AssayIndex
Incretin analogues and co-agonists

Pramlintide

AC137 · amylin analogue · C171H267N51O53S2 · monoisotopic 3947.1064 Da. The index holds 33 assay reports on this compound across 5 batches from 5 suppliers.

33 reports5 batchesmedian 98.84 %index spec 97.5 %
Section 1

Analytical fingerprint

Hand-authored chemistry. These properties describe the substance and do not change when a record is added.

Pramlintide was engineered with three proline substitutions specifically to suppress the fibrillation that makes native human amylin unusable, and that shows in the assay: reconstituted pramlintide is stable enough for a 24-h autosampler queue, which native amylin is not. The Cys2–Cys7 disulfide still reduces, giving the +2 Da open chain 0.9 min early. Thin coverage; the index has fewer than 50 pramlintide reports.

Molecular formula
C171H267N51O53S2
Monoisotopic mass
3947.1064Da
Average mass
3949.44Da
Residues
37
Nominal retention (RG-2, 30 min)
13.94min
Retention window
0.35min
Counter-ion as usually shipped
acetate
Typical label claims
1 mg · 2 mg · 5 mg
Analytical difficulty (index scale)
1.15 — moderate
Purity is a defined quantity
YES
Section 2

Representative chromatogram

Drawn from this page's own medians. Not a scan, not an illustration, and not any single report.

01915382957447659 Pramlintide13.94 min · 98.84 % 13.0216.88 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. A representative Pramlintide trace on the index reference method RG-2, constructed from this page's own numbers: the main peak carries the index median purity of 98.84 % area at the nominal retention time of 13.94 min, and each impurity peak carries the median area the index has observed for that named species at its characteristic retention offset. It is not a scan of any single report — every individual record's own chromatogram is on its own page. The lower panel is the same trace at a stated vertical expansion, baseline-corrected, so the impurities are visible; the main peak runs off-scale there by design. Baseline noise is seeded from the compound slug.
Section 3

What the index has observed

Arithmetic over the 33 records the index holds. Aggregates on this page are computed over the records the index holds, which are not a random sample of the material on the market. Lots that get tested are lots someone chose to test. Read every figure here as a description of this dataset rather than as an estimate of a population.

Median purity 98.84% n=33
Interquartile range 0.64pp n=33
Minimum 97.87% n=33
Maximum 99.93% n=33
Pass rate vs spec 100.0% n=33
Median recovery vs claim 95.5% n=22
Median water 5.07% n=33
Median |mass error| 3.0ppm n=24
024692.093.094.095.096.097.098.099.0100.092.00–92.25 %: n=092.25–92.50 %: n=092.50–92.75 %: n=092.75–93.00 %: n=093.00–93.25 %: n=093.25–93.50 %: n=093.50–93.75 %: n=093.75–94.00 %: n=094.00–94.25 %: n=094.25–94.50 %: n=094.50–94.75 %: n=094.75–95.00 %: n=095.00–95.25 %: n=095.25–95.50 %: n=095.50–95.75 %: n=095.75–96.00 %: n=096.00–96.25 %: n=096.25–96.50 %: n=096.50–96.75 %: n=096.75–97.00 %: n=097.00–97.25 %: n=097.25–97.50 %: n=097.50–97.75 %: n=097.75–98.00 %: n=298.00–98.25 %: n=298.25–98.50 %: n=398.50–98.75 %: n=798.75–99.00 %: n=699.00–99.25 %: n=699.25–99.50 %: n=299.50–99.75 %: n=399.75–100.00 %: n=2median 98.84 Purity (% area) Reports
Figure 2. Purity distribution across all 33 Pramlintide records. Dashed line is this compound's median (98.84 %); the solid vertical is the index acceptance specification for the incretin analogues and co-agonists class (97.5 %). Domain is fixed at 92–100 % on every purity histogram on this site so that compounds can be compared by eye — a wide distribution here is a hard compound, a narrow one is an easy one, and neither is a statement about the suppliers.
Section 4

By supplier

Suppliers with fewer than two purity records on this compound are omitted from the figure rather than drawn as a line. The full table, including the thin cells, is on the by-supplier page.

97.898.298.598.999.399.7100.1MKMMKM: Q1 98.65, median 98.90, Q3 99.28, n=11n=11QSCQSC: Q1 98.82, median 99.13, Q3 99.32, n=10n=10TFCTFC: Q1 98.41, median 98.61, Q3 98.81, n=10n=10 Purity (% area)
Figure 3. Pramlintide purity by supplier, ordered by coverage. The vertical line is the index acceptance specification. Boxes that overlap are suppliers this dataset cannot separate, and most of them overlap.

Full per-supplier table with n= caveats →

Section 5

Characteristic impurities and degradants

The left three columns are authored chemistry — what this molecule characteristically carries and where it elutes. The right three are what the index has actually reported.

