Overview

Solid State Characterization for Formulation and Regulatory Filings

The physical properties of any pharmaceutical solid material can impact the bulk properties of the material, formulation performance, ease of processing, stability, and final appearance. Solid state characterization is essential to understanding these properties and ensuring that the pharmaceutical product has an optimal physical form.

To support your R&D and regulatory filings, VIMTA offers physical characterization services including polymorph characterization, thermal analysis, spectroscopic analysis, and particle size determination. Our offerings include:

Services

VIMTA Physical Characterization Services

Identification and characterization of polymorphs
Polymorph screening
Qualitative identification
Quantitative estimation
Melting point and range for drug substances
Exotherm and endotherm determination
Decomposition temperature
Glass transition
Thermal analysis of plastics and polymers as per USP (HDPE, LDPE, homopolymer polypropylene, and copolymer polypropylene)
Loss on drying in drug substances and drug products
Residue on ignition (NCEs)
Hydrate confirmation in drug substances
Carbonate content estimation in drug substances
Bound moisture estimation
Monitoring of polymorph stability
Method development, validation, and verification for polymorph identification and quantification
Particle size distribution through wet and dry methods