Dear Sean,
`
`In response to your request and based upon my personal knowledge and review of
`
`Metrics' business records and procedures, I am informed and understand that the
`
`following facts are true:
`
`From about at least 2010 through at least the end of 2015, Metrics conducted aluminum
`
`analysis on samples labeled Sandoz L-Cysteine HCl Injection, USP for KABS
`
`Laboratories, Inc. (hereinafter "KABS"). Each product sample that Metric's received
`
`from KAB S had an associated unique lot number. Metrics used the lot number to track
`
`the product samples throughout the analysis process and to ensure that the written test
`
`results reported back to KABS corresponded to the correct product sample.
`
`Attached at Exhibit A is a true and correct copy of Document Number ASTD-0335
`
`titled "Analysis of Aluminum in L-Cysteine HCl Injection", which sets forth the
`
`analytical method that Metrics used to analyze the Sandoz product samples received
`
`from KABS. The analytical method set forth in Exhibit A is the analytical method that
`
`Metrics followed from 2010 until at least the end of 2015 with respect to the product
`
`samples that it received from KABS, including the product sample lot numbers
`
`referenced below.
`
`Attached as Exhibit B is a true and correct copy of an Analytical Report issued to
`
`KABS for sample lot nos. 2093015, 2100115, and 2100215 on or about the date noted
`
`.contract services
`
`Mayne Pharma Inc.
`DBA Metrics Contract Services
`metricsinc.com
`
`T +1 252 752 3800 F +1 252 758 8522
`1240 Sugg Parkway, Greenville, NC 27834, USA
`
`Eton Ex. 1078
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`
`

`

`.contract services
`
`on the Report. The Report attached as Exhibit B ( and the other Reports referenced
`
`herein) is representative of the format of reports that Metrics provided to KABS. These
`
`Reports were made at or near the time of the events recorded therein by individuals who
`
`had knowledge and were responsible for generating these Reports. It was, and still is,
`
`Metrics' regular business practice to create Reports like those attached as Exhibit B and
`
`the other Exhibits, and such reports were generated and kept in the ordinary course of
`
`Metrics' business.
`
`Attached as Exhibit C is a true and correct copy of the notebook pages corresponding to
`
`sample lot number 2100115 referenced in Exhibit B. These notebook pages attached as
`
`Exhibit C, as well as the other notebook pages referenced herein, were made at or near
`
`the time of the events recorded therein by individuals who had knowledge and were
`
`responsible for generating these pages and conducting the analysis set forth therein. It
`
`was, and still is, Metrics' regular business practice to prepare notebook pages like those
`
`attached as Exhibit C and the other Exhibits, and such notebook pages were generated
`
`and kept in the ordinary course of Metrics' business.
`
`Eton Ex. 1078
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`
`

`

`.contract services
`
`Attached as Exhibit D is a true and correct copy of an Analytical Report issued to
`
`KABS for sample lot nos. 2081915, 2082015, and 2082115 on or about the date noted
`
`on the Report.
`
`Attached as Exhibit E is a true and correct copy of the notebook pages corresponding to
`
`sample lot number 2081915 referenced in Exhibit D.
`
`Attached as Exhibit F is a true and correct copy of an Analytical Report issued to
`
`KABS for sample lot nos. 2012114 and 2012214 on or about the date noted on the
`
`Report.
`
`\ Attached as Exhibit G is a true and correct copy of the notebook pages corresponding to
`
`lot number 2012114 referenced in Exhibit F.
`
`Attached as Exhibit His a true and true and correct copy of an Analytical Report issued
`
`to KABS for sample lot nos. 2072115 and 2072215.
`
`Attached as Exhibit I is a true and correct copy of the notebook pages corresponding to
`
`lot number 2072115 referenced in Exhibit H.
`
`I declare that statements made herein of my own knowledge are true and that all
`
`statements made on information and belief are believed to be true; and that these
`
`Eton Ex. 1078
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`
`

`

`.contract services
`
`statements were made with the knowledge that willful false statements and the like so
`
`made are punishable by fine or imprisonment, under Section 1001 of Title 18 of the
`
`United States Code.
`
`Mayne Pharma dba Metrics Contract Services Representative:
`
`Printed Name
`
`Title
`
`Signature
`
`JI
`
`Eton Ex. 1078
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`
`

`

`Exhibit A
`
`Exhibit A
`
`Eton Ex. 1078
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`
`Eton Ex. 1078
`5 of 58
`
`

`

`ASTD-0335 Revision: 00
`
`etrics
`
`[Pharmaceutical Development & Analytical Services]
`
`Metrics, Inc .
`
`1240 Sugg Parkway Greenville, NC 27834
`
`Tel: 252 -752 -3800
`
`Fax: 252 -758-8522
`
`www.metricsinc .com
`
`Client:
`
`Parenta
`
`Document Number:
`
`ASTD-0335
`
`Document Title:
`
`Analysis of Aluminum in L-Cysteine HCl Injection
`
`Document Information
`Document Information
`
`Revision:
`
`Release Date:
`
`Release Date:Release Date:
`
`Status:
`
`Status:Status:
`
`Type:
`
`Type:Type:
`
`Author:
`
`Author:Author:
`
`00
`
`28 Jun 2007
`
`Release
`
`Analytical Standard
`
`AKENWARD
`
`Heritage Doc. No.:
`
`Heritage Doc. No.:Heritage Doc. No.:
`
`PE008
`
`Expiration Date:
`
`Expiration Date:Expiration Date:
`
`Change Number:
`Change Number:
`
`Printed on: 01 May 2020, at 02:54:35 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
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`
`

