Method Transfer Services

HPLC Method Services

Moravek can perform method transfer, including method protocol and method transfer reports for your [14C] or [3H] labeled API.
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Non-Chiral Method Transfer Options

GMP analytical services provided are:

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

    • Step 1) Customer writes or provides a transfer demonstration protocol.
    • Step 2) Moravek reviews and approves the protocol.
    • Step 3) Moravek performs the required analysis utilizing qualified instrumentation, using a non-chiral analytical column provided by customer, at a fixed rate of $435 per injection as specified in the protocol.
    • 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.
    • Base cost of Option A*) $12,140
      *This price includes up to 24 injections. Additional injections can be run at an additional fee of $435 per injection.
  • Option B) Demonstration of Method Performance Suitability, Moravek Derived Documentation
    Description: Limited in nature to the evaluation of system suitability, repeatability, 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 utilizing qualified instrumentation, using a non-chiral analytical column provided by customer, at a fixed rate of $435 per injection as specified in the protocol.
    • 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.
    • Base cost of Option B*) $20,440
      *This price includes up to 24 injections. Additional injections can be run at an additional fee of $435 per injection.
  • Option C) Full Method Transfer, Customer 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.
    • Step 3) Moravek performs the required analysis utilizing qualified instrumentation, using a non-chiral analytical column provided by customer, at a fixed rate of $535 per injection* as specified in the protocol.
      *The increased price per injection includes the cost of a second qualified chromatographic system and involvement of a second QC technician to demonstrate Intermediate Precision (reproducibility).
    • 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.
    • Base cost of Option C*) $22,060
      *This price includes up to 36 injections. Additional injections can be run at an additional fee of $535 per injection.
  • 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.
    • Step 3) Moravek performs the required analysis utilizing qualified instrumentation, using a non-chiral analytical column provided by customer, at a fixed rate of $535 per injection* as specified in the protocol.
      *The increased price per injection includes the cost of a second qualified chromatographic system and involvement of a second QC technician to demonstrate Intermediate Precision (reproducibility).
    • 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.
    • Base cost of Option D*) $32,960
      *This price includes up to 36 injections. Additional injections can be run at an additional fee of $535 per injection.

Chiral Method Transfer Options

GMP analytical services provided are:

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

    • Step 1) Customer writes or provides a transfer demonstration protocol.
    • Step 2) Moravek reviews and approves the protocol.
    • Step 3) Moravek performs the required analysis utilizing qualified instrumentation, using a chiral analytical column provided by customer, at a fixed rate of $435 per injection as specified in the protocol.
    • 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.
    • Base cost of Option A*) $17,290
      *This price includes up to 34 injections. Additional injections can be run at an additional fee of $435 per injection.
  • Option B) Demonstration of Method Performance Suitability, Moravek Derived Documentation
    Description: Limited in nature to the evaluation of system suitability, repeatability, 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 utilizing qualified instrumentation, using a chiral analytical column provided by customer, at a fixed rate of $435 per injection as specified in the protocol.
    • 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.
    • Base cost of Option B*) $25,590
      *This price includes up to 24 injections. Additional injections can be run at an additional fee of $435 per injection.
  • Option C) Full Method Transfer, Customer 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.
    • Step 3) Moravek performs the required analysis utilizing qualified instrumentation, using a chiral analytical column provided by customer, at a fixed rate of $535 per injection* as specified in the protocol.
      *The increased price per injection includes the cost of a second qualified chromatographic system and involvement of a second QC technician to demonstrate Intermediate Precision (reproducibility).
    • 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.
    • Base cost of Option C*) $28,710
      *This price includes up to 46 injections. Additional injections can be run at an additional fee of $535 per injection.
  • 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.
    • Step 3) Moravek performs the required analysis utilizing qualified instrumentation, using a chiral analytical column provided by customer, at a fixed rate of $535 per injection* as specified in the protocol.
      *The increased price per injection includes the cost of a second qualified chromatographic system and involvement of a second QC technician to demonstrate Intermediate Precision (reproducibility).
    • 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.
    • Base cost of Option D*) $39,610
      *This price includes up to 46 injections. Additional injections can be run at an additional fee of $535 per injection.