5200 Oxygen USP

Airgas
Validation (Equivalency) Study

of a Method of Assay of
Oxygen USP
Comparison of a Modified Method Utilizing a

Servomex 5200 Series Paramagnetic Oxygen
Analyzer with the Official USP Method
Report prepared by:
Dr Derek F Gill – Technical Director, Airgas

October 22, 2004
Airgas
PREFACE
The following study was conducted by Airgas, Inc on behalf of Servomex Group
Ltd. The study was designed to show equivalency between the Servomex 5200
Series analyzer and the official USP method of assay of Oxygen USP.
The USP method determines product purity by the chemical absorption of

Oxygen (Orsat method).
The alternative method proposed relies on the measurement of Oxygen content

based on the paramagnetic property of Oxygen. This analytical technique is
specific for Oxygen and is applicable over the full range of concentration.
The study was executed following guidance laid out in USP 25, Section 1225,
“Validation of Compendial Methods”. This report will address the items required
under 1225, in the order that they appear in that document. A copy of the
“Validation of Compendial Methods” is provided as an Attachment.
As stated in this document, “Validation of an analytical method is the process by

which it is established, by laboratory studies, that the performance characteristics
of the method meet the requirements for the intended analytical applications.
Typical analytical performance characteristics that should be considered in the
validation of the types of methods described in this document are listed in Table
1.”
Table 1
Typical Analytical Characteristics Used in Method Validation
Accuracy
Precision
Specificity
Detection Limit
Quantitation Limit
Linearity
Range
Compendial assay procedures vary from highly exacting analytical

determinations to subjective evaluation of attributes. Considering this variety of
assays, it is only logical that different test methods require different validation
schemes. The most common categories of assays for which validation data
should be required are:
1
Airgas
Category I – Analytical methods for quantitation of major components of bulk

drug substances or active ingredients in finished pharmaceutical
products.
Category II – Analytical methods for determination of impurities in bulk drug

substances or degradation compounds in finished pharmaceutical
products. These methods include quantitative assays and limit
tests.
The required analytical performance characteristics for each type of test are
listed in Table 2.
Table 2
Data Elements Required for Assay Validation
Analytical
Assay Assay
Performance
Category I Category II
Characteristic
Quantitative Limit Tests
Accuracy Yes Yes *

Precision Yes Yes No
Specificity Yes Yes Yes
Detection Limit No No Yes
Quantitation Limit No Yes No
Linearity Yes Yes No
Range Yes Yes *
* May be required, depending on the nature of the specific test.
2
Airgas
Rationale
The USP method requires assay of Oxygen by the chemical absorption of

Oxygen from an original known volume, and measurement of the residual gas
volume. The purity of Oxygen is the original volume of gas minus the residual
volume of gas expressed as a percentage of the original volume.
Problems encountered when using the USP method include:

• Errors that may results from:
− Subjective interpretation of results.
− Inadequate operator manipulative skills.
− Incomplete reaction.
− Changes in temperature and barometric pressure.
− Degradation of absorption chemicals over time.
• The method is not amenable to automation or unattended operation.
• The handling and disposal of corrosive chemicals.
• The equipment is fragile and difficult to set up.
• The method is slow and time consuming.
The Servomex analyzer operates on paramagnetic principles, using Servomex
Magneto-dynamic measuring technology. Oxygen molecules are attracted into a
strong magnetic field, deflecting a dumb-bell mounted on a torque suspension
from its null (i.e. zero) position. This deflection is detected optically and a current
is applied to a coil around the dumb-bell which restores it to the null position.
The current required to do this is directly proportional to the Oxygen
concentration. Oxygen is strongly paramagnetic, whereas most common gases,
including Nitrogen, Argon, Helium, Carbon Dioxide, and Nitrous Oxide, are
diamagnetic. Hence the method is specific to Oxygen. The paramagnetism of the
Oxygen molecule allows it to behave as a temporary magnet when it passes
through a magnetic field. Diamagnetic gases are unaffected by a magnetic field.
The use of a gas analyzer offers a number of advantages:
• Rapid set up.

• Simple calibration.
• Portable instrument.
• Durable instrument.
• Limited skill and training requirement.
• Objective reading.
3
Airgas
1. Proposed Analytical Procedure for Routine Analysis Using the
Servomex 5200 Series Oxygen Analyzer
1.1 Routine Method
This section describes the general analytical method that will be used
to determine the assay of Oxygen, after acceptance of the validation
study (equivalency study).
1.1.1 Operational Conditions

The analyzer is to be set up as specified in the manufacturer’s
operating manual.
1.1.2 Calibration
Calibration shall be conducted according to the manufacturer’s
operating manual. Nitrogen, with a certified Oxygen content of less
than 1 ppm, shall be used as a zero gas and Oxygen, with a purity
of greater than 99.99%, as the calibration gas.
1.1.3 Sample Analysis

