Formulation & Analytical Testing
Integrated pre-formulation, formulation, and analytical services to ensure First in Rodent® readiness and beyond.
The Importance of Quality Data
At Xyzagen, we extend discovery and nonclinical programs into the formulation & analytical space through trusted local partnerships. This collaborative model allows clients to generate high-quality stability and formulation data early, keeping studies on track without losing momentum between phases and accelerating the path to IND.
Integrated Services at Xyzagen
Our capabilities are designed for early-stage programs advancing toward IND and beyond. Whether you need method development, pre-formulation support for biocompatibility, or stability data to support shelf life and storage conditions, we work seamlessly across disciplines and vendors to provide:
Core Formulation & Analytical Testing Capabilities
Analytical Method Development & Validation
We develop and optimize robust analytical methods to characterize both active pharmaceutical ingredients (APIs) and drug product formulations.
- Assay and impurity testing using LC-MS/MS and HPLC (UV and Fluorescence)
- Method development for quantitation, purity, dissolution, and content uniformity
- Forced degradation and stability-indicating method validation
Stability Testing & Forced Degradation Studies
Stability testing is essential to determine the shelf life and storage requirements of drug products. Our partners conduct ICH-compliant studies across various stress conditions.
- Long-term and accelerated stability studies
- Photostability, thermal, oxidative, and hydrolytic stress testing
- Identification of degradation pathways via LC-MS/MS
- Real-time and predictive modeling to inform formulation decisions
Formulation Development & Characterization
We support formulation strategies for a variety of delivery routes—oral, injectable, and more—through formulation testing and excipient compatibility assessments.
- Solubility, permeability, and pH stability profiling
- Excipient screening and compatibility studies
- Development of prototype formulations for oral, parenteral, and novel delivery systems
- Evaluation of formulation impact on ADME properties
Why Choose Xyzagen for Your Formulation Needs?
Xyzagen bridges the gap between discovery and clinical studies with integrated services that are fast, flexible, and quality-driven. By partnering with expert, local vendors and aligning closely with your drug development strategy, we help accelerate timelines and reduce friction between all phases of development.
The Xyzagen
Advantage
Contact Us
Contact us today to learn how our formulation & analytical testing services can help you generate high-quality data and move your program forward with confidence.
