Protein & Peptide Testing for FDA compliance
Reliable protein & peptide testing designed for FDA compliance. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
Resultados em 48 h 
100 % garantia 
Resposta rápida
Protein & Peptide Testing for FDA compliance 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 fda compliance processes efficiently.
FDA Warns Protein Powder Brands Over Nitrogen-Spiking Practices
The FDA issued a warning letter to protein supplement brands using non-protein nitrogen compounds to artificially inflate protein label claims — an issue detectable only through amino acid profile testing.
Achieving fda compliance requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides protein & peptide testing tailored for fda compliance requirements. Accurate protein and amino acid testing is critical for sports nutrition, meal replacement, and protein supplement brands. Qalitex Laboratories provides HPLC-based amino acid analysis and protein quantification methods that go beyond the Kjeldahl/Dumas total nitrogen approach to deliver true protein and individual amino acid data. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your fda compliance process.
How Protein & Peptide Testing Supports FDA compliance
FDA compliance requires documented evidence of product safety and quality. Qalitex provides the specific testing and documentation needed to support your fda compliance 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.
Amino Acid Profile Testing
We provide complete amino acid profiling (AAA) using HPLC with pre-column derivatization, covering all essential and non-essential amino acids. This allows verification of label claims for BCAA content (leucine, isoleucine, valine) and total amino acid spectrum.
Protein Content Quantification
We use Kjeldahl, Dumas, and HPLC methods to determine total protein content, verifiable to label claims. For collagen and hydrolyzed proteins, we apply hydroxyproline-based methods to distinguish true protein from non-protein nitrogen sources.
Adulteration & Spiking Detection
Protein spiking — adding low-cost amino acids to inflate nitrogen readings — is a known industry problem. Our comprehensive amino acid profiling detects unusual enrichment of specific amino acids, protecting your brand and customers from adulterated raw materials.
Ensaios e Métodos Principais
Normas Aplicáveis
Setores que Atendemos
Como Funciona
Três passos simples para os seus resultados
Envie as suas amostras
Envie amostras para o nosso laboratório de Irvine ou San Diego com o seu formulário de pedido.
Análise e resultados
Os nossos cientistas acreditados pela ISO 17025 aplicam métodos de ensaio validados.
Receba o seu CoA
Obtenha um Certificado de Análise assinado em 48–72 horas.
Perguntas Frequentes
Perguntas Frequentes
What testing is required for fda compliance?
FDA compliance 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 fda compliance needs.
How long does testing take for fda compliance?
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 fda compliance 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.
What is amino acid profile testing?
Amino acid profile testing (AAA) uses HPLC with pre-column derivatization to identify and quantify all essential and non-essential amino acids in a product. This allows verification of BCAA content and total amino acid spectrum for sports nutrition and protein supplements.
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