Certa Analytical methods

The method behind the meaning.

Each analysis is produced by a specific method, and the report states which one was used. Only methods that are supported are listed here.

Our analytical techniques

Technique / 01HPLC / LC

High-performance liquid chromatography

Reverse-phase separation with UV detection. The basis for purity figures and for resolving related substances.

What it helps establish

  • Chromatographic purity
  • Related substances
  • Largest single impurity
Technique / 02LC-MS

Liquid chromatography – mass spectrometry

Chromatographic separation coupled to mass detection with electrospray ionisation, used to establish what a peak actually is.

What it helps establish

  • Molecular identity
  • Mass characterization
  • Additional analytical signals
Technique / 03LC-MS QUANT

LC-MS quantification

Quantification against an external calibration with a reference standard, reported as the mean of replicate determinations.

What it helps establish

  • Peptide content
  • Content relative to declared quantity
  • Replicate spread
Technique / 04AAA

Amino acid analysis

Acid hydrolysis followed by chromatographic separation and quantification of the constituent amino acids.

What it helps establish

  • Amino acid composition
  • Residue ratios
  • Net peptide content
Technique / 05ENDOTOXIN

Bacterial endotoxin determination

Quantitative determination of bacterial endotoxin, reported with the unit and the quantification threshold applied.

What it helps establish

  • Endotoxin level
  • Reporting unit
  • Quantification threshold
Technique / 06MICRO

Microbiological analysis

Enumeration and identification of microbial contamination in a submitted sample.

What it helps establish

  • Total microbial count
  • Yeast and mould
  • Specified microorganisms

Scope

Method availability is confirmed per request. Where a sample needs a method that is not listed, the request is assessed before any testing is agreed rather than fitted to the methods above.

Request a QuoteAnalytical services