CERTIFICATE OF ANALYSIS AND QUALITY
Product Omega Cardioprotector
SKU OMEGA
Barcode 866033000253
Formula 1
Date 20 September 2019
Label
Certifications
Good Manufacturing Practice (GMP) Certificate
Capsule Certificate of Analysis from Supplier
Capsule Certificate of Analysis from Manufacturing
Capsule Identity Test Results (FTIR) from Manufacturing
Combined Ingredients Certificate of Analysis from Manufacturing
Excipient Rice Flour Certificate of Analysis from Supplier
Excipient Rice Flour Certificate of Analysis from Manufacturing
Excipient Rice Flour Identity Test Results (FTIR) from Manufacturing
Excipient Silicon Dioxide Certificate of Analysis from Supplier
Excipient Silicon Dioxide Certificate of Analysis from Manufacturing
Excipient Silicon Dioxide Identity Test Results (FTIR) from Manufacturing
French Maritime Pine Certificate of Analysis from Supplier
French Maritime Pine Certificate of Analysis from Manufacturing
French Maritime Pine Identity Test Results (FTIR) from Manufacturing
French Maritime Pine Identity Test Results (HPTLC) from Manufacturing
French Maritime Pine Potency Test Results (UV-VIS) from Manufacturing
Garlic Certificate of Analysis from Supplier
Garlic Certificate of Analysis from Manufacturing
Garlic Identity Test Results (FTIR) from Manufacturing
Garlic Identity Test Results (HPTLC) from Manufacturing
Garlic Potency Test Results (HPLC) from Manufacturing
Omega 3 Certificate of Analysis from Supplier
Omega 3 Certificate of Analysis from Manufacturing
Omega 3 Identity Test Results (FTIR) from Manufacturing
Color Hit Quality
948
Compound name
10032 Capsule 0 HPMC 61604 Standard 1
CAS Number Molecular formula Molecular weight
Color File
2761-10032 Capsule HPMC 0 Clear 7296.0
Path
C:\Users\Israel\Documents\Bruker\OPUS_7.5.18\Data\MEAS
Spectrum Type
Query Spectrum
Product Number
Entry No.
Library name
Library description
Copyright
10032 Capsule 0 HPMC 61604 Standard 1
47
ORIGIN STANDARDS LIBRARY.S01
Library for Origin Nutra Materials
Origin Nutraceutical Materials Only
500100015002000250030003500Wavenumber cm-1
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PO Box 565Spanish Fork, UT 84660(801) 210-2084
18 12307Report Number:7/2/2018Approved Date:
MDLTest Result UnitsCertificate of Analysis
Item #: Description: Lot #:Received:
50363Omega1817116/28/2018 2:47 PM
CTLA1077 S 1675 WOrem, UT 84058
SpecificationsMethod
Sample Details Customer Information
Heavy Metals0.098 ppmArsenic <2 0.001USP 40 <2232>0.010 ppmCadmium <2 0.001USP 40 <2232>0.133 ppmLead <1 0.001USP 40 <2232>
<0.001 ppmMercury <0.5 0.001USP 40 <2232>
This report is provided for the exclusive use of the addressee. The Laboratory accepts no responsibility/liability except for the due performance of inspection and/or analysis in good faith.
Report Approved by:* = Please review Client Specifications
Page 1 of 1
_______________________________Joel L. Nelson
Laboratory Manager
Report Numbers that have been revised or amended will include a revision number.
Color Hit Quality
982
Compound name
10108 Rice Flour 62241 Standard 3
CAS Number Molecular formula Molecular weight
Color File
2927-10108 Rice Flour 5433.0
Path
C:\Users\Israel\Documents\Bruker\OPUS_7.5.18\DATA\MEAS
Spectrum Type
Query Spectrum
Product Number
Entry No.
Library name
Library description
Copyright
10108 Rice Flour 62241 Standard 3
125
ORIGIN STANDARDS LIBRARY.S01
Library for Origin Nutra Materials
Origin Nutraceutical Materials Only
500100015002000250030003500Wavenumber cm-1
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0.25
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Color Hit Quality
986
Compound name
10030 Silicon Dioxide Precipitation 63211 Standard 1
CAS Number Molecular formula Molecular weight
Color File
2928-10030 Silicon Dioxide 5492.0
Path
C:\Users\Israel\Documents\Bruker\OPUS_7.5.18\DATA\MEAS
Spectrum Type
Query Spectrum
Product Number
Entry No.
