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G-016

FN08191501
Revision 00
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Product of USA

Certified Reference Material - Certificate of Analysis


Product Name: Green Tea Catechin Mix
Catalog Number: G-016
Solution Lot: FN08191501
Expiration Date: August 2018
Solvent: 80::20 Acetonitrile::Water with 5% 1M HCl (degassed)
Volume per Ampoule: Not less than 1 mL
Storage: Store Unopened in Freezer.
Shipping: Ship Cold. See Stability Section.
Intended Use: For R&D/ analytical purposes only. Not suitable for human or animal consumption.
For qualitative or quantitative applications.
Safety: Danger. See Safety Data Sheet.

 Expiration Date has been established through real time stability studies.
 Ampules are overfilled to ensure a minimum 1 mL volume. We advise laboratories to quantitively transfer measured volumes of this standard
solution before diluting to the desired concentration.
 For quantitative applications, the minimum sample size for intended use is 1 µL.

Component Certified Concentration

(-)-Epigallocatechin 3-gallate 100.0 ± 0.5 µg/mL


(+)-Catechin 100.0 ± 0.5 µg/mL 1
(-)-Epicatechin 100.1 ± 0.5 µg/mL 1
(-)-Epicatechin 3-gallate 100.0 ± 0.5 µg/mL 1
(-)-Gallocatechin 100.0 ± 0.5 µg/mL 1
(-)-Gallocatechin 3-gallate 100.1 ± 0.5 µg/mL 1
(-)-Catechin 3-gallate 99.98 ± 0.5 µg/mL
Caffeine 100.0 ± 0.5 µg/mL
 Uncertainty of the concentration is expressed as an expanded uncertainty in accordance with ISO 17025 and Guide 34 at the approximate
95% confidence interval using a coverage factor of k = 2 and has been calculated by statistical analysis of our production system and
incorporates uncertainty of the purity factor, material density, homogeneity of the ampouled standard, and balance and weighing technique.
Uncertainty terms for verification and stability are excluded.
 This standard is prepared gravimetrically and mass results are reported on the conventional basis for weighing in air. Concentration is
calculated based on: the actual measured mass; Purity Factor of the analyte(s); measured mass of the solution; and the density of the pure
diluent at 20°C.
 Concentration is corrected for chromatographic purity, residual water, residual solvents and residual inorganics.
 The Certified Concentration represents the True Value and is expressed in terms of concentration per volume of solution with stated
uncertainty at µg/mL. We recommend the Certified Concentration be used for all calculations and dilutions.
1
Concentration has been corrected using vendor supplied data for residual solvents and residual organics. Cerilliant has not analytically
verified this data. Inaccuracies in concentration may exist.

Cerilliant certifies that this standard meets the specifications stated in this certificate and warrants this product to meet the stated
acceptance criteria through the expiration/retest date when stored unopened as recommended. Product should be used shortly
after opening to avoid concentration changes due to evaporation. Warranty does not apply to ampoules stored after opening.

October 13, 2015


Darron Ellsworth, Quality Assurance Manager Date

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
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Product of USA

Traceability
 Gravimetrically prepared using qualified balances calibrated semi-annually by Mettler Toledo using NIST traceable weights. Calibration
verification performed weekly and prior to each use utilizing NIST traceable weights. Each balance has been assigned a minimum weighing
by Mettler Toledo taking into consideration the balance and installed environmental conditions to ensure weighing complies with USP
tolerances of no more than 0.1% relative error.
 Weigh tapes provide traceability to SI units of measure.
 Balances and NIST traceable weights calibrated by ISO 17025 accredited vendors.
 Concentration is verified against an independently prepared calibrator gravimetrically prepared using balances calibrated to NIST.
 In addition, each neat material utilized has been identified and thoroughly characterized by an ISO 17025 accredited laboratory.
Spectral data is provided on subsequent pages of the COA.

