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 protocol. Estimated cost of Step 3) $9,240*
      *This price is based on the assumption that the protocol specifies 24 injections. The price is subject to increase based on revisions to the protocol requested by the customer’s Quality Assurance group.
    • 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) $10,240
  • 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. Combined cost of Steps 1 and 2) $3,800
    • Step 3) Moravek performs the required analysis at a fixed rate of $385 per injection as specified in the protocol. Estimated cost of Step 3) $9,240*
      *This price is based on the assumption that the protocol specifies 24 injections. The price is subject to increase based on revisions to the protocol requested by the customer’s Quality Assurance group.
    • 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) $18,540
  • 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 protocol. Estimated cost of Step 3) $19,260*
      *This price is based on the assumption that Moravek will need to run 36 injections. The price is subject to increase based on revisions to the protocol requested by the customer’s Quality Assurance group.
    • 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) $21,360
  • 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 protocol. Estimated cost of Step 3) $19,260*
      *This price is based on the assumption that Moravek will need to run 36 injections. The price is subject to increase based on revisions to the protocol requested by the customer’s Quality Assurance group.
    • 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) $32,260