LABORATORIOS UNIDOS S.A.

Departamento de Control de Calidad

Analista: L. FAJARDO
Fecha de Analisis: 28/04/2022 01:37:21 p.m. :LUSA
Fecha de Impresion: 03/05/2022 10:58:54 a.m. :LUSA
Metodo: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\Method\IRRICER PLUS TAB. REC.
-CITICOLINA.met
Secuencia: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\Sequence\IRRICER PLUS TAB
RECUB\CITICOLINA\2120201.seq
Data: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\DATA\IRRICER PLUS
TAB\CITICOLINA\2120201\IRRICER PLUS TAB.REC LOTE 2120201-D01-015.dat
Muestra: IRRICER PLUS TAB.REC LOTE 2120201-D01
Cromatograma de Muestra

500 UV-WL1 500

ST CITICOLINA SÓDICA
4215
Retention Time 1197
mAU

mAU
ICA
250 Name SOD 250
O LINA
Area CITIC
0 2.4 0
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Minutes

Cromatograma de Muestra

500
UV-WL1 500
ST CITICOLINA SÓDICA
Retention Time 4000
1194
mAU

mAU
250 Name ICA 250
SOD
Area OL INA
CITIC
0 2.4 0

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Minutes

Cromatograma de Muestra

500
UV-WL1 500
ST CITICOLINA SÓDICA
Retention Time 4751
1190
mAU

mAU

250 Name ICA 250

SOD
Area
ICO LINA
CIT
0 2.4 0

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Minutes

Cromatograma de Muestra

UV-WL1
500 500
ST CITICOLINA SÓDICA
Retention Time
8412
1193
mAU

mAU

250 Name A 250

DI C
Area A SO
ITIC OLIN
0 2.4 C 0

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Minutes
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

Cromatograma de Muestra

UV-WL1
500 ST CITICOLINA SÓDICA 500
Retention Time
Name
mAU

mAU
Area
250
5789 250
A 1194
A S ODIC
OLIN
.4 CITIC
0 2 0

0 1 2 3 4 5
Minutes

Cromatograma de Muestra

UV-WL1
500 CHECK ST 500
Retention Time
Name
mAU

mAU
Area
250 4010 250
A 1199
DIC
A SO
ITIC OLIN
C
0 2.4 0

0 1 2 3 4 5
Minutes

Cromatograma de Muestra

UV-WL1
500 IRRICER PLUS TAB.REC LOTE 2120201-D01 500
Retention Time
Name
Area
mAU

mAU
250 250
365
A 14407
IC
SOD
OLINA
CITIC
0 2.4 0

0 1 2 3 4 5
Minutes

Cromatograma de Muestra

UV-WL1
500 IRRICER PLUS TAB.REC LOTE 2120201-D02 500
Retention Time
Name
Area
mAU

mAU

250 250
0584
CA 1438
I
SOD
ICOLINA
CIT
0 2.4 0

0 1 2 3 4 5
Minutes
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

Cromatograma de Muestra

UV-WL1
500 IRRICER PLUS TAB.REC LOTE 2120201-D03 500
Retention Time
Name
Area
mAU

mAU
250 250
2845
A 1478
IC
SOD
IC OLINA
CIT
0 2.4 0

0 1 2 3 4 5
Minutes

Cromatograma de Muestra

UV-WL1
500 IRRICER PLUS TAB.REC LOTE 2120201-D04 500
Retention Time
Name
Area
mAU

mAU
250 250
5315
A 1478
D IC
A SO
ITIC OLIN
C
0 2.4 0

0 1 2 3 4 5
Minutes

Cromatograma de Muestra

UV-WL1
500 IRRICER PLUS TAB.REC LOTE 2120201-D05 500
Retention Time
Name
Area
mAU

mAU

250
2 985 250
1463
SODICA
LINA
4 C ITICO
0 2. 0

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Minutes

Cromatograma de Muestra

UV-WL1
500 IRRICER PLUS TAB.REC LOTE 2120201-D06 500
Retention Time
Name
Area
mAU

mAU

250 250
2009
A 1465
IC
SOD
IC OLINA
CIT
0 2.4 0

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Minutes
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

----------------------------------------------------------------------
---< General Method Parameters >--------------------------------------
----------------------------------------------------------------------

Custom Parameters
=================
None

Chromaster 5310 Column Oven

==========================
Max Temperature for Column (°C): 70
Wait With Tolerance (±°C): 1.0
Wait Time (min): 0
Control Off at Shutdown: Yes
Valve Position: 3

