Analytical Method Development – In guiding your product to market, ensuring its contents are accurately measured is of utmost importance. Avazyme experts take pride in developing analytical methods for acquiring the following product data and more:
- Potency – Your product’s ability to elicit a specific response is inseparably tied to its value. We determine assays that will characterize your product, demonstrate its intended effects (e.g., antimicrobials), and be manufacturing-ready. We routinely produce the following potency data: the amount of active ingredient in intermediate manufacturing products, and formulated end-products, as well as criteria for identifying sub-potent batches and ensuring drug product consistency and that the product meets the required specifications (IS/OOS).
- Purity and Impurities – Manufacturing processes can naturally result in the production of substances other than the intended product. Such impurities can come from process contaminants, API and non-active component degradation, leachables, unreacted monomers/oligomers, and oxidized additives. We typically measure less volatile impurities with LC-MS and more volatile impurities with GC-MS, as the absence of a proper mobile phase can allow for a more accurate structural evaluation in some cases. Upon isolating your impurity, we have the capacity to perform further MS, NMR, and ICP or other specialized investigations.
- Degradants – Various stress conditions are deliberately applied to your product for the purpose of estimating the degradants that will occur during stability studies. HPLC is then used to separate product peaks from degradant peaks for quantification. These studies are essential in proposing a shelf life to the FDA.
- Moisture – In food and beverage processing, it is important to know the maximum allowable moisture content for each step in the process, as this information has implications for manufacturing, but also for shelf life and consumer safety. Compounds with functional groups such as amides and esters can be hydrolytically degraded, so moisture content control is quite important. Avazyme determines moisture content primarily using the following three methods: halogen heating moisture analysis, chemical titration, and moisture loss upon freeze-drying.
- Dissolution (coming soon) – All solid product forms require dissolution testing, and product release and stability testing also benefit from dissolution testing. Dissolution testing can also be used to optimize drug release. Avazyme employs United States Pharmacopoeia (USP) dissolution apparatuses 1-7 for technical dissolutions, with 1 and 2 being most commonly used. The USP 1 basket is used with a dissolution bath to test products that would otherwise float, while the Paddle apparatus (USP 2) is used to test extended releases along with immediate and modified releases. USP 3-7 are used in other, more nuanced circumstances. In any event it is crucial that the dissolution methods are accompanied by the appropriate analytical determinations.
- Residual Solvents – Toxicity is the primary basis for measuring the residual solvents present and produced in the manufacture of food and beverage products. A GC Limit Test is used to detect classes 1 and 2 of residual solvents, while class 3 residual solvents are detected using a separate LOD test. Quantitative data is acquired through further chromatographic analysis.
- Stability-Indicating Assays – Forced degradation of your food or beverage product is used to generate samples representing the effect of time and other factors on its many properties. Avazyme achieves various levels of degradation by exposing your product to UV light, pH, temperature and certain oxidative/reductive reagents. Stability is indicated by the amount of active ingredient and degradation products as measured by GCMS or LCMS or other suitable methods (API specific, customized approach).
Method Validation (GLP/non-GLP) – Our expert staff routinely uses GCMS and LCMS to identify new chromatographic peaks across a full range of reference standards. To validate these methods and prove that the analytical test system is capable of providing legitimate analytical data, we carefully document numerous assessments and associated data in accordance with GLP. These are a few common acceptance criteria we provide for method validation:
- Limit of Detection
- Limit of Quantitation
- Linearity and Range
- Precision and Accuracy
- Robustness
- Specificity
- System Suitability
Avazyme uses both agar plate methods and qPCR to test for the following foodborne pathogens, among others: Salmonella spp., Listeria monocytogenes & Listeria spp., Bacillus cereus enterotoxin, E.coli O157:H7 & Escherichia & coliform spp., Staphylococcus aureus, yeast and mold, Vibrio cholerae & Vibrio spp., and Enterobacteriaceae.
- Antioxidants
- Vitamins
- Nutritional Contents
- Micronutrients
- USDA-Organic pesticide screen
Food Quality Testing – As the value of proper nutrition continues to grow, so does your ability to offer valuable verified food and beverage quality information to customers. Avazyme utilizes GC-MS and LC-MS to provide precise quantitative information on the following nutrients:
- Antioxidants
- Vitamins
- Nutritional Contents
- Micronutrients
- USDA-Organic pesticide screen
Food Safety Testing – Avazyme combines microbiology, analytical chemistry, pesticide residue testing, and stability research to ensure your food or beverage product is safe for human consumption and labeled in compliance with FDA standards. Listed below are some of our standard food safety tests:
- Foodborne Pathogen screens – Avazyme uses both agar plate methods and qPCR to test for the following foodborne pathogens, among others: Salmonella spp., Listeria monocytogenes & Listeria spp., Bacillus cereus enterotoxin, E.coli O157:H7 & Escherichia & coliform spp., Staphylococcus aureus, yeast and mold, Vibrio cholerae & Vibrio spp., and Enterobacteriaceae.
