Probiotic Testing

Probiotic testing is a critical quality control process used to evaluate the identity, purity, and viable count of beneficial microorganisms in probiotic formulations. These products are designed to deliver live microorganisms that provide health benefits, making viability and strain accuracy essential for product performance.

Inadequate probiotic quality can result in reduced efficacy, incorrect label claims, or loss of viable organisms during manufacturing and shelf life. Therefore, probiotic testing ensures that products meet regulatory expectations and maintain consistent biological activity throughout their shelf life.

This testing is especially important for dietary supplements, functional foods, and nutraceutical formulations containing live bacterial or yeast strains.

Tests We Offer

• Probiotic Enumeration
• Probiotic Testing — USP <64>

 Test Methodology

USP <64> Methodology (Probiotic and Live Biotherapeutic Testing)

Under USP <64>, probiotic testing is performed using a selective and differential culture-based approach designed to accurately quantify viable microorganisms and confirm strain identity.

• Sample preparation under controlled aseptic conditions to preserve organism viability
• Serial dilution of probiotic product to obtain countable microbial range
• Inoculation onto selective and non-selective growth media depending on target strains
• Incubation under strain-specific temperature and atmospheric conditions (aerobic or anaerobic as required)
• Enumeration of colony-forming units (CFU) to determine viable microbial count
• Confirmation of identity using morphological, biochemical, or molecular methods (when applicable)

This method ensures accurate recovery of probiotic organisms, even in complex formulations such as capsules, powders, gummies, and dairy-based products.

Probiotic Enumeration Methodology (General Quality Control)

Probiotic enumeration is performed to determine the total viable count of beneficial microorganisms present in a finished product.

• Sample homogenization to ensure uniform microbial distribution
• Dilution and plating using appropriate growth media for target strains
• Controlled incubation under optimized environmental conditions
• Colony counting to determine CFU per serving or dosage unit
• Verification against product label claims for potency and viability

This process ensures that probiotic products maintain their intended microbial concentration throughout manufacturing and shelf life.

Why It Matters

• Confirms viability of probiotic strains throughout shelf life
• Ensures label claim accuracy (CFU counts per dose)
• Supports clinical efficacy and product performance claims
• Detects loss of viability due to processing or storage conditions
• Ensures compliance with USP <64> and regulatory expectations for live biotherapeutic products

How to Connect

Partner with Unicorn Analytical Services for accurate probiotic enumeration and USP-compliant probiotic testing.