Library name
Library description
Copyright
10030 Silicon Dioxide Precipitation 63211 Standard 1
45
ORIGIN STANDARDS LIBRARY.S01
Library for Origin Nutra Materials
Origin Nutraceutical Materials Only
500100015002000250030003500Wavenumber cm-1
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CertificateofAnalysis
1077 S 1675 W, Orem, UT 84058
CTLA ID: 2756
Date Received: 3/27/18
Sample Name: 10622 Pycogenol
Lot Number: 7267
Analysis Specification Method ResultsTotal Plate Count Report USP <2021> <100 cfu/g
Total Coliforms Report BAM CH.4 <10 cfu/g
E. coli Report USP <2022> Absent
Staph. aureus Report USP <2022> Absent
Salmonella Report USP <2022> Absent
Total Yeast & Mold Report USP <2021> <100 cfu/g
Sample Information
Quality Manager
Color Hit Quality
966
Compound name
10622 Pycnogenol Maritime Bark 7267 Standard 1
CAS Number Molecular formula Molecular weight
Color File
2756-10622 Pycnogenol Maritime Bark 7267.0
Path
C:\Users\Israel\Documents\Bruker\OPUS_7.5.18\Data\MEAS
Spectrum Type
Query Spectrum
Product Number
Entry No.
Library name
Library description
Copyright
10622 Pycnogenol Maritime Bark 7267 Standard 1
1109
ORIGIN STANDARDS LIBRARY.S01
Library for Origin Nutra Materials
Origin Nutraceutical Materials Only
500100015002000250030003500Wavenumber cm-1
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Certificate of Analysis: 10622 Pycnogenol (7267) High Performance Thin-Layer Chromatography with Photo-Documentation
1 2
Certificate Issued To: CTLA 1077 S. 1675 W Orem, UT 84058 USA
Company Name: CTLA Title: 10622 Pycnogenol Plant Part: bark Sample Received: 05/08/18 Sample Packaging: Clear Whirl-Pak Form of Botanical: powdered extract Appearance: red/brown fine powder Lot Number: (7267) ÆLanes 4(0.5µl), 5(1µl) Sample: TS12818CTLA1_1 Latin Name: Pinus maritima / pinus pinaster Poir. [Pinaceae] Reference Sample: Lane 2(2µl) (TS12205HEC), Lane 3(4µl) (TS12205HEC) Pinus maritima / pinus pinaster (bark); Lane 6(3µl) (LI20203BH)
Pinus strobus (bark); held at Alkemist Labs, Garden Grove, CA. Analyst: A. Davis, N. Hoang, P. Fast, N. Afendikova, K. Tran, S. Kabbaj, E. Garcia, M. Lababidi, J. Nguyen 102337 Sample Preparation: 0.3g+3mL 70% grain Ethanol, sonicate/heat at 50° C for 30 min. Stationary Phase: Silica gel 60, HPTLC plates Mobile Phase: ethyl acetate: Formic Acid: Water [10/1/0.6] Detection: (1) Vanillin/Sulfuric, 110°C, 2min, vis (Reich, E., 2007)
(2) Vanillin/Sulfuric, 110°C, 2min, 366nm (Reich, E., 2007) Reference Standard: Lane 1(2µl) Maritime Pine Extract (F0K092, USP), Methanol (57236, VWR); Lane 7(3µl) Ferulic Acid (41, XSYN),
Methanol (042317C, BDH); Lane 8(3µl) Protocatechuic Acid (1129/0, XSYN), Methanol (042317C, BDH) Reference Source: USP 36 TLC ID c IDT-SOP-72-01 Comments & Conclusions: Lanes 4, 5 are the test sample 10622 Pycnogenol (7267) Lanes 2, 3, 6 are the reference samples used for comparison. This test sample, 10622 Pycnogenol (7267), is consistent with the chromatographic profile of the reference samples of Pinus maritima / pinus pinaster used above. This test sample 10622 Pycnogenol (7267) has characteristics of a customized extract derived from Pinus maritima / pinus pinaster bark, targeting procyanidins. NOTE: The above conclusion may be a function of the natural variance found in botanicals &/or the extraction process used to create specific extracts. The growing and drying conditions, age, seasonal variations, geographic location, extraction solvents, etc. all play a role in the phytochemical fingerprint of botanicals as well as their extracts; hence, chromatographic variations are expected.
