Certified Reference Material Certificate of Analysis AOCS 0411

Certified Reference Material
Address:
2710 S. Boulder Drive, Urbana, IL 61802 USA
Email: [email protected]
Tel:+1-217-359-2344; Fax: +1-217-351-8091
Certificate of Analysis
AOCS 0411-C, non-modified maize powder
Certified Property
Certified Presence
5307
No
Pure, non-modified
maize
Measurement
Uncertainty
Test Method
NA
event-specific realtime PCR
Description:
This is the first batch of non-modified maize CRM prepared by AOCS for
Syngenta Biotechnology Inc. This material is for limited purposes only: see
"Intended Use" and “Terms and Conditions.”
This certificate is valid through: March 2016
This validity may be extended when further evidence of stability becomes
available. Customers will be notified by AOCS if a stability issue arises at AOCS
Headquarters. Introduced: 16 March 2015
AOCS Chief Science Officer
AOCS Reference Materials Manager
and Technical Director
G. M. Clapper
R. C. Cantrill
Urbana, IL 61802
Urbana, IL 61802
AOCS Mission: AOCS advances the science and technology of oils, fats,
surfactants and related materials, enriching the lives of people everywhere.
Characterization
Product Description
AOCS 0411-C has been prepared by AOCS from maize devitalized seed.
AOCS 0411-C is available in 27-mL glass headspace vials containing
approximately 10 g of maize powder. Users are informed that this
reference material has been produced from devitalized seed of nonmodified maize (NP2171 x NP2460) delivered by Syngenta Biotechnology
Inc.
Homogeneity
Ten packaged samples, 10 g each, were tested using event-specific qualitative
PCR methods developed and validated by Syngenta Biotechnology Inc. Test
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-C
Page 1 of 4, © AOCS, 2015
results received from Eurofins-GeneScan, New Orlean, LA (an ISO 17025
accredited laboratory) for qualitative, event-specific analysis were entered into
the SeedCalc8 program for Impurity Estimation & Confidence Intervals. The
statistical analysis shows within 95 % confidence that the lower bound of true
purity of AOCS 0411-C is < 1.0 g/kg 5307 in this non-modified maize.
Stability
AOCS Certified Reference Materials are tested for stability on an annual
basis and certificates may be extended based on the outcome of this
testing.
Analytical Method Used for Certification
Eurofins-GeneScan, New Orlean, LA (an ISO 17025 accredited laboratory)
performed event-specific real-time PCR for 5307 to validate the certification
value of AOCS 0411-C.
Warnings and Precautions
This product is for laboratory use only and is not for consumption. The user
of this CRM should follow safety requirements and rules issued by voluntary
organizations and government agencies expert in the field of laboratory
safety.
Intended Use
This CRM, AOCS 0411-C, is intended for use as quality control material or
calibrant in methods for the detection, identification, and/or quantification
of biotechnology-derived events.
Instructions for Use
Upon receipt the product should be stored in a sealed container at +4° C
in the dark. The product may have settled during shipment, therefore,
thoroughly mix the CRM before use to insure homogeneity.
Product opening date: _____________________________(completed by
customer)
Recommended test portion for DNA extraction: minimum of 1 g
Protocols have been followed to insure that the certified presence
represents the true presence. AOCS cannot be held responsible for
changes that happen during storage of the product at the buyer’s
location.
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-C
Page 2 of 4, © AOCS, 2015
Note:
The AOCS 0411-C Certification Report is available online though a paper
copy will be supplied upon request.
Terms and Conditions (i – ix)
i.
The CRM AOCS 0411-C shall be used solely 1) in assays for (a)
detecting the presence of non-modified, or (b) quantification of nonmodified; or 2) for determining whether an assay cross-reacts with CRM
AOCS 0411-C. CRM AOCS 0411-C shall be used for no other purpose.
Specifically the CRM may not be used to develop a detection method
for non-modified nor trait(s) present therein. No other rights are
conveyed by the sale of the CRM 0411-C to any purchaser, including
any rights to any pending or granted Syngenta Biotechnology Inc
Patents or other Syngenta Biotechnology Inc Intellectual Property that
may protect the CRM or non-modified or trait(s) present therein or a
detection method for non-modified.
ii.
