Analytical and Stability Services
Pharmaceutical Development Center (PDC) offers complete analytical development and quality control services required for all phases of the drug development process, including stability studies.
Our analytical laboratories are fully equipped to perform complete analytical method development and validation for drug substance and dosage forms using current regulatory guidelines. We work closely with our clients to develop method validation protocols. We also employ client-developed methods or compendial methods with agreed-upon transfer protocols to perform testing on drug substance and formulated dosage forms (solids, semi-solids, liquids - sterile and non-sterile). We have a fully equipped microbiology laboratory for quality control of sterile products.
PDC offers full stability storage and testing services for accelerated or long-term stability studies. Drug substance and drug products are stored under temperature and humidity controlled conditions following ICH guidelines. All chambers have undergone installation and operational qualification and are continuously monitored.
Analytical Services
- Methods Development and Validation for drug substance and drug products.
- Preformulation and compatibility studies.
Compendial testing.
- Release testing of drug products manufactured by PDC or others by PDC-developed, client-developed, or USP methods.
- Dissolution methods development and testing.
- Comparative dissolution.
- Accelerated and long-term stability studies.
- Stability storage facilities.
- Cleaning validation/methods development.
Pharmaceutical Development Center (PDC), 4221 Faber Place Drive, North Charleston, SC 29405-8510. Tel: 843-746-2500; Fax: 843-746-2550.