Method Development and Forced Degradation

Rationale for HPLC Method Development for the API Release

Forced Degradation and Understanding of the Degradation Pathway

Chiral Separations

Method Development with HPLC-CAD

Impurity Isolation and Structure Elucidation

Isolation Strategies

LC-MS, NMR and LC-HR/MS Data Acquisition & Interpretation

Derivation of the Structural Formula

Method Validation & Verification

Method Validation

Method Verification

Method Transfer

Reference Standard Certification

What are Reference Standards?

Retention Markers

Quantitative Reference Standards

Characterization of Reference Standards

ICH Stability Studies

Stability Studies: GMP and non-GMP

Stability Chambers Set to ICH Conditions

Color-Coding for Accuracy

     ICH Guideline Test Intervals

     Stability Study Quality Attributes

     Stability Study Analysis & Reporting

Formulation Development Studies

EZ Labs performs the following studies in support of all stages of formulation development process:

Excipient Compatibility

Solubility Screening

Early Development Stability

Photostability Studies

Thermal Cycling and Freeze-Thaw Studies

GMP Analytical Services

Substantial Laboratory Space

Quality Management System

Phase Appropriate through Phase 1-2 Clinical Trials