Examined, Reviewed & Authorized by: Jonathan Nguyen, HPTLC Supervisor, Alkemist Labs Report Date: 05/14/18 Note: Any unidentified lanes in the above chromatograms are confidential and may represent internal studies or other test samples not related to 7267. This report applies to the sample investigated and is not necessarily indicative of the quality or condition of apparently identical or similar products. This report is for the exclusive use of the party who requested the report and not for public dissemination or use by third parties, including for promotional purposes, without the prior written permission of Alkemist Labs, Inc. This report provides technical results for a specific sample and the report shall not be altered, modified, supplemented or abstracted in any manner. Any violation of these conditions renders the report and its results void. © 2018Alkemist Labs, Inc. All Rights Reserved
Work performed at: Alkemist Labs 12661 Hoover Street Garden Grove, CA 92841 714-754-HERB (4372) 714-668-9972 (FAX) [email protected] www.Alkemist.com
Per Unit MethodResultAnalysis
Description: 10622 PycnogenolSample ID: 7267Lot No:
Location:
Client: CTLA1077 S 1675 WOrem, UT 84058
Received: 5/7/2018 Completed: 5/15/2018Lab No: 152107-01PO No:
Test Certificate
Part Code:
Email: [email protected] Registration #3006423386
Phone: (801) 485-1800 Fax: (801) 484-921140 West Louise Ave., Salt Lake City, UT 84115
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%75.337 UV-Vis†Pycnogenol
Pycnogenol analyzed as total vanillin-catechin conjugates using modified methodology of Larry G.Butler et al., “Vanillin Assay for Proanthocyanidins [Condensed Tannins]: Modification of the solvent for Estimation of the degree of Polymerization” as published in J. Agric. Food Chem., 30, 1087-1089, vanillin reagent prepared as 750ml with 15g ammonium iron sulfate in n-butanol/hydrochloric acid (95:5). For the determination of total catechin on 2% sol of initial extract in a 50ml volumetric flask containing 25ml of methanol; 2.5ml of Vanillin reagent added and heated to 95°C for 40mins after cooling diluted to volume with methanol, the absorbance of both the standard solutions and sample is measured at 550nm. Authentic reference material obtained from Sigma-Aldrich.
Printed: 5/15/2018 3:58:52 PMPage 1 of 1
Results Approved By:Alisa Farnsworth-Quality Technician
Dated: 5/15/2018
THESE RESULTS APPLY ONLY TO THE SAMPLE SUBMITTED AND NOT TO THE PRODUCT FROM WHICH IT WAS TAKEN. THESE RESULTS ARE PROVIDED ONLY FOR THE BENEFIT OF CLIENT, WITHOUT REPRESENTATION OR WARRANTY OF ANY KIND, EXCEPT FOR THE EXPRESS LIMITED WARRANTY PROVIDED SOLELY TO CLIENT IN ADVANCED LABORATORIES’ TERMS OF SERVICE.
THIS CERTIFICATE SHALL NOT BE REPRODUCED EXCEPT IN FULL, WITHOUT WRITTEN APPROVAL FROM ADVANCED LABORATORIES.
Tests marked with † were done at Atlas Bioscience Labs, LLC, a joint venture with Advanced Laboratories. -1775 S. Pantano Rd - Ste #110, Tucson, AZ 85710
CertificateofAnalysis
1077 S 1675 W, Orem, UT 84058
CTLA ID: 2610
Date Received: 3/6/18
Sample Name: 10620 Garlic 1%
Lot Number: 6807
Analysis Specification Method ResultsID Report FTIR >95%Total Plate Count Report USP <2021> 1,200 cfu/gTotal Coliforms Report BAM CH.4 <10 cfu/gE. coli Report USP <2022> AbsentStaph. aureus Report USP <2022> AbsentSalmonella Report USP <2022> AbsentTotal Yeast & Mold Report USP <2021> 700 cfu/g
Sample Information
Quality Manager
Color Hit Quality
954
Compound name
10657 Garlic Powder 7634 Standard 1
CAS Number Molecular formula Molecular weight
Color File
2610-10620 Garlic 6807.1
Path
C:\Users\Israel\Documents\Bruker\OPUS_7.5.18\DATA\MEAS
Spectrum Type
Query Spectrum
Product Number
Entry No.
