Reconstitution Solution

Lot SP02412 Tested October 7, 2026

Overall Result

Outside spec

Accumark Labs reported one result outside specification:

Test information

Individual test results from the independent laboratory report.

Measured 0.72%

Specification 0.9% (v/v) ±20%

Measured, no lab verdict

Measured <0.2 EU/mL

Specification ≤0.25 EU/mL

Met spec

Result Not Detected

Method Rapid Sterility Screening (PCR)

Met spec

Measured 7.48

Specification 4.5 – 7.0

Outside spec Above the upper limit of 7

Testing Methods View methods used for this report

Endotoxin: Endotoxin testing performed using Limulus Amebocyte Lysate assay in accordance with USP <85> under validated laboratory conditions.
Sterility: Rapid sterility screening performed by real-time polymerase chain reaction (qPCR) targeting conserved microbial DNA sequences under validated laboratory conditions.

Chromatographic analysis of benzyl alcohol content (Accumark Labs).

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Plotted from Accumark Labs' instrument data. Drag across the chart to zoom in; double-click to reset. Tap the chart to read a point.

Peak Detail View reported peak data

Peaks Accumark Labs identified in this chromatogram
Peak	Retention time (min)	Height (mAU)	Area	Area %
1	3.180	99.36	6.25	84.48%

Summary of results, specifications, and laboratory verdicts.

Analytical results against the specifications entered for this report
Test	Result	Specification	Status
Benzyl Alcohol	0.72%	0.9% (v/v) ±20%	Measured, no lab verdict
Endotoxin	<0.2 EU/mL	≤0.25 EU/mL	Met spec
Sterility	Not Detected	Rapid Sterility Screening (PCR)	Met spec
pH	7.48	4.5 – 7.0	Outside spec

Source information and report details from the testing laboratory.