CERTIFICATE OF ANALYSIS For Research Use Only
Version 2.0
Reference Material Name
Lactulose EP Impurity F
1,4,5-trihydroxypentan-2-one/2-(hydroxymethyl)tetrahydrofur
an-2,4-diol
QCS CAT Number Lot Number
RM-L010316 56584
CAS Number Long-term Storage
3343-53-1+136272-61-2 -20 °C hygroscopic
Mol. Formula Shipping Condition
C5H10O4 Blue Ice
Mol. Weight Solubility
134.13 ACN/water
Test Description Specifications Results
Appearance Colorless Oil Conforms
Identification NMR&MS Conforms
Loss On Drying (by TGA) N/A 1.64 %
Purity (HPLC) Not less than 95.0 % 99.28 %
Assay (C5H10O4) Not less than 90.0 % 97.65 %
Method of Characterisation: Assay(%) = (1-LOD(by TGA)) x Purity(%) / 100%
Reviewed and Approved By Release By
Certified Date Retest Date
Quality Control Quality Assurance
28 Mar. 2024 27 Mar. 2027
QUALITY CONTROL SOLUTIONS LTD.
B1203 Life Science Park, SCT Creative Factory, Pingshan District, ShenZhen, China
Tel: +86 755-66853366 Fax: +86 755-28363542
www.qcsrm.com E-mail: orders@qcsrm.com ISO 9001:2015
Data File D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\RM-L010316.D
Sample Name:RM-L010316,56584
=====================================================================
Acq. Operator : Seq. Line : 3
Acq. Instrument : Instrument 2 Location : Vial 9
Injection Date : 3/20/2024 11:58:22 AM Inj : 1
Inj Volume : 2.000 µl
Different Inj Volume from Sequence ! Actual Inj Volume : 20.000 µl
Acq. Method : D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\L+G+H2O-ACN+TFA+5-20-
40+20MIN+1.0+40.M
Last changed : 1/23/2024 4:34:36 PM
Analysis Method : D:\METHOD\QCS\L+G+H2O-ACN+TFA+5-20-40+20MIN+1.0+40.M
Last changed : 1/23/2024 4:34:36 PM
Method Info : Column: Waters XBridge C18(4.6*150mm,3.5um)
Mobile phase A: 0.04%TFA-H2O
Mobile phase B: 0.02%TFA-ACN
Column tempreture: 40 Flow: 0.8mL/min Diluent: ACN-H2O
Time(min): 0.0 3.0 6.0 9.0 12.0 20.0
A(%): 95 80 60 60 95 95
B(%): 5 20 40 40 5 5
Additional Info : Peak(s) manually integrated
DAD1 B, Sig=210,4 Ref=off (D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\RM-L010316.D)
2.202
mAU
.4
97
22
500
a: e
Ar
400
300
200
100
51
72
.
16
A1.910
a:
re
-100
2.5 5 7.5 10 12.5 15 17.5 min
=====================================================================
Area Percent Report
=====================================================================
Sorted By : Signal
Multiplier : 1.0000
Dilution : 1.0000
Use Multiplier & Dilution Factor with ISTDs
Instrument 2 3/20/2024 3:07:32 PM
Data File D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\RM-L010316.D
Sample Name:RM-L010316,56584
Signal 1: DAD1 B, Sig=210,4 Ref=off
Peak RetTime Type Width Area Height Area
# [min] [min] [mAU*s] [mAU] %
----|-------|----|-------|----------|----------|--------|
1 1.910 MM 0.0829 16.72510 3.36102 0.7227
2 2.202 MM 0.0730 2297.39502 524.46918 99.2773
Totals : 2314.12012 527.83019
=====================================================================
*** End of Report ***
Instrument 2 3/20/2024 3:07:32 PM
Data File D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\H2O+ACN.D
Sample Name:RM-L010316,56584
=====================================================================
Acq. Operator : Seq. Line : 1
Acq. Instrument : Instrument 2 Location : Vial 3
Injection Date : 3/20/2024 11:13:55 AM Inj : 1
Inj Volume : 2.000 µl
