Analytical Method Development & Validation
Custom method development and ICH Q2(R1) validation for novel ingredients and regulatory submissions.
Analytical method development creates custom test procedures for novel ingredients or formulations that lack existing pharmacopeial monographs, followed by ICH Q2(R1) validation covering specificity, linearity, accuracy, precision, and robustness to produce methods suitable for regulatory submission.
Not every ingredient has a pharmacopeial monograph. When existing methods don't fit your product matrix, Qalitex Laboratories develops and validates custom analytical methods tailored to your specific formulation and regulatory requirements.
Method Development Process
Our scientists start with a review of your product, target analyte, and regulatory requirements, then select the appropriate analytical platform (HPLC, GC, ICP-MS, etc.), optimize chromatographic conditions, and establish system suitability criteria. Development is typically completed in 2–4 weeks.
Method Validation (ICH Q2(R1))
Validation per ICH Q2(R1) includes: specificity/selectivity, linearity and range, accuracy (recovery studies), precision (repeatability, intermediate precision), limits of detection (LOD) and quantitation (LOQ), and robustness studies. A full Validation Report is provided for regulatory submission.
Method Transfer
If you are bringing an existing validated method from another laboratory, we perform method transfer studies to confirm the method performs equivalently in our laboratory under ISO 17025 conditions.
Ensayos y métodos incluidos
- ✓ Specificity & selectivity
- ✓ Linearity & range
- ✓ Accuracy (recovery)
- ✓ Precision (repeatability & intermediate)
- ✓ LOD & LOQ determination
- ✓ Robustness & system suitability
Normas y conformidad regulatoria
- ICH Q2(R1) method validation
- USP <1225> Validation
- FDA Guidance for Industry (analytical)
- ISO 17025 accreditation
Sectores que atendemos
- Novel ingredient suppliers
- Brands launching first-to-market formulations
- Regulatory submission support
- Contract manufacturers
- Ingredient standardization
Solicitar presupuesto
El precio depende de su producto. Indíquenos qué necesita y le enviaremos un presupuesto detallado en 24 horas.
Solicitar presupuesto →Preguntas frecuentes
When do I need custom method development?
Custom method development is needed when your ingredient or formulation does not have an existing pharmacopeial monograph (USP, AOAC), or when existing methods do not adequately separate or detect your target analyte in your specific product matrix.
What does ICH Q2(R1) method validation include?
ICH Q2(R1) validation includes specificity/selectivity, linearity and range, accuracy through recovery studies, precision (repeatability and intermediate), limits of detection and quantitation (LOD/LOQ), and robustness studies. Qalitex provides a full Validation Report suitable for FDA submission.
How long does method development take at Qalitex?
Method development at Qalitex is typically completed in 2–4 weeks, including analytical platform selection, chromatographic optimization, and system suitability criteria establishment. Full ICH Q2(R1) validation follows development and adds an additional 2–4 weeks.
Páginas de ensayos especializados
Method Development for FDA compliance
analytical method development validation for FDA compliance
Method Development for Amazon listing approval
analytical method development validation for Amazon listing approval
Por qué las marcas eligen Qalitex para analytical method development & validation
Entrega en 48 h
CoA firmado en 48–72 horas
Acceso directo al científico
Hable con el químico que realiza sus ensayos
Sin pedido mínimo
1 SKU o 100 — la misma calidad
Artículos relacionados
ISO 17025 Method Validation: What the Standard Actually Requires — and the Questions Every Brand Should Be Asking Their Lab
ISO 17025 accreditation doesn't guarantee every method is validated for your matrix. Learn what Clause 7.2 requires and the four questions to ask your contract lab.
Lab InsightsMethod Validation Under ISO 17025: What Accredited Labs Actually Have to Prove Before Reporting Your Results
ISO 17025 method validation explained: the six performance parameters every accredited supplement and cosmetic testing lab must document before your COA is defensible.
Lab InsightsWhat ISO 17025 Accreditation Actually Means When You're Choosing a Supplement Testing Lab
Learn what ISO 17025 accreditation really means for supplement testing labs — method validation, scope of accreditation, and defensible COA data.
Quality & AccreditationISO 17025 Lab: How Accreditation Elevates Testing Accuracy and Reliability
Understand how ISO 17025 accreditation transforms laboratory operations, from method validation and equipment calibration to continuous improvement — and why it matters for the brands that depend on lab results.
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Solicitar presupuesto →Aviso legal: Los resultados de los ensayos proporcionados por Qalitex Laboratories son datos analíticos destinados a fines de control de calidad. No constituyen asesoramiento legal, regulatorio ni de conformidad. Los clientes son los únicos responsables de garantizar que sus productos cumplen todas las normativas federales, estatales y locales aplicables.