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Details : C20RMP7 - ID-LC-MS/MS-based reference measurement procedure for the quantification of carbamazepine in human serum and plasma

Type (acronym)rmp
Typereference measurement procedure
Unique Nomination NumberC20RMP7
Analyte Namecarbamazepine
Method capable of Traceability of Analyte to SI or Defined Procedureyes
Applicable Matriceshuman serum and plasma; fresh or frozen
NameID-LC-MS/MS-based reference measurement procedure for the quantification of carbamazepine in human serum and plasma
Organization that developed Validated MethodThis 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 UsedIsotope dilution mass spectrometry
QuantityMass concentration
From (0)0.8
To (0)18
Unit (0)µg/mL
From (1)2
To (1)2.4
Unit (1)%
Level of Confidence (%)95%
Comments on Uncertainty RangeThe lowest expected measurement uncertainty of 2.0 % is at the mass concentration of 1.20 µg/mL, where n = 6 measurements. The highest expected measurement uncertainty of 2.4 % is at the mass concentration of 16.0 µg/mL, where n = 6 measurements
Peer Reviewed PublicationAn isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of carbamazepine in human serum and plasma, Taibon J. et al, Clinical Chemisty and Laboratory Medicine 2023 Dec. 13
Comments to be published via JCTLM DBThis 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 amongA method comparsion study between the candidate RMP and the JCTLM listed RMP C14RMP5 was performed. See Supplemental material 1 of the CCLM 2023 61(11) method publication cited above.
Analyte Category NameDrugs
Measurement principle/techniqueIsotope dilution mass spectrometry