D-2000: Samples Series: 13454 Report Name: modified System: Sys 1

D-2000 Elite HPLC System Manager Report

Analyzed Date and Time: 08/08/2018 Reported Date and Time: 08/09/2018
06:32 PM 10:44 AM
Processed Date and Time: 08/09/2018
10:44 AM
Data Path: C:\Win32app\D2000HSM\samples\DATA\13454\
Processing Method: Levoproksasin_project080818
System (acquisition): Sys 1 Series: 13454
Application(data): Samples Vial Number: 21
Sample Name: IV.K1.1 Vial Type: UNK
Volume: 20.0 ul
Sample Description:

Chrom Type: HPLC Channel : 1

Ciprofloxacin, 70423
Levoproxacin, 132829
14

12
Intensity (mV)

10

0 1 2 3 4 5 6 7
Retention Time (min)

Processing Method: Levoproksasin_project080818

Column Type: Column Method Developer: User
Pump A: L-2130
Pump A Solvent A: Air Pump A Solvent B: Metanol
Pump A Solvent C: ACN Pump A Solvent D: Dapar Fosfat pH 3
Method Description: Levofloksasin
Chrom Type: HPLC Channel : 1
Peak Quantitation: AREA
Calculation Method: EXT-STD
Scale Factor 1: 1.000
No. RT Name Area

1 4.53 Levoproxacin 132829

2 5.19 Ciprofloxacin 70423

203252

Peak rejection level: 0

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D-2000: Samples Series: 13454 Report Name: modified System: Sys 1
D-2000 Elite HPLC System Manager Confidence Report
Analyzed Date and Time: 08/08/2018 06:32 PM Report Date and Time: 08/09/2018
Processed Date and Time: 08/09/2018 10:44 AM 10:44 AM
Processing Method: Levoproksasin_project080818
System (acquisition): Sys 1 Series: 13454
Application(data): Samples Vial Number: 21
Sample Name: IV.K1.1 Vial Type: UNK
Injection from this vial: 1 of 1 Volume: 20.0 ul
Sample Description:
Chrom Type: HPLC Channel : 1
System Suitability Report (Complete)
RT of Non-Retained Peak: 0.01 min

RT Name k' Asym N Res Alpha

(min) (USP) (USP)

4.53 Levoproxacin 451.67 1.25 5965 --- ---

5.19 Ciprofloxacin 518.33 1.27 6431 2.70 1.15

RT Name N Res N Res S/N Noise

(min) (EP) (EP) (JP) (JP) (uV)

4.53 Levoproxacin 6022 --- 6033 --- --- ---

5.19 Ciprofloxacin 6495 2.71 6507 2.71 --- ---

Acceptable range of Asymmetry: 0.80 to 2.00

No. of theoretical plates warning at less than: 1000
Below criterion of Resolution: 2.00
Signal to noise ratio warning at less than: 3

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