Standard Solution Assay Parameters Calibration Curve


Analysis Method: HPLC/UV Calibration Curve: Linear Regression
Column: Ascentis ES Cyano 3 µm, 4.6 x 100 mm Number of Points: 1
Mobile Phase: A:: Acetonitrile
B:: Acetonitrile::Water with 0.2% Acetic acid (5::95)
Gradient: Time (min) %A %B
0.0 5 95
5.0 25 75
5.1 5 95
Flow Rate: 1.5 mL/min
Wavelength: 278 nm

Solution Standard Verification and Homogeneity


Verified Concentration %RSD - Homogeneity
Compound µg/mL Acceptance Criteria % Acceptance Criteria

(-)-Epigallocatechin 3-gallate 105.0 ± 10% 0.3 ≤ 5%


(+)-Catechin 101.4 ± 10% 0.6 ≤ 5%
(-)-Epicatechin 102.0 ± 10% 0.4 ≤ 5%
(-)-Epicatechin 3-gallate 102.9 ± 10% 0.5 ≤ 5%
(-)-Gallocatechin 105.7 ± 10% 0.7 ≤ 5%
(-)-Gallocatechin 3-gallate 102.4 ± 10% 0.3 ≤ 5%
(-)-Catechin 3-gallate 100.7 ± 10% 0.5 ≤ 5%
Caffeine 101.8 ± 10% 0.3 ≤ 5%
 The Verified Concentration and acceptance criteria incorporate variability of the analytical method and technique. We recommend the Certified
Concentration be used for performing calculations and dilutions.
 Concentration is verified through comparison of multiple ampules to an independently prepared calibrator and reported as the average.
 Homogeneity is ensured through rigorous production process controls statistically analyzed to evaluate risk and verified by analysis. The %RSD of
samples pulled from across the lot demonstrate homogeneity.

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 3 of 14
Product of USA
Solution Standard Analysis

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 4 of 14
Product of USA

Neat Material Data


CAS Chemical Molecular Identity
Compound Lot Number Number Formula Weight Confirmed By

(-)-Epigallocatechin 3-gallate PN072911-01 989-51-5 C22H18O11 458.37 LC/MS


(+)-Catechin PN072911-02 154-23-4 C15H14O6 290.27 LC/MS
(-)-Epicatechin PN072911-03 490-46-0 C15H14O6 290.27 LC/MS
(-)-Epicatechin 3-gallate PN072911-04 1257-08-5 C22H18O10 442.37 LC/MS
(-)-Gallocatechin PN072911-05 3371-27-5 C15H14O7 306.27 LC/MS
(-)-Gallocatechin 3-gallate PN072911-06 4233-96-9 C22H18O11 458.37 LC/MS
(-)-Catechin 3-gallate PN072911-07 130405-40-2 C22H18O10 442.37 LC/MS
Caffeine PN031008-01 58-08-2 C8H10N4O2 194.19 GC/MS

Chromatographic Residual Residual Residual Purity


Compound Purity Solvent Water Inorganics Factor

(-)-Epigallocatechin 3-gallate 99.36% None Detected 3.69% < 0.2% 95.69%


(+)-Catechin 99.27% < 0.05% 5.05% < 0.1% 94.26%
(-)-Epicatechin 98.06% < 0.05% BQL < 0.1% 98.06%
(-)-Epicatechin 3-gallate 99.54% < 0.05% 0.69% < 0.1% 98.85%
(-)-Gallocatechin 99.60% 0.10% 9.39% < 0.1% 90.15%
(-)-Gallocatechin 3-gallate 99.67% < 0.05% 4.07% < 0.1% 95.62%
(-)-Catechin 3-gallate 95.01% 13.41% 2.04% 0.50% 79.65%
Caffeine
Ca e e 99.95% None Detected Not Detected < 0.2% 99.95%
 Neat Materials obtained from Phytolab GmbH. Caffeine obtained from Sigma Aldrich.
 Phytolab certification of neat materials includes identity, purity, residual solvent, residual water and residual inorganic content.
Residual solvent and residual inorganic values may be obtained from vendor supplied COA.
 Identity, chromatographic purity and residual water values were certified by Cerilliant. Residual solvent values may be independently
certified by Cerilliant or obtained from vendor COA.
 Purity Factor = [(100 - wt% residual solvent - wt% residual water - wt% residual inorganics) x Chromatographic Purity/100].
 Purity factor does not include adjustment for chiral and/or isotopic purity.

