Pharma, Cosmetics | Lovis 2000 M/ME: Intrinsic Viscosity of Hyaluronic Acid
Sodium hyaluronate is an important raw material for various pharmaceutical and medical applications. To ensure consistent quality and a safe application sodium hyaluronate undergoes various tests described in the EU Pharmacopoeia. The intrinsic viscosity is one of the required test parameters for sodium hyaluronate and can easily be measured using a Lovis 2000 M.
1 Quality Control of Sodium Hyaluronate
Sodium hyaluronate is the sodium salt of hyaluronic acid, which is naturally present in the human body. For medicinal applications, hyaluronic acid either has to be extracted from rooster combs or is synthesized by bacteria under lab conditions. Sodium hyaluronate can be classified into different grades and is widely used in several industries. Some applications are listed in the table below.
1.1 Tests required in EU Pharmacopoeia
The EU Pharmacopoeia is a collection of test methods for the identification and quality control of several pharmaceuticals/medicines. The qualitative and quantitative composition and the tests to be carried out on medicines, raw materials used in production, and on the intermediates of synthesis are described. All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards in order to market their products. Apart from other parameters, sodium hyaluronate has to be tested for its intrinsic viscosity, which has to be stated additionally when labeling the substance.
1.2 Lovis 2000 M/ME in pharmaceutical industry
Lovis 2000 M/ME is a reliable partner in strongly regulated fields such as the pharmaceutical industry, as it is compliant with 21 CFR Part 11 and a Pharma Qualification Package can be offered. In addition to dynamic and kinematic viscosity, Lovis 2000 M/ME offers an integrated polymer software for automatic calculation of polymer parameters such as intrinsic viscosity and molar mass
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