Sodium Hyaluronate Analysis

Expert sodium hyaluronate testing, ensuring regulatory success

 

Sodium hyaluronate (NaHA) is a critical ingredient in pharmaceutical formulations, medical devices and life science applications. At RSSL, we offer a comprehensive suite of testing services aligned with European Pharmacopeia (Ph. Eur) standards to help you verify the identity, purity and concentration of NaHA, supporting your product’s regulatory success and market readiness.

 

What is Sodium Hyaluronate? Sodium hyaluronate is the sodium salt of hyaluronic acid which is widely used for its hydrating and viscoelastic properties. It is widely used in treatments for joint disorders, ophthalmic solutions, skin care formulations and medical device applications. Given its functional versatility, tight regulatory benchmarks relating to quality attributes including concentration, impurity profile and microbiological purity is essential to ensure safety and efficacy.

 

 

European Pharmacopeia compliant testing services

 

Our expert scientists perform an extensive range of Ph. Eur compliant tests designed to meet the exact requirements of your formulations

 

  •  Presence confirmation of sodium hyaluronate through IR spectroscopy and specific chemical identification tests.
  •  Assay content determination using a quantification method. NaHA is a polysaccharide with repeating disaccharide units, one of which is Glucuronic acid.  As the ratio is fixed between the two, the content can be accurately determined by measuring the glucuronic acid. This measurement is carried out using the Carbazole reaction and UV/Visible spectroscopy, ensuring accurate dosing and regulatory label claims.
  •  Purity testing to evaluate and quantify impurities such as proteins, heavy metals & endotoxins. Utilising techniques such as atomic absorption spectroscopy (AAS) ensures the levels are within acceptable limits, critical for product safety and stability.
  • Microbial limit testing to confirm the absence of harmful microbial contaminants to meet Ph. Eur safety and hygiene standards.
  •  Assessment of the physicochemical properties of a product to confirm compatibility with the target formulation or therapeutic use through pH analysis.
  • Moisture content measurement using the loss on drying (LOD) method. This forms a key parameter for stability, compliance and assay calculations.

 

 

RSSL is a trusted partner to leading global manufacturers, supporting regulatory compliance and product excellence through a uniquely comprehensive approach. Our deep understanding of Pharmacopeia monographs and international regulatory requirements ensures that clients remain aligned with global standards. This expertise is backed by state of the art facilities and advanced analytical technologies, enabling us to tackle even the most complex testing challenges. 

 

We are committed to exceptional customer service, offering responsive communication, fast turnaround times, and tailored testing solutions that meet the specific needs of each client. With decades of experience and a proven track record, RSSL consistently delivers reliable, high-quality data to the Life Science industry. 

 

Whether you’re developing a new sodium hyaluronate based product or validating a current formulation, RSSL provides the analytical support and regulatory assurance you need to move forward with confidence.

 

 

Get in touch today to learn more about our testing solutions and how we can support your journey to regulatory success.

 

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