Phase-Appropriate Analytical Method Development

Analytical R&D at Crystal Pharmatech is far more than a "testing station"—it is the scientific compass used to navigate complex delivery systems from initial hurdles to successful clinical solutions. Our team provides comprehensive analytical research and quality control services for New Chemical Entities (NCEs) throughout their entire life cycle, from early clinical stages to commercial manufacturing.

Navigating Complex OSD Analytical Challenges

We move beyond data generation to provide proactive risk mitigation and reveal the scientific truth behind every molecule.

1. Overcoming Incomplete Extraction

The Challenge: High-viscosity polymers can "trap" the API in complex matrices, leading to low recovery. The Solution: We design extraction protocols based on release mechanisms—optimizing solvent, pH, and surfactants to ensure 100% extraction.

2. Establishing Discriminatory Dissolution

The Challenge: Conventional methods are often insensitive to process variations and fail to provide predictive insight into in vivo performance. The Solution: We build biorelevant dissolution systems through rigorous media screening and sink condition balancing to reflect formulation changes to guide formulation design.

3. Solving Early-Phase Stability & Compatibility

The Challenge: Incompatibilities between API and excipients often go undetected, resulting in insufficient data to support clinical advancement. The Solution: We implement binary compatibility screening with various stress conditions and conduct "root cause" identification by mapping mechanistic degradation pathways.

4. Innovation for New Modalities

The Challenge: Modern molecules often lack UV chromophores or exist at ultra-low exposure levels that exceed conventional HPLC detection limits. The Solution: Utilizing our Analytical Technology Platform (ATP), we leverage MS, derivatization, ELSD or CAD to push the boundaries of detection and quantification.

Our Philosophy: Science-Driven & Phase-Appropriate

We believe Analytical R&D is the invisible bridge between a molecule and medicine. Our approach ensures that we are not just "testing samples" to generate numbers but are actively revealing the data necessary to ensure clinical success.

Core Analytical Capabilities

Method Development & Validation

Guided by Quality by Design (QbD), we provide comprehensive method development and validation in accordance with ICH Q2/Q14.

Method Development

Phase-Appropriate method development and validation.

Forced Degradation Studies

Force degradation studies and stability-indicating method development.

Biorelevant Evaluation

Biorelevant dissolution for formulation rank order.

QC Dissolution Setup

Fit-for-purpose QC dissolution method development.

Impurity Profiling

Genotoxic, elemental impurity, and microbial limit testing.

Uniformity & Residuals

Content uniformity for super low dose and residual solvent analysis.

Advanced Enabling Methods

Novel analytical methods to enable formulation screening and optimization.

Comprehensive Stability Studies

Our stability data provides the evidence required for packaging selection, expiration dating, and lifecycle evaluation.

Early Stage

Probe, IND, and Product Characterization Studies (PCS) for packaging definition.

Late Stage

Primary, registration, and Formal Stability Studies (FSS).

Specialized Testing

Photostability (ICH Q1B), in-use stability, and hold-time stability for intermediates like Spray Dried Intermediates (SDI).

cGMP Product Release

We strictly adhere to the NMPA, FDA, and EMA regulations to release drug products for global distribution.

Full testing suite: Appearance, Assay, CU/BU, identification, related substances, dissolution, and water content, microbial limit.

Rigorous release testing: Testing performed for API, excipients, and packaging components to control quality straight from the source.

Achieve Your Success with Our Expertise

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Our capabilities span three specialized platforms:

Small Molecule
Crystal Bio Solutions
Crystal NAX

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