API Polymorphism Development- Azaricta Research

API Polymorphism Development & Solid-State Studies

ARL Labs offers comprehensive API polymorphism development and solid-state characterization services, focused on the identification, development, and optimization of novel and non-infringing polymorphic forms to enhance product performance and intellectual property positioning. Our studies are designed to support drug substance development, formulation robustness, regulatory compliance, and lifecycle management, while ensuring scalability and manufacturability.

ARL Labs’ Polymorphism Development Services Include:

Systematic polymorph screening (solvents, anti-solvents, temperature, pH, cooling profiles)
Development and stabilization of novel polymorphic forms
Salt, co-crystal, and amorphous form screening
Solid-state process optimization for scalable manufacturing
Green and cost-effective crystallization strategies
Polymorph interconversion and stability studies
Impurity–polymorph interaction evaluation
Patent-safe polymorph identification and documentation

Advanced Characterization Capabilities:

PXRD, DSC, TGA
FT-IR, Raman spectroscopy
Optical microscopy and particle size analysis
Hygroscopicity and stress stability studies

Leveraging strong expertise in solid-state chemistry, API process development, and IP strategy, ARL Labs enables pharmaceutical partners to achieve robust solid forms with improved bioavailability, stability, and freedom to operate.