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Details : C19RMP3 - ID-LC-MS/MS-based reference measurement procedure for the quantification of topiramate in human serum and plasma
| Type (acronym) | rmp |
|---|---|
| Type | reference measurement procedure |
| Unique Nomination Number | C19RMP3 |
| Analyte Name | topiramate |
| IUPAC IFCC Number | CAS97240-79-4 |
| Method capable of Traceability of Analyte to SI or Defined Procedure | yes |
| Applicable Matrices | human serum and plasma; fresh or frozen |
| Name | ID-LC-MS/MS-based reference measurement procedure for the quantification of topiramate in human serum and plasma |
| Organization that developed Validated Method | This reference measurement procedure was developed and validated by the laboratory of Dr. Risch Ostschweiz AG in Buchs SG, Switzerland in collaboration with Roche Diagnostics GmbH in Penzberg, Germany |
| Measurement Techniques Used | Isotope dilution mass spectrometry |
| Quantity | Mass concentration |
| From (0) | 1.2 |
| To (0) | 36 |
| Unit (0) | µg/mL |
| From (1) | 4.2 |
| To (1) | 3.6 |
| Unit (1) | % |
| Level of Confidence (%) | 95% |
| Comments on Uncertainty Range | The lowest expected measurement uncertainty of 4.2 % is at the mass concentration of 1.60 µg/mL, where n = 6, sample preparations. The highest expected measurement uncertainty of 3.6 % is at the mass concentration of 16.0 µg/mL, where n = 6, sample preparations |
| Peer Reviewed Publication | An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of topiramate in human serum and plasma, Taibon J. et al, Clinical Chemisty and Laboratory Medicine 2023 61(11) 1942-1954 |
| Comments to be published via JCTLM DB | This reference measurement procedure was developed and validated by the laboratory of Dr. Risch Ostschweiz AG in Buchs SG, Switzerland in collaboration with Roche Diagnostics GmbH in Penzberg, Germany |
| Hyperlink to Final Report of extent of Equivalence Studies among | A method comparison with the existing JCTLM listed method C10RMP8, namely NIST method for antiepileptic (topiramate) was not possible, as the method is no longer used by NIST. |
| Analyte Category Name | Drugs |
| Measurement principle/technique | Isotope dilution mass spectrometry |