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.
检测项目与方法
- ✓ Specificity & selectivity
- ✓ Linearity & range
- ✓ Accuracy (recovery)
- ✓ Precision (repeatability & intermediate)
- ✓ LOD & LOQ determination
- ✓ Robustness & system suitability
法规标准与合规性
- ICH Q2(R1) method validation
- USP <1225> Validation
- FDA Guidance for Industry (analytical)
- ISO 17025 accreditation
服务行业
- Novel ingredient suppliers
- Brands launching first-to-market formulations
- Regulatory submission support
- Contract manufacturers
- Ingredient standardization
常见问题
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.
专项检测页面
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
为什么品牌选择 Qalitex 进行 analytical method development & validation
48 小时交付
签名 CoA 在 48–72 小时内
直接对接科学家
与负责您检测的化学家直接沟通
无最低订量
1 个或 100 个 SKU — 同等品质
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免责声明：Qalitex Laboratories 提供的检测结果是用于质量控制目的的分析数据，不构成法律、监管或合规建议。客户自行负责确保其产品符合所有适用的联邦、州和地方法规。