COREALIS PHARMA

ANALYTICAL

ANALYTICAL

COREALIS Pharma provides analytical methods development, qualification and GMP analytical services to exclusively support its internal formulation development and clinical supplies manufacturing projects. COREALIS Pharma prides itself on producing rapid, accurate, and precise results on the chemical and physical properties of raw materials and finished products. The phase appropriate analytical methods qualification/ validation and GMP analysis for release testing and stability studies are performed in order to respect the guidelines of regulatory agencies in the country where the clinical studies are held.

PRE-FORMULATION AND FORMULATION DEVELOPMENT

This analysis of active pharmaceutical ingredients (API),
analytical methods development, and analysis of excipients, drug products intermediates and finished products includes, but is not limited to:

• assay,
• impurities (related substances),
• content and blend uniformity,
• dissolution (UV, HPLC),
• degradation products (including forced degradation),
• solubility studies,
• stability studies,
• compatibility studies (API-API, API-Excipients),
• Cleaning verification.

The stability studies are executed according to ICH guidelines.

Some of the specific analytic services offered include:

• identification and quantification of impurities and degradation products,
• photo stability studies,
• microbiological testing,
• analysis of the polymorphic form(s) of the active ingredients,
• determination and particle size and distribution,
• permeability studies (PAMPA),
• solubility determination, and
• Water content determination.

The measurements of the physical and chemical properties of an API allows formulators to:

• select suitable API and API moieties that are suitable for oral solid dosage formulation;
• define formulation development strategies;
• identify API variability between different batches.