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 Pharmacopeal 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 dose, Hardness, Friability, Moisture, Disintegration.
• Dissolution and drug release profiling.
• Particle size analysis of powders.
• Leachables and extractables testing.
• Cleaning validation methods development and validation.

Analytical Infrastructure and Equipment :

• LC/MS/MS.
• HPLC systems with the following detectors: UV, PDA, RI, ELSD, Flourescent.
• Preparative HPLC system.
• Mass Spectrometry.
• UV, Spectrophotometers, Fluorimeter, Viscometer, Osmometer, Culometer Karl Fischer (olso coulometric)ELISA reader.
• Laser scattering and Laser difraction Particle Size Analyzers (Coulter).
• Dissolution testers.
• Tapped density, Loss on drying (Mettler), Disintegration, Friability, 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

The validation methods are applied by a highly skilled technical staff who are trained in the use of the latest equipment. Our Sops and systems ensure compliance to EU, ICH and FDA requirements.

Our Bioanalytical capabilities provide the following services:

• Bio-analytical method development and validation for drug analysis in biological fluids
• GLP Bioanalysis of plasma 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, ELSD, Fluorescent