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.
Tests & Methods Included
- ✓ Specificity & selectivity
- ✓ Linearity & range
- ✓ Accuracy (recovery)
- ✓ Precision (repeatability & intermediate)
- ✓ LOD & LOQ determination
- ✓ Robustness & system suitability
Regulatory Standards & Compliance
- ICH Q2(R1) method validation
- USP <1225> Validation
- FDA Guidance for Industry (analytical)
- ISO 17025 accreditation
Industries We Serve
- Novel ingredient suppliers
- Brands launching first-to-market formulations
- Regulatory submission support
- Contract manufacturers
- Ingredient standardization
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Get a Quote →Frequently Asked Questions
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.
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