`

`ASTD-0335 Revision: 00
`
`Metrics, Inc.
`
`Analytical Method
`
`Document Code: PE/008
`
`Title: Analysis of Aluminum in L-Cysteine HCl Injection
`
`Page 1 of 5
`
`Date Issued:
`
`Author:
`Angela Moore
`
`Quality Assurance:
`
`Approved by:
`Tom Wilson
`
`INTRODUCTION
`
`Testing Instructions
`
`L-Cysteine HCl injection is analyzed for aluminum content using graphite furnace atomic
`absorption spectrometry. Values are determined by comparison to an acid-matrix matched
`calibration curve. This method is based on USP <206>, ALUMINUM.
`
`TEST METHOD
`
`Materials:
`
`Spectrometer:
`
`Equipment:
`
`Varian 220FS or 240FS Atomic Absorption Spectrometer ( or equivalent
`instrumentation)
`
`Top-Loading Balance
`Analytical Balance
`High Purity DI Water
`Mechanical Pipettes
`Sonicator
`
`Primary Standard:
`
`Inorganic Ventures, Inc., Custom Grade, Stock Single Element, NIST
`traceable, nominal concentration 1000 µg/mL Al
`
`Reagents:
`
`High purity DI water (16-18 Mn•cm)
`Concentrated Nitric Acid (HN03), J.T. Baker Ultrex II (or equivalent)
`
`Note: Use plastic labware wherever possible. All labware should be acid cleaned where
`applicable.
`
`Metrics, Inc.
`PE/008
`
`Printed on: 01 May 2020, at 02:54:35 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`7 of 58
`
`

`

`ASTD-0335 Revision: 00
`
`METRICS, Inc.
`
`Analytical Method
`
`Document Code: PE/008
`
`Title: Analysis of Aluminum in L-Cysteine HCl Injection
`
`Page 2 of 5
`
`Standard Preparation:
`
`4% HNO3 Diluent: Dilute 40 mL HNO3 to volume in a 1000 mL volumetric flask with high
`purity DI water. Mix well. This solution may be scaled as necessary.
`
`Intermediate Standard (10 µg/mL): Add 1.0 mL of the aluminum reference standard to a 100 mL
`volumetric flask. Dilute to volume with HNO3 diluent and mix well.
`
`Working Calibration Standards:
`
`For pre-mixed standards, prepare the calibration standards as follows using the Intermediate
`Standard solution.
`
`Standard ID
`
`Cal Zero
`Std 1
`Std 2
`Std 3
`
`mL
`Intermediate
`Standard
`0
`0.1
`0.2
`0.4
`
`Final Volume,
`mL HNO3 Diluent
`
`Nominal Al,
`ng/mL
`
`100
`100
`100
`100
`
`0
`10
`20
`40
`
`Alternatively, if using auto-mixed standards, prepare a 50 ng/mL bulk standard and a 25 ng/mL
`calibration verification standard as follows: for the bulk standard, dilute 0.5 mL Intermediate
`Standard solution to 100 mL in a volumetric flask with HNO3 diluent. Mix well. For the
`calibration verification standard, dilute 0.25 mL Intermediate Standard solution to 100 mL in a
`volumetric flask with HNO3 diluent. On the autosampler, use the HNO3 diluent as the make-up
`solution.
`
`Sample Preparation:
`
`Transfer 40.0 mL of sample, accurately weighed, to a 100-mL volumetric flask and proceed as
`directed in USP <206>. Aliquots from multiple ampoules of the same lot may be combined if
`necessary. Use volumetric glassware to transfer the samples and prepare at least one laboratory
`blank, substituting DI H20 for sample, per lot of L-Cysteine HCl Injection. If 40mL of sample is
`unavailable, use the maximum volume possible that can be volumetrically transferred, scaling
`the final dilution to match the ratio of 40mL initial/I 00mL final.
`
`Instrument Settings and Furnace Program:
`
`Metrics, Inc.
`PE/008
`
`Printed on: 01 May 2020, at 02:54:35 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
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`
`

