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Laboratory Services |
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Formulations & Analytical Chemistry
SNBL USA offers pre-formulation and dosage form selection services in support of toxicology and pharmacokinetic studies. Test articles are routinely evaluated for characterization, concentration, homogeneity and stability under conditions of use in compliance with domestic and international regulatory guidelines. Cross-site validation services are also available for existing methods.
Test Article Pre-Formulation & Formulation
- Dosage form selection & development
- Materials compatibility
- Parenteral solutions & dispersions
- Bioavailability improvement
- Solubility enhancement
- Preparation of solutions, suspensions, emulsions, & encapsulation
- Controlled storage facilities including continuous monitoring of temperature conditions and back-up generator
- Documentation of all test articles from receipt through storage, use, and disposition
Formulation Analysis
- HPLC & spectrophotometric capabilities
- Characterization, concentration & homogeneity analysis
- Stability under conditions of use
- Formulation degradation
- Impurity characterization
- Moisture content
- Osmometry and turbidimetry
Analytical Chemistry
- Method development & validation
- Cross validation of existing methods
SNBL USA offers clinical and non-clinical bioanalytical method development and validation in accordance with current FDA guidelines to identify and quantitate test articles, metabolites
and degradation products in blood, urine, and other biological fluids or tissues. Cross-site validation services are also available for existing assays.
Bioanalysis
- HPLC, LC/MS, and LC/MS/MS capabilities
- Metabolites & degradation product analysis
- Test article identity & quantitation
- Blood, urine, biological fluid, and tissue analysis
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