Analytical Method Development and Validation

Validation of measurement methods used in the pharmaceutical industry is a regulatory requirement of pharmaceutical pharmacopoeias and drug authorities. Method validation demonstrates that the generated measurement data are accurate, reliable, reproducible, and suitable for the intended application.

The requirements for validation of pharmaceutical analytical methods are described in the USP <1225> and ICH Q2 (R1) guidelines.

At Arman Shimi Sanj, upon client request, we first carry out analytical method development, followed by method validation in accordance with pharmaceutical pharmacopoeias, ICH Q2 (R1) guidance, the client’s own specific protocol, and/or the company’s internal protocol.

Key performance characteristics evaluated during method validation include:

• Accuracy
• Repeatability
• Reproducibility
• Linearity and Linear Range
• Limit of Detection (LOD) and Limit of Quantification (LOQ)
• Method Robustness

Additional specific characteristics can also be evaluated upon request.

The final report provided by our company clearly describes the obtained results, the test method, the protocol used, the instruments and chemical reagents applied, as well as all statistical calculations performed. All chromatograms, spectra, and other instrumental reports are attached to the final documentation.

We take pride in having provided high‑quality, accurate, and timely services tailored to the needs of numerous pharmaceutical companies across the country. This is just one of the many specialized pharmaceutical services we can offer our clients.