The method described in the European Pharmacopoeia (01/2011:1472 in Ph. Eur. 8.6) for determining the content of hyaluronic acid can only be applied with considerable effort to products containing hyaluronic acid and only determines the hyaluronic acid content indirectly. Other standard processes, such as determining the HPLC concentration of monomers and oligomers following the enzymatic degradation of the hyaluronic acid, are not easy to implement in products with more complex matrices.
As a result, we decided to develop a direct method for determining the concentration of native hyaluronic acid. This method offers the following advantages over the commonly used methods:
- Good reproducibility
- Determines native hyaluronic acid → thus suitable for stability studies
- Also suitable for lower concentrations
- Low susceptibility to disruption, e.g. by different matrix components
- Raw material can be qualified as a standard
Labor LS offers you the following services to achieve the routine testing of your product in four steps:
- Suitability test: can the method be used on your product?
- Establish a workup of the sample
- Product-specific validation in accordance with ICH guidelines (Q2(R1)), specificity, linearity, accuracy, reproducibility, robustness