Library name
Library description
Copyright
10657 Garlic Powder 7634 Standard 1
1142
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Library for Origin Nutra Materials
Origin Nutraceutical Materials Only
500100015002000250030003500Wavenumber cm-1
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Certificate of Analysis: 10620 Garlic (6807) High Performance Thin-Layer Chromatography with Photo-Documentation
1 2
Certificate Issued To: CTLA 1077 S. 1675 W Orem, UT 84058 USA
Company Name: CTLA Title: 10620 Garlic Plant Part: bulb Sample Received: 05/08/18 Sample Packaging: Clear Whirl-Pak Form of Botanical: powder Appearance: white/cream fine powder Lot Number: (6807) ÆLanes 4(4µl), 5(8µl) Sample: V12818CTLA1_1 Latin Name: Allium sativum L. [Liliaceae] Reference Sample: Lane 2(8µl) (V14604PB), Lane 3(8µl) (V17317AHP1) Allium sativum (bulb); Lane 6(4µl) (AGE17317AHP1), Lane 7(2µl)
(AGE17317AHP1) Allium cepa (bulb); held at Alkemist Labs, Garden Grove, CA. Analyst: A. Davis, N. Hoang, P. Fast, N. Afendikova, K. Tran, S. Kabbaj, E. Garcia, M. Lababidi, J. Nguyen 102332 Sample Preparation: 0.3g+3mL 70% grain Ethanol, sonicate/heat at 50° C for 30 min. Stationary Phase: Silica gel 60, HPTLC plates Mobile Phase: n-butanol: Water: Acetic acid: Formic Acid [5.8/1.6/1.8/0.4] Detection: (1) Ninhydrin, 120°C, 5min, vis (Reich, E., 2007)
(2) Ninhydrin, 120°C, 5min, 366nm (Reich, E., 2007) Reference Standard: Lanes 1(6µl) and 8(6µl) Alliin (00001541-42A, CHR), Methanol (56154, EMD) Reference Source: BTM-715-0037 IDT-SOP-72-01 Comments & Conclusions: Lanes 4, 5 are the test sample 10620 Garlic (6807). Lanes 2, 3, 6, 7, are the reference samples used for comparison. This test sample, 10620 Garlic (6807) is consistent with the chromatographic profile of the reference samples of Allium sativum, used above. This test sample 10620 Garlic (6807) has characteristics of Allium sativum bulb. NOTE: The above conclusion may be a function of the natural variance found in botanicals &/or the extraction process used to create specific extracts. The growing and drying conditions, age, seasonal variations, geographic location, extraction solvents, etc. all play a role in the phytochemical fingerprint of botanicals as well as their extracts; hence, chromatographic variations are expected.
Examined, Reviewed & Authorized by: Jonathan Nguyen, HPTLC Supervisor, Alkemist Labs Report Date: 05/15/18 Note: Any unidentified lanes in the above chromatograms are confidential and may represent internal studies or other test samples not related to 6807. This report applies to the sample investigated and is not necessarily indicative of the quality or condition of apparently identical or similar products. This report is for the exclusive use of the party who requested the report and not for public dissemination or use by third parties, including for promotional purposes, without the prior written permission of Alkemist Labs, Inc. This report provides technical results for a specific sample and the report shall not be altered, modified, supplemented or abstracted in any manner. Any violation of these conditions renders the report and its results void. © 2018Alkemist Labs, Inc. All Rights Reserved
Work performed at: Alkemist Labs 12661 Hoover Street Garden Grove, CA 92841 714-754-HERB (4372) 714-668-9972 (FAX) [email protected] www.Alkemist.com
Per Unit MethodResultAnalysis
Description: 10620 GarlicSample ID: 6807Lot No:
Location:
Client: CTLA1077 S 1675 WOrem, UT 84058
Received: 5/7/2018 Completed: 5/15/2018Lab No: 152107-06PO No:
Test Certificate
Part Code:
Email: [email protected] Registration #3006423386
Phone: (801) 485-1800 Fax: (801) 484-921140 West Louise Ave., Salt Lake City, UT 84115
If you liked our service, please tell a friend. If you didn't, please tell us!
