Dietary Supplements and Botanicals
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.
Testing 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 labs listed below are fully compliant cGMP/GLP testing facilities following ISO 17025 standards.
- Micro Quality Labs ISO/IEC 17025:2017 Certificate | FDA Establishment Identifier 3011857110
- Microconsult Inc. ISO/IEC 17025:2017 Certificate | FDA Establishment Identifier 3003838850
- ABC Testing ISO/IEC 17025:2017 Certificate
Testing by Category
Protein Digestibility Corrected Amino Acid Scores (PDCAAS), identification & quantification of essential amino acids, Conditionally Indisputable Amino Acids, non-essential amino acids
Testing for all plant derived herbal products from dried to oils to tinctures.
Amylase, protease, & lipase
Specifications testing for minerals include identity, purity, strength, and composition, as well as identification of any contaminants.
Verified & Validated data for development of Supplement Facts Panel per 21 CFR 101.
Complete nutritional analysis profiles for all Fatty Acids, including Omega 3 & Omega 6.
Other Dietary Components
Developing methods for any matrix when compendials are not available.
Physical and sensory assessment including visual & organoleptic.
Pesticides, PCBs, mycotoxins, allergens, GMOs, Class I, II and III residual solvents, heavy metals, and more.
Impurities, pathogen strains including salmonella, yeasts, & mold, probiotics.
Stability & Shelf life Testing
Expiration and “best by” dates based on microbial, chemical, physical, & organoleptic measures while correlating sensory degradation.
Scientifically valid & fit for purpose. Ensuring accuracy, precision, linearity, ruggedness, specificity, & applicable quantitation limits.
Unique Method Development
Design methods unique to your product & matrix that address the problems you are looking to solve.
Dissolution and Disintegration Analyses
Degradation details help to confirm products are rugged throughout their shelf life.