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Is a 97.1% result from Medutest comparable to 99.1% from Janoshik?

Asked 19 Apr 2026Modified 21 days agoViewed 2.4k times
3

Setup, so nobody has to ask: 97.1% · Medutest · 99.1% · Janoshik.

Both of these get recommended confidently by different people, which suggests neither is obviously right.

My constraints are cost, measurement resolution and how much handling I am prepared to do — in roughly that order.

What is the actual trade-off, and does it matter at the scale I am working at?

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DS
askedDr_Ravi_Selvarajah35k13719 Apr 2026

5 Answers

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35

97.1 and 99.1 are 2 percentage points apart, which sounds small until you restate it as impurity. Medutest is leaving 2.9 per cent of the detected area unassigned and Janoshik 0.9 per cent — a factor of 3.22 between them. The impurity fraction is the quantity that moves when a method changes, and it is the one worth arguing about; the headline is just its complement. Comparable means same column chemistry, same gradient slope, same detection wavelength, same integration convention. Until you have those four from both laboratories, 97.1 and 99.1 are two measurements of slightly different quantities that happen to share a unit.

The single most important distinction is between what purity measures — the fraction of detected material that is your target — and what you actually want to know — how much of the material in the vial is your target.

Sample solvent strength affects peak shape — if you inject in strong solvent on a gradient starting in weak solvent, the solvent peak can distort your main peak or create a false shoulder.

What each test answers

TestAnswersDoes NOT answer
RP-HPLC, area %What fraction of detected material is the targetHow much target is present
Quantified contentMilligrams of peptide per vialWhat the impurities are
ESI-MS identityWhether the molecular weight matchesPurity, or isomeric substitution
Peptide mappingSequence, localised to a fragmentQuantity
Karl FischerWater content of the solidSolvent content
LAL endotoxinPyrogen load in EU/mgSterility
Sterility testGrowth in defined media over 14 daysEndotoxin, or bioburden count

Specifically, gradient slope controls resolution, and gentler slopes resolve co-eluting impurities into separate peaks — so the better method reports the worse purity number.

The ICH Q3A impurity thresholds and the relevant pharmacopoeial chapters all specify method validation requirements that almost no research-grade certificate claims to meet.

One qualification: achieving purity above roughly 98 per cent on a 30-residue peptide is fighting the chemistry of synthesis, not the quality of the purification.

Compare purity within a single laboratory on the same method, never across laboratories.

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GA
answeredgrainne_ahearn50k3816 Jun 2026
3The distinction between purity and content cannot be repeated often enough here. – Dr_Fatima_Belkacem 5 months ago
4Thank you — this is the answer I was looking for. – tobias_maartens 6 months ago
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23

The underlying point is that identity and purity are orthogonal, and a high purity says almost nothing about whether the peak is actually what you think it is.

Temperature affects the dynamics of molecular conformation, and if a peptide has proline residues that interconvert on the chromatographic timescale, the peak will split or shoulder at low temperature and collapse at high temperature.

The part that matters: integration of the shoulder — whether you use perpendicular drop or tangent skim — determines what area gets assigned to the main peak versus the impurity table.

Proline conformer interconversion kinetics are well-characterised and the half-life is of the same order as the chromatographic peak width at room temperature.

The limitation is that single-digit micro-impurities become invisible at typical reporting thresholds, so "no impurities detected" means "none above one in two thousand."

If you are ranking vendors, specify a method and have all samples tested at the same place.

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KA
answeredkwn_analytical147k3589 Jul 2026
4Confirming from the other direction: I ignored the method section once and paid for it. – Dr_Colm_Fitzhenry 10 months ago
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15

The short answer is that two competent laboratories on identical material will disagree, and the disagreement is almost always explainable by method differences.

Mass on column affects detector linearity and peak overlap — overloading broadens peaks and hides neighbours, while underloading improves resolution but loses sensitivity.

It helps to be literal here: retention time is sequence-specific and method-specific, so comparing your result to a supplier value using a different method is meaningless without method documentation.

Published side-by-side method comparisons show that a two-point difference in purity on the same vial is easily explained by method choice alone.

The practical summary: ask for the chromatogram and the method, and ignore the headline number until you have both.

edited 3 Jun 2026 by s_kalniete — corrected a unit error in the worked example

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SK
answereds_kalniete57k3814 May 2026
11

The underlying point is that purity is a method-dependent figure, and that is not a limitation of the measurement, it is a property of what the measurement actually answers.

Buffer versus acid in the mobile phase changes the ionisation state of basic and acidic residues, shifting retention and selectivity — same vial, potentially different separation.

Inter-laboratory studies on identical peptide material routinely find half-a-per-cent to a full-per-cent spreads in reported purity on the same sample.

The caveat is that purity without identity is only half an answer — a high purity does not mean the peak is actually what you think it is.

If you only pay for one test, pay for quantified content. Purity is the number everyone quotes and content is the number that changes what you do.

edited 1 Jul 2026 by petra_hovland — expanded the table to cover the lower concentration

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PH
answeredpetra_hovland35k386 Jun 2026
-2

Start from what the detector sees, because that tells you what the number means.

Tailing factor measures peak shape, and a badly tailing peak spreads into the region where small impurities live, forcing tangent-skim integration that assigns tail area to the main peak.

The Arrhenius relationship for peptide degradation is the basis of accelerated stability testing and also governs how quickly methods drift with temperature.

Worth noting that method standardisation is poor in the research-grade space compared to pharmaceutical work, so identical-looking methods can produce different results.

In practice: ask for the chromatogram, check the method section, check the lot number against the vial, and set your accept threshold before you see the result rather than after.

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TR
answeredtobias_reint20k3821 Apr 2026
7Small correction: the limit of quantitation, not the limit of detection, is the relevant one there. – t_oyelaran 6 months ago
8For what it is worth, my own independent result was within half a per cent of this. – Dr_Colm_Fitzhenry 7 months ago
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