Dry Reference Standards for Pharmaceutical XRF Analysis
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Solution Overview
Problem
The preparation of reliable and safe reference standards for X-ray fluorescence (XRF) measurements in the pharmaceutical sector is challenging due to the use of organometallics, which are time-consuming and potentially hazardous, and there is a lack of suitable dry reference standards commercially available for pharmaceutical applications.
Innovation Solution
A method involving the transfer of a reference sample with a known concentration of a predetermined element into a solvent, mixing with a pharmaceutical excipient material, and evaporating the solvent to create a dry reference standard with the element homogeneously dispersed, using solvents like acetone and excipients such as lactose or calcium carbonate, allowing for the production of multiple standards with varying concentrations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If organometallics are used to prepare reference standards, then reference standards can be produced, but the process becomes time-consuming and potentially hazardous to health
Solution Approach 1:
The patent changes the chemical form of metal standards from organometallic to inorganic salts, and changes the matrix from cellulose to pharmaceutical excipients. This parameter change eliminates the need for complex organic synthesis while maintaining standard quality, thereby reducing preparation time and eliminating health hazards associated with organometallics
Solution Approach 2:
The patent uses commercially available inorganic metal salts as starting materials instead of requiring synthesis of organometallic compounds. These simple inorganic salts can be directly dissolved in solvents and mixed with excipients to create stable reference standards, eliminating time-consuming synthesis steps
2Reliability
If organometallics are used to prepare reference standards, then reference standards can be produced, but the process becomes potentially hazardous to health
Solution Approach 1:
The patent converts potentially hazardous organometallic synthesis into a safe process by using benign inorganic metal salts. The harmful aspect of organometallic handling is eliminated while the beneficial outcome of producing reliable reference standards is maintained through direct dissolution and mixing with pharmaceutical excipients
Solution Approach 2:
The patent replaces hazardous organometallic compounds with safe, commercially available inorganic metal salts. These simple salts eliminate health hazards while allowing direct preparation of reference standards through dissolution and mixing, making the process both safe and efficient
3Adaptability or versatility
If suitable dry reference standards are not available commercially, then XRF can be used in limited applications, but wider commercial applications including pharmaceuticals cannot be supported
Solution Approach 1:
The patent creates reference standards using pharmaceutical excipients as matrices, making them universally applicable to pharmaceutical analysis. This universal approach allows a single preparation method to serve multiple pharmaceutical applications, enabling wider commercial adoption of XRF technology across the pharmaceutical sector
Solution Approach 2:
The patent enables laboratories to prepare their own reference standards using readily available pharmaceutical excipients and inorganic metal salts. This self-service capability eliminates dependence on commercial suppliers and allows customization for specific pharmaceutical applications, thereby expanding XRF versatility
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method simplifies the creation of dry reference standards, ensuring excellent homogeneity and safety, enabling accurate XRF measurements for multiple metals and reducing the complexity and hazards associated with previous methods, thus facilitating wider commercial applications of XRF in the pharmaceutical sector.
Implementation Method 1
evaporating the solvent to form a dry reference sample with the known concentration of the metal homogeneously dispersed in the excipient material
Data Source
AI summary
A measurement standard suitable for measuring amounts of certain elements in pharmaceutical excipients is described. A reference standard is dissolved in a solvent, for example acetone, and mixed with a pharmaceutical excipient such as cellulose, lactose or calcium carbonate. The solvent is then evaporated to provide a dry standard.