Analytical Services

Onyx Scientific provides an independent and comprehensive range of analytical chemistry services.

  Quality Control Analysis

We can provide full or partial QC analysis of customer samples using out extensive range of analytical instrumentation. Below is a list of our analytical instrumentation:

• HPLC (UV detection and ELS detection)
• HRGC (standard injection and headspace sampling)
• LC-MS (Ion-trap)
• FT-IR
• UV spectroscopy
• DSC
• TGA
• Raman spectroscopy
• XRPD
• DVS
• HSM
• Polarimeter
• Karl Fischer analysis
• Vacuum oven (Loss on drying determinations)
• Muffle oven (sulphated ash / residue on ignition)

Any of these may be used in the routine QC analysis of drug substances, drug products, starting materials, raw materials and intermediates to GLP / GMP standards if required.

  Method Development and Validation

Onyx Scientific has extensive experience in the development and validation of analytical methods. All validations are carried out to ICH guidelines which include the generation of validation protocols outlining the tests to be performed, analytical methodology, validation solution preparation and acceptance criteria all prior to initiating the validation study. Our protocols can be reviewed by the customer at their request. Finally, a comprehensive report is produced which details all of the findings from the study.

  Impurity Isolation and Characterisation

We can manufacture and characterise impurities at customer request. Using preparative HPLC (or column chromatography) a specific impurity contained within a sample matrix may be isolated, purified and then identified using our LC-MS, NMR and FT-IR capabilities.

  Reference Standard Characterisation

As part of comprehensive GMP manufacturing service, reference standard purification and characterisation is provided. However, the customer may want only the reference standard synthesis and characterisation performed, this is also a service provided by Onyx Scientific. We also offer a periodic re-characterisation service if applicable.

Request a Quote