Reference standard
synthesis /
qualification

Catalent Pharma Solutions is pleased to be able to offer GMP-compliant synthesis and characterization of materials as reference standards. We can provide standards for your regulatory studies by either isolation and purification from commercial sources or direct synthesis. Areas of synthetic expertise include:

• Nucleosides and Nucleotides
• Carbohydrates
• Carbocyclic and acyclic systems
• Heterocycles
• Peptides and peptide mimics
• Terpenes
• PEG derivatives
• Stable isotopic labeling of compounds
• Asymmetric Synthesis

Characterization testing typically includes¹:

• Proof of Structure by NMR
• Molecular weight confirmation by Mass spectrometry
• FTIR spectrum (with interpretation in terms of structure)
• UV spectrum (for reference purposes, ? max and molar absorptivity reported)
• Differential Scanning Calorimetry (onset of melting and check for polymorphism)
• Elemental Analysis (CHON) (consistency with molecular formula)

When potency assignment is required further testing includes:

• Assay by HPLC
• Moisture by Karl Fisher or Thermal Gravimetric Analysis (correction to potency)

¹FDA Guidance "Analytical Procedures and Methods Validation"

FTIR spectrum of 16-dehydropregnenolone

1H- 13C edited HSQC spectrum of 16-dehydropregnenolone in CDCl3

For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.