Time Table
----------
Time (min): 0.0 Temp (°C): 30

Trace: Temperature
Display : No
Unit : degrees C

Trace: Ambient Temperature

Display : No
Unit : degrees C

Chromaster Pump
===============

Pump Parameters
---------------

Turn Off at Shutdown: Yes

Check Degassing Unit Status: No

Pump 1

Minimum Pressure (psi): 57

Maximum Pressure (psi): 4793
Gradient Mode: LFM
Solvent A Name: FASE MOVIL
Solvent B Name: METANOL
Solvent C Name: ACETONITRILO
Solvent D Name: AGUA

Pump Time Table

---------------

Pump 1, Time(min): 0.0

-----------------------

Solvent A Percent: 100.0

Solvent B Percent: 0.0
Solvent C Percent: 0.0
Solvent D Percent: 0.0
Flow Rate (mL/min): 1.000
Event 1:
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

Event 2:
Event 3:
Event 4:

Trace: Pressure pump 1

Display : Yes
Unit : psi

Chromaster 5260 Autosampler

============================
ASP Syringe Speed: 3
DSP Syringe Speed: 3
Needle Down Speed: Fast
Syringe Volume (µL): 175
Air Volume (µL): 2
Injection Method: Cut
Lead Volume (µL): 10
Rear Volume (µL): 50
Feed Volume (µL): 50
Waste Volume (µL): 100
Time Injection With Pump (PASS): No
Sense Missing Vial: Yes
Rinse Port Wash Time (s): 1
Needle Wash before Injection: No
Needle Wash Solvent: Solvent1and2
Needle Wash Time Solvent1 (s): 5
Needle Wash Time Solvent2 (s): 5
Plunger Wash after Sequence Run: No
Plunger Wash Time (s): 15
Solvent1 Name:
Solvent2 Name:

Trigger Type
============
External Trigger

----------------------------------------------------------------------
---< UV >-------------------------------------------------------------
----------------------------------------------------------------------

Chromaster 5410 UV Detector - Channel 1

=======================================
Stop Time (min): 5.0
Response Time (s): 1.00
Sampling Period (ms): 400
Offset (AU): 0.000
Polarity: Positive
Range: 2.0
Auto Zero Before Injection: Yes
Lamp Off at Shutdown: Yes
Wavelength Setting: Single Wavelength
Wavelength1(nm): 280
Wavelength2(nm): 305

Time Table
----------
Time (min): 0.0 Wavelength (nm): 280 Baseline: Auto Zero

Integration Events
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

==================
Start Stop
Enabled Event Type (Minutes) (Minutes) Value
-------- ------------------------------ ---------- ---------- --------
Yes Width 0 0 2
Yes Threshold 0 0 1000
Yes Integration Off 0 1.8 0
Yes Integration Off 3.5 5 0

Manual Integration Fixes

========================
Data File: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\DATA\IRRICER PLUS
TAB\CITICOLINA\2120201\IRRICER PLUS TAB.REC LOTE 2120201-D01-015.dat
Start Stop
Enabled Event Type (Minutes) (Minutes) Value
-------- ------------------------------ ---------- ---------- --------
None
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

Analista: L. FAJARDO
Run time: 28/04/2022 01:18:21 p.m. :LUSA
Metodo: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\Method\IRRICER PLUS TAB.
REC. -CITICOLINA.met
Secuencia: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\Sequence\IRRICER PLUS
TAB RECUB\CITICOLINA\2120201.seq
Data: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\DATA\IRRICER PLUS
TAB\CITICOLINA\2120201\IRRICER PLUS TAB.REC LOTE 2120201-M2-012.dat
Muestra: IRRICER PLUS TAB.REC LOTE 2120201-M2

Cromatograma de Estandar

1000 1000
UV-WL1
STD CITICOLINA
Name
Area

500 500
mAU

mAU
CITICOLINA SODICA 6355818

0 0

0 1 2 3 4 5
Minutes

Cromatograma de Muestra

1000 1000
UV-WL1
IRRICER PLUS TABLETAS RECUBIERTAS LOTE_2010541_6M_ELP_D1
Name
Area

500 500
mAU

mAU

CITICOLINA SODICA 7792293

0 0

0 1 2 3 4 5
Minutes

UV-WL1 Results
Name Retention Time Area
CITICOLINA SODICA 2.42 12343550
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

----------------------------------------------------------------------
---< General Method Parameters >--------------------------------------
----------------------------------------------------------------------

