You would like to analyse the hydroxylapatite and beta-tricalcium content of your DM according to the ASTM F1185-25
Firstly, the ASTM F1185-23 specification is evolving to meet the requirements of ICH Q3D and USP 233.
What does ASTM F1185-23 say ?
ASTM F1185-23 governs the physicochemical and mechanical properties of hydroxyapatite (HAP) materials used in medical devices. This standard provides guidelines on characterisation tests, composition specifications, porosity, density, flexural strength, and many other parameters crucial to assessing the quality and performance of these materials.
This standard concerns the analysis of elemental impurities by ICP in hydroxyapatites. It covers the chemical and crystallographic requirements for hydroxylapatite used in surgical implants. For a material to qualify as medical grade hydroxylapatite, it must comply with this specification.
The FILAB laboratory can assist you with your analysis needs in accordance with ASTM F1185-23 standard
Importance of the ASTM F1185-23 standard
ASTM ASTM F1185-23 is fundamental pillar of the hydroxyapatite medical device industry. It guarantees that these materials comply with the most stringent quality requirements. In this way, they promote the safety and efficacy of medical devices, and improve 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 F1185-23 ?
The ASTM F1185-23 standard is crucial for the medical devices sector for several reasons :
FILAB offers you a wide range of services, some of which are COFRAC 17025 accredited, to help you assess your medical devices
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.
Notre FAQ
ASTM F1185 analysis defines the chemical and crystallographic requirements for medical-grade hydroxyapatite used in surgical implants. It ensures that the material meets strict composition criteria, including calcium/phosphorus ratio and phase purity.
ASTM F1088 testing focuses on the characterization of beta-tricalcium phosphate (β-TCP) used in medical devices.
It evaluates key parameters such as chemical composition, particle size, porosity, and mechanical properties to ensure material performance and safety.
ASTM F1185 analysis typically involves:
- ICP-MS or ICP-OES for elemental impurities
- X-ray diffraction (XRD) for phase identification
- chemical analysis of calcium and phosphorus content
These techniques ensure that hydroxyapatite meets the required purity and structural specifications.
These standards apply to:
- hydroxyapatite powders and raw materials
- beta-tricalcium phosphate (β-TCP)
- biomaterials used in implants or bone substitutes
- materials used for coatings or implant manufacturing
They cover both raw materials and components used in medical devices.
To request a quote for ASTM F1185 or ASTM F1088 analysis, you can contact our team via our contact form, by phone, or by email.
Simply provide details about your requirements, such as:
- type of material (hydroxyapatite, beta-TCP, etc.)
- required analysis (ASTM F1185, ASTM F1088, or related testing)
- applicable standards
- project urgency
- number of samples
Our experts will send you a customized technical and financial proposal within 24–48 hours.
Turnaround times for ASTM F1185 and ASTM F1088 analysis vary depending on the type of testing and the complexity of the project, including the number of samples and analytical techniques required.
However, FILAB is committed to providing fast and flexible timelines, tailored to your industrial constraints and project urgency.
To obtain a quote, you can contact our team via our contact form, by phone, or by email.
Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
