Shilpa Medicare Limited
FDA Compliant • GMP Certified

Analytical Support

From Concept to Commercial

Learn more about our analytical development & support services and capabilities.

Immediate Release Tablets
Modified Release Systems
Oral Liquid Formulations
Sterile Injectables
Topical Preparations
Specialty Dosage Forms
Formulation Development
500+
Formulations Developed
15+
Dosage Forms

Our Formulation Development Process

Pre-formulation

API characterization, excipient compatibility and risk assessment.

Development

Prototype formulation, optimization and robustness studies.

Scale-up

Pilot and validation batches with process optimization.

Manufacturing

cGMP commercial manufacturing with in-house quality control and QA.

Comprehensive Analytical Support

The Analytical Service Team is equipped with state-of-the-art infrastructure to support product development activities across the entire pharmaceutical development lifecycle. Our experienced team provides comprehensive analytical solutions from method development through commercial manufacturing support.

Core Analytical Services

Analytical Method Development

Custom method development for API, intermediates, and drug products using advanced analytical techniques

Analytical Method Validation

ICH-compliant validation protocols ensuring method reliability and regulatory compliance

Analytical Method Transfer

Seamless transfer of analytical methods from development to quality control laboratories

Dissolution Method Development

Specialized dissolution method development for various dosage forms and release profiles

Stability Testing

Comprehensive stability studies including real-time, accelerated, and stress testing programs

Reverse Engineering

Analytical characterization and method development for reference products and competitive analysis

Specifications Design

Development of test procedures and specifications aligned with regulatory requirements

Impurity Characterization

Comprehensive impurity profiling and characterization studies for drug substances and products

Extractables & Leachables

Complete analysis of packaging components and container closure systems for patient safety

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