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 5 of 14
Product of USA
(-)-Epigallocatechin 3-gallate
Material Purity by HPLC
Peak # Ret Time Area Height Area %

1 9.33 0.45 0.03 0.03


2 9.40 0.15 0.03 0.01
3 12.65 0.20 0.03 0.01
4 15.53 1479.39 188.24 99.35
5 16.32 3.52 0.19 0.24
6 19.16 4.96 0.61 0.33
7 20.41 0.23 0.02 0.02
8 22.76 0.11 0.01 0.01

Material Identity by LC/MS

PRM-303 PN072911-01 (-)-Epigallocatechin 3-gallate Cone Voltage 20


CE 6
W09031457 564 (2.050) Cm (564:594) 1: TOF MS ES-
457.0779 3.01e5
100 Theoretical [M - H]-: 457.0771
Found [M - H]-: 457.0779

458.0815
%

112.9854 455.0605 571.0722 915.1617


0 m/z
100 200 300 400 500 600 700 800 900 1000 1100

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 6 of 14
Product of USA
(+)-Catechin
Material Purity by HPLC
Peak # Ret Time Area Height Area %

1 7.39 0.16 0.01 0.02


2 12.67 789.01 93.77 99.32
3 13.54 1.15 0.10 0.15
4 13.85 0.30 0.03 0.04
5 14.61 0.54 0.08 0.07
6 15.26 0.24 0.02 0.03
7 15.66 0.11 0.01 0.01
8 16.72 0.26 0.03 0.03
9 21.24 0.74 0.10 0.09
10 21.39 0.88 0.11 0.11
11 21.69 0.08 0.01 0.01
12 22.28 0.28 0.03 0.03
13 22.76 0.63 0.06 0.08

Material Identity by LC/MS

PRM-304 PN072911-02 (+)-Catechin Cone Voltage 20


CE 6
W09031445 458 (1.672) Cm (458:485) 1: TOF MS ES-
289.0713 3.93e5
100
Theoretical [M - H]-: 289.0712
Found [M - H]-: 289.0713
%

290.0750
112.9852 403.0634 579.1498
0 m/z
100 200 300 400 500 600 700 800 900 1000 1100

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 7 of 14
Product of USA
(-)-Epicatechin
Material Purity by HPLC
Peak # Ret Time Area Height Area %

1 12.72 3.30 0.40 0.42


2 15.20 777.41 111.57 98.07
3 17.09 0.15 0.01 0.02
4 17.60 10.16 1.38 1.28
5 18.17 0.19 0.02 0.02
6 18.35 0.30 0.03 0.04
7 18.45 0.25 0.03 0.03
8 19.38 0.21 0.03 0.03
9 19.77 0.35 0.05 0.04
10 20.29 0.12 0.01 0.02
11 22.77 0.30 0.03 0.04

Material Identity by LC/MS

PRM-305 PN072911-03 (-)-Epicatechin Cone Voltage 20


CE 6
W09031447 539 (1.961) Cm (539:564) 1: TOF MS ES-
289.0707 3.20e5
100
Theoretical [M - H]- : 289.0712
Found [M - H]-: 289.0707
%

290.0742
112.9849 403.0654 579.1487
0 m/z
100 200 300 400 500 600 700 800 900 1000 1100

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 8 of 14
Product of USA
(-)-Epicatechin 3-gallate
Material Purity by HPLC
Peak # Ret Time Area Height Area %

1 15.21 0.33 0.05 0.02


2 15.59 1.25 0.17 0.06
3 18.15 1.84 0.24 0.09
4 19.20 1995.31 253.55 99.63
5 19.94 2.40 0.19 0.12
6 21.01 0.19 0.02 0.01
7 22.77 0.09 0.01 0.00
8 23.70 0.33 0.04 0.02
9 25.89 0.45 0.04 0.02
10 26.56 0.37 0.02 0.02
11 26.73 0.09 0.01 0.00

Material Identity by LC/MS

PRM-306 PN072911-04 (-)-Epicatechin-3-gallate Cone Voltage 20


CE 6
W09031449 695 (2.518) Cm (695:729) 1: TOF MS ES-
100
441.0823 3.72e5
Theoretical [M - H]-: 441.0822
Found [M - H]-: 441.0823
%

442.0858
112.9849 883.1714
439.0681 555.0751
883.1509 885.1741
0 m/z
100 200 300 400 500 600 700 800 900 1000 1100

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 9 of 14
Product of USA
(-)-Gallocatechin
Material Purity by HPLC
Peak # Ret Time Area Height Area %

1 5.18 0.21 0.04 0.09


2 6.96 227.31 22.95 99.51
3 7.44 0.12 0.03 0.05
4 15.90 0.28 0.03 0.12
5 21.61 0.52 0.06 0.23

Material Identity by LC/MS

PRM-307 PN072911-05 (-)-Gallocatechin Cone Voltage 20


CE 6
W09031478 670 (2.429) Cm (666:718) 1: TOF MS ES-
305.0665 3.42e5
100
Theoretical [M - H]- : 305.0661
Found [M - H]-: 305.0665
%

