Analytical Services

Working according to cGMP and GLP guidelines, Nextar provides analytical support and services for a wide variety of product development and manufacturing programs. With an extensive range of state-of-the art fully qualified, and calibrated analytical equipment available as well as comprehensive stability chambers, we work closely with our clients to assist every analytical stage of the product development cycle.

Our contract analytical services include the following full range of assays for drugs, biological and medical devices:

• Analytical methods development and validation for API and drug products.
• Method development services for:
• Assay, Dissolution, Degradants, Impurities, Moisture, Residual solvents.
• Raw materials testing and QC release according to Pharmacopeial monographs.
• Characterization of drug substances and drug products.
• Determination of API and drug product specifications.
• Impurity analysis and profiling.
• Preparation and characterization of reference standards.
• Full range of short and long term stability tests according to ICH guidelines.
• Accelerated tests for prediction of shelf life.
• Forced degradation studies.
• Photostability studies for API and drug products.
• Contaminant identification.
• Assay, Dissolution, Uniformity of dosage units, Hardness, Friability, Moisture, Disintegration.
• Dissolution and drug release profiling.
• Particle size analysis of powders.
• Leachables and extractables.
• Cleaning validation methods development and validation.

Analytical Infrastructure and Equipment:

• LC/MS/MS.
• HPLC systems with the following detectors: UV, PDA, Fluorescent, Corona CAD.
• Preparative HPLC system.
• UV Spectrophotometers, Fluorimeter, Viscometer, Osmometer, Karl Fischer (also coulometric), ELISA.
• Particle Size Analyzers (Coulter) - Laser scattering and Laser diffraction.
• Dissolution testers- Hanson with autosampler.
• Tapped density, Loss on drying (Mettler), Disintegration, Friability and Hardness.

GLP Bioanalytical services

Our Bioanalytical labs at Nextar offer quantitative bioanalysis services of active drugs, natural compounds and metabolites in biological fluids such as plasma, serum, urine, vitreous fluid and tissues. Bioanalytical assays are carried out routinely for small molecules, peptides and proteins in GLP-audited and accredited facility.

The professional bio analytical team at Nextar has the expertise and skills to deliver high quality data in order to support your research from the earliest phases.

The range of services we offer can support drug development program from preclinical to late stage clinical trial support

Our Bioanalytical capabilities provide the following services:

• Bio-analytical method development and validation for drug analysis in biological fluids and tissues
• GLP Bioanalysis of samples from human clinical trials
• GLP bioanalysis of samples from Bioequivalence/ Bioavailability studies
• Dose confirmation of test articles from GLP preclinical animal studies
• Support of ADME screening, preclinical pharmacokinetic (PK) and toxicokinetic (TK) studies
• Preliminary metabolite identification, screening of samples generated from both in vitro and in vivo studies
• Determination of test article stability

Bioanalytical infrastructure and equipment:

• LC/MS/MS
• HPLC systems with the following detectors: UV-PDA, Corona CAD, Fluorescent