Mycophenolic Acid in Plasma/Serum - HPLC

Order No.: 46000, for 100 tests
Parameters:
Mycophenolic Acid

Fast and easy sample preparation
Detection of physiologically active MPA

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

Mycophenolic Acid

Clinical relevance

Mycophenolic acid (MPA) is used as an immunosuppressant agent to prevent organ transplant rejection. It is also used to treat autoimmune disorders with chronic inflammation of the skin (psoriasis), eyes, and the digestive tract (Crohn's disease).

Currently available drugs contain mycophenolate mofetil or mycophenolate sodium, which are both completely metabolised into the active metabolite MPA. MPA is partially further metabolised into the inactive mycophenolate glucuronide (MPAG), which then can undergo deglucuronidation in the enterohepatic circulation system and is available again in the body as an active metabolite. Therapeutic monitoring of MPA is required to reach blood concentrations within the therapeutic window to achieve a favourable ratio between therapeutic effects and side effects for the patient.

The Chromsystems assay allows the quantitative detection of mycophenolic acid in human plasma or serum samples by HPLC (high performance liquid chromatography).
It is intended as a monitoring test for patients treated with mycophenolate mofetil or mycophenolate sodium as an aid to ensure drug levels are maintained within the therapeutic range.

 

Product advantages

• Fast and easy sample preparation
• Detection of physiologically active MPA

 

Assay characteristics

Sample preparation is performed by means of selective solid phase extraction, in which physiologically inactive MPAG is separated. The analyte is quantified by the inclusion of an internal standard to compensate losses during sample preparation.

Our TDM Parameter Set Mycophenolic Acid from the MassTox® TDM Series A is available as an alternative for the measurement of MPA and MPAG using LC-MS/MS.

Detailed performance evaluation data for this assay can be found in the appendices of the instruction manual.

More Information
Method of Analysis HPLC
Number of Tests 100
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 the appendices of the instruction manual.
Lower and Upper Limit of Quantitation 0.1 mg/l – 30 mg/l
Specimen Plasma/Serum
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.

  • Centrifuge specimens before sample preparation (10 min at 2800 x g)!
  • Precondition the Sample Clean Up Columns with 1 ml Equilibration Buffer 1 and draw through by centrifugation (approx. 30–60 s at 190 x g) or suction.
  • Repeat with 1 ml Equilibration Buffer 2.
  • Mix 250 μl plasma/serum sample with 250 μl Internal Standard.
  • Apply complete sample to the Sample Clean Up Column and draw through by centrifugation (1 min at 190 x g) or suction; discard effluent.
  • Draw 2 x 1 ml Wash Buffer through Sample Clean Up Column by centrifugation (2 min at 1100 x g) or suction; discard effluent.
  • Elute the mycophenolic acid with 400 μl of the Elution Buffer.
  • Inject 20–40 μl eluate into the HPLC system.
Run Time 8–9 min
Injection Volume 20–40 µl
Flow Rate 1 ml/min
Column Temperature ambient (~ 25 °C)
Wavelength 215 nm
Gradient isocratic
Additional Info Any isocratic HPLC system with UV detector is suitable.
Parameters Mycophenolic Acid
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

Clinical relevance

Mycophenolic acid (MPA) is used as an immunosuppressant agent to prevent organ transplant rejection. It is also used to treat autoimmune disorders with chronic inflammation of the skin (psoriasis), eyes, and the digestive tract (Crohn's disease).

Currently available drugs contain mycophenolate mofetil or mycophenolate sodium, which are both completely metabolised into the active metabolite MPA. MPA is partially further metabolised into the inactive mycophenolate glucuronide (MPAG), which then can undergo deglucuronidation in the enterohepatic circulation system and is available again in the body as an active metabolite. Therapeutic monitoring of MPA is required to reach blood concentrations within the therapeutic window to achieve a favourable ratio between therapeutic effects and side effects for the patient.

The Chromsystems assay allows the quantitative detection of mycophenolic acid in human plasma or serum samples by HPLC (high performance liquid chromatography).
It is intended as a monitoring test for patients treated with mycophenolate mofetil or mycophenolate sodium as an aid to ensure drug levels are maintained within the therapeutic range.

 

Product advantages

• Fast and easy sample preparation
• Detection of physiologically active MPA

 

Assay characteristics

Sample preparation is performed by means of selective solid phase extraction, in which physiologically inactive MPAG is separated. The analyte is quantified by the inclusion of an internal standard to compensate losses during sample preparation.

Our TDM Parameter Set Mycophenolic Acid from the MassTox® TDM Series A is available as an alternative for the measurement of MPA and MPAG using LC-MS/MS.

Detailed performance evaluation data for this assay can be found in the appendices of the instruction manual.

More Information
Method of Analysis HPLC
Number of Tests 100
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 the appendices of the instruction manual.
Lower and Upper Limit of Quantitation 0.1 mg/l – 30 mg/l
Specimen Plasma/Serum
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.

  • Centrifuge specimens before sample preparation (10 min at 2800 x g)!
  • Precondition the Sample Clean Up Columns with 1 ml Equilibration Buffer 1 and draw through by centrifugation (approx. 30–60 s at 190 x g) or suction.
  • Repeat with 1 ml Equilibration Buffer 2.
  • Mix 250 μl plasma/serum sample with 250 μl Internal Standard.
  • Apply complete sample to the Sample Clean Up Column and draw through by centrifugation (1 min at 190 x g) or suction; discard effluent.
  • Draw 2 x 1 ml Wash Buffer through Sample Clean Up Column by centrifugation (2 min at 1100 x g) or suction; discard effluent.
  • Elute the mycophenolic acid with 400 μl of the Elution Buffer.
  • Inject 20–40 μl eluate into the HPLC system.
Run Time 8–9 min
Injection Volume 20–40 µl
Flow Rate 1 ml/min
Column Temperature ambient (~ 25 °C)
Wavelength 215 nm
Gradient isocratic
Additional Info Any isocratic HPLC system with UV detector is suitable.
Parameters Mycophenolic Acid
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.