`

`ASTD-0335 Revision: 00
`
`METRICS, Inc.
`
`Analytical Method
`
`Document Code: PE/008
`
`Title: Analysis of Aluminum in L-Cysteine HCl Injection
`
`Page3of5
`
`Follow the manufacturer's instructions for appropriate instrumental conditions and settings. For
`the above mentioned spectrometers, the following conditions are suggested:
`
`Element:
`Wavelength:
`Slit Width:
`Background Correction:
`Lamp Current:
`Measurement Mode:
`Standard Replicates:
`Sample Replicates:
`
`Al
`309.3 nm
`0.5 nm
`D2
`10.0 mA
`Peak Height
`3
`3
`
`Furnace Program: 15.0 µL Injection Volume
`
`Step
`1
`2
`3
`4
`5
`6
`7
`8
`9
`
`Temp °C
`85
`95
`120
`600
`600
`600
`2500
`2500
`2500
`
`Time (s)
`5.0
`40.0
`10.0
`5.0
`1.0
`2.0
`0.9
`2.0
`2.0
`
`Flow (L/min) Gas Type
`Normal
`3.0
`3.0
`Normal
`3.0
`Normal
`Normal
`3.0
`Normal
`3.0
`0.0
`Normal
`0.0
`Normal
`0.0
`Normal
`Normal
`3.0
`
`Read
`No
`No
`No
`No
`No
`No
`Yes
`Yes
`No
`
`Signal Storage
`No
`No
`No
`No
`No
`Yes
`Yes
`Yes
`Yes
`
`Analysis Procedure:
`
`Calibration and Quality Control: After a suitable warm up period, perform a three-point
`calibration using the working standards. Using linear regression, determine the correlation
`coefficient of the theoretical concentrations versus the measured peak height. Next, measure the
`25 ng/mL calibration verification standard as a sample, obtaining the mean of the three
`exposures for the solution to determine system suitability.
`
`System Suitability: The following system suitability requirements must be met before proceeding
`with sample analysis: the correlation coefficient for the calibration curve must be at least 0.99
`and the measured value of the calibration verification standard must agree with its theoretical
`value to within 15%. In the event of a failure to meet either criteria, make any necessary
`adjustments and re-calibrate.
`Sample Measurement: Measure three replicate injections of the sample test solutions. The
`calibration verification standard should be run initially and after no more than six samples during
`
`Metrics, Inc.
`PE/008
`
`Printed on: 01 May 2020, at 02:54:35 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`9 of 58
`
`

`

`ASTD-0335 Revision: 00
`
`METRICS, Inc.
`
`Analytical Method
`
`Document Code: PE/008
`
`Title: Analysis of Aluminum in L-Cysteine HCl Injection
`
`Page 4 of 5
`
`analysis. Any samples not bracketed by passing calibration verification standards should be
`reanalyzed. Any sample solution whose absorbance exceeds that of Std 3 should be diluted
`appropriately with HNO3 diluent and reanalyzed.
`
`Calculations:
`
`Construct a calibration plot of the peak heights of the calibration standards versus their
`respective Al concentrations in ng/mL. Using an appropriate data manipulation software, obtain
`the slope, y-intercept, and standard error of estimate of the "best-fit" line.
`
`A working limit of detection refers to the lowest concentration within the solution that can be
`detected by the instrument under the operating conditions. This value is calculated for Al from the
`regression data as:
`
`where Sy1x is the Standard Error of Estimate for the regression and m is the slope. An LOD is
`calculated using appropriate sample weights and/or dilution factors.
`
`A working limit of quantitation refers to the lowest concentration within the solution that can be
`quantitated by the instrument under the operating conditions. This value is calculated for each
`element from the regression data as:
`
`where Sy/x is the Standard Error of Estimate for the regression and m is the slope. An LOQ is
`calculated using appropriate sample weights and/or dilution factors.
`
`Blank corrections are to be performed on elements where the blank is greater than or equal to the
`wLOD before applying the dilution factor.
`
`Calculate the Al content of the sample preparations in ng/mL using the slope and y-intercept of
`the best-fit line. This may be converted to ppb Al in the bulk samples by the following
`calculation:
`
`Al, ppb = ( measured Al ng )(
`)
`100 mL
`mL
`Sample Volume, mL
`
`The aluminum limit is not more than 5000 ppb. See Specification in References, below.
`
`Metrics, Inc.
`PE/008
`
`Printed on: 01 May 2020, at 02:54:35 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`10 of 58
`
`

`

`ASTD-0335 Revision: 00
`
`METRICS, Inc.
`
`Analytical Method
`
`Document Code: PE/008
`
`Title: Analysis of Aluminum in L-Cysteine HCl Injection
`
`Page 5 of 5
`
`References:
`
`Parenta Pharmaceuticals Specifications, L-Cysteine HCl Injection, USP (50MG/ML), 10 ML
`Fill, Document Number SPC-3014(03)
`
`Metrics, Inc.
`PE/008
`
`Printed on: 01 May 2020, at 02:54:35 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`11 of 58
`
`

`

`Exhibit B
`
`Exhibit B
`
`Eton Ex. 1078
`12 of 58
`
`Eton Ex. 1078
`12 of 58
`
`

`

`REPORT-10420 Revision: 00
`
`etrics
`
`[Pharmaceutical Development & Analytical Services]
`
`Metrics, Inc .
`
`1240 Sugg Parkway Greenville, NC 27834
`
`Tel : 252 -752 -3800
`
`Fax: 252 -758-852 2
`
`www.metr ics inc.com
`
`Client:
`
`KABS Laboratories Inc
`
`Document Number:
`
`REPORT-10420
`
`Document Title:
`
`KABS Laboratories, Inc.
`L-Cysteine HCl Injection, USP
`Transaction 37274
`Lot 2093015, 2100115, 2100215
`
`Document Information
`Document Information
`
`Revision:
`
`Release Date:
`
`Release Date:Release Date:
`
`00
`
`26 Oct 2015 10:53 AM
`
`Release
`
`Report
`
`DANIEL
`
`Status:
`
`Status:Status:
`
`Type:
`
`Type:Type:
`
`Author:
`
`Author:Author:
`
`Heritage Doc. No.:
`
`Heritage Doc. No.:Heritage Doc. No.:
`
`Expiration Date:
`
`Expiration Date:Expiration Date:
`
`Change Number:
`Change Number:
`
`Printed on: 01 May 2020, at 02:06:23 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`13 of 58
`
`