%1.087 HPLC†Garlic (Allicin)
Garlic (Allicin) analysis performed using HPLC by method adapted from Lawson, L.D., Wood, S.G., and Hughes, B., “HPLC Analysis of Allicin and other Thiosulfinates in Garlic Clove Homogenates,"" as published in Planta Medica, 57: 263–270, 1991. Allicin standard prepared and quantified employing method of Han, J., Lawson, L., Hand, G., and Han, P.; “A Spectrophotometric Method for Quantitative Determination of Allicin and Total Garlic Thiosulfinates,"" as published in Anal. Biochem. 225: 157, 1995; utilizing a Phenomenex Prodigy ODS(3) column, 5 µm, 4.6 x 250 mm, with an isocratic mobile phase of acetonitrile:0.1% formic acid at 1.0 ml/min, detection by scanning photo diode array (200-400nm) with signal extraction at 205nm for quantification.
Printed: 5/15/2018 3:58:52 PMPage 1 of 1
Results Approved By:Alisa Farnsworth-Quality Technician
Dated: 5/15/2018
THESE RESULTS APPLY ONLY TO THE SAMPLE SUBMITTED AND NOT TO THE PRODUCT FROM WHICH IT WAS TAKEN. THESE RESULTS ARE PROVIDED ONLY FOR THE BENEFIT OF CLIENT, WITHOUT REPRESENTATION OR WARRANTY OF ANY KIND, EXCEPT FOR THE EXPRESS LIMITED WARRANTY PROVIDED SOLELY TO CLIENT IN ADVANCED LABORATORIES’ TERMS OF SERVICE.
THIS CERTIFICATE SHALL NOT BE REPRODUCED EXCEPT IN FULL, WITHOUT WRITTEN APPROVAL FROM ADVANCED LABORATORIES.
Tests marked with † were done at Atlas Bioscience Labs, LLC, a joint venture with Advanced Laboratories. -1775 S. Pantano Rd - Ste #110, Tucson, AZ 85710
Certificate of AnalysisSample Information
CTLA ID:Date Received:Sample Name:Lot Number:Customer:
104348/29/2019Thrivous Omega181711Origin Nutraceutical
Analysis SpecificationMethod ResultMDL Units
Complete MicroReportUSP <2021> <100Total Plate Count 100 cfu/gReportBAM CH.4 <10Total Coliforms 10 cfu/gReportUSP <2022> NegativeEscherichia coliReportUSP <2022> NegativeSalmonellaReportUSP <2022> NegativeStaphylococcus aureusReportUSP <2021> <100Yeast & Mold 100 cfu/g
DHA/EPA Combo Test200GC-MS 85.74DHA mg/cap300GC-MS 164.3EPA mg/cap
1055 S 1675 W, OREM, UT 84059 (385) 477-4999
Quality Manager
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Specifications provided by the Customer. Results with an asterisk (*) denote Specifications should be reviewed by the Customer.This Certificate of Analysis represents data for the sample submitted and does not constitute a guarantee of quality for the entireproduct from which it was taken. These results are provided for the benefit of the Customer. MDL = Method Detection Limit.
Color Hit Quality
976
Compound name
10621 Omega 3 lot 7588 Standard 1
CAS Number Molecular formula Molecular weight
Color File
2850-10621 Omega 3 7588.0
Path
C:\Users\Israel\Documents\Bruker\OPUS_7.5.18\Data\MEAS
Spectrum Type
Query Spectrum
Product Number
Entry No.
Library name
Library description
Copyright
10621 Omega 3 lot 7588 Standard 1
1135
ORIGIN STANDARDS LIBRARY.S01
Library for Origin Nutra Materials
Origin Nutraceutical Materials Only
500100015002000250030003500Wavenumber cm-1
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