PharmaBlock's analytical and QC team provides comprehensive services to customers, covering the entire process from RSM and intermediates to API development. These services include analytical method development and validation, release testing, and stability studies.

• Experienced in analytical support from early to late-stage to commercial CMC projects
• Phase-appropriate methods development, validation and transfer including stability-indicating method development and forced degradation studies for DS

  - Microbiological testing (microbial limits test, test for specified microorganisms, bacterial endotoxins test) methods development, validation

  - Elemental impurities test (ICP-MS) methods development, validation

  - Particle size distribution methods development, validation

• Specification setting for early, late clinical to commercial stage RM, intermediate, API
• RMs and in-process control, API release tests (chemical and physical properties)
• Impurity profiling, impurity isolation and structural identification
• Reference standard characterization and qualification
• Evaluation of genotoxic impurities (GTIs) with internal database
• Formal and informal stability studies

• Class D cleanroom with local Class A areas
• Capable of conducting microbial limits, bioburden, utility system testing, and environmental monitoring
• Subjected to periodic and routine monitoring

• LC, LC-MS, UPLC, UPLC-MS, UPCC, UPCC-MS, LC-MS/MS, GC, GC-MS, IC, Prep-HPLC, SFC

• NMR, LC-Q-TOF, Orbitrap (HRMS), IR

• ICP-MS, ICP-OES, Microwave Digestion

• Analytical Balance, KF Titrator with Oven, Polarimeter, Melting Point, Potentiometric Titrator, Muffle Furnace, Drying Oven, Halogen Moisture Meter, Ultra-Pure Water System