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Analytics and spectra · Method transfer

“The method runs at the sponsor's site, but in our lab the peaks no longer separate, and the original column is discontinued.”

Analytical method transfer and validation for HPLC

A method transfer rarely fails because of chemistry, but because of instrument, column and documentation. CovaSyn converts the method to your instrument and your column, checks every adjustment against USP <621> and EP 2.2.46 and drafts the validation protocol under ICH Q2(R2). Your analytical team reviews and signs off.

Starting point

When you need this

  • A method arrives from a sponsor or from development, and on your instrument retention times and resolution shift.
  • The prescribed column is no longer available, and you need an equivalent one.
  • An HPLC method is to be moved to UHPLC, and it is open which changes are allowed without revalidation.
  • Validation under ICH Q2(R2) is due for a new or changed method, and the protocol is missing.

If nothing changes

What it costs when the case stays open

  • The transfer drags on for weeks, and release testing or stability testing waits.
  • An adjustment outside the allowed limits becomes an audit finding or forces a revalidation.
  • Every run on the instrument costs columns, solvent and lab time without it being clear where the problem lies.

Result

What you get

  • Converted method

    Gradient, flow and injection volume converted to the column dimensions, particle size and dwell volume of your instrument, with the expected retention times.

  • Check under USP <621> and EP 2.2.46

    Every change checked against the allowed adjustments, with a clear statement of what is possible without revalidation and what is not.

  • Equivalent columns

    Proposals for replacement columns with similar selectivity and the system suitability criteria you use to confirm equivalence.

  • Protocol for transfer and validation

    Validation parameters and acceptance criteria under ICH Q2(R2) and a draft protocol for comparative transfer, approved by your QA.

How it works

From an open case to a signed-off report

  • 1. Describe the case

    In the initial call, 30 minutes on Microsoft Teams. We tell you honestly whether we can solve your problem.

  • 2. Send the data

    Confidential from the start. We run the evaluation, typically within 5 working days once we have your data.

  • 3. Sign off the report

    You receive the result with reasoning and input data. Your expert reviews and approves it.

CovaSyn

What we evaluate for this

Every number is calculated, not estimated. Every evaluation is documented with its input data and reasoning, so your expert can review and sign it off.

  • Method transferred to your instrument

    Conversion between columns, instruments and HPLC and UHPLC, accounting for dwell volume, with predicted retention times.

  • Adjustments checked against the pharmacopoeia

    Check of changed method parameters against USP <621> and EP 2.2.46.

  • Validation planned under ICH Q2(R2)

    Selection of validation parameters matching the purpose of the method and a draft protocol with acceptance criteria.

Audience

Who it is for

For analytical and QC teams at contract labs, CDMOs and generics manufacturers who take over HPLC methods, move them to new instruments or columns, or validate them.

What the computation does not replace

  • Conversion does not replace the run on the instrument. Only the measurement in your lab shows whether the method meets system suitability.
  • A replacement column only counts as equivalent once your system suitability data confirms it.
  • Protocol and acceptance criteria are approved by your QA. You perform the validation itself in your lab.

Insights

Read on

Questions

Common questions

Which changes to an HPLC method are allowed without revalidation?

USP <621> and chapter 2.2.46 of the European Pharmacopoeia allow adjustments within fixed limits, for example column length and particle size via the ratio of length to particle size, flow, temperature and injection volume. Outside those limits a revalidation is needed. CovaSyn checks every change and justifies the result.

How do I transfer a method from HPLC to UHPLC?

Gradient and flow are scaled to the new column dimensions, and the dwell volume of the instrument has to be taken into account, otherwise early peaks shift. CovaSyn converts the method and shows whether the result is still within the allowed adjustments.

What to do when the column in the method is discontinued?

You need a column with similar selectivity, not just the same phase on the label. CovaSyn proposes equivalent columns and names the system suitability criteria you use to confirm equivalence.

Which parameters belong in a validation under ICH Q2(R2)?

That depends on the purpose: for an assay, specificity, accuracy, precision and range are central, for impurities the quantitation limit and, where relevant, the detection limit are added. CovaSyn selects the parameters to match the method and drafts the protocol.

Who can support us with method transfer?

CovaSyn does this as Done-for-You: you describe method and goal in the initial call, we agree on scope, and you typically receive the evaluation within 5 working days once we have your data. Handled confidentially from the start.

Analytics and spectra

Related problems we solve

Next step

Tell us about your method.

30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.