Parameter Set Mycophenolic Acid - LC-MS/MS

Order No.: 92916
Parameters:
Mycophenolic Acid, Mycophenolic Acid Glucuronide

For the analysis of MPA and MPAG
3PLUS1® and 6PLUS1® Multilevel Calibrator Sets available
Part of the continuously updated MassTox® TDM Series A
Sample preparation with 96 well filter plates also possible

CE-IVD validated product ready for IVDR within timeframes and transition periods specified by the IVDR 2017/746

Mycophenolic Acid

Mycophenolic Acid Glucuronide

Clinical relevance

Mycophenolic acid (MPA) is used as an immunosuppressant agent to prevent organ transplant rejection. MPA selectively inhibits the synthesis of purines and specifically reduces the growth of B- and T-lymphocytes. Furthermore, MPA is also used to treat autoimmune diseases such as psoriasis, systemic lupus erythematosus or scleroderma.

Therapeutic monitoring of MPA in the blood is required to adjust individual concentrations within the therapeutic window and to attain a favourable ratio between therapeutic effects and side effects. Currently available drugs contain mycophenolate mofetil or mycophenolate sodium, which are both completely metabolised into the active metabolite MPA. For excretion, MPA is bound to glucuronic acid. As this step is reversible, it is advisable to analyse MPA glucuronide (MPAG) in serum/plasma, too.

 

Product advantages

With the Parameter Set Mycophenolic Acid in serum/plasma, MPA and its metabolite MPAG can be measured fast and efficiently using LC-MS/MS. Due to the careful optimisation of all kit components as well as the chromatographic separation, matrix effects (“ion suppression”) is minimised and the robustness of the method is enhanced. Sample preparation is based on a protein precipitation step. The use of deuterated internal standards allows this method to produce reproducible results despite the presence of in-source fragmenting, which is characteristic of this substance. The use of 3PLUS1® or 6PLUS1® multilevel calibrators guarantees high precision and reliable quantification. The method is comprehensively validated.

The Parameter Set is a part of the Series A modular system, which enables the analysis of all parameters without switching column or changing the mobile phases, thereby minimising required workload in the laboratory. The Basic Kit A contains all components required for sample preparation and all necessary mobile phases. The MasterColumn® A is the analytical column used for the determination of all Series A analytes. Our portfolio contains further MassTox® Parameter Sets.

For the analysis you require the MassTox® TDM Basic Kit A, the specific MassTox® TDM Parameter Set and the analytical column MassTox® TDM MasterColumn® A.

More Information
Method of Analysis LC-MS/MS
Please note The information listed here, including the sample preparation, is not sufficient for using the product. Please read the information provided in the instruction manual, which includes detailed information on limitations associated with the use of the product in line with its intended purpose. Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Lower and Upper Limit of Quantitation

MPA: 0.2 – 75 mg/l
MPAG: 2.5 – 500 mg/l

Different systems might show different performance data.

Run Time 1.8 min
Specimen Serum/Plasma
Sample Preparation

The information on the sample preparation presented here is not sufficient for use in the laboratory. For a detailed step by step description, please refer to the instruction manual.

  • Reconstitute the Internal Standard Mix
  • Add 800 μl Internal Standard mix to 12 ml Precipitation Reagent to form mixture A
  • Pipette 50 μl sample/calibrator/MassCheck® control into a 1.5 ml reaction vial
  • Add 25 μl Extraction Buffer, mix briefly (vortex) and incubate 2 min.
  • Add 250 μl of mixture A and mix 30 s minimum (vortex) and centrifuge 5 min.
  • Dilute the supernatant with Dilution Buffer prior to injection depending on the instrument sensitivity
Injection Volume 0.2 – 50 µl
Gradient

Starting point: 60 % Mobile Phase 2
0.00→0.50 min  100 % Mobile Phase 2
0.51–1.00 min    100 % Mobile Phase 2
1.01→1.10 min    60 % Mobile Phase 2
1.11–1.80 min      60 % Mobile Phase 2

Ionisation ESI positive
MS/MS Mode MRM
Parameters Mycophenolic Acid, Mycophenolic Acid Glucuronide
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.

