Would you like to analyze the beta-tricalcium phosphate in your medical devices according to ASTM F1088-23?
First of all, the ASTM F1088-23 specification is evolving to meet the requirements of ICH Q3D and USP 233.
What does ASTM F1088-23 say?
The ASTM F1088-23 standard covers the chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate used in surgical implant applications. Elemental analysis of calcium and phosphorus shall comply with the expected stoichiometry of beta-TCP (Ca3(PO4)2).
The calcium and phosphorus content shall be determined using a suitable method such as X-ray fluorescence. A quantitative analysis by X-ray diffraction (XRD) shall indicate a minimum beta-tricalcium phosphate content of 95%, determined using the powder diffraction method.
FILAB supports you with your ASTM F1088-23 testing needs
The importance of ASTM F1088-23
The ASTM F1088-23 standard is a fundamental pillar of the medical device industry using beta-tricalcium phosphate. It ensures that these materials meet the strictest quality requirements. In doing so, it promotes the safety and effectiveness of medical devices while improving patients’ lives.
To learn more about this standard and its application in your industry, please do not hesitate to contact us. We are here to guide you toward high-quality, standards-compliant solutions for your medical devices.
Why perform testing according to ASTM F1088-23?
The ASTM F1088-23 standard is crucial for the medical device industry for several reasons:
FILAB offers a wide range of services, some accredited to COFRAC 17025, to support you in evaluating your medical devices
FILAB laboratory has developed extensive expertise in chemical analysis and material characterization to provide you with a comprehensive service for the chemical characterization of all your biomaterials:
- AET calculation
- Validation of extraction completeness according to ISO 10993-12
- Detection and quantification of organic and inorganic residues by ICP, GC\/MS, LC, HS\/GCMS, CLI…
- Identification of impurities by LC-QTOF
- TOC\/TC analysis
- Inorganic residue analysis
- Particulate contamination analysis
With our 3 levels of service – analysis, expertise and R&D support – our laboratory supports industrial companies of all sizes and across all sectors in resolving their industrial challenges. FILAB provides you with the know-how and expertise of its team and offers you a dedicated technical contact.