112.9852 303.0528 306.0706 419.0600 611.1411


613.1477
0 m/z
100 200 300 400 500 600 700 800 900 1000 1100

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 10 of 14
Product of USA
(-)-Gallocatechin 3-gallate
Material Purity by HPLC
Peak # Ret Time Area Height Area %

1 4.50 0.38 0.04 0.02


2 11.95 1.05 0.07 0.06
3 12.06 0.84 0.06 0.05
4 16.39 1618.31 214.15 99.66
5 17.23 1.65 0.11 0.10
6 17.63 0.24 0.03 0.01
7 18.50 0.15 0.02 0.01
8 18.69 0.72 0.05 0.04
9 19.25 0.21 0.02 0.01
10 19.62 0.07 0.01 0.00
11 21.37 0.10 0.01 0.01
12 21.46 0.07 0.01 0.00
13 21.94 0.09 0.01 0.01

Material Identity by LC/MS

PRM-308 PN072911-06 (-)-Gallocatechin 3-gallate Cone Voltage 20


CE 6
W09031453 586 (2.129) Cm (585:634) 1: TOF MS ES-
100
457.0775 3.61e5
Theoretical [M - H]- : 457.0771
Found [M - H]-: 457.0775

458.0814
%

112.9848 571.0697
455.0606 915.1655
0 m/z
100 200 300 400 500 600 700 800 900 1000 1100

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 11 of 14
Product of USA
(-)-Catechin 3-gallate
Material Purity by HPLC
Peak # Ret Time Area Height Area %

1 4.51 0.12 0.02 0.01


2 12.70 0.22 0.03 0.02
3 15.56 0.18 0.02 0.01
4 16.50 0.11 0.02 0.01
5 16.71 0.10 0.01 0.01
6 17.05 0.64 0.06 0.05
7 17.70 0.13 0.02 0.01
8 18.43 1.06 0.10 0.08
9 18.81 0.15 0.02 0.01
10 19.20 10.20 1.35 0.73
11 19.45 1318.92 167.72 95.06
12 20.18 2.29 0.16 0.17
13 21.51 0.33 0.04 0.02
14 21.66 0.89 0.07 0.06
15 22.74 19.31 2.07 1.39
16 23.24 0.88 0.08 0.06
17 24.90 0.20 0.02 0.01
18 25.73 0.70 0.06 0.05
19 26.77 30.41 2.04 2.19
20 32.40 0.68 0.04 0.05

Material Identity by LC/MS

PRM-309 PN072911-07 (-)-Catechin 3-gallate Cone Voltage 20


CE 6
W09031455 687 (2.490) Cm (685:710) 1: TOF MS ES-
441.0821 3.43e5
100 Theoretical [M - H]-: 441.0822
Found [M - H]-: 441.0821
%

442.0851
112.9845 555.0745 883.1711
0 m/z
100 200 300 400 500 600 700 800 900 1000 1100

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 12 of 14
Product of USA
Caffeine
Material Purity by HPLC
VWD1 A, Wavelength=254 nm (S:\HPLC\HPLC9\2012\LC90812\K0830204.D) Peak # Ret Time Area Height Area %
4.605

mAU
1 4.61 1412.29 243.97 100.00

200

150

100

50

0 2 4 6 8 10 12 14 16 18 mi

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 13 of 14
Product of USA
Caffeine
Material Identity by GC/MS

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974
G-016
FN08191501
Revision 00
Page 14 of 14
Product of USA

Stability
Short Term Stability : A summary of accelerated stability findings for this product is listed below.

Storage Condition Mean Kinetic Temperature (MKT) Time Period


Sub-Freezer -70 °C
Freezer -15 °C No decrease in solution purity (sum of eight peaks) was
Refrigerator 4 °C noted after four weeks.
Room Temperature 21 °C
1.46% decrease in solution purity (sum of eight peaks)
40 °C 40 °C
was noted after one week.
Transport/Shipping : Product is shipped cool as a precautionary measure. Stability data supports normal
laboratory use at ambient conditions.

Short Term Storage: Stability data supports short term storage of less than 1 month at Refrigerate conditions.

Long Term Stability: Long term stability has been assessed for Freezer storage (-10 °C to -25 °C) conditions.
Stability of a minimum of 37 months has been established through real-time stability studies.

COA Revision History


Revision No. Date Reason for Revision
00 October 13, 2015 Initial version

Cerilliant Corporation 811 Paloma Drive, Suite A, Round Rock, TX 78665 800-848-7837 / 512-238-9974

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