`

`Signature Manifest
`
`REPORT-10420 Revision: 00
`
`Page 1 of 1
`
`Signature Manifest
`
`Revision: 00
`Document Number: REPORT-10420
`Title: KABS Laboratories, Inc. L-Cysteine HCI Injection, USP Transaction 37274 Lot 2093015,
`2100115,2100215
`
`All dates and times are in Eastern Standard Time .
`
`Approve Report-10420 Rev 00
`
`Collaboration
`I Name/Signature
`
`Amber Decker (ADECKER)
`Daniel Ingles (DANIEL)
`
`j1 Title
`AC1
`Team Leader
`
`Mgmt Approval
`I Name/Signature
`
`j1 Title
`Richard Durham (RICHARDO) Group Leader
`
`QA Approval
`
`j1 Date
`21 Oct 2015, 02:41 :46 PM
`21 Oct 2015, 02:45:48 PM
`
`I Meaning/Reason
`
`Complete
`Complete
`
`j Date
`21 Oct 2015, 03:02:20 PM
`
`I Meaning/Reason
`
`Approved
`
`j1 Name/Signature
`Lillian Willter (LWILL TER)
`
`j1 Title
`QA Specialist
`
`j1 Date
`26 Oct 2015, 10:53:23 AM
`
`I Meaning/Reason
`
`Approved
`
`file://C:\Adlib Express\Work\20151026T105442.953\{C62D2FA4-C29E-4728-B... 10/26/2015
`
`Printed on: 01 May 2020, at 02:06:23 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`14 of 58
`
`

`

`REPORT-10420 Revision: 00
`
`Metrics, Inc.
`Analytical Report
`
`KABS Laboratories, Inc.
`L-Cysteine HCI Injection, USP
`Transaction# 37274
`Lot #2093015,2100115,2100215
`
`Revision History:
`
`Revision
`Number
`00
`
`Section
`
`NIA
`
`Change
`
`New Document
`
`Metrics, Inc.
`Trans. 37274 Report-10420
`
`Page i
`
`Printed on: 01 May 2020, at 02:06:23 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`15 of 58
`
`

`

`REPORT-10420 Revision: 00
`
`Metrics, Inc.
`Analytical Report
`
`KABS Laboratories, Inc.
`L-Cysteine HCI Injection, USP
`Transaction# 37274
`Lot #2093015,2100115,2100215
`
`Sample ID
`
`Lot Number
`
`Al Specification, ppb Al, ppb
`
`Al Result
`
`37274-1
`
`2093015
`
`NMT 5000
`
`37274-2
`
`2100115
`
`NMT 5000
`
`4 7
`
`48
`
`Conforms to Specification
`
`Conforms to Specification
`
`37274-3
`
`2100215
`
`NMT 5000
`
`< 43
`
`Conforms to Specification
`
`Test Method Reference: ASTD-0335 Rev. 00; USP38 NF33 S0l <206>
`
`Analyst: Amber Decker
`
`Notebook Reference: 15/1356-27
`
`Date Tested: October 20, 2015
`
`Metrics, Inc.
`Trans. 37274 Report-10420
`
`Page 1 of 1
`
`Printed on: 01 May 2020, at 02:06:23 pm; Printed by: :DANIEL
`
`Eton Ex. 1078
`16 of 58
`
`

`

`Exhibit C
`
`Exhibit C
`
`Eton Ex. 1078
`17 of 58
`
`Eton Ex. 1078
`17 of 58
`
`

`

`" ?A ttf}ru/\'f:
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`METRICS ASSET #2016
`Termir1al SHR: 1125323312
`1125323312
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`µg/mL Lot# (r]-clL<t:/1'::i 7 Expiration o, rJ011lo1<-
`
`Al= Job I
`
`Reference Standards: NIST Traceable from Inorganic Ventures
`
`I
`
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`Lot# oooo°IOllit)~ Expiration 5a lor:)
`
`Ultrex II HN03, JT Baker,
`Milli-Q High Purity DI Water, Asset# n. o, 7
`
`Reagents:
`
`*Note: Plastic labware used wherever possible.
`
`O(> '-I> i:
`
`Neslab Chiller, Asset#
`
`oog 1
`
`Varian ll0GTA, Asset#
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`Varian 220FS AA, Asset # o o<:o 3
`Fisher FS220 Sonicator, Asset# u·,Ci"'6 l
`
`METRICS ASSET #2016
`Terminal SNR: 1125323312
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`Page 1 of 5
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`4:51 PM 10/20/2015
`
`Al
`37329 37274
`10205616aa01 b
`3:08 FM 10/20/2015
`l'vETRICS\adecker
`
`Methods
`Comment
`Worksheet
`Date Started
`Analyst
`
`SpectrAA Report.
`
`""' \ ,~c;v-'f/-,
`
`\
`
`52
`51
`50.05 ug/L
`2
`10uL
`10 uL
`0.0nm
`
`150.0%
`20.0%
`Linear
`99
`125.0%
`75.0%
`2
`99
`40.04 ug/L
`20.02 ug/L
`10.01 ug/L
`
`BCOn
`4
`10.0rffi
`31 %
`0.5nm
`309.3 nm
`
`2
`7 point
`Disabled
`1.0
`
`3
`3
`Raak Height
`Concentration
`AutoMx
`
`ug/L
`Furnace
`Al -L-Cysteine HCI
`
`Sam pie Last Dry Step:
`Sam pie No. of Injections:
`Makeup Vial No.:
`Bulk Vial No.:
`Bulk Cone.:
`Vol. Reduction Factor:
`Sample Volume:
`Total Volume:
`Workhead Height:
`
`Cal. Upper Limit:
`Cal. Lower Lim it:
`Calibration Algorithm:
`Recalibration Rate:
`Reslope Upper Limit:
`Reslope Lower Limit:
`Reslope Standard No.:
`Reslope Rate:
`STANDARD 3:
`STANDARD 2:
`STANDARD 1:
`
`Background Correction:
`Lamp Position:
`Lamp Current:
`Gain:
`Slit Width:
`Wavelength:
`
`Cone. Dec. Places:
`Smoothing:
`Minimum Reading:
`Expansion Factor:
`
`Replicates Sample:
`Replicates Standard:
`Measurement Mode:
`Calibration Mode:
`Sampling Mode:
`
`Cone. Units:
`Instrument Type:
`Bement• Matrix:
`
`Method: Al L-Cysteine HCI (Furnace)
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`Eton Ex. 1078
`19 of 58
`
`

