Analytical Research and Quality Control

Scientific Compass for Clinical Success

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.

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

Analytical R&D is the invisible bridge between a molecule and medicine. Our approach ensures that we are actively revealing the data necessary to ensure clinical success.

Core Capabilities

Method Development & Validation

Analytical Development

Phase-appropriate method development & validation
Forced degradation studies & stability-indicating method development
Biorelevant dissolution for formulation rank order
Fit-for-purpose QC dissolution method development
Novel analytical methods to enable formulation screening

Specialized Testing

Genotoxic, elemental impurity, and microbial limit testing
Content uniformity for super low dose
Residual solvent analysis
Innovation for new modalities (Degraders & Peptides)

Comprehensive Stability

Early Stage: Probe, IND, and PCS for packaging definition
Late Stage: Primary, registration, and Formal Stability (FSS)
Specialized: Photostability (ICH Q1B), in-use, and hold-time stability

Quality Assurance

cGMP Product Release

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

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

Achieve Your Success with Our Expertise

Have a question or need support with your project? Please complete the form, and our team will get back to you shortly.  

Our capabilities span three specialized platforms:

Small Molecule
Crystal Bio Solutions
Crystal NAX

By providing your e-mail address, you agree to receive an e-mail response from Crystal Pharmatech to your inquiry. The information you submit will be governed by our Privacy Policy.