Cyanta Analytical Laboratories specializes in providing early phase development and investigative methods for the purpose of material characterization and identification. We also specialize in early phase problem solving and late phase failure investigations.

We specialize in providing non-routine analytical support for:

• Drug substances and excipients
• Oral dosages (tablets, capsules)
• Topical dosages (creams, ointments, lotions)
• Liquid dosages (injectables, suspensions, ophthalmics)
• Inhalation dosages (MDI, DPI, Nasal)
• Medical devices (implantables, drug delivery systems, containers and protective devices)

Reference Standard Characterization
Cyanta Drug Development Services applies a customized approach to reference standard characterization projects according to client needs. The purity and structure of the standard is confirmed through a variety of analytical techniques including NMR, IR, GC/MS, LC/MS, DSC, TGA, Karl Fischer, ICP and IT/MS. Methods are validated according to cGMP/GLP protocols. Reference standard characterization capabilities include:

• Elemental analysis
• Structure confirmation
• Detection and identification of degradants and impurities
• Detection of residual solvents
• Quantitation of degradants, volatiles and water
• Chromatographic purity

Impurity Profiles/Degradation Studies
Cyanta Drug Development Services can assist with impurity profile characterization and degradation studies. Our expertise includes:

• Organic impurities
• Residual solvents/process reagents
• Inorganic impurities

Cyanta follows FDA guidelines to characterize or identify potential degradants by performing degradation studies under acidic, basic, oxidative, and various heat and light conditions. Degradant products can be identified by LC/MS and/or GC/MS. We can also isolate degradants or impurities by preparative methods (column, prep HPLC, flash chromatography) and further characterize these analytes to determine structure using tools such as elemental analysis, IR, NMR and MS.

Contaminant Identification
Cyanta Drug Development Services has developed expertise in materials identification analysis to detect and identify product contaminants. Instrumental and wet chemical methods are used to identify simple and complex mixtures. Contaminants are identified using the following general processes:

• Isolation
• Purification
• Identification