- Environmental (facility) testing – Avazyme utilizes stability chambers and plate testing to provide the following environmental testing services, among others:
- Thermal Shock
- Fungus
- Life Cycle
- Shelf Life
- Temperature Cycle
- Mycotoxin Screens – Samples are extracted, diluted, and run on an LC-MS or GC-MS instrument to determine the presence and concentration of the following mycotoxins, among others:
- B1 Fumonisin
- B2 Fumonisin
- 15-Acetyl-DON
- 3-Acetyl-DON
- Deoxynivalenol
- Nivalenol
- Cytochalasin B
- Cytochalasin D
- Cytochalasin A
- Cytochalasin E
- Cytochalasin C
- Aflatoxin G2
- Aflatoxin G1
- Aflatoxin B1
- Aflatoxin B2
- Zearalenone
- Tenuazonic Acid
- Diacetoxyscirpenol
- Moniliformin
- T2
- Ochratoxin A
- Fusarenone X
- Cytochalasin J
- Cytochalasin H
- 19,20-Epoxycytochalasin C
- 19,20-Epoxycytochalasin D
- Chaetoglobosin A
- Dihydrocytochalasin B
- Neosolaniol
- Monoacetoxyscirpenol
- HT2-Toxin
- Ochratoxin B
- Alternariol
- Alternariol ME
- Sterigmatocystin
- T2-Tetraol
- Adulterant and Contaminant Testing – Manufacturing processes can naturally result in the production of substances other than the intended product. Such impurities can come from process contaminants, API and non-active component degradation, leachables, unreacted monomers/oligomers, and oxidized additives. We typically measure less volatile impurities with LC-MS and more volatile impurities with GC-MS, as the absence of a proper mobile phase can allow for a more accurate structural evaluation in some cases. Upon isolating your impurity, we have the capacity to perform further MS, NMR, ICP, or other specialized investigations.
Pesticide Residue Screens – Avazyme offers both a comprehensive pesticide residue screen as well as a customized USDA Organic pesticide residue screen, both of which are performed using LC-MS.
- Heavy Metal Screens – Avazyme performs the inorganic mass spectrometry necessary to detect heavy metals using an inductively coupled plasma mass spectrometer. We can detect the following elements in concentrations as small as parts per billion (ppb):
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- Aluminum
- Arsenic
- Antimony
- Barium
- Bismuth
- Cadmium
- Cobalt
- Calcium
- Copper
- Germanium
- Gold
- Indium
- Iron
- Lead
- Lithium
- Magnesium
- Manganese
- Mercury
- Molybdenum
- Nickel
- Palladium
- Platinum
- Potassium
- Selenium
- Silver
- Sodium
- Tin
- Titanium
- Thallium
- Yttrium
- Zinc
- Zirconium
“There are not words to describe the dedication and attention that the staff at Avazyme offer their clients. In the face of the hurricane, they were at the lab running samples until the last minute. The level of accuracy and protocol that they provide for every sample is quite impressive. The staff at Avazyme are committed to a high level of accuracy and professionalism and that is why I have total confidence in my test results.”
“Highly knowledgeable staff, quick turnaround, and accurate results you can count on! They are all very helpful with any questions you may have, and conduct business professionally. Ask for Suzanne; she’s the best!”
“If you’re looking for a top notch testing lab for any of your farm, food, or beverage needs this is the place to go. As a family farm we’ve appreciated the analytic rigor, personal touch and customer service that the Borneman’s and their team deliver every day. We’ve used them for dozens of tests this year and cannot say enough about the accuracy and trust we put in their results. Needless to say, we’re customers for life!”
“The staff at Avazyme, Inc. are extremely professional, caring, knowledgeable and helpful. Suzanne is a great resource at Avazyme. She was always there to help me from start to finish. She will go above and beyond to insure that you are taken care of. The lab technicians work really hard to provide you with your results in a timely manner. I wish I could rate this company 10 stars because they truly deserve it!”
“Above and beyond customer service. We made mistakes and they fixed them.”
“Results driven, detail oriented lab at the right place at the right time.”
“Avazyme created services for me that other labs where not willing to do. This is the most service oriented company I have seen in the industry.”
“Avazyme provided us with great communication and expedited service in the middle of a hurricane-rushed harvest. Your samples will be in good hands … expect instant notifications as your sample is being received and processed.”
“I visited this lab today. Wow an amazing, qualified team. They took time to explain the process and I felt at ease. I am so happy to have found quality and a passion for what’s right. Excellence in my testing is very important. As a company owner, I am so pleased to find standards I expect and need. Thank you.”
“The team at Avazyme is experienced, passionate, and dedicated to providing a great customer experience. We have full confidence in Avazyme’s analysis of our samples.”
“Avazyme has outstanding team of experienced scientists who perform precise studies under GLP standards.”
“In our project, they found metabolites of a food chemical that have never been reported previously in the scientific literature. Great analytic team that is a true pleasure to work with.”
“The Premier Laboratory for all your cannabis/hemp and food testing in North Carolina!”
“It is Avazyme’s personalized client-care-instincts and their dynamic and individual designed solutions that demonstrates competency and distinguishes Avazyme from other contract labs.”
“I did hear from them and visited their lab yesterday (a Sunday). Just by my conversations, they have the knowledge, and the equipment, to do the testing we require, and more! Better prices than a legal state.”