HPLC Testing for Regulatory submission
Reliable hplc testing designed for regulatory submission. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
Resultados en 48 h 
100 % garantía 
Respuesta rápida
HPLC Testing for regulatory submission 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 regulatory submission processes efficiently.
Qalitex Raises Concern Over Stability Data Gaps in Novel Dosage Formats
Qalitex Laboratories identified systemic stability testing blind spots as new dosage formats (gummies, nano-emulsions) proliferate, urging brands to invest in HPLC-based potency validation.
Achieving regulatory submission requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides hplc testing tailored for regulatory submission requirements. High-Performance Liquid Chromatography (HPLC) is the gold standard for quantifying active ingredients in dietary supplements, cosmetics, and foods. Qalitex Laboratories uses HPLC systems including RP-HPLC, UHPLC, and HPLC-UV/DAD to deliver precise, validated results for identity, potency, purity, and impurity profiling. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your regulatory submission process.
How HPLC Testing Supports Regulatory submission
Regulatory submission requires documented evidence of product safety and quality. Qalitex provides the specific testing and documentation needed to support your regulatory submission 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.
HPLC Applications at Qalitex
We apply HPLC to: active ingredient potency (label claim verification), identification of botanical actives, purity and impurity profiling, vitamin and nutrient quantification, preservative and additive analysis, and stability studies tracking degradation over time.
Methods & Instrumentation
Our HPLC capabilities include Reverse Phase HPLC (RP-HPLC), UHPLC for high-throughput analysis, HPLC-UV/DAD, HPLC-FLD (fluorescence), and HPLC-MS coupling for confirmation. Methods are validated per ICH Q2(R1) or aligned with USP monographs.
Ensayos y métodos clave
Normas aplicables
Sectores que atendemos
Cómo funciona
Tres sencillos pasos hasta sus resultados
Envíe sus muestras
Envíe las muestras a nuestro laboratorio de Irvine o San Diego junto con su formulario de pedido.
Análisis y resultados
Nuestros científicos acreditados según ISO 17025 aplican métodos de ensayo validados.
Reciba su CoA
Obtenga un certificado de análisis firmado en 48–72 horas.
Preguntas frecuentes
Preguntas frecuentes
What testing is required for regulatory submission?
Regulatory submission 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 regulatory submission needs.
How long does testing take for regulatory submission?
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 regulatory submission 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 HPLC testing used for?
High-Performance Liquid Chromatography (HPLC) is used for quantifying active ingredients, verifying label claims, testing purity and impurity profiles, and tracking stability degradation in dietary supplements, cosmetics, and foods.
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