Analytical &
Research Services
Bilcare GCS’ analytical and research services evaluate the performance of formulations using various investigative testing procedures, enabling the foundation for future developments.
Bilcare GCS develops and qualifies a range of analytical methods to be used for subsequent phases of drug development and manufacturing. Our analytical and research services are protocol-driven and can be tailored to fulfil specific client needs.
Our GMP qualified scientists oversee comprehensive testing of materials and ensure that your products comply with required regulatory standards. Our dedicated teams provide technical support during each phase of the product’s development and manufacturing programs.
Bilcare GCS’ comprehensive offering of analytical services for drugs, packaging materials, components and
systems includes:
- HPLC analysis
- Content uniformity studies
- Chromatographic impurity profiling
- Identification testing
- Performance type testing (e.g. friability, hardness and dissolution testing)
- Release testing
- Stability and storage testing
- Cleaning verification / validation
- Accelerated drug stressing
- Dissolution profile testing
- Extractable studies for parenteral products
- Competitor analysis for unbiased de-formulation
- Hygroscopicity studies
- Method development and validation for all phases and components in development of drug substances, non-compendial excipients and drug products
- Process development support
- Reference standard qualification testing
- Stability study protocol design (ICH and custom)
- Mapped environmental chambers including 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, 25°C/40% RH, 40°C/25% RH, 5°C, and photo stability
Bilcare GCS’ Analytical & Research Infrastructure
- Spectroscopy laboratory
- Dissolution laboratory
- Chromatography laboratory
- Physical testing laboratory
- Sample preparation laboratory
- Development laboratories
- Stability storage suite

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