`

`Pf.. OCFuJl s:-
`
`?)-
`
`~
`
`\C
`
`0.0076
`
`0.0327
`
`0.0087
`
`26.8
`
`10/20/2015 3:57:24 FM
`
`0.0161
`
`0.0116
`
`0.0084
`
`0.0130
`
`0.0027
`
`20.6
`
`67.9
`
`66.0
`
`7irre
`
`64.0
`
`61.0
`
`0.021
`
`Abs
`
`0.0160
`
`0.0093
`
`0.0163
`
`0.0021
`
`12.8
`
`10/20/2015 3:47:40 FM
`
`0.2509
`
`0.0092
`
`0.2472
`
`0.0033
`
`1.3
`
`67.9
`
`66.0
`
`lirre
`
`64.0
`
`'""*---~--"'·""""''
`
`Chk CV Std
`
`61.0
`
`0.00 J
`
`0.10
`
`0.20
`
`o.2i
`
`Abs
`
`10/20/2015 3:42:48 FM
`
`0.2189
`
`0.0109
`
`0.2291
`
`0.0106
`
`4.6
`
`10/20/2015 3:37:56 FM
`
`0.2134
`
`0.0103
`
`0.2253
`
`0.0138
`
`6.1
`
`10/20/2015 3:37:56 FM
`
`0.2134
`
`BG Abs
`
`MaanAbs
`
`%RSD SD
`
`Page 3of5
`
`1
`
`2000 th\':S
`
`Readings
`
`1.19
`
`0.0114
`
`Readings
`
`-1.25
`
`DB-B
`
`~ 1..o oCCl.JD,<
`
`67.9
`
`66.0
`
`T,re
`
`64.0
`
`61.0
`
`o.ao J =-~-.;;.~, .. .,,~~.~~"!' ...... '&.:"'..;.~~~~";;.~~;,-.t".:-,"¢1l
`0.10
`
`37329-1 di!
`
`0.0144
`
`0.0185
`
`Readings
`
`-0.85
`
`0.2457
`
`0.2449
`
`Readings
`
`27.91
`
`67.9
`
`66.0
`
`lirre
`
`64.0
`
`~~--4..~~~~-=----~·~-~
`
`CV Std
`
`0.2401
`
`0.2283
`
`0.2405
`
`Readings
`
`25.65
`
`0.2221
`
`Readings
`
`25.19
`
`0.2405
`
`0.2221
`
`Readings
`
`Cone ug/L
`
`0.20
`
`0.28
`
`DB-A
`
`37329-1 di!
`
`61.0
`
`0.00 J
`0.10
`
`0.20
`
`o.2i
`
`ChkOJ Std
`
`a/Std
`
`Sarrple ID
`
`O.OOJt:::-----r-:-:---7,;---;r;;;;---40_1)0
`
`10.00
`
`0.00
`
`40.00
`
`30.00
`
`Alug/L
`20.00
`
`0.10
`
`0.20
`
`4:51 PM 10/20/2015
`
`Linear -Cal. Set 1
`
`SpectrAA Report.
`
`1 "\ ,-i,<;\e--'Lo
`
`Se.e, "'"\c__ "1 ,et,
`
`~ 37329-2dil
`
`Abs
`
`Abs
`
`0.34
`
`Abs
`
`2,t ~~
`
`67.9
`
`66.0
`
`7irre
`
`64.0
`7
`
`61.0
`
`STANDARD3
`
`0.30~ ::LL_\_ __
`
`0.38
`
`Abs
`
`10/20/2015 3:33:02 FM
`
`0.3415
`
`0.0073
`
`0.3366
`
`0.0103
`
`3.1
`
`10/20/2015 3:28:08 FM
`
`0.2023
`
`0.0061
`
`0.1989
`
`0.0083
`
`4.2
`
`67.9
`
`66.0
`
`7irre
`
`64.0
`
`61.0
`
`O.OOl~~ .... ~"'".ir·.1..,,.. ,..r,;;\r,}~¼~~~~~~~ij
`
`Yes
`Yes
`Yes
`Yes
`No
`No
`No
`No
`No
`
`Signal Storage
`
`Page 2 of 5
`
`STANDARD1
`
`0.05
`
`0.10
`
`0.13.
`
`Abs
`
`10/20/2015 3:23:12 FM
`
`0.1030
`
`0.0080
`
`0.1054
`
`0.0070
`
`6.6
`
`10/20/2015 3:18:16 FM
`
`0.0120
`
`0.0096
`
`0.0141
`
`0.0021
`
`15.1
`
`BG Abs
`
`MaanAbs
`
`%RSD SD
`
`No
`Yes
`Yes
`No
`No
`No
`No
`No
`No
`Read
`
`Normal
`Normal
`Normal
`Normal
`Normal
`Normal
`Normal
`Noma!
`Noma!
`
`3.0
`a.a
`0.0
`0.0
`3.0
`3.0
`3.0
`3.0
`3.0
`
`2.0
`2.0
`0.9
`2.0
`1.0
`5.0
`10.0
`40.0
`5.0
`
`Gas Type
`
`Row (Unin)
`
`4:51 PM 10/20/2015
`
`'] D (?C\]h -~
`
`Abs= 0.00803 x C+ 0.02:312
`
`-0.24 -1.87 1.00
`
`= 1.12
`
`Residuals
`
`= -1.12 10.25 21.89 39.04
`
`calculated Cone
`
`= 0.9970
`
`= -2.33 ug/L
`
`Characteristic Cone
`
`= Linear
`
`Curve Ft
`
`67.9
`
`66.0
`
`7irre
`
`64.0
`
`61.0
`
`0.00 ,---_,.._.,..= ........ ..___-,~=~--:i~.~"-~-&~.;..~~~'~,r4¢...e-~~~¥1
`
`STANDARD2
`
`0.10
`
`0.2:i
`
`Abs
`
`0.3436
`
`0.3247
`
`Readings
`
`40.04
`
`0.2049
`
`0.1894
`
`Readings
`
`20.02
`
`67.9
`
`66.0
`
`7irre
`
`64.0
`
`STANCl'\RD3
`
`STANCl'\RD2
`
`61.0
`
`-0.019_J1 ______ ..-----,-----,
`
`CAL ZERO
`
`0.1133
`
`0.1000
`
`Readings
`
`10.01
`
`0.0142
`
`0.0163
`
`Readings
`
`0.00
`
`Cone ug/L
`
`2500
`2500
`2500
`600
`600
`600
`120
`95
`85
`
`9
`8
`7
`6
`5
`4
`3
`2
`1
`
`0.000
`
`0.010
`
`0.019
`
`Abs
`
`STANCl'\RD1
`
`CAL ZERO
`Sarrple ID
`
`7irre (s)
`
`Terrp (C)
`
`Step
`
`SpectrAA Report.
`
`i
`
`i'
`
`,sv,sv -1::i
`
`20
`
`Eton Ex. 1078
`20 of 58
`
`

