We develop and validate a wide variety of analytical methods for small molecules and natural actives in the dietary supplements industry in either the liquid or solid state. We perform identity, composition, strength, moisture content, and microbial analyses which are among the most often required methods for various stages of dietary supplement development. The analytical techniques used for developing these methods include HPLC, MS, IR, thermal analysis, vapor sorption, particle size, microscopy, and others. Explain here whatever other methods you all do to validate the products you develop. All methods developed are validated according to cGMP and FDA guidelines.
More than twenty years of scientific expertise, advanced technology and access to customer-needs add value to your development and manufacturing needs. The excellent experienced team offers a complete collection of chemistry-based testing services from the raw materials to the finished products in accordance with USP,_____, _____, and ______standard methods. The internal quality assurance department routinely audits our methods for stringent compliance with existing cGMP and FDA requirements. We are available to consult with you to support all your development efforts to steer you through the regulatory arena. We are here to be your partners for success.
Identity and Strength Testing by HPLC
DBS primarily tests dietary supplement ingredients as raw materials, and some finished products, depending on the matrix or delivery system.
DBS offers fast, accurate, and competitive raw materials as well as finished product evaluation for dietary supplements and nutraceuticals. Our experts in analytical chemistry, organic chemistry, microbiology, natural-products formulations, and quality assurance have years of DS and/or nutraceutical superior quality development and evaluation.
Heavy metal contaminants and elemental analysis by ICP-MS
Analysis for elemental impurities involves analysis of trace heavy metal testing to evaluate dietary supplements and nutraceutical products for elevated concentrations of metal elements including arsenic, cadmium, lead, and mercury that are of significant toxicological health concern. Trace heavy metal impurities can delay development or cause a recall of a product that is already on the market. This analysis is particularly critical in dietary supplements and nutraceuticals development because impurities can impact the safety of the final products. DBS follows FDA and ICH recommendations regarding testing and acceptable limits for impurities.
Pesticide screening by LC-MS/MS
The presence of pesticide residues in raw materials that are used in dietary supplements and nutraceutical products must be established in accordance with FDA regulations. Pesticide testing is needed in dietary supplements and nutraceutical products since many are botanically based. is necessary to guarantee consumer safety. Current Good Manufacturing Practices (cGMPs) regulations require testing that ensures product safety to guarantee consumer safety.
The pesticide levels will be analyzed using the standard USP 561 list recommended for dietary supplements.
Microbiological Contaminants by AOAC and FDA-BAM
We test for E. coli, total aerobic count, yeast, and mold.
At DBS, our goal is to make sure your dietary supplements and nutraceuticals meet regulatory compliance in the most accurate, timely and cost-effective manner. We will work with you to help you choose the appropriate methods for the tests and the frequency of testing best suited to your specific needs. We service your needs for raw materials, the production environment, or finished products to abate risks in your company. Our microbial testing methods are based on the Association of Official Analytical Chemistry (AOAC) and the Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM).
List of Equipment for Analytical Services
We use calibrated and well-maintained instrumentation for all our analytical services. We implement the dietary supplement/nutraceutical cGMP requirements using one of several analytical methods and technologies. DBS offers a range of instrument choices to enable customers to choose the most appropriate test for their samples.
- GC-MS/FID
- Microscopy
- Thin Layer Chromatography (TLC)
- Chromatography methods using Diode Array or Mass Spectrometry
- Fourier Transform Infrared (FTIR)
- Near Infrared (NIR)
- Enzyme Linked Immunosorbent Assay (ELISA)
- Inductively Coupled Mass Spectrometry (ICPMS)
- Wet Chemistry methods
- FTC, FCC and Other Compendia