High Performance Liquid Chromatography (HPLC) Method Transfer Service

HPLC Method Services

Moravek can perform method transfer, including method protocol and method transfer reports for your [14C] or [3H] labeled API.

Method Transfer Options

GMP analytical services provided are:

  • Option A) Demonstration of Method Performance Suitability, Client Derived Documentation
    Description: Limited in nature to the evaluation of system suitability, reproducibility, related compounds and Limit Of Quantitation.

    • Step 1) Customer writes or provides a transfer demonstration protocol.
    • Step 2) Moravek reviews and approves the protocol. Combined cost of Steps 1 and 2) $500
    • Step 3) Moravek performs the required analysis at a fixed rate of $385 per injection as specified in the validated method. Estimated cost of Step 3) $6,930*
      *This price is based on the assumption that the validated method specifies 18 injections. The actual cost of Step 3 will be determined by the total number of injections specified in the validated method.
    • Step 4) Moravek provides a summary of the data generated to the customer.
    • Step 5) Customer writes or provides a transfer demonstration report.
    • Step 6) Moravek reviews and approves the report. Combined cost of Steps 4, 5 and 6) $500 Estimated cost of Option A) $7,930
  • Option B) Demonstration of Method Performance Suitability, Moravek Derived Documentation
    Description: Limited in nature to the evaluation of system suitability, reproducibility, related compounds and Limit Of Quantitation.

    • Step 1) Moravek writes or provides a transfer demonstration protocol.
    • Step 2) Customer reviews and approves the protocol.
    • Step 3) Moravek performs the required analysis at a fixed rate of $385 per injection as specified in the validated method. Estimated cost of Step 3) $6,930*
      *This price is based on the assumption that the validated method specifies 18 injections. The actual cost of Step 3 will be determined by the total number of injections specified in the validated method.
    • Step 4) Moravek provides a summary of the data generated to the customer.
    • Step 5) Moravek writes or provides a transfer demonstration report.
    • Step 6) Customer reviews and approves the report. Combined cost of Steps 4, 5 and 6) $5,500 Estimated cost of Option B) $16,230
  • Option C) Full Method Transfer, Client Derived Documentation
    Description: Evaluation of system suitability, linearity, repeatability, reproducibility, Limit Of Quantitation, Limit Of Detection, and related compounds.

    • Step 1) Customer writes or provides a method transfer protocol.
    • Step 2) Moravek reviews and approves the protocol. Combined cost of Steps 1 and 2) $900
    • Step 3) Moravek performs the required analysis at a fixed rate of $535 per injection as specified in the validated method. Estimated cost of Step 3) $18,190*
      *This price is based on the assumption that Moravek will need to run 34 injections. The actual cost of Step 3 will be determined by the total number of injections specified in the validated method.
    • Step 4) Moravek provides a summary of the data generated to the customer.
    • Step 5) Customer writes or provides a method transfer report.
    • Step 6) Moravek reviews and approves the report. Combined cost of Steps 4, 5 and 6) $1,200 Estimated cost of Option C) $20,290
  • Option D) Full Method Transfer, Moravek Derived Documentation
    Description: Evaluation of system suitability, linearity, repeatability, reproducibility, Limit Of Quantitation, Limit Of Detection, and related compounds.

    • Step 1) Moravek writes or provides a method transfer protocol.
    • Step 2) Customer reviews and approves the protocol. Combined cost of Steps 1 and 2) $4,500
    • Step 3) Moravek performs the required analysis at a fixed rate of $535 per injection as specified in the validated method. Estimated cost of Step 3) $18,190*

      *This price is based on the assumption that Moravek will need to run 34 injections. The actual cost of Step 3 will be determined by the total number of injections specified in the validated method.

    • Step 4) Moravek provides a summary of the data generated to the customer.
    • Step 5) Moravek writes or provides a method transfer report.
    • Step 6) Customer reviews and approves the report. Combined cost of Steps 4, 5 and 6) $8,500 Estimated cost of Option D) $31,190