`

`J½-:Q:£Zt~C ..
`
`1~
`
`B2--
`
`oct---io\S-
`
`Tirre
`
`61.0
`67.9
`--,...--------,,------,-----!
`--,,\,~~.~~~..,.~~.i;!I
`
`66.0
`
`64.0
`
`0.00
`
`0.10
`
`0.20
`
`0.26
`
`CV Std
`
`10/20/2015 4:51:00 FM
`
`0.2375
`
`0.0117
`
`0.2330
`
`0.0088
`
`3.8
`
`10/20/2015 4:46:08 FM
`
`0.2672
`
`0.0105
`
`0.2636
`
`0.0063
`
`2.4
`
`67.9
`
`66.0
`
`Tirre
`
`64.0
`
`61.0
`
`0.06_
`
`0.10
`
`0.20·
`
`0.26·
`
`CV Std
`
`10/20/20154:41:14 FM
`
`0.2088
`
`0.0099
`
`0.2198
`
`0.0146
`
`6.7
`
`10/20/2015 4:36:22 FM
`
`0.0077
`
`0.0083
`
`0.0098
`
`0.0018
`
`18.2
`
`10/20/2015 4:36:22 FM
`
`0.0077
`
`BG Abs
`
`Moan Abs
`
`%RSD SD
`
`Tirre
`
`67.9
`o.oo_,1~-------,----,---:::--:i
`
`66.0
`
`64.0
`
`61.0
`
`0.05
`
`0.10·
`
`Page 5 of 5
`
`37274-3
`
`7 o QGCl-0£._
`
`pt () e("'t#/\<
`
`l--S
`
`67.9
`
`66.0
`
`Tirre
`
`64.0
`
`61.0
`
`Abs
`
`32329-2 Oil
`
`o.aai--1---__,
`0.10
`
`0.20
`
`0.29
`
`Abs
`
`0.2386
`
`0.2228
`
`Readings
`26.14
`
`0.2563
`
`0.2673
`
`Readings
`29.95
`
`OJ Std
`
`317:,"l.-'\-1..iY \
`~ ~1001,,1.-0~<
`dJJJQ 2 Bil ~tOD01.ol')
`
`67.9
`
`66.0
`
`Tirre
`
`64.0
`
`61.0
`
`Abs
`
`OB-E
`
`0.2142
`
`0.2364
`
`Readings
`24.50
`
`0.0108
`
`0.0107
`
`Readings
`-1.66
`
`0.0108
`
`0.0107
`
`Readings
`Cone ug/L
`
`67.9
`
`66.0
`
`Tirre
`
`64.0
`
`OJ Std
`
`DB-E
`
`Safll)ie ID
`
`61.0
`
`0.15
`0.19
`
`Abs
`
`0.020'
`
`Abs
`
`4:51 PM 10/20/2015
`
`SpectrAA Report
`
`---1S \,"\Sv -1,7
`
`0.0087
`
`0.0114
`
`67 .9
`
`sci.a
`
`sci.a
`
`67.9
`
`Page 4of5
`
`10/20/2015 4:31:30 FM
`
`0.1683
`
`0.1573
`
`0.0179
`
`11.4
`
`10/20/2015 4:26:38 FM
`
`0.0170
`
`0.0156
`
`0.0030
`
`19.6
`
`Tirre
`
`5J.o
`
`61.0
`
`'
`
`:·.::.~1p;· ~---~---:;;:-.,;; .. ;; .. :;.;;;.:al ___ J---~>11,J" .. "~•'ii~-il',.,.._.,..,.,.,.,,,.)
`
`37274-2
`
`0.10
`
`0.15
`
`0.20
`
`Abs
`
`10/20/2015 4:21:46 FM
`
`0.1785
`
`0.0096
`
`0.1785
`
`0.0017
`
`10/20/2015 4:16:54 FM
`
`0.9
`
`0.0176
`
`0.0080
`
`0.0153
`
`0.0023
`
`14.9
`
`Tirre
`
`67 .9
`I __ J ... \_~.-,.,,:.;~"i,-~~"'"'-c..--,
`
`64.0
`1
`
`61.0
`
`o.oo 1
`0.05 \
`
`0.10
`
`0.15
`
`0.20
`
`37274-1
`
`10/20/2015 4:12:02 FM
`
`0.1701
`
`0.0089
`
`0.1753
`
`0.0051
`
`10/20/2015 4:07:10 FM
`
`2.9
`
`0.2163
`
`0.0096
`
`0.2162
`
`0.0010
`
`0.5
`
`66.0
`
`Tirre
`
`64.0
`
`61.0
`
`0.000
`
`0.020
`
`OB-B
`10/20/2015 4:02:16 FM
`
`0.0250
`
`].J) o 0:. b" ~
`
`0.1669
`
`0.1367
`
`Readings
`16.72
`
`0.0121
`
`0.0176
`
`Readings
`-0.94
`
`67.9
`
`66.0
`
`Tirre
`
`64.0
`
`37274-3
`
`00-D
`
`61.0
`
`0.1769
`
`0.1802
`
`Readings
`19.36
`
`0.0130
`
`0.0154
`
`Readings
`-0.97
`
`67.9
`
`66.0
`
`Tirre
`
`64.0
`
`·.:-,-~'$~~Fl~..;.-~~~~ ... ~.,_.,l!
`
`Abs
`
`0.1756
`
`0.1803
`
`Readings
`18.96
`
`0.2171
`
`0.2152
`
`Readings
`24.05
`
`CV Std
`
`Tirre
`
`64.0
`
`T
`
`0.047
`
`Abs
`
`0.0308
`
`0.0422
`
`37329-2 dil
`
`0.010
`
`0.020
`
`Abs
`
`37274-2
`
`OB-C
`
`61.0
`
`0.10
`
`0.20
`0.24
`
`Abs
`
`37274-1
`
`OJ Std
`
`61.0
`I
`
`0.010
`
`0.019
`
`Abs
`
`4:51 PM 10/20/2015
`
`SpectrAA Report
`
`,~\1?s1__~ -1-\
`
`1-, '
`
`Eton Ex. 1078
`21 of 58
`
`

