Method Development and Validation
BioScreen has over 20 years of analytical experience. We specialize in the validation of HPLC, LC-MS, GC, GC-MS, ICP and ICP-MS methods in particular, and have state of the art equipment to meet industry standards and your expectations. All validation packages are delivered to the client ready for FDA review or submission. Studies can be conducted GMP or GLP.
Stability Studies
BioScreen offers a comprehensive cGMP stability program. Multiple chambers are used to meet a variety of temperature conditions as required by FDA and ICH as well as various client directed conditions give our program depth and versatility. BioScreen has new state-of-the-art validated stability chambers. All stability chambers have back up power and are monitored continuously. BioScreen can assist companies at all stages of the drug development process. The company is experienced with IND and NDA projects
- Accelerated Stability
- Long Term Stability
- Drug Substance or Drug Product Stability
- IND, NDA, ANDA Stability
- Photostability
- Protocol Design for R&D Stability and Formulation Evaluations
- Stability Storage
Common Tests Offered:
- Pharmacopoeia Testing per USP, EP, BP, JP, FCC, ACS, AOAC and Other Monographs
- Active Pharmaceutical Ingredient (API) - Drug Substance
- Excipient
- Bulk Release
- Drug Product/ Finished Product
- Water Testing
- Total Organic Carbon Determination, TOC USP, EP (2.2.44)
- Conductivity Measurement, USP
- Heavy Metals Testing, USP <232><233>
- Elemental Impurities- Limits, USP
- Elemental Impurities- Procedures, USP
- Cleaning Validation Studies
- Leachables and Extractables, USP, EP (3.2.2)
- Residual Solvents, USP 467
- Container Closure Integrity/Dye Imersion
- Content Uniformity
- Dissolution Testing, USP
- Physical Testing
- Color
- Odor
- Appearance
- Specific Gravity
- Viscoscity
- Weight Change