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ISO 17025 Acreditado

Probiotic Testing for Product launch

Reliable probiotic testing designed for product launch. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.

ISO 17025 Accredited 48-Hour Turnaround Available 500+ Test Methods FDA-Compliant Reporting Dual Locations: Irvine & San Diego, CA
ISO 17025 Acreditado ISO 17025
Ensaios rápidos em 48 horas Resultados em 48 h
100 % garantido 100 % garantia

Resposta rápida

Probiotic Testing for product launch ensures products meet the specific regulatory and quality standards required for market entry. ISO 17025 accredited laboratories like Qalitex provide validated testing methods, detailed COA reports, and expert guidance to support product launch processes efficiently.

ALERTA FDA

FDA Alert: Probiotic Products Fail to Meet Label Claims for CFU Count

A review of popular probiotic products found that over 40% failed to meet the advertised CFU count at expiration, highlighting the critical importance of independent potency and viability testing.

FDA.gov · 2025-08 Ler mais →

Achieving product launch requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides probiotic testing tailored for product launch requirements. 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. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your product launch process.

How Probiotic Testing Supports Product launch

Product launch requires documented evidence of product safety and quality. Qalitex provides the specific testing and documentation needed to support your product launch process, including detailed COA reports, method validation documentation, and expert consultation on testing scope. Our ISO 17025 accreditation ensures your results are accepted by regulatory bodies and marketplace platforms.

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.

Ensaios e Métodos Principais

Total viable count (CFU/g)
Species-specific enumeration
Strain identification (16S rRNA)
End-of-shelf-life potency
Real-time & accelerated stability

Normas Aplicáveis

USP <2022> Microbial enumerationNPA probiotic standardsFDA cGMP 21 CFR Part 111ISO 17025 accreditation

Setores que Atendemos

Probiotic supplement brands
Functional foods with probiotics
Private label supplement manufacturers
Amazon FBA probiotic sellers

Como Funciona

Três passos simples para os seus resultados

01

Envie as suas amostras

Envie amostras para o nosso laboratório de Irvine ou San Diego com o seu formulário de pedido.

02

Análise e resultados

Os nossos cientistas acreditados pela ISO 17025 aplicam métodos de ensaio validados.

03

Receba o seu CoA

Obtenha um Certificado de Análise assinado em 48–72 horas.

Perguntas Frequentes

Perguntas Frequentes

What testing is required for product launch?

Product launch typically requires identity testing, purity analysis, potency verification, and contaminant screening. The exact panel depends on your product type and target market. Qalitex Labs can recommend the appropriate testing scope for your specific product launch needs.

How long does testing take for product launch?

Standard turnaround at Qalitex is 5–7 business days, with rush 48-hour service available for most test types. We recommend planning testing 2–3 weeks ahead of your product launch deadline to allow for any retesting if needed.

Is Qalitex Laboratories ISO 17025 accredited?

Yes. Qalitex Laboratories holds ISO/IEC 17025 accreditation, the international standard for testing and calibration laboratories. This ensures our methods, equipment, and quality systems meet the highest standards of accuracy and reliability.

What is your turnaround time?

Standard turnaround is 5–7 business days. Rush service with 48-hour turnaround is available for most test types. Contact us to discuss your timeline requirements.

What types of products do you test?

Qalitex tests dietary supplements (capsules, powders, gummies, liquids), cosmetics and personal care products, food and beverage items, botanical extracts, and raw materials. We serve brands, contract manufacturers, and Amazon FBA sellers.

How do I submit samples for testing?

Ship your samples to our Irvine or San Diego laboratory with a completed sample submission form. We provide prepaid shipping labels for qualifying orders. Results are delivered electronically via secure portal.

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.

Pronto para começar?

Solicite orçamento para probiotic testing for product launch. A nossa equipa responde em 24 horas.

ISO 17025 AcreditadoEnsaios rápidos em 48 horas100 % garantido