Analytical R&D

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Tergus has been providing analytical expertise and laboratory services for several years now. We provide analytical method development, validation and testing for your topical and specialty semi-solid dosage form. Our scientists have expertise in analyzing complex semi-solid matrices to support development, informal and ICH stability studies, and release of clinical trial materials.

Our Analytical Services Include

Analytical Method Development

Phase- Specification Analytical method development, validation and testing for ANDA, NDA & OTCs

Cleaning Validation

Cleaning methods for manufacturing equipment.

Batch/lot release
testing

Batch/lot release testing for APIs and finished drug products including method transfers.

Stability

Stability testing (to support formulation development, preclinical, clinical and commercial activities)

Global Regulatory Compliance

Compendial testing to meet various global regulatory needs, such as USP, EP, JP, MHRA, TGA, ANVISA, etc.

Analytical
Instrumentation

HPLC / UPLC

Dissolution
Apparatus

UV-VIS / FTIR / TLC

GC

LC-MS

Karl Fischer

Rheometers

Viscometers

pH Meters

Particle size analyzer

Photostability chambers

Texture Analyzer

High-resolution microscopes

Dropping Point Apparatus

Years of experience providing
analytical and laboratory services

Analytical R&D from Tergus Pharma on Vimeo.