You want to analyse the beta-tricalcium content of your DM in accordance with ASTM F1088-23
Firstly, the ASTM F1088-23 specification is evolving to meet the requirements of ICH Q3D and USP 233.
What does ASTM F1088-23 say ?
ASTM F1088-23 covers the chemical and crystallographic requirements of biocompatible beta-tricalcium phosphate for surgical implant applications. Elemental analysis of calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate.
Calcium and phosphorus content should be determined using an appropriate method such as X-ray fluorescence. Quantitative X-ray diffraction (XRD) analysis should indicate a minimum beta-tricalcium phosphate content of 95%, as determined by the powder diffraction method.
The FILAB laboratory can assist you with your analysis needs in accordance with ASTM F1088-23 standard
Importance of the ASTM F1088-23 standard
ASTM F1088-23 is a fundamental pillar of the hydroxyapatite and beta-tricalcium phosphate medical device industry. It guarantees that these materials comply with the most stringent quality requirements. It thus promotes the safety and effectiveness of medical devices, and improves patients’ lives.
To find out more about these standards and how they apply to your sector, please contact us. We’re here to guide you towards high-quality, standards-compliant solutions for your medical devices.
Why carry out analyses in accordance with ASTM F1088-23 standards ?
The ASTM F1088-23 standard is crucial for the medical devices sector for several reasons :
The FILAB laboratory has developed a wide range of skills in chemical analysis and materials characterisation to provide you with a comprehensive service for the chemical characterisation of all your biomaterials :
- Calculation of TEA
- Validation of extraction completeness according to ISO 10993-12 standard
- Search for and determination of organic and inorganic residues by ICP, GC/MS, LC, HS/GCMS, IC
- Identification of impurities by LC-QTOF
- HCT/COT analysis
- Analysis of inorganic residues
- Analysis of particulate contamination
With our 3 levels of services – analysis, expertise and R&D support – our laboratory supports industrial companies of all sizes and in all sectors in solving their industrial problems. FILAB puts the know-how and expertise of its team at your disposal and provides you with a dedicated technical contact.
