Method Development & Validation

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Method Development & Validation

Accurate Methods. Assured Results. Regulatory Ready.

Reliable testing begins with reliable methods. At Prism Analytical Research, we specialize in developing and validating analytical methods as per ICH, USFDA, and WHO guidelines. Whether you’re launching a new drug, nutraceutical, or cosmetic, we ensure your analytical methods are scientifically sound, reproducible, and audit-ready.

Our expert chemists and analysts work closely with clients to deliver high-precision methods that reduce errors and support faster regulatory approvals.

Core Testing Services

Custom development of HPLC, GC, UV, and FTIR methods for:

  • Assay

  • Related Substances

  • Dissolution

  • Content Uniformity

    We optimize methods for better accuracy, robustness, and reduced runtime.

Validation of analytical procedures for:

  • Specificity

  • Accuracy

  • Precision

  • Linearity

  • Range

  • Robustness

    We perform full validation protocols for both drug substances (DS) and drug products (DP).

Smooth and documented transfer of validated methods to production/QC sites — with protocol drafting and comparative testing.

We carry out stress testing to develop stability-indicating methods and identify degradation pathways under acidic, basic, oxidative, thermal, and photolytic conditions.

Development of media and conditions for IR, CR, and SR formulations — optimized for drug release profiling.

We help clients cut analysis time with simplified, robust methods for routine QC without compromising accuracy.

Techniques Used for Method Development & Validation

Our laboratory is equipped with validated, industry-leading instrumentation including:

Get Reliable Methods. Make Confident Decisions.

Whether you’re filing for approvals or scaling to manufacturing, our validated methods give you the clarity and confidence you need.