Named speciesΔRT (min, RG-2)Δ mass (Da)Seen inMedian % areaMax % area
open-chain (reduced disulfide, +2 Da)-0.92+2.016100%0.391.09
C-terminal free acid (+1 Da)+0.29+0.984100%0.191.21
des-Lys1 (−128 Da)-0.51-128.09594%0.141.44
pramlintide dimer+2.94+3945.09194%0.160.43

Degradation pathways

  • disulfide reduction and subsequent scrambling
  • C-terminal amide hydrolysis below pH 3

Full impurity profile, with what each named species implies about the synthesis →

Section 6

Clinical context

Included because it is routinely misapplied. Trial data describes a licensed medicinal product manufactured under a marketing authorisation, and it does not transfer to research-grade material of unknown provenance.

Pramlintide has been approved as an adjunct to insulin since 2005.

Section 7

Quarterly coverage

QuarterReportsMedian purityRange
2024-Q10n<3—
2024-Q20n<3—
2024-Q32198.7397.93–99.57
2024-Q40n<3—
2025-Q10n<3—
2025-Q20n<3—
2025-Q30n<3—
2025-Q41n<3—
2026-Q11099.1398.23–99.93
2026-Q20n<3—
2026-Q31n<3—

Quarter-by-quarter detail →

Section 8

Most recent records

The 25 most recent Pramlintide records of 33.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043488WXTWXT-2603-D6052Janoshik2026-Q397.874.37—Supplier-supplied1MARGINAL
AX-2026-041569QSCQSC-2511-T6680VendorInvestigate2026-Q198.795.6394.4Buyer-sourced2MARGINAL
AX-2026-041568QSCQSC-2511-T6680Janoshik2026-Q199.165.45—Supplier-supplied0PASS
AX-2026-041563QSCQSC-2511-T6680PeptideMeter2026-Q199.106.1094.2Supplier-supplied0PASS
AX-2026-041572QSCQSC-2511-T6680Janoshik2026-Q199.375.63—Supplier-supplied0PASS
AX-2026-041567QSCQSC-2511-T6680Janoshik2026-Q198.735.07—Supplier-supplied1MARGINAL
AX-2026-041566QSCQSC-2511-T6680PeptideMeter2026-Q199.935.27106.7Supplier-supplied1MARGINAL
AX-2026-041571QSCQSC-2511-T6680PeptideMeter2026-Q199.515.2596.7Supplier-supplied0PASS
AX-2026-041565QSCQSC-2511-T6680PeptideMeter2026-Q199.155.74—Supplier-supplied0PASS
AX-2026-041564QSCQSC-2511-T6680Janoshik2026-Q198.925.77103.2Laboratory-retained0PASS
AX-2026-041570QSCQSC-2511-T6680VendorInvestigate2026-Q198.235.45—Buyer-sourced1MARGINAL
AX-2025-018539WWBWWB-2511-L4181Medutest2025-Q499.937.01—Supplier-supplied1MARGINAL
AX-2024-005099MKMMKM-2405-U4415Janoshik2024-Q398.574.3196.3Supplier-supplied0PASS
AX-2024-004711TFCTFC-2403-Y7884Janoshik2024-Q398.715.0499.3Supplier-supplied0PASS
AX-2024-004710TFCTFC-2403-Y7884Nordanalyt2024-Q398.994.91—Supplier-supplied0PASS
AX-2024-004716TFCTFC-2403-Y7884Janoshik2024-Q398.525.50—Supplier-supplied0PASS
AX-2024-005101MKMMKM-2405-U4415Janoshik2024-Q399.194.63—Supplier-supplied0PASS
AX-2024-005096MKMMKM-2405-U4415Janoshik2024-Q398.734.2497.2Buyer-sourced0PASS
AX-2024-004708TFCTFC-2403-Y7884Janoshik2024-Q398.725.82—Supplier-supplied0PASS
AX-2024-004714TFCTFC-2403-Y7884Janoshik2024-Q398.405.25102.3Supplier-supplied0PASS
AX-2024-005103MKMMKM-2405-U4415PeptideMeter2024-Q398.244.3593.5Buyer-sourced0PASS
AX-2024-005098MKMMKM-2405-U4415PeptideMeter2024-Q398.794.2094.5Supplier-supplied0PASS
AX-2024-004713TFCTFC-2403-Y7884PeptideMeter2024-Q398.444.7896.9Supplier-supplied0PASS
AX-2024-005105MKMMKM-2405-U4415Janoshik2024-Q398.904.3393.8Supplier-supplied0PASS
AX-2024-005100MKMMKM-2405-U4415Kestrel2024-Q399.554.9493.7Laboratory-retained1MARGINAL