Mycophenolic Acid

Mycophenolic Acid Glucuronide

Clinical relevance

Mycophenolic acid (MPA) is used as an immunosuppressant agent to prevent organ transplant rejection. MPA selectively inhibits the synthesis of purines and specifically reduces the growth of B- and T-lymphocytes. Furthermore, MPA is also used to treat autoimmune diseases such as psoriasis, systemic lupus erythematosus or scleroderma.

Therapeutic monitoring of MPA in the blood is required to adjust individual concentrations within the therapeutic window and to attain a favourable ratio between therapeutic effects and side effects. Currently available drugs contain mycophenolate mofetil or mycophenolate sodium, which are both completely metabolised into the active metabolite MPA. For excretion, MPA is bound to glucuronic acid. As this step is reversible, it is advisable to analyse MPA glucuronide (MPAG) in serum/plasma, too.

 

Product advantages

With the Parameter Set Mycophenolic Acid in serum/plasma, MPA and its metabolite MPAG can be measured fast and efficiently using LC-MS/MS. Due to the careful optimisation of all kit components as well as the chromatographic separation, matrix effects (“ion suppression”) is minimised and the robustness of the method is enhanced. Sample preparation is based on a protein precipitation step. The use of deuterated internal standards allows this method to produce reproducible results despite the presence of in-source fragmenting, which is characteristic of this substance. The use of 3PLUS1® or 6PLUS1® multilevel calibrators guarantees high precision and reliable quantification. The method is comprehensively validated.

The Parameter Set is a part of the Series A modular system, which enables the analysis of all parameters without switching column or changing the mobile phases, thereby minimising required workload in the laboratory. The Basic Kit A contains all components required for sample preparation and all necessary mobile phases. The MasterColumn® A is the analytical column used for the determination of all Series A analytes. Our portfolio contains further MassTox® Parameter Sets.

For the analysis you require the MassTox® TDM Basic Kit A, the specific MassTox® TDM Parameter Set and the analytical column MassTox® TDM MasterColumn® A.

More Information
Method of Analysis LC-MS/MS
Please note The information listed here, including the sample preparation, is not sufficient for using the product. Please read the information provided in the instruction manual, which includes detailed information on limitations associated with the use of the product in line with its intended purpose. Detailed performance evaluation data for this assay can be found in Appendices II and III of the instruction manual.
Lower and Upper Limit of Quantitation

MPA: 0.2 – 75 mg/l
MPAG: 2.5 – 500 mg/l

Different systems might show different performance data.

Run Time 1.8 min
Specimen Serum/Plasma
Sample Preparation

The information on the sample preparation presented here is not sufficient for use in the laboratory. For a detailed step by step description, please refer to the instruction manual.

  • Reconstitute the Internal Standard Mix
  • Add 800 μl Internal Standard mix to 12 ml Precipitation Reagent to form mixture A
  • Pipette 50 μl sample/calibrator/MassCheck® control into a 1.5 ml reaction vial
  • Add 25 μl Extraction Buffer, mix briefly (vortex) and incubate 2 min.
  • Add 250 μl of mixture A and mix 30 s minimum (vortex) and centrifuge 5 min.
  • Dilute the supernatant with Dilution Buffer prior to injection depending on the instrument sensitivity
Injection Volume 0.2 – 50 µl
Gradient

Starting point: 60 % Mobile Phase 2
0.00→0.50 min  100 % Mobile Phase 2
0.51–1.00 min    100 % Mobile Phase 2
1.01→1.10 min    60 % Mobile Phase 2
1.11–1.80 min      60 % Mobile Phase 2

Ionisation ESI positive
MS/MS Mode MRM
Parameters Mycophenolic Acid, Mycophenolic Acid Glucuronide
The following components are included in the kit:
The following products are not included in the kit but are required for the application of the method:
General lab equipment (non-CE-IVD products), available from Chromsystems:
As a customer please login or register to gain full access.