Dietary Supplements & Botanicals Testing
Certified Laboratories ensures dietary supplement manufacturers and Own Label Distributors meet established specifications for identity, purity, strength and composition. We help you to understand your products’ make up and to meet FDA requirements for current Good Manufacturing Practices (cGMPs) per 21 CFR 111 through testing and regulatory expertise. Our wide array of instrumentation and monograph solutions meet demanding Federal and industry requirements including use of AOAC, USP, FCC, BAM, EPA, and other recognized standards to assess raw materials, in-process and finished goods.
Micro Quality Labs, ABC Testing, and Microconsult are now Certified Laboratories. Same locations with expanded services and capabilities.
Supplement Test Solutions to Meet Regulatory Guidance
We help you to meet Federal Regulations found in 21 CRF 111 for cGMPs, including confirmation of established specifications for identity, purity, strength, and composition. Additionally, we can support your international GFSI compliance, help you create accurate supplement facts panels, facilitate Food Fraud Mitigation plans, and defend against adulteration and counterfeiting. We also support day to day testing for all your dietary supplement products, providing brand protection, validations and support. We also conduct full Amazon-compliant testing, including providing CoAs, as required e-commerce retailers like Amazon.
Certified Laboratories provides all your testing needs with industry leading turnaround times.
For a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement.
FDA cGMPs require 100% identity testing for all dietary ingredients and finished products to confirm the identity of components and determine whether other specifications for components are met.
Dietary supplement ingredients and finished products must be free from adulteration and contamination, including pathogens, residual solvents, heavy metals, and other contaminants as confirmed through laboratory testing.
The strength or potency of a dietary supplement is evaluated via the concentration, weight, or measure of each dietary ingredient and for the finished product.
Dietary supplement components include ingredients such as vitamins, minerals, herbs, amino acids, enzymes, and other ingredients, all of which must have defined specifications clearly articulated and documented in Master Manufacturing Records against which Batch Manufacturing Records will be evaluated.
Instrumentation – How We Test Dietary Supplements
Our laboratories use state-of-the-art instruments and the latest compendial methods. We also design methods unique to your products and matrices when compendial methods are not available.
NIR Spectroscopy (Near Infrared)
FTIR Spectroscopy (Fourier Transform Infrared)
HPTLC (High Performance Thin Layer Chromatography)
HPLC – UV, ELSD (Evaporative Light-Scattering Detection), MS
UPLC (Ultra Performance Liquid Chromatography) – UV, ELSD, MS
PCR (Polymerase Chain Reaction)
ELISA (Enzyme-linked Immunosorbent Assay)
Certifications & Accreditations
Certified Laboratories is a fully compliant cGMP/GLP testing facility following the 21 CFR 111 sub J and ISO 17025 standards.