Probiotic Testing Services
Enumeration and identification of probiotic strains. Potency at time of manufacture and end of shelf life.
Probiotic testing verifies the identity, viability, and potency of probiotic strains in dietary supplements using culture-based enumeration and 16S rRNA molecular identification, ensuring that CFU (Colony-Forming Unit) counts on labels accurately reflect the product at both manufacture and end of shelf life.
Probiotic products require specialized testing to validate that the claimed strains are present, viable, and at the labeled potency at both manufacture and throughout shelf life. Qalitex Laboratories provides ISO 17025 accredited probiotic testing using culture-based and molecular methods to deliver accurate, defensible results.
Probiotic Enumeration
We perform total viable count (TVC) and species-specific enumeration for commonly used probiotic strains including Lactobacillus, Bifidobacterium, Streptococcus, and Saccharomyces. Results are reported in CFU/g or CFU per serving as required for label compliance.
Strain Identification
We use 16S rRNA sequencing and culture-based identification to confirm strain identity at the species level. Essential for brands making specific strain claims on labels (e.g., Lactobacillus acidophilus NCFM).
Probiotic Stability Testing
Probiotic viability decreases over time. Our stability studies test products at defined intervals to establish accurate expiration dating, ensuring your potency claim is valid at end of shelf life — as required by NPA, USP, and industry standards.
Tests & Methods Included
- ✓ Total viable count (CFU/g)
- ✓ Species-specific enumeration
- ✓ Strain identification (16S rRNA)
- ✓ End-of-shelf-life potency
- ✓ Real-time & accelerated stability
Regulatory Standards & Compliance
- USP <2022> Microbial enumeration
- NPA probiotic standards
- FDA cGMP 21 CFR Part 111
- ISO 17025 accreditation
Industries We Serve
- Probiotic supplement brands
- Functional foods with probiotics
- Private label supplement manufacturers
- Amazon FBA probiotic sellers
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Get a Quote →Frequently Asked Questions
How are probiotic CFU counts measured?
Probiotic CFU (Colony-Forming Units) are measured through culture-based enumeration methods that count viable organisms. Qalitex performs total viable count and species-specific enumeration for Lactobacillus, Bifidobacterium, Streptococcus, and Saccharomyces strains.
Why is probiotic stability testing important?
Probiotic viability decreases over time, meaning the CFU count at manufacture may differ significantly from the count at expiration. Stability testing at defined intervals ensures your potency claim is valid at end of shelf life — as required by NPA, USP, and industry standards.
Can Qalitex identify specific probiotic strains?
Yes, Qalitex uses 16S rRNA sequencing and culture-based identification to confirm probiotic strain identity at the species level. This is essential for brands making specific strain claims on labels.
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