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Piramal Pharma Solutions (PPS)
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  5. Piramal - Development Analytical ...

Piramal - Development Analytical Support Services

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We offer analytical support services for oral solids, liquids, creams, ointments and sterile injectable from our facilities in the US, UK, and India. As a leader in integrated solutions, we seamlessly engage our global sites to conduct drug development work in parallel,accelerating time to market and reduce costs for our customers.

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API Properties
  • Chemical: Solubility (equilibrium/kinetic), hygroscopicity, thermal behaviour, log P, and stability.
  • Physical: Microscopy, particle size
Pre-formulation
  • Solubility
  • Forced degradation
  • Particle size
  • Excipient Compatibility
  • Fast content uniformity

Formulation

  • Analytical methods development/validation/transfer
  • Clinical supply release
  • ICH stability studies
  • Identification of unknown impurities
  • Cleaning validations
  • Stability Studies
    • We currently offer stability programs with chambers covering -20°C, 2 ? 8°C, 25°C/60%RH, and 40°C/75%RH, as well as an R&D photostability chamber. Our wide variety of testing services, according to the International Conference on Harmonization (ICH) guidelines, will equip you with the data needed for your filing.
  • Analysis of Support Formulation Development
    • Excipient Compatibility
    • Fast content uniformity
    • Bio-relevant Dissolution for formulation selection
    • Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients
Analytical (Microbiology)
  • Environment Monitoring of classified areas
  • Microbiological analysis of Water
  • Microbial enumeration test
  • Stability Studies along with preservative efficacy testing
  • All testing as GLP requirements.
Analytical Testing Services
  • Liquid chromatography (HPLC)
  • Diode array detectors (DAD)
  • Refractive index detector (RID)
  • Gas chromatography (GC)
  • Protein concentration (TOC)
  • UV/Vis
  • Infrared spectroscopy
  • Karl Fisher (KF) moisture analysis
  • pH determination
  • Total organic carbon (TOC)
  • Viscosity
  • USP particulate testing: HIAC 9705
  • Specific gravity
  • Dissolution testing
  • Particle size testing
  • Zeta potential