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.
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 conduct Amazon-compliant lab testing, 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.
Certified Laboratories provides all your testing needs with competitive 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.
IDENTITY
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.
PURITY
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.
STRENGTH
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.
COMPOSITION
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)
Direct UV
HPTLC (High Performance Thin Layer Chromatography)
HPLC – UV, ELSD (Evaporative Light-Scattering Detection), MS
UPLC (Ultra Performance Liquid Chromatography) – UV, ELSD, MS
Gas Chromatography
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.
Burbank, CA
Formerly Micro Quality Labs
- FDA (21 CFR 210, 211)
- ISO 17025 – Biological
- ISO 17025 – Chemistry
- DEA
- Health Canada
Carrollton, TX
Formerly Microconsult
- FDA (21 CFR 210, 211)
- ISO 17025
- ISO 9001
- DEA
- Health Canada
Tustin, CA
Formerly ABC Testing
- ISO 17025
Testing by Category
Amino Acids
Protein Digestibility Corrected Amino Acid Scores (PDCAAS), identification & quantification of essential amino acids, Conditionally Indisputable Amino Acids, non-essential amino acids
Botanicals
Testing for all plant-derived herbal products, from dried oils to tinctures.
Enzymes
Amylase, protease, & lipase
Minerals
Specifications testing for minerals include identity, purity, strength, and composition, as well as identification of any contaminants.
Vitamins
Verified & Validated data for development of Supplement Facts Panel per 21 CFR 101.
Fatty acids
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 Examination
Physical and sensory assessment including visual & organoleptic.
Contaminants
Pesticides, PCBs, mycotoxins, allergens, GMOs, Class I, II and III residual solvents, heavy metals, and more.
Microbial Analysis
Impurities, pathogen strains including salmonella, yeasts, & mold, probiotics.
CBD Testing
Stability & Shelf life Testing
Expiration and “best by” dates based on microbial, chemical, physical, & organoleptic measures while correlating sensory degradation.
Method Validation
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.
