Cromatograma HPLC

D-7000 HSM: MERCK LACHROM Series: 6966 Report: modified System: HPLC
Flemalis
Analyzed Date and Time: 29/10/18 03:28 p.m.
Processing Method: FLEMALIS BREMYMG
System(acquisition): HPLC Series:6966
Sample Name: STD FLEMALIS Apt sistema Vial Number: 1
Injection from this vial: 1 of 1 Vial Type: UNK
Sample Description: STD FLEMALIS Apt Volume: 20,0 ul
sistemas
Chrom Type: HPLC Channel : 1
2000
17103083, GUAYACOLATO DE GLICERILO

2920434, N-ACETILCISTEINA
1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10
Retention Time (min)
Acquisition Method: FLEMALIS BREMYMG

Developed by: SAF SAS.
Pump A Type: L-7100
Solvent A: AGUA Solvent B: METANOL
Solvent C: FASE MOVIL Solvent D: AGUA
Method Description: Valoración Flemalis ( Guayacolato de Glicerilo + N-
Acetilcisteina)
Peak Quantitation: AREA
No. Name RT Area
1 N-ACETILCISTEINA 1,77 2920434

2 GUAYACOLATO DE GLICERILO 2,55 17103083
20023517
Peak rejection level: 500000
Page Indicator 1 / 43
APTITUD DEL SISTEMA
System Suitability Report (Full width)

System (acquisition): HPLC
Sample Name: STD FLEMALIS Apt sistema
Injection from this vial: 1 of 1
Sample Description: STD FLEMALIS Apt sistemas
RT of Non-Retained Peak: 0,01 min
RT Name k' Asym N Res

(min) (USP) (USP)
1,77 N-ACETILCISTEINA 176,00 1,07 822 ---

2,55 GUAYACOLATO DE GLICERILO 254,00 1,50 1821 3,21
RT Name Alpha S/N Noise

(min) (uV)
1,77 N-ACETILCISTEINA --- --- ---

2,55 GUAYACOLATO DE GLICERILO 1,44 --- ---
Asymmetry warning outside the range of: 0,800 to 2,000

No. of theoretical plates warning at less than: 500
Resolution warning at less than: 0,800
Signal to noise ratio warning at less than: 3
Vial Summary for Channel 1
Vial Number: 1
Name Mean Conc 1 1 Mean
RT(min) CONC1
N-ACETILCISTEINA 1,77 0,000000 0,000000

GUAYACOLATO DE GLICERILO 2,55 0,000000 0,000000
Statistics Report for Repetitive Injections (Channel 1)

Vial Number: 1 Injections: 1
Concentration (Conc1)
Name Mean Conc 1 Standard % Standard Variance

Deviation Deviation
N-ACETILCISTEINA 0,000000 --- --- ---

GUAYACOLATO DE GLICERILO 0,000000 --- --- ---
Retention Time
Name Mean Standard % Standard Variance

RT(Min) Deviation Deviation
N-ACETILCISTEINA 1,770 --- --- ---

GUAYACOLATO DE GLICERILO 2,550 --- --- ---
Flemalis
Sample Name: STD FLEMALIS Vial Number: 1
Sample Description: Volume: 20,0 ul
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

20435053
APTITUD DEL SISTEMA

Sample Name: STD FLEMALIS
Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

20315316
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

20375120
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Vial Number: 1
Name Mean Conc 1 1 Conc 1 2 Conc 1 3 Mean
RT(min) CONC1
N-ACETILCISTEINA 1,78 0,000000 0,000000 0,000000 0,000000

GUAYACOLATO DE GLICERILO 2,53 0,000000 0,000000 0,000000 0,000000

Vial Number: 1 Injections: 1, 2, 3

Deviation Deviation
N-ACETILCISTEINA 0,000000 0,000E+00 --- 0,000E+00

GUAYACOLATO DE GLICERILO 0,000000 0,000E+00 --- 0,000E+00
Retention Time

N-ACETILCISTEINA 1,775 2,886E-03 0,16 8,333E-06

GUAYACOLATO DE GLICERILO 2,530 5,773E-03 0,23 3,333E-05
Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