`

`'t1 b~~
`
`Continued on Page 2½
`
`Signed
`
`tt'--
`
`Read and Understood By
`
`11
`
`'~-z_1oc:(k)~
`
`-S/lWU ~ ttO"'~/L1!J11,L d,I~-·~
`
`(1) Lo'v\LoD..
`
`O Lt7)>1c;-
`
`AI, ng/mL
`
`50
`
`37.5
`
`25
`
`12.5
`
`0
`
`0.0 -F------,----.----~---
`
`Al, µg/L
`Reported
`
`Al, µgig Al, µg/L
`
`Limit
`
`Bulk
`
`Bulk
`
`BlkCorr
`
`H
`
`I
`
`G
`
`I
`
`F
`
`I
`
`E
`
`I
`
`25
`
`0.1
`
`0.2
`
`0.3
`
`0.4
`
`NIA
`NIA
`NIA
`NIA
`NIA
`NIA
`NIA
`NIA
`NIA
`NIA
`
`NA
`0.041 NMT 5000 < 43; Conforms
`NA
`0.048 NMT5000 48; Conforms
`NIA
`0.047 NMT5000 47; Conforms
`NIA
`
`NIA
`
`NIA
`
`H
`
`G
`
`F
`
`NA
`
`NA
`
`NIA
`
`NA
`
`NA
`
`NIA
`
`NIA
`0.206 NMT 5000 209; Conforms
`
`NIA
`
`NIA
`
`CiJ--9:44,g NMT 5000 225; Conforms
`
`NA
`41.79
`NA
`48.39
`NIA
`47.39
`NIA
`224.64
`NIA
`209.32
`Dil Factor Al, nglmL Al, nglmL Al, µg/L
`
`-1.65
`16.71
`-0.93
`19.35
`-0.97
`18.96
`1.20
`89.86
`-0.84
`83.73
`
`Digest
`
`r
`
`1
`1
`1
`1
`1
`1
`1
`3
`1
`3
`
`-1.65 ~ -.
`16.71
`-0.93
`19.35
`-0.97
`18.96
`1.20
`29.95
`-0.84
`27.91
`
`Al, nglmL
`
`Meas
`
`40.50984
`40.50733
`40.48713
`20.28869
`20.29385
`
`37274-3
`37274-2
`37274-1
`37329-2
`37329-1
`
`49
`48
`47
`~-46
`45
`
`------1 44 Sample ID NBR 1511356-16
`
`mass, g
`
`I 43
`
`B
`
`I
`
`A
`
`Ia1 \'I\\A\"'.,
`
`DB-E
`37274-3
`DB-D
`37274-2
`DB-C
`37274-1
`DB-B
`37329-2
`DB-A
`37329-1
`
`~ 62
`
`D
`
`I
`
`C
`
`B
`
`A
`
`Continued from Page 1':) \y,,;-½' -1--'-\
`Project
`
`'?
`
`~
`
`\
`
`ng/mL
`ng/mL
`
`=STEYX(C9:C 12,B9:B 12)
`=1NTERCEPT(C9:C12,B9:Bl2)
`=SLOPE(C9:C12,B9:Bl2)
`=CORREL(C9:Cl2,B9:Bl2)
`
`~
`"'
`.,Q
`
`Abs
`
`0.3366
`0.1989
`0.1054
`0.0141
`
`10205616AAOlb
`E
`
`D
`
`I
`
`1..= 309.3nm
`
`Data File
`
`C
`
`E::B~ 2, Oc.,,L,{)f:::
`
`(3)o.1.'L\
`
`Date
`
`:J ' Q L."' 7A'l \$
`
`~
`
`Signed
`
