Hyaluronic Acid Quality Control Testing Services
Quality control testing services to ensure the quality of hyaluronic acid products focused on determining the quantity purity, physico-chemical properties, chemical composition and microbiological properties
Hyaluronic acid (HA) testing is critical to the development of new injectable soft tissue fillers, wrinkle-filling gels, cosmetics and medical devices such as tissue scaffolds. HA is also used in ophthalmic liquids, parenteral administration drugs, nasal sprays, aerosol applications and is a major active ingredient in products dedicated to the prevention of skin aging such as viscosupplements.
Understanding the quantity purity, physico-chemical properties, chemical composition and microbiological properties are critical to supporting research and development, monitoring the quality of raw materials and production processes. Our scientists also provide method development and validation, stability studies at controlled temperature and humidity and extractable and leachable studies.
For nearly ten years, our laboratory teams in France and the UK have developed and validated analytical methods and performed this unique suite of analytical services for the control of raw materials and finished products based on hyaluronic acid. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards for your HA products.
Quality Control Testing Services for Hyaluronic acid
Our scientists provide a range of chemical, biochemical, microbiological and physicochemical testing services to aid your quality control to ensure production of the highest quality products that meet both regulatory and consumer expectations for safety and efficacy.
Following the Eu.Ph. monograph, we can evaluate your HA products for (i) appearance, shape, colour; (ii) identification/confirmation of structure (iii) assay describing the stability (iv) impurities describing the presence of organic volatile impurities and particulate matter, water content, proteins content, residual chemicals, or solvents, degradation products (quantified by gas chromatography (GC-MS)). Also, the specification includes physico-chemical properties, such as pH, osmolarity, viscosity, and particle size.
Dosage/Concentration of Hyaluronic Acid
We determine hyaluronic acid concentration in samples using different quantitative methods, chemical method inspired from the Eur Ph monograph and enzyme-linked immunoassay technique (ELISA) according internal method. Our experienced scientists can readily overcome any challenges presented by product viscosity and dilution requirements and perform method development and verification for your specific product characteristics.
Determination of 1,4-butanediol diglycidyl ether (BDDE)
BDDE is the crosslinking agent used to stabilise most hyaluronic acid fillers. It has an important impact on the physical and functional properties of the finished product and degradation of BDDE over time can produce a number of nonreactive by-products. Our scientists can determine the trace levels of residual unreacted BDDE in dermal fillers to help you meet the safety risk assessment expectations of regulatory authorities.
Determination of Lidocaine Hydrochloride and its impurities
Lidocaine hydrochloride is a local anaesthetic used in HA formulations. We determine levels of lidocaine and its common impurities.
Bioburden and Endotoxin Determination
We conduct bacterial endotoxins testing to detect or quantify bacterial endotoxins of gram-negative bacterial origin as per the European Pharmacopeia 2.6.14 as part of our quality control suite of services. Our microbiology team also provide bioburden testing according to ISO 11731-1 to help clients evaluate sterilization processes, monitor control of raw materials, components and manufacturing processes.
Microbiological Total Viable Count Analysis
To ensure product quality and safety for consumers, we assist producers of HA products through quantification and detection of bacteria present in the products according to ISO 21149:2017. We can also perform quantification of yeast and mould present according to ISO 16212:2017.
Raw Materials Quality Control Testing
We offer modular raw materials quality control testing services from one off testing to comprehensive ongoing programs to determine and monitor the identity, purity and quality of raw materials and also to monitor the impurities to demonstrate that they are present at levels in compliance with regulatory expectations. Raw materials testing solutions are available for Hyaluronic Acid, OEDB, and Lidocaine Hydrochloride.
Physical Properties Determination
Molecular weight range and viscosity are two key parameters in the clinical performance i.e. perceived feel and persistence) and function of HA materials. The degree of cross-linking of the polymer, microstructure and rheological behaviour (i.e. flow characteristics as a function of shear rate, stress, and previous deformation history) will all have an impact. Our Research and Development laboratories also provide robust mechanical and rheological testing.