23321812
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

23676516
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000 3261978, N-ACETILCISTEINA
1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

24226510
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)

2,56 GUAYACOLATO DE GLICERILO 255,33 1,03 --- 1,89

(min) (uV)


Vial Number: 2
RT(min) CONC1



Deviation Deviation

Retention Time


Flemalis
Sample Name: BFL-670817-T12 FLEMALIS Vial Number: 3
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

26018294
APTITUD DEL SISTEMA

Sample Name: BFL-670817-T12 FLEMALIS
Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

26432768
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

26053986
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Vial Number: 3
RT(min) CONC1



Deviation Deviation

Retention Time


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

17751688
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

17868559
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

17817576
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Vial Number: 4
RT(min) CONC1



Deviation Deviation

Retention Time


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

18527850
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

18745338
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)


Flemalis
2000

1500
Intensity (mV)
1000
500
0 1 2 3 4 5 6 7 8 9 10

Pump A Type: L-7100
Acetilcisteina)
No. Name RT Area

18751423
APTITUD DEL SISTEMA

Sample Description:

(min) (USP) (USP)


(min) (uV)



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D-7000 HSM: MERCK LACHROM Series: 6966 Report: modified System: HPLC

17103083, GUAYACOLATO DE GLICERILO

Acquisition Method: FLEMALIS BREMYMG

1 N-ACETILCISTEINA 1,77 2920434

Peak rejection level: 500000

APTITUD DEL SISTEMA

System Suitability Report (Full width)

RT of Non-Retained Peak: 0,01 min

RT Name k' Asym N Res

1,77 N-ACETILCISTEINA 176,00 1,07 822 ---

RT Name Alpha S/N Noise

1,77 N-ACETILCISTEINA --- --- ---

Asymmetry warning outside the range of: 0,800 to 2,000

N-ACETILCISTEINA 1,77 0,000000 0,000000

Statistics Report for Repetitive Injections (Channel 1)

Name Mean Conc 1 Standard % Standard Variance

N-ACETILCISTEINA 0,000000 --- --- ---

Name Mean Standard % Standard Variance

N-ACETILCISTEINA 1,770 --- --- ---

17196475, GUAYACOLATO DE GLICERILO

Acquisition Method: FLEMALIS BREMYMG

1 N-ACETILCISTEINA 1,77 3238578

Peak rejection level: 500000

APTITUD DEL SISTEMA

System Suitability Report (Full width)

RT of Non-Retained Peak: 0,01 min

RT Name k' Asym N Res

1,77 N-ACETILCISTEINA 176,33 1,12 772 ---

RT Name Alpha S/N Noise

1,77 N-ACETILCISTEINA --- --- ---

Asymmetry warning outside the range of: 0,800 to 2,000

17101913, GUAYACOLATO DE GLICERILO

Acquisition Method: FLEMALIS BREMYMG

1 N-ACETILCISTEINA 1,77 3213403

Peak rejection level: 500000

APTITUD DEL SISTEMA

System Suitability Report (Full width)

RT of Non-Retained Peak: 0,01 min

RT Name k' Asym N Res

1,77 N-ACETILCISTEINA 176,33 1,12 768 ---

RT Name Alpha S/N Noise

1,77 N-ACETILCISTEINA --- --- ---

Asymmetry warning outside the range of: 0,800 to 2,000

17135513, GUAYACOLATO DE GLICERILO

Acquisition Method: FLEMALIS BREMYMG

1 N-ACETILCISTEINA 1,78 3239607

Peak rejection level: 500000

APTITUD DEL SISTEMA

System Suitability Report (Full width)

RT of Non-Retained Peak: 0,01 min

RT Name k' Asym N Res

1,78 N-ACETILCISTEINA 176,83 1,11 770 ---

RT Name Alpha S/N Noise

1,78 N-ACETILCISTEINA --- --- ---

Asymmetry warning outside the range of: 0,800 to 2,000

N-ACETILCISTEINA 1,78 0,000000 0,000000 0,000000 0,000000

Statistics Report for Repetitive Injections (Channel 1)