`iJ?i LOQ = =CI9*50120
`(y LOD
`=Cl8*50120
`
`wLOQ = =l0*Cl 7IC15
`wLOD = =3*C17IC15
`Steyx
`
`21
`20
`19
`18
`17
`16
`15
`14
`13
`12
`11
`10
`9
`8
`7
`~ Calibration:
`~ Element:
`3
`~NBR: 1511356-18
`~TRANS 37329 & 37274
`
`b
`m=
`r=
`
`40.04
`20.02
`10.01
`0
`Al, nglmL
`
`Std 3
`Std2
`Std 1
`Blank
`STD ID
`
`Al
`
`-
`
`----i 42 Calculations:
`
`,.
`.,
`!
`.,,---
`
`--50
`
`l---
`
`104.4
`
`97.9
`
`96.1
`
`<-Dilution prepared incorrectly
`
`Q)
`
`101.9
`100.6
`
`H
`
`I
`
`I G
`
`F
`
`I
`
`E
`
`I
`
`D
`
`I
`
`...._
`<)
`·-
`
`'\)
`-~
`
`Al,nglmL
`
`50
`
`37.5
`
`25
`
`12.5
`
`0
`
`ng/mL
`ng/mL
`
`0.0
`
`0.1
`
`0.2
`
`0.3
`
`0.4
`
`~
`"'
`.,Q
`
`I
`
`H
`
`G
`
`F
`
`10205616AA0lb
`
`E
`
`D
`
`61
`60
`59
`·--58
`57
`56
`55
`54
`53
`52 Sample ID
`51
`
`
`
`--
`
`Date
`
`1/\ Cl&('uf\<
`
`Signed
`~
`
`Read and Understood By
`
`Continued on Page 'l <
`
`-
`
`---,
`
`---
`
`Date
`
`'l..'-s<::> (.;\:_ l,\)\"-'.,
`
`Signed
`
`~
`
`~ 'l -..oG.::.741\-..::_
`
`" ~ \"h
`
`("-Q Sc{, ""<>"' 0
`
`26.14
`29.95
`24.50
`-1.65
`16.71
`-0.93
`19.35
`-0.97
`18.96
`24.05
`1.20
`NA
`-0.84
`27.91
`25.66
`25.18
`
`Al, nglmL Std% Rec
`
`0.2330
`0.2636
`0.2198
`0.0098
`0.1573
`0.0156
`0.1785
`0.0153
`0.1753
`0.2162
`0.0327
`
`NA
`
`0.0163
`0.2472
`0.2291
`0.2253
`Al,Abs
`
`C
`
`I
`
`B
`
`I
`
`A
`
`---
`
`35
`34
`33
`32
`31
`30
`29 37329-2 di!
`28
`27 37329-1 di!
`26 CV StdChk
`25
`I 24 Sample ID
`23
`22 Analysis:
`I I
`
`..i!
`40
`39 37329-2 di!
`38
`37
`
`CV Std
`
`CV Std
`DB-E
`37274-3
`DB-D
`37274-2
`DB-C
`37274-1
`CV Std
`DB-B
`
`DB-A
`
`CV Std
`
`LOQ=
`LOD
`wLOQ=
`wLOD=
`Steyx =
`
`b=
`m=
`r
`
`40.04
`20.02
`10.01
`
`0
`
`AI, nglmL
`
`Std 3
`Std 2
`Std 1
`Blank
`STD ID
`
`'
`
`----
`
`21
`~ 20
`I 19
`18
`17
`16
`15
`14
`13
`12
`11
`10
`9
`8
`7
`6 Cali