Neither the CRM AOCS 0411-C nor any extract or portion thereof shall
be resold or redistributed by any purchaser, unless the resale or
redistribution is required by national law in force in the purchaser’s
country.
iii.
Neither the CRM AOCS 0411-C, nor any extract or portion thereof, shall
be used for human or animal consumption or human or animal trials.
iv.
Neither the CRM AOCS 0411-C nor non-modified DNA, nor any part of
either of these, shall be used for transformation or breeding.
v.
No characterization or derivation of non-modified, of the trait or traits
present in CRM AOCS 0411-C, or of the CRM AOCS 0411-C shall be
performed, except as allowed for in section (i).
vi.
All assay activities undertaken using the CRM AOCS 0411-C shall be
conducted in strict compliance with all Applicable Laws governing
such activities, and shall comply with conditions of all permits and
authorizations which may be required for such activities; and such
activities shall be strictly limited to assays in contained facilities, for
example, laboratories.
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-C
Page 3 of 4, © AOCS, 2015
vii. Prior to disposal of any used or excess CRM AOCS 0411-C or residues
thereof, such material or residue must be treated in a manner that
degrades non-modified in the CRM material, such as by autoclaving.
viii. CRM AOCS 0411-C shall not be exported nor re-exported in violation of
any Applicable Laws or without securing any necessary export or
import clearances or permits.
ix.
THE CRM 0411-C IS PROVIDED FOR THE PURPOSES STATED HEREIN AND
FOR NO OTHER PURPOSE. ALL CRM AOCS 0411-C AND Syngenta
Biotechnology Inc MATERIALS ARE PROVIDED “AS IS” WITHOUT
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. Syngenta
Biotechnology Inc MAKES NO REPRESENTATION OR WARRANTY THAT THE
USE OF THE CRM AOCS 0411-C, WHETHER BEFORE, ON OR AFTER THE
EFFECTIVE DATE OF THE APPLICABLE CERTIFICATE, WILL NOT INFRINGE
ANY PATENT OR OTHER PROPRIETARY RIGHTS.
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-C
Page 4 of 4, © AOCS, 2015
Certified Reference Material
Address:
2710 S. Boulder Drive, Urbana, IL 61802 USA
Email: [email protected]
Tel:+1-217-359-2344; Fax: +1-217-351-8091
Certificate of Analysis
AOCS 0411-D, 5307 maize powder
Certified Property
Certified Presence
5307
Yes
Pure, Heterozygous
5307 maize
Measurement
Uncertainty
Test Method
NA
event-specific realtime PCR
Description:
This is the first batch of 5307 maize CRM prepared by AOCS for Syngenta
Biotechnology Inc. This material is for limited purposes only: see "Intended Use"
and “Terms and Conditions.”
This certificate is valid through: March 2016
This validity may be extended when further evidence of stability becomes
available. Customers will be notified by AOCS if a stability issue arises at AOCS
Headquarters. Introduced: 16 March 2015
AOCS Chief Science Officer
AOCS Reference Materials Manager
and Technical Director
G. M. Clapper
R. C. Cantrill
Urbana, IL 61802
Urbana, IL 61802
AOCS Mission: AOCS advances the science and technology of oils, fats,
surfactants and related materials, enriching the lives of people everywhere.
Characterization
Product Description
AOCS 0411-D has been prepared by AOCS from maize devitalized seed.
AOCS 0411-D is available in 27-mL glass headspace vials containing
approximately 10 g of maize powder. Users are informed that this
reference material has been produced from devitalized seed of 5307
maize ((NP2171 x NP2460 / 5307)) delivered by Syngenta Biotechnology
Inc.
Homogeneity
Ten packaged samples, 10 g each, were tested using event-specific qualitative
PCR methods developed and validated by Syngenta Biotechnology Inc. Test
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-D
Page 1 of 4, © AOCS, 2015
results received from Eurofins-GeneScan, New Orlean, LA (an ISO 17025
accredited laboratory) for qualitative, event-specific analysis were entered into
the SeedCalc8 program for Impurity Estimation & Confidence Intervals. The
statistical analysis shows within 95 % confidence that the lower bound of true
purity of AOCS 0411-D is > 998.8 g/kg 5307 maize.
