AssayIndex

SSA-2603-C6950

Enclomiphene citrate · 50 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · manufactured 04 Mar 2026

PARTIALLY CHARACTERISED
Lot code
SSA-2603-C6950
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Compound
Enclomiphene citrate
Compound class
Non-peptide adjuncts
Declared label claim
50mg
Manufacture date
04 Mar 2026
Index quarter
2026-Q2
Independent assays
2
Laboratories involved
VendorInvestigate, Medutest
Provenance mix
Buyer-sourced ×2
Section 1

Reproducibility across independent tests

Every report below is an observation of the same physical material. What they disagree about is measurement; what they agree about is the lot. The size of the disagreement is compared against what the contributing laboratories' own repeatability figures predict.

Independent assays 2
Median purity 97.83% n=2
Spread (max − min) 0.19pp n=2
Standard deviation n<3 n=2
97.397.898.298.799.299.7100.1This lot (SSA-2603-C6950)This lot (SSA-2603-C6950): Q1 97.78, median 97.83, Q3 97.87, n=2n=2All Enclomiphene citrateAll Enclomiphene citrate: Q1 98.27, median 99.23, Q3 99.75, n=55n=55 Purity (% area)
Figure 1. This lot's independent purity results against the whole Enclomiphene citrate record set in the index. The vertical line is the index acceptance specification for the non-peptide adjuncts class, 98.5 % area. A narrow box on the top row against a wide box on the bottom row is the ideal reading: it means the disagreement between lots is much larger than the disagreement within this one.
Section 2

Member reports 2

Every report the index holds on this lot. Each is a page carrying its own chromatogram, mass spectrum, mass balance, provenance and caveats.

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043145SSA-2603-C6950VendorInvestigate2026-Q297.733.64—Buyer-sourced2FAIL
AX-2026-043146SSA-2603-C6950Medutest2026-Q297.923.1192.9Buyer-sourced2FAIL
Section 3

By laboratory

Where more than one laboratory assayed this lot, the difference between them is a paired observation of their relative bias — the same material, the same time window, different instruments. Those pairs are what the index's bias estimates are built from.

LaboratoryReportsPurity results (% area)MedianGradientPublished bias (pp)Bias-adjusted
VendorInvestigate197.7397.7332min-0.1197.84
Medutest197.9297.9225min+0.0897.84

This lot contributes 1 paired comparison to the inter-lab analysis.

Section 4

The supplier's certificate for this lot

One number the supplier wrote, beside the median of the numbers other people measured on the same physical material. That comparison is only available because the index groups by lot.

FigureSupplier COAThis reportIndex note
Purity (% area)99.097.73divergence +1.17 pp vs batch median
Total impurities (% area)1.002.27
Largest single impurity (% area)0.391.01
Water (%)not stated3.64
Counter-ion (%)not stated33.06
Peptide content (%w/w)91.7not determined
Endotoxin (EU/mg)0.66not determined
Method stated on certificateYES—column, gradient and wavelength given
Section 5

Impurity fingerprint

The named impurities reported across this lot's assays, with how consistently each was seen. A fingerprint is what allows two lot numbers held by different companies to be identified as one bulk.

Named impurityReported inMedian % areaRange
N-oxide (+16 Da)2 / 20.870.73–1.01
free base (des-citrate)2 / 20.460.36–0.55
zuclomiphene (cis-isomer)2 / 20.480.37–0.59
des-ethyl enclomiphene (−28 Da)2 / 20.370.34–0.40
Section 7

What this rollup does not establish