Analytical Development

Method development & validations for API and finished product.
Testing of API, excipient(s) and drug product
Method transfer to manufacturing site.

Our Analytical Development Services team has the competence to develop and validate laboratory methodologies for new and generic pharmaceutical products to monitor ongoing stability and support the formulation and manufacturing process from development to commercialization. This in-house activity utilizes modern equipment such as Dissolution Test App. (14 stn), UPLC, HPLC, FTIR, UV/VIS, GC with HS, Laser Particle Sizer, Osmometer, Liquid Particle Counter.

Analytical development services include:

• Method Development
• Method Validation
• Dissolution testing
• Stability testing to meet ICH guidelines
• Impurities Characterization
• Polymorphic Characterization
• Membrane Permeability Studies
• Caco Cell model studies (external Lab)

Regulatory support Includes:

• Filing of ANDA
• eCTD compilation
• Preparation of dossiers to various geographies

Quick links:

contact us:

Address:

STAR DRUGS AND RESEARCH LABS LTD, UNIT# 414, LEVEL 4, PRESTIGE CENTRE POINT, # 7, EDWARD ROAD, ( CUNNINGHAM ROAD ), BANGLORE-560001, KARNATAKA, INDIA.

Mail Us:

info@stardrugsresearch.com URL : https://stardrugsresearch.com

Phone:

+91-80-48669918; +91-90719 16473