Chromaster 5310 Column Oven

==========================
Max Temperature for Column (°C): 70
Wait With Tolerance (±°C): 1.0
Wait Time (min): 0
Control Off at Shutdown: Yes
Valve Position: 3

Time Table
----------
Time (min): 0.0 Temp (°C): 30

Trace: Temperature
Display : No
Unit : degrees C

Trace: Ambient Temperature

Display : No
Unit : degrees C

Chromaster Pump
===============

Pump Parameters
---------------

Turn Off at Shutdown: Yes

Check Degassing Unit Status: No

Pump 1

Minimum Pressure (psi): 57

Maximum Pressure (psi): 4793
Gradient Mode: LFM
Solvent A Name: FASE MOVIL
Solvent B Name: METANOL
Solvent C Name: ACETONITRILO
Solvent D Name: AGUA

Pump Time Table

---------------

Pump 1, Time(min): 0.0

-----------------------

Solvent A Percent: 100.0

Solvent B Percent: 0.0
Solvent C Percent: 0.0
Solvent D Percent: 0.0
Flow Rate (mL/min): 1.000
Event 1:
Event 2:
Event 3:
Event 4:
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

Trace: Pressure pump 1

Display : Yes
Unit : psi

Chromaster 5260 Autosampler

============================
ASP Syringe Speed: 3
DSP Syringe Speed: 3
Needle Down Speed: Fast
Syringe Volume (µL): 175
Air Volume (µL): 2
Injection Method: Cut
Lead Volume (µL): 10
Rear Volume (µL): 50
Feed Volume (µL): 50
Waste Volume (µL): 100
Time Injection With Pump (PASS): No
Sense Missing Vial: Yes
Rinse Port Wash Time (s): 1
Needle Wash before Injection: No
Needle Wash Solvent: Solvent1and2
Needle Wash Time Solvent1 (s): 5
Needle Wash Time Solvent2 (s): 5
Plunger Wash after Sequence Run: No
Plunger Wash Time (s): 15
Solvent1 Name:
Solvent2 Name:

Trigger Type
============
External Trigger

----------------------------------------------------------------------
---< UV >-------------------------------------------------------------
----------------------------------------------------------------------

Peak Table
==========
Name: CITICOLINA SODICA
Enabled: Yes
ID Number: 1 Ref. ID #: 0 Resolution ID #: 0
ISTD. ID #: 0 Std Peak ID #: 0 Std Peak Multiplier: 0
Manual RF Used: No
Analysis Channel: UV-WL1
Quantitation: Area
Calibration Flag: Wt Average
Calibration Weight: 100 Calibration Unit: %
Level Amount Response
----- --------------------- --------------------
1 95.79850468 0

Fit Type: Linear Force Zero: Yes

Weight Method: None
% Calibration Margin: 0 Scale: None
Low Conc: 0 High Conc: 0
Spike 1 Amount: 0 Spike 2 Amount: 0
Low Spike Limit: 0 High Spike Limit: 0
Duplicate %RD Limit: 0 RF %RSD Limit: 0
Check Std 1 Conc: 96.2111 Check Std 1 %RD: 2
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

Check Std 2 Conc: 0 Check Std 2 %RD: 0

Check Std 3 Conc: 0 Check Std 3 %RD: 0
Check Std 4 Conc: 0 Check Std 4 %RD: 0
Check Std 5 Conc: 0 Check Std 5 %RD: 0
Expected Retention Time: 2.5 (Minutes)
Expected Retention Window: 2 (Minutes)
Retention Time Update: None
Limit of Detection: 0.000000
Limit of Quantitation: 0.000000

Name: CITICOLINA SODICA

Enabled: No
ID Number: 2 Ref. ID #: 0 Resolution ID #: 0
ISTD. ID #: 0 Std Peak ID #: 0 Std Peak Multiplier: 0
Manual RF Used: No
Analysis Channel: UV-WL1
Quantitation: Area
Calibration Flag: Wt Average
Calibration Weight: 100 Calibration Unit: %
Level Amount Response
----- --------------------- --------------------
1 86.218654 11941433.4

