In all, more than twenty different parameters can be measured and analyzed internally and externally, according to very strict practices and validated methods.
Measurements take place throughout development, during process validation sequences, but also during manufacturing and on finished products.
Syrhatech - Swiss quality system

As a CDMO, we place great emphasis on the quality of the products we manufacture. To measure and quantify this quality, physical and chemical analysis are essential. This is why we have developed a large range of characterization and analyses.

Today, we are proud to offer you these analyses for the characterization of your products :

Physical characterization

In order to satisfy the needs of our customers, we use very advanced gel characterization methods that allow us to differentiate the gels from each other.
Here is the complete list of physical characterization analyses we offer :

Elastic modulus (G”)Rheological measurement
Loss modulus (G”)
Tangent delta (G’ / G”)
G’ / G” crossover frequency
Zero-shear viscosity
Resistance to compression force
Extrusion forceInjectability at constant speed
Extactable volumePh. Eur. 2.9.17
Average molecular weight and mass distributionGPC measurement method

Degradation Analysis

The formulation development of an hydrogel is a series of very important steps to ensure that the product has the best possible attributes for our customers. It is therefore important to evaluate the behavior of the hydrogel throughout its shelf life, and after it has been implanted in the body. To do this, we have developed techniques to simulate several possible degradations mechanisms.
Here is the complete list of hydrogel degradation tests that we offer :

Resistance to radical degradationRheological measurement
Resistance to enzymatic degradation
Resistance to thermal degradation (stability study at Room Temperature and/or 40°C)According to ICH Q1A (R2) (Stability Testing of New Drug Substances and Products)

Chemical Analysis

In order to ensure compliance with product specifications, or to assess R&D prototypes, for example
during a reverse engineering study, the analysis of the different gel ingredients is a key step.
Here is the full list of assay tests we offer :

Hyaluronic acid contentPh. Eur. 1472
1,4-Butanediol diglycidyl ether “BDDE” residual contentGas chromatography coupled with a mass spectrometer
Degree of modification (crosslinking)Method developed by Nord & al
Lidocaine and lidocaine degradation products contentHPLC method
Chemical characterization of extractable and leacheblesISO 10993-18
pHPh. Eur. 2.2.3
OsmolarityPh. Eur. 2.2.35
Antioxidant activity (TEAC)ABTS method

Microbiological Analysis

Conducting meticulous microbiological tests, including endotoxin, bioburden, and sterility
assessments, is essential for ensuring the utmost safety and efficacy of our hyaluronic acid-based
hydrogels, thereby providing our customers with the highest standard of injectable medical devices.

Bioburden contentPh. Eur. 2.6.12
Endotoxins contentPh. Eur. 2.6.14 (method D)
SterilityPh. Eur. 2.6.1
Proteins contentUSP 1056

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