Analytical Methods Development and Validation

What is Analytical Method Development?

Analytical Method Development is the scientific process of creating a reproducible and reliable testing procedure to measure, detect, and quantify specific components within a product. It is the foundation of accurate product analysis and regulatory compliance across industries such as dietary supplements, cosmetics, foods and beverages, and consumer goods.

The goal of method development is to design a procedure that delivers:

• Accuracy: True representation of the analyte in the sample.

• Precision: Consistent results under identical conditions.

• Specificity: Distinguishing the target compound from other components.

• Sensitivity: Ability to detect low levels of analyte.

• Robustness: Stability of the method across varying conditions.

At Qalitex, we engineer methods to meet these critical performance parameters based on the unique chemistry, formulation, and matrix of your product.

How Analytical Method Development is Performed

At Qalitex, method development follows a detailed and systematic process, including:

1. Defining the Analytical Objective

• Understanding the target analyte(s).

• Determining the product matrix complexity.

• Establishing regulatory or client-specific acceptance criteria.

2. Selecting the Analytical Technique

• Choosing instrumentation such as HPLC, GC-MS/MS, ICP-MS, UV-Vis, or FTIR based on analyte properties.

• Evaluating sample preparation needs (extraction, filtration, concentration).

3. Developing Sample Preparation Protocols

• Designing optimized procedures to extract analytes efficiently without degradation.

• Considering factors like pH, solvents, temperature, and extraction techniques.

4. Optimizing Instrumental Conditions

• Fine-tuning parameters like flow rates, gradients, detector settings, and column types.

• Enhancing resolution, peak shape, and sensitivity.

5. Preliminary Method Validation

• Testing for selectivity, recovery, and repeatability during early development.

• Adjusting method conditions to resolve any issues.

6. Full Method Validation

Once the method is finalized, a formal validation is performed to confirm it meets industry standards for:

• Accuracy and Precision

• Specificity and Selectivity

• Linearity and Range

• Limit of Detection (LOD) and Limit of Quantitation (LOQ)

• Robustness and Ruggedness

Validation ensures the method is scientifically sound, regulatory compliant, and fit for routine quality control or R&D applications.

Why Choose Qalitex for Analytical Method Development and Validation?

• ISO 17025 Accreditation: Ensures scientifically validated, audit-ready methodologies.

• Cross-Industry Expertise: Supporting supplements, foods, cosmetics, antimicrobials, and CPG products.

• Regulatory Alignment: FDA, FSMA, USP, ICH, and international standards compliance.

• Tailored Methodologies: Custom-designed protocols for your unique product matrix and claims.

• Rapid Turnaround: Accelerated development timelines without sacrificing data integrity.

Method Development and Validation Services We Offer

Our laboratory offers complete analytical support, including:

1. New Method Development

• Custom assays designed for unique formulations or challenging matrices.

• Protocol creation for active ingredients, contaminants, or novel compounds.

2. Method Validation

• Accuracy, precision, specificity, linearity, range, limit of detection (LOD), and limit of quantification (LOQ) studies.

• Robustness and reproducibility testing.

3. Method Verification

• Transfer and confirmation of previously validated methods in compliance with regulatory guidelines.

4. Method Optimization

• Troubleshooting and enhancement of existing methods for improved performance and cost-effectiveness.

5. Stability-Indicating Method Validation

• Analytical validation specifically targeting stability studies for shelf-life claims.

Industries We Support with Analytical Method Development and Validation

Qalitex supports method development and validation across multiple sectors:

• Dietary Supplements and Nutraceuticals

• Botanical and Herbal Products

• Functional Foods and Beverages

• Cosmetics and Personal Care Products

• Antimicrobial and Sanitizer Products

• Consumer Packaged Goods (CPG)

• Suncare and Topical Formulations

Analytical Method Development and Validation Standards

We develop and validate methods in alignment with globally recognized standards, including:

• ISO 17025 Laboratory Accreditation

• FDA Guidance for Industry: Bioanalytical Method Validation

• USP <1225> Validation of Compendial Procedures

• ICH Q2(R1) Validation of Analytical Procedures

• AOAC International Guidelines

Related Qalitex Services

• Chemistry Testing Services

• Microbiology Testing Services

• Shelf-Life and Stability Testing

• Regulatory and Label Compliance Consulting

• Dietary Supplement and Nutraceutical Testing

Frequently Asked Questions About Analytical Method Development and Validation

Q: Why is method validation important?
A: Method validation ensures that analytical procedures produce reliable, consistent, and accurate results necessary for regulatory compliance and product quality assurance.

Q: Can Qalitex develop stability-indicating methods?
A: Yes. We specialize in developing methods that can detect product degradation and confirm shelf-life claims.

Q: How long does method development and validation take?
A: Timelines vary by complexity but generally range from 3–6 weeks for full development and validation projects.

Q: Are your validated methods accepted by Amazon, FDA, and international authorities?
A: Yes. Our ISO 17025-accredited reports meet Amazon requirements and FDA, USP, and ICH global standards.