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

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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

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Analytical Method Transfer

Seamless transfer of analytical methods from development to quality control laboratories

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Dissolution Method Development

Specialized dissolution method development for various dosage forms and release profiles

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Stability Testing

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

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Reverse Engineering

Analytical characterization and method development for reference products and competitive analysis

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Specifications Design

Development of test procedures and specifications aligned with regulatory requirements

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Impurity Characterization

Comprehensive impurity profiling and characterization studies for drug substances and products

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Extractables & Leachables

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

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