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Analytical Services

We provide testing of Active Pharmaceutical Substances (API) / Drug Substances and finished drug products / devices containing pharmaceutically active substances.

Our Strength:
 

Method development and validation for

·    Small molecules to Large molecules (peptides, proteins).

·   Single component and multi-components

·    Different modes of HPLC like Normal-phase, Reversed Phase (RP-HPLC), Ion-Pair, Ion- Exchange (Cation-Exchange and Anion Exchange), Size Exclusion (SEC-HPLC), Chiral Separations, Amino acids analysis, Sugar Analysis, etc.

·    Difficult to develop compounds by HPLC like (No / Poor UV Compounds, In-organic Ions, etc)

Pre-Formulation Services

Formulation Services

Analytical and Stability Services

Clinical Manufacturing Services

Key Capabilities:
 

·    HPLC’s equipped with UV-Vis., PDA, Refractive Index (RI) and Fluorescence Detection Capabilities and Fraction collectors.

·    Thin Layer Chromatography.

·    USP Dissolution Apparatus (USP Apparatus 1 and 2) and Modified In-Vitro Release Apparatus for Different New Dosage forms and Devices containing pharmaceutically active substances.

·   Disintegration Tester

·    UV-Visible Spectrophotometer (Single Beam and Double Beam)

·    Stability Chambers at 2°C to 8°C, -20°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH and chambers to meet Custom conditions needed by clients.

·   Differential Scanning Calorimeter (DSC)

·    Scanning Electron Microscope (SEM)

·    Malvern Particle Size Analyzer.

·    Osmometer

Services:
 

Ø       Assay Method Development and validation services for following as per ICH/FDA/USP guidelines:

v Support in formulation development

v Release testing of Active Pharmaceutical Substances (API) / Drug Substances and finished drug products / devices containing pharmaceutically active substances

v Stability testing programs.

Ø       Impurities Method Development and validation services for following as per ICH/FDA/USP guidelines:

v Active Pharmaceutical Substances (API) / Drug Substances.

v Pre-formulation / Drug-Drug and Drug-Excipients compatibility studies.

v Finished drug products

v Devices containing pharmaceutically active substances and

v Stability testing programs.

Ø       Dissolution (In- Vitro Drug Release) Method Development and validation for following as per ICH/FDA/USP guidelines:

v Intrinsic Dissolution / Solubility of Active Pharmaceutical Substances (API) / Drug Substances.

v Finished drug products including Modified Release Dosage forms.

v Devices containing pharmaceutically active substances and

v Stability testing programs.

Ø       Cleaning Validation method to determine, if residual cleaning agents and/or active ingredients are present in equipment, coupons or a swab/wipe including swab recovery and Material recovery form swab after controlled spike.

Ø       Stability testing for Active Pharmaceutical Substances (API) / Drug Substances, Finished drug products / Devices containing pharmaceutically active substances in bulk and final packaging as per ICH/FDA guidelines at the following conditions.

v Refrigerated (2°C to 8°C),

v Freezer (-20°C),

v Controlled Room Temperature (25°C/60%RH),

v Intermediate Condition (30°C/65%RH),

v Accelerated Condition (40°C/75%RH) and

v Any other Custom conditions needed by clients.

Ø       Powder Morphology Testing using Scanning Electron Microscopy (SEM) and Malvern Particle size analysis.

Ø       Polymorph / Excipients Interaction testing using Differential Scanning Calorimeter (DSC).

Ø       Osmolarity of solutions using Osmometer.

Ø      Laboratory Enzyme assays for measuring enzymatic activity for the study of enzyme kinetics and enzyme inhibition using UV-Vis Spectrophotometer.