Method Development, Validation & Batch Analysis
Every result a pharmaceutical company reports — in a regulatory submission, a stability study, or a routine batch release — is only as reliable as the analytical method behind it. DALPL's Pharma Testing Division develops, validates, and routinely applies analytical methods using HPLC (UV, PDA and RI detection), UV spectrophotometry, and dissolution testing, aligned to the current ICH Q2(R2)/Q14 framework and relevant USP general chapters. Whether the need is a new method built from scratch, transfer and verification of an existing one, or ongoing batch analysis for release and stability, DALPL's approach is built on the same science- and risk-based principles regulators now expect.
Our Method Development & Validation Services
Comprehensive analytical services across the entire method lifecycle.
Analytical Method Development
Analytical method development for assay, related substances/impurities, and dissolution, using HPLC (UV/PDA/RI) and UV spectrophotometry.
Method Validation
Method validation per ICH Q2(R2) — accuracy, precision, specificity, LOD/LOQ, linearity, range, and robustness.
ICH Q14-Based Method Development
Method development documentation aligned to ICH Q14 principles, including a defined Analytical Target Profile for each method.
Method Transfer & Verification
Method transfer and verification between laboratories or sites.
Dissolution Method Development & Validation
Dissolution method development and validation per USP <711> and <1092>.
Batch Analysis
Once methods are validated or transferred, DALPL applies them for ongoing compliance and regulatory reporting.
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Routine Release & Stability Routine batch release and stability testing using validated methods.
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Regulatory Submission Data Batch analysis data prepared in a format suitable for regulatory submission: CTD Module 3.2.S.4.4 / 3.2.P.5.4
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Specification-Setting Support Specification-setting support aligned to ICH Q6A.
Analytical Instrumentation
DALPL's dedicated Pharma Testing Division is equipped with precise analytical systems to support comprehensive method lifecycles.
HPLC with UV, PDA and RI Detectors
High-Performance Liquid Chromatography with multiple detection options for robust assay and impurity methodologies.
UV Spectrophotometer
Accurate ultraviolet spectrophotometric analysis for identification, assay, and routine analytical workflows.
Dissolution Apparatus
In-vitro dissolution testing aligned with USP chapters for drug product performance evaluation.
From Method Development to Routine Batch Analysis
A complete end-to-end framework governing the creation, validation, transfer, and application of pharmaceutical analytical procedures.
Develop
Build the analytical method for the intended purpose.
Validate
Establish method performance under ICH Q2(R2).
Transfer / Verify
Transfer or verify an established method between laboratories or sites.
Apply
Use validated methods for routine release and stability testing.
Report
Prepare analytical data suitable for regulatory submission and specification-setting support.
Why DALPL
Delivering high-accuracy impurity profiling with uncompromised regulatory integrity.
Talk to Us About Your Method Development or Batch Analysis Needs
Speak with our pharmaceutical testing specialists to discuss your method development, validation, or batch release requirements.