weight loss and is not exclusive for water. Alcohol, Volatile oils and decomposition products, for example, could all be lost under heat and measured as a weight loss. Karl Fisher reactions are specific for only water. Bio-Botanica’s unit is fully automated and can calculate with great accuracy any traces of water. This is important as many herbs contain vital volatile constituents.
Total Organic Carbon Analyzer (TOC):
TOC monitors the quality of Purified Water used in all of our products. Water samples are taken daily. The total carbon in the water should be less than 500 parts per billion. If there is carbon present in the water above this level, it would suggest the presence of chemicals or microorganisms which can be found in deionized water as well as reversed osmosis water. Our ultra purified water used in Bio-Botanica’s products meets or exceeds the U.S.P. standards for pharmaceutical quality water.
Ultra Violet/ VisibleSpectrophotometer :
-UV. This instrument measuresabsorption in the UV portion of light. Standards of a known concentration can be measured and then compared to samples of an unknown concentration. In the visible region we can measure colored solutions or make use of chemical reactions, which turn color. The more of the chemical compound of interest, the stronger the color. UV is simple and accurate.
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A calibration curve obeying Becr's law is usually used
- A UV/Visible spectrum of a certain compound may give an indication of the type of compound we are dealing with.
