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Q1 Stability Report
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Q1 Stability Report — API-2025-03A · Lot 4521
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Author: Dr. Jessica Martin · Site: Atlanta · Confidential
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Assay
98.4%
▲ within spec
Diss. T0
85%
▲ Q ≥ 80
Microbial
<10
▲ TVC pass
Assay % over Stability Timepoints Lot 4521 Spec ≥ 95
T0 M1 M2 M3 M6 M9 M12
↪ data source: ELN · exp_4521-Q1 refreshed 2h ago
Sample ID Test Result Status
S-4521-T0 HPLC Assay 99.2% PASS
S-4521-M3 Dissolution Q=83% PASS
S-4521-M6 Impurities 0.18% REVIEW
S-4521-M9 HPLC Assay 96.1% PASS
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PROPERTIES
Chart1
DATA
Source ELN · exp_4521-Q1
Series Assay%
CHART
Type Line + area
Spec line ≥ 95%
LAYOUT
Location 0in, 1.2in
Size 6.5in, 2in
MISC
Name Chart1
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