Acq. Method : D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\L+G+H2O-ACN+TFA+5-20-
40+20MIN+1.0+40.M
Last changed : 1/23/2024 4:34:36 PM
Analysis Method : D:\METHOD\QCS\L+G+H2O-ACN+TFA+5-20-40+20MIN+1.0+40.M
Last changed : 1/23/2024 4:34:36 PM
Method Info : Column: Waters XBridge C18(4.6*150mm,3.5um)
Mobile phase A: 0.04%TFA-H2O
Mobile phase B: 0.02%TFA-ACN
Column tempreture: 40 Flow: 0.8mL/min Diluent: ACN-H2O
Time(min): 0.0 3.0 6.0 9.0 12.0 20.0
A(%): 95 80 60 60 95 95
B(%): 5 20 40 40 5 5
Additional Info : Peak(s) manually integrated
DAD1 B, Sig=210,4 Ref=off (D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\H2O+ACN.D)
mAU
60
40
20
-20
-40
2 4 6 8 10 12 14 16 18 min
=====================================================================
Area Percent Report
=====================================================================
Sorted By : Signal
Multiplier : 1.0000
Dilution : 1.0000
Use Multiplier & Dilution Factor with ISTDs
No peaks found
Instrument 2 3/20/2024 3:08:18 PM
Data File D:\DATA\2024\03\20240320\20240320-1 2024-03-20 11-09-53\H2O+ACN.D
Sample Name:RM-L010316,56584
=====================================================================
*** End of Report ***
Instrument 2 3/20/2024 3:08:18 PM R
Sample Name:RM-L010316,56584
4.53
4.52
4.47
4.45
4.45
4.36
4.31
4.30
4.25
4.12
4.11
4.09
4.08
4.06
4.06
4.04
4.03
3.98
3.95
3.94
3.91
3.91
3.89
3.77
3.74
3.55
3.52
3.51
3.50
3.48
3.46
3.45
3.43
3.43
3.42
2.62
2.58
2.57
2.56
2.29
2.27
2.25
2.24
2.19
2.15
2.13
2.07
2.07
2.04
2.03
1.89
1.88
1.85
Current Data Parameters
NAME 20240321-RM-L010316 HNMR
EXPNO 2
PROCNO 1
F2 - Acquisition Parameters
Date_ 20240321
Time 20.06 h
INSTRUM Avance
PROBHD Z163739_0685 (
PULPROG zg30
TD 65536
SOLVENT D2O
NS 16
DS 2
SWH 8196.722 Hz
FIDRES 0.250144 Hz
AQ 3.9976959 sec
RG 71.8
DW 61.000 usec
DE 13.89 usec
TE 298.7 K
D1 1.00000000 sec
TD0 1
SFO1 400.2124713 MHz
NUC1 1H
P0 2.67 usec
P1 8.00 usec
PLW1 23.88400078 W
F2 - Processing parameters
SI 65536
SF 400.2100000 MHz
WDW EM
SSB 0
LB 0.30 Hz
GB 0
PC 1.00
10 9 8 7 6 5 4 3 2 1 ppm
0.42
1.19
0.79
0.47
0.23
2.00
1.16
0.20
0.19
0.22
0.11
Print of window 80: MS Spectrum
Sample Name:RM-L010316,56584
MS Spectrum
*MSD1 SPC, time=0.954 of D:\DATA\2024\3\20\20230320-1 2024-03-20 08-56-39\RM-L010316.D ES-API, Pos, Scan, Frag: 70
117.2
100
Max: 33912
80
60
40
233.2
384.3
134.2
20
273.2
389.2
215.1
523.3
114.2
268.3
200 400 600 800 m/z
Instrument 2 3/21/2024 9:45:46 AM
Sample Name:RM-L010316,56584
TG /% Flow /(ml/min)
150
250
Mass Change: -1.640 %
Residual mass: 98.358 %
100 200
150
50
100
[35]
0
50
[35]
-50
0
50 100 150 200 250 300
Temperature /°C
Main 2024-03-21 11:10 User: CFR Administrator RM-L010316.ngb-taa [Content: CFR]; Signed by: CFR Administrator (Created)
Instrument : NETZSCH TG 209F3 File : <ROOT>\20240321\RM-L010316.ngb-dt6
Project : Sample : RM-L010316 Sample car./TC : TG 209F3 std (Al2O3 support)/P Atmosphere : -- / N2 / N2
Identity : RM-L010316 Material : Sample mass : 10.2545 mg Corr/m. range : 6:2:0/2000 mg
Date/time : 2024/3/21 10:46:30 Correction file : BK 20240318.ngb-bt6 Mode/type of meas. : TG/sample with correction
Laboratory : Temp. calib. file : 25-04-2021 13:44 Segments : 1/1
Operator : Admin Range : 30°C/30.0(K/min)/300°C Crucible : Al2O3 85 µl, open
Created with NETZSCH Proteus software
