Supplements Testing

Under U.S. FDA regulations (21 CFR 111), dietary supplement manufacturers are required to verify that incoming components, raw materials, and finished products meet established specifications.

ANALYZETESTING LABS provides laboratory testing to confirm that finished dietary supplements meet requirements for:

• Identity
  
  
• Purity
  
  
• Strength
  
  
• Composition
  
  
• Limits on contaminants that may adulterate the product
  
  

Our testing supports cGMP compliance by verifying product quality and confirming the absence of potential contaminants, in alignment with FDA regulatory expectations.

In addition to FDA compliance, ANALYZETESTING LABS provides dietary supplement testing services required for selling products on Amazon and other major e-commerce platforms.

These services include:

• Contaminant screening (heavy metals, microbial contaminants, and other analytes)
  
  
• Verification of product content and label claims
  
  
• Data support for development of Supplement Facts Panels
  
  

Our laboratories help brands meet marketplace requirements while maintaining compliance with U.S. regulations.

ANALYZETESTING LABS offers a broad portfolio of analytical testing services tailored to dietary supplement products across multiple dosage forms.

Artificial Colors Testing

Testing for FD&C artificial colors including:

• Blue #1, Blue #2
  
  
• Green #3
  
  
• Red #3, Red #40
  
  
• Yellow #5, Yellow #6
  
  

Applicable matrices include gummies, powders, nutrient bars, protein bars, and shakes.

Amino Acid Testing

• Identification and quantification of essential, conditionally indispensable, and non-essential amino acids
  
  
• PDCAAS (Protein Digestibility Corrected Amino Acid Score) testing for protein quality assessment
  
  

Botanicals Testing

Comprehensive testing for herbal and plant-derived supplements, including:

• Dried botanicals
  
  
• Oils
  
  
• Tinctures
  
  

CBD Testing

• Accurate quantification of CBD content
  
  
• Screening for contaminants and impurities
  
  

Contaminants Testing

Comprehensive screening for:

• Pesticides
  
  
• PCBs
  
  
• Mycotoxins
  
  
• Allergens
  
  
• GMOs
  
  
• Residual solvents (Class I, II, III)
  
  
• Heavy metals
  
  
• Additional regulated contaminants
  
  

Dissolution & Disintegration Analyses

• Evaluation of product breakdown and bioavailability
  
  
• Assessment of stability and performance over shelf life
  
  

Enzymes Analysis

Measurement of digestive enzymes including:

• Amylase
  
  
• Protease
  
  
• Lipase
  
  

Fatty Acids Testing

Nutritional profiling for:

• Omega-3
  
  
• Omega-6
  
  
• Omega-7
  
  
• Omega-9
  
  

Microbial Analysis

Detection and enumeration of microbial contaminants, including:

• Escherichia coli
  
  
• Clostridium perfringens
  
  
• Listeria monocytogenes
  
  
• Pseudomonas aeruginosa
  
  
• Salmonella spp.
  
  
• Staphylococcus aureus
  
  
• Yeast & Mold Count
  
  
• Total Aerobic Plate Count
  
  
• Coliform Count
  
  
• Enterobacteriaceae
  
  

Minerals Testing

Analysis for a wide range of minerals, including:

• Calcium
  
  
• Magnesium
  
  
• Iron
  
  
• Zinc
  
  
• Selenium
  
  
• Potassium
  
  
• Additional trace minerals
  
  

Physical Examination

Physical and sensory assessments, including:

• Visual inspection
  
  
• Organoleptic evaluation
  to ensure product consistency and quality.
  
  

Probiotics Testing

• Total probiotic count testing
  
  
• Verification of label claims
  
  

Stability & Shelf-Life Testing

Determination of:

• Expiration dates
  
  
• “Best by” dates
  
  

Based on microbial, chemical, physical, and organoleptic evaluations, correlated with sensory degradation over time.

Vitamins Analysis

Testing to support Supplement Facts Panels under 21 CFR 101, including:

• Vitamin A
  
  
• Vitamin B1, B2, B3 (Niacin), B5, B6, B9 (Folic Acid), B12
  
  
• Vitamin C
  
  
• Vitamin D
  
  
• Vitamin E
  
  

Vitamin K

• ANALYZETESTING LABS utilizes a wide range of FDA-recognized and scientifically validated methods, including:

  • AOAC, AOCS, USP, FDA BAM methods
    
    
  • 3,000+ compendial methods
    
    
  • 2,000+ in-house validated methods
    
    
  Client-provided methods
  
  

• Our dietary supplement testing laboratories maintain recognized certifications and accreditations, including:

  • ISO/IEC 17025
    
    
  • FDA (21 CFR 210 & 211)
    
    
  • DEA
    
    
  • Health Canada
    
    

  cGMP / GLP Compliance
  

• Our laboratories are equipped with state-of-the-art instrumentation, including:

  • FTIR Spectroscopy
    
    
  • Direct UV
    
    
  • UV-VIS Spectrophotometry
    
    
  • HPTLC
    
    
  • HPLC (MS, UV, ELSD)
    
    
  • UPLC (UV, ELSD, MS)
    
    
  • GC
    
    
  • LC/MS
    
    
  • PCR
    
    
  • ELISA
    
    

• ANALYZETESTING LABS supports dietary supplement companies with regulatory consulting services through qualified regulatory partners, including former FDA professionals.

  Services include:

  • FDA registration and labeling compliance
    
    
  • cGMP audits and training
    
    
  • New Dietary Ingredient (NDI) notifications
    
    
  • Structure/function claim reviews
    
    
  • Dietary supplement safety assessments
    
    
  • Support with 21 CFR 111 compliance
    
    
  • Mock FDA inspections