Fit Type: Linear Force Zero: Yes

Weight Method: None
% Calibration Margin: 0 Scale: None
Low Conc: 0 High Conc: 0
Spike 1 Amount: 0 Spike 2 Amount: 0
Low Spike Limit: 0 High Spike Limit: 0
Duplicate %RD Limit: 0 RF %RSD Limit: 0
Check Std 1 Conc: 86.59 Check Std 1 %RD: 2
Check Std 2 Conc: 0 Check Std 2 %RD: 0
Check Std 3 Conc: 0 Check Std 3 %RD: 0
Check Std 4 Conc: 0 Check Std 4 %RD: 0
Check Std 5 Conc: 0 Check Std 5 %RD: 0
Expected Retention Time: 2.5 (Minutes)
Expected Retention Window: 2 (Minutes)
Retention Time Update: None
Limit of Detection: 0.000000
Limit of Quantitation: 0.000000

Chromaster 5410 UV Detector - Channel 1

=======================================
Stop Time (min): 5.0
Response Time (s): 1.00
Sampling Period (ms): 400
Offset (AU): 0.000
Polarity: Positive
Range: 2.0
Auto Zero Before Injection: Yes
Lamp Off at Shutdown: Yes
Wavelength Setting: Single Wavelength
Wavelength1(nm): 280
Wavelength2(nm): 305

Time Table
----------
Time (min): 0.0 Wavelength (nm): 280 Baseline: Auto Zero

Integration Events
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

==================
Start Stop
Enabled Event Type (Minutes) (Minutes) Value
-------- ------------------------------ ---------- ---------- --------
Yes Width 0 0 2
Yes Threshold 0 0 1000
Yes Integration Off 0 1.8 0
Yes Integration Off 3.5 5 0

Manual Integration Fixes

========================
Data File: C:\EZChrom Elite\Enterprise\Projects\PRODUCTO TERMINADO\DATA\IRRICER PLUS
TAB\CITICOLINA\2120201\IRRICER PLUS TAB.REC LOTE 2120201-M2-012.dat
Start Stop
Enabled Event Type (Minutes) (Minutes) Value
-------- ------------------------------ ---------- ---------- --------
None

User Logged Source Activity Reason

L. FAJARDO 03/05/2022 Offline: Electronic Approved
11:32:14 Electronic signature
a.m. :LUSA Signature applied by
L. FAJARDO
in project
PRODUCTO
TERMINADO
L. FAJARDO 03/05/2022 Offline: Analysis
09:42:06 Updated last
a.m. :LUSA results
(Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
ESTABILIDADES
\Method\IRRIC
ER PLUS TAB.
REC.
(CITICOLINA).
met)
L. FAJARDO 03/05/2022 Offline: Analysis
09:36:19 Updated last
a.m. :LUSA results
(Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
ESTABILIDADES
\Method\IRRIC
ER PLUS TAB.
REC.
(CITICOLINA).
met)
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

L. FAJARDO 03/05/2022 Offline: Analysis

08:41:45 Updated last
a.m. :LUSA results
(Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
PRODUCTO
TERMINADO\Met
hod\IRRICER
PLUS TAB.
REC.
(CITICOLINA).
met)
L. FAJARDO 28/04/2022 Updated last Analysis
03:54:09 results
p.m. :LUSA (Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
PRODUCTO
TERMINADO\Met
hod\IRRICER
PLUS TAB.
REC.
(CITICOLINA).
met)
L. FAJARDO 28/04/2022 Updated last Analysis
03:35:18 results
p.m. :LUSA (Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
PRODUCTO
TERMINADO\Met
hod\IRRICER
PLUS TAB.
REC.
(CITICOLINA).
met)
J. Mujica 28/04/2022 Offline: Analysis
01:48:57 Updated last
p.m. :LUSA results
(Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
PRODUCTO
TERMINADO\Met
hod\IRRICER
PLUS TAB.
REC.
(CITICOLINA).
met)
 LABORATORIOS UNIDOS S.A.
Departamento de Control de Calidad

J. Mujica 28/04/2022 Offline: Analysis

01:47:47 Updated last
p.m. :LUSA results
(Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
PRODUCTO
TERMINADO\Met
hod\IRRICER
PLUS TAB.
REC.
(CITICOLINA).
met)
L. FAJARDO 28/04/2022 Updated last Analysis
01:23:30 results
p.m. :LUSA (Method
used:
C:\EZChrom
Elite\Enterpr
ise\Projects\
PRODUCTO
TERMINADO\Met
hod\IRRICER
PLUS TAB.
REC.
(CITICOLINA).
met)
L. FAJARDO 28/04/2022 HPLC-CHROMAST New data
01:17:12 ER file created.
p.m. :LUSA

Electronic
Signature
User Time Reason Role Comment
L. FAJARDO 03/05/2022 Approved Analista CONFORME
11:32:14
a.m. :LUSA