Analytical Development

image

Analytical Solutions for CDMO Services at Zasya Life Sciences

At Zasya Life Sciences, we offer a comprehensive range of analytical solution. Our experienced analytical team provides tailored solutions for every stage of drug development, from early-phase research to commercial production.

Key Services

1st_icon

Method Development and Validation

We develop and validate robust analytical methods for small molecules, Peptides, API intermediates and APIs

2nd_icon

Impurity Profiling:

We specialize in impurity identification, isolation, and characterization.

Stability studies

Stability Studies

We conduct stability studies following ICH guidelines under long-term, intermediate, and accelerated conditions.

drug discovery

Forced Degradation Studies

We perform degradation studies to demonstrate the specificity and robustness of analytical methods under various degradation conditions (acidic, basic, thermal, etc.).

Accurate Results

Reference Standard Characterization

We generate and qualify reference standards, ensuring their potency, identity, and purity through techniques such as NMR, HRMS, HPLC and FT-IR.

Services Across the Drug Development Lifecycle

Analytical methods for critical quality attributes (CQAs) are developed in line with process development, including verification of methods for assays, related substances, and residual solvents.

We validate methods for Key Starting Materials (KSMs), intermediates, and final APIs, ensuring consistent product quality before batch manufacturing.
We ensure smooth method transfer to the quality control team for seamless integration into production.
blue_sirin

Specialized Analytical Activities

1st_icon

Impurity Profiling and characterization

We use HRMS, NMR, and HPLC for thorough impurity profiling, ensuring that all impurities are identified, isolated, and characterized to meet regulatory requirements.

2nd_icon

Polymorphic Characterization

We analyze polymorphic forms to ensure product consistency and performance.

3rd_icon

Stability Chambers and Storage Conditions

Our facilities support a range of climatic conditions for stability studies, meeting regulatory requirements.

At Zasya Life Sciences, we provide accurate, affordable, and efficient analytical support, helping you meet standards and ensuring product consistency throughout the development process.