Analytical Method Development Validation

Analytical Method Development Validation

Our analytical development group specializes in inhalation-specific assays and validation to control product quality and support regulatory filings. We develop stability-indicating potency assays, impurity profiling, residual solvent methods, content uniformity assessments, and bioanalytical methods as needed for PK studies. We are experienced with cascade impactor APSD testing, delivered dose uniformity, emitted dose, and fine particle fraction measurements and next-generation impactors. Method validation follows ICH Q2(R1) with accuracy, precision, specificity, linearity, LOD, LOQ, and robustness. Analytical transfers to QC labs, instrument qualification, LIMS documentation, and trending ensure defensible data for audits and global submissions. We provide method training and ongoing support.

List Of Options

1 Stability-Indicating Potency Assays

Quantifying API while detecting degradation products.

2 Impurity Profiling

Identification and quantification of known and unknown impurities.

3 Residual Solvent Testing

Ensuring compliance with ICH Q3C limits.

4 Content Uniformity Assessment

Testing dosage consistency across batches.

5 Aerosol Performance Testing

APSD via cascade impactor/NGI, delivered dose uniformity, emitted dose, fine particle fraction.

6 Method Validation (ICH Q2(R1))

Accuracy, precision, specificity, linearity, LOD, LOQ, robustness.

Service Testimonial

Brandon Maxwell

NewYork

Raymond Castillo

NewYork

Emily Robinson

First Time Patient

Their deep expertise in inhalation therapy, especially Dry Powder Inhalers, combined with state-of-the-art facilities, ensured that our project progressed smoothly and efficiently.

The team’s professionalism, transparent communication, and problem-solving ability stood out at every stage.

Vamsipharma delivered high-quality results within the agreed timelines while maintaining strict regulatory compliance.

Service FAQ

What is the purpose of analytical method development?

Analytical method development ensures reliable, accurate, and reproducible testing to confirm product quality, safety, and efficacy, supporting regulatory compliance.

Do you specialize in inhalation-specific tests?

Yes. We focus on inhalation performance testing, including APSD (cascade impactor/NGI), delivered dose uniformity, emitted dose, and fine particle fraction analysis.

How do you validate methods?

We follow ICH Q2(R1) guidelines, assessing parameters such as accuracy, precision, specificity, linearity, LOD, LOQ, and robustness to ensure compliance.