Stability
AOCS Certified Reference Materials are tested for stability on an annual
basis and certificates may be extended based on the outcome of this
testing.
Analytical Method Used for Certification
Eurofins-GeneScan, New Orlean, LA (an ISO 17025 accredited laboratory)
performed event-specific real-time PCR for 5307 to validate the certification
value of AOCS 0411-D.
Warnings and Precautions
This product is for laboratory use only and is not for consumption. The user
of this CRM should follow safety requirements and rules issued by voluntary
organizations and government agencies expert in the field of laboratory
safety.
Intended Use
This CRM, AOCS 0411-D, is intended for use as quality control material or
calibrant in methods for the detection, identification, and/or quantification
of biotechnology-derived events.
Instructions for Use
Upon receipt the product should be stored in a sealed container at +4° C
in the dark. The product may have settled during shipment, therefore,
thoroughly mix the CRM before use to insure homogeneity.
Product opening date: _____________________________(completed by
customer)
Recommended test portion for DNA extraction: minimum of 1 g
Protocols have been followed to insure that the certified presence
represents the true presence. AOCS cannot be held responsible for
changes that happen during storage of the product at the buyer’s
location.
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-D
Page 2 of 4, © AOCS, 2015
Note:
The AOCS 0411-D Certification Report is available online though a paper
copy will be supplied upon request.
Terms and Conditions (i – ix)
i.
The CRM AOCS 0411-D shall be used solely 1) in assays for (a) detecting
the presence of 5307, or (b) quantification of 5307; or 2) for
determining whether an assay cross-reacts with CRM AOCS 0411-D.
CRM AOCS 0411-D shall be used for no other purpose. Specifically the
CRM may not be used to develop a detection method for 5307 nor
trait(s) present therein. No other rights are conveyed by the sale of the
CRM 0411-D to any purchaser, including any rights to any pending or
granted Syngenta Biotechnology Inc Patents or other Syngenta
Biotechnology Inc Intellectual Property that may protect the CRM or
5307 or trait(s) present therein or a detection method for 5307.
ii.
Neither the CRM AOCS 0411-D nor any extract or portion thereof shall
be resold or redistributed by any purchaser, unless the resale or
redistribution is required by national law in force in the purchaser’s
country.
iii.
Neither the CRM AOCS 0411-D, nor any extract or portion thereof, shall
be used for human or animal consumption or human or animal trials.
iv.
Neither the CRM AOCS 0411-D nor 5307 DNA, nor any part of either of
these, shall be used for transformation or breeding.
v.
No characterization or derivation of 5307, of the trait or traits present in
CRM AOCS 0411-D, or of the CRM AOCS 0411-D shall be performed,
except as allowed for in section (i).
vi.
All assay activities undertaken using the CRM AOCS 0411-D shall be
conducted in strict compliance with all Applicable Laws governing
such activities, and shall comply with conditions of all permits and
authorizations which may be required for such activities; and such
activities shall be strictly limited to assays in contained facilities, for
example, laboratories.
vii. Prior to disposal of any used or excess CRM AOCS 0411-D or residues
thereof, such material or residue must be treated in a manner that
degrades 5307 in the CRM material, such as by autoclaving.
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-D
Page 3 of 4, © AOCS, 2015
viii. CRM AOCS 0411-D shall not be exported nor re-exported in violation of
any Applicable Laws or without securing any necessary export or
import clearances or permits.
ix.
THE CRM 0411-D IS PROVIDED FOR THE PURPOSES STATED HEREIN AND
FOR NO OTHER PURPOSE. ALL CRM AOCS 0411-D AND Syngenta
Biotechnology Inc MATERIALS ARE PROVIDED “AS IS” WITHOUT
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. Syngenta
Biotechnology Inc MAKES NO REPRESENTATION OR WARRANTY THAT THE
USE OF THE CRM AOCS 0411-D, WHETHER BEFORE, ON OR AFTER THE
EFFECTIVE DATE OF THE APPLICABLE CERTIFICATE, WILL NOT INFRINGE
ANY PATENT OR OTHER PROPRIETARY RIGHTS.
ISO Guide 34
A2LA Certificate 3438.01
Certificate of Analysis for 0411-D
Page 4 of 4, © AOCS, 2015