Drug Testing Services

FDA requirements for OTC drug products are defined through OTC Monographs and current Good Manufacturing Practices (cGMP), including:

• 21 CFR 210 – Manufacturing, Processing, Packing, or Holding of Drugs
  
  
• 21 CFR 211 – Finished Pharmaceuticals
  
  

Under 21 CFR 211.165, manufacturers are required to conduct appropriate laboratory testing prior to product release and distribution, including:

• Verification of identity and strength of each active ingredient
  
  
• Testing to confirm products are free from objectionable microorganisms, where applicable
  
  

ANALYZETESTING LABS provides precise, timely laboratory results to support compliant product release and regulatory readiness.

ANALYZETESTING LABS is an Amazon-approved Testing, Inspection, and Certification (TIC) organization for select OTC product categories, including ophthalmic and skin-lightening products.

We conduct the laboratory testing required by Amazon policies and verify product compliance, enabling brands to confidently list OTC products on e-commerce platforms.

Our OTC testing laboratories maintain recognized certifications and accreditations, including:

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

cGMP / GLP Compliance

21 CFR 211.166 requires manufacturers to evaluate the stability characteristics of OTC drug products in order to establish scientifically supported expiration dates.

ANALYZETESTING LABS maintains one of the industry’s most comprehensive OTC stability testing capabilities, including:

• 100+ stability chambers
  
  
• Full range of ICH-based storage conditions
  
  
• Long-term, intermediate, accelerated, and photostability protocols
  
  

Stability Testing Parameters Include:

• Active ingredient assays
  
  
• Microbial limits
  
  
• BP, EP, JP, and USP monograph testing
  
  
• Antimicrobial effectiveness / Preservative Efficacy Testing (PET)
  
  
• Color, odor, appearance
  
  
• pH, specific gravity, viscosity
  
  
• Package compatibility
  
  
• Hardness
  
  
• Weight loss / gain
  
  
• Period-After-Opening (PAO)
  
  
• Freeze / thaw analysis
  
  
• Ambient & above-ambient conditions
  
  
• UV exposure
  
  

• Certain OTC products must meet sterility or pyrogen-free claims, particularly injectables, ophthalmics, and specialized dosage forms.

  ANALYZETESTING LABS provides sterility testing and additional analyses to meet FDA regulatory expectations, including:

  • Sterility testing
    
    
  • Testing for contaminants in ophthalmic ointments
    
    

  Dissolution testing for controlled-release dosage forms
  

• Compliance with FDA OTC Monographs helps ensure product quality, efficacy, and reliability. Our laboratories provide expert monograph testing using validated and verified methods.

  Our OTC testing services include:

  • Chemistry testing
    
    
  • Microbiology testing
    
    
  • In-package stability & shelf-life testing
    
    
  • Sterility testing
    
    

  Quantitative analysis to support labeling of APIs and excipients
  

• Chemistry testing includes:

  • Active ingredient assays
    
    
  • Microbial limits
    
    
  • BP, EP, JP, and USP monograph testing
    
    
  • Antimicrobial effectiveness / PET
    
    
  • Color & artificial colors (FD&C Blue #1, Blue #2, Green #3, Red #3, Red #40, Yellow #5, Yellow #6)
    
    
  • Odor & appearance
    
    
  • Moisture
    
    
  • GMOs
    
    
  • Mycotoxins
    
    
  • Heavy metals
    
    
  • Allergens
    
    
  • Pesticides & PCBs
    
    
  • Adulterants
    
    

• Microbiology testing includes:

  • Microbial and pathogen contamination
    
    
  • Microbial enumeration
    
    
  • Preservative effectiveness
    
    
  • Challenge studies
    
    

  Probiotic testing
  

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• In-package stability testing evaluates product degradation and performance over time.

  Testing includes:

  • Degradation studies
    
    
  • Accelerated stability
    
    
  • Photostability

• Organoleptic testing supports product consistency and consumer acceptability.

  Organoleptic analysis includes:

  • Flavor
    
    
  • Color
    
    
  • Texture
    
    
  • Odor
    
    

• ANALYZETESTING LABS tests a wide range of OTC drug products, including:

  • Acne medications
    
    
  • Dandruff shampoos
    
    
  • Cough suppressants
    
    
  • Decongestants
    
    
  • Fever reducers
    
    
  • Pain relievers
    
    
  • Antihistamines
    
    
  • Anti-diarrheal products
    
    
  • Topical analgesics
    
    
  • Sunscreens
    
    
  • Eczema creams
    
    
  • Ophthalmic solutions
    
    

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• 1. Customize Your Plan – Identify required testing services
     
     
  2. Submit Samples – Ship directly or use courier services (location dependent)
     
     
  3. Laboratory Testing – Testing performed by accredited laboratories
     
     

  Receive Results – Access Certificates of Analysis (COA) through our online portal
  

• 1. ANALYZETESTING LABS delivers consistent, compliant, and collaborative OTC testing services, supported by:

     • Competitive turnaround times
       
       
     • Turn-key pricing
       
       
     • Direct access to technical experts
       
       
     • Real-time data access
       
       
     • Flexible courier options
       
       

• 1. • Through qualified regulatory partners, ANALYZETESTING LABS supports OTC manufacturers with FDA regulatory consulting, including:

       • GMP, GLP, and GCP compliance
         
         
       • Facility audits & mock FDA inspections
         
         
       • Quality system implementation
         
         
       • 483 / warning letter / recall remediation
         
         
       • Label and formula review for monograph compliance
         
         
       • Facility registration, drug listing, and annual FDA submissions
         
         
       • Cosmetic-to-OTC crossover guidance