Samples are to be introduced into the sample port at the pressure
required in the Operating Manual. Once the reading has stabilized it
shall be recorded.
1.1.4 System Suitability

An appropriate system suitability test should be carried out on any
new or modified installation of the analyzer.
4
Airgas
2. Analytical Procedure Employed for the Validation Study of the
Servomex 5200 Series Oxygen Analyzer
2.1 Instrument Set Up

The analyzer was set up according to the manufacturers operating
manual.
Samples were introduced at a pressure of 3 psig.
The analyzer was equipped with two transducers, one providing a
display resolution of 100.00% (Transducer 1 – Part Number 03601000)
and the other a resolution of 100.0% (Transducer 2 – Part Number
01116000).
For each transducer, two methods of output were utilized:
Instrument panel display

RS-232 interface
2.2 Calibration
Nitrogen Research Grade and Oxygen Research Grade were used as
zero and calibration gases, respectively. The Certificates of Analysis
for these gases are included as Attachments.
2.3 Sample Analysis

The number and type of analyses performed were those required to
generate the data necessary to complete the validation study.
The analytical samples were prepared gravimetrically to produce

known concentrations of Oxygen in a balance of Nitrogen with an
accuracy of ± 0.02% absolute of the minor component.
The mixtures were as follows:
98.54% Oxygen in Nitrogen

≥ 99.994% Oxygen in Nitrogen (UHP Oxygen)
99.04% Oxygen in Argon for the specificity test
Certificates of Analysis are provided for all sample mixtures as

Attachments.
Each sample was run a total of three times, with a zero gas run
between each measurement. The 99.42% standard was, however, run
a total of six times. For each sample, data was recorded for each of the
two outputs, for each transducer.
5
Airgas
3. Validation Study Data Elements
The assay of Oxygen, the bulk drug substance, is determined directly by

measurement of the concentration of Oxygen in a sample.
The determination of the Oxygen concentration is, therefore, a Category I

assay test as defined in USP 25, Section 1225, “Validation of Compendial
Methods”. Consequently, the following data elements were determined:
Accuracy
Precision
Specificity
Linearity
Range
6
Airgas
3.1 Accuracy
Accuracy was determined by performing at least three measurements

of each mixture. The results for each transducer, listing each of the two
outputs in comparison to the official Orsat method are contained in
Table 3.1.
Conclusion: Both transducers, with each readout method, of the

Servomex 5200 Series Oxygen analyzer show accuracies comparable
to that of the USP Orsat method. In all cases accuracy is well within
the requirements for the assay of Oxygen USP, and therefore the
equivalency requirement is satisfied.
7
Table 3.1: Accuracy Data
Transducer 1
Known USP Orsat Absolute Servomex Absolute Servomex Absolute

Concentration Method Difference 5200 Difference 5200 Difference
Oxygen Oxygen
Analyzer Analyzer
Readout RS 232
Output
98.54% 98.5% -0.04% 98.58% +0.04% 98.59% +0.05%
99.00% 99.0% 0% 99.02% +0.02% 99.02% +0.02%
99.42% 99.4% -0.02% 99.45% +0.03% 99.45% +0.03%
>99.99% 100.0% +0.01% 100.01% +0.02% 100.01 +0.02%
Transducer 2

Oxygen Oxygen
Analyzer Analyzer
Readout RS 232
Output
98.54% 98.5% -0.04% 98.6% +0.06% 98.6% +0.06%
99.00% 99.0% 0% 99.0% 0% 99.0% 0%
99.42% 99.4% -0.02% 99.4% -0.02% 99.4% -0.02%
>99.99% 100.0% +0.01% 100.0% +0.01% 100.0 +0.01%
8
3.2 Precision
The 99.42% Oxygen in Nitrogen standard was analyzed six times and
the Oxygen reading recorded for each transducer, for each output. The
standard deviation of the method was calculated using the following
formula:
(y1 −y)2 +(y2 −y)2 +(y3−y)2 +...+(yn −y)2

s= ∑
(n−1)
Where y1, y2, y3. = Analyzer reading

y = Average analyzer reading
n = total number of data points used
USP Orsat Method
s = √ [(99.4-99.4)2 + (99.4-99.4)2 + (99.4-99.4)2 + (99.4-99.4)2 +

(99.4-99.4)2 + (99.4-99.4)2] / 5
s = √ [0 + 0 + 0 + 0 + 0 + 0] / 5
s = √ [0 / 5]
s=0
Servomex 5200
The standard deviation for the Servomex outputs were similarly

calculated and the results are recorded in Table 3.2
Conclusion: The precision of both transducers, with each of the

outputs, of the Servomex 5200 Series Oxygen analyzer are acceptable
and equivalent to that of the USP Orsat method, and therefore the
analyzer satisfies the equivalency requirement.
9
Table 3.2: Precision
Standard Deviation Data
Transducer 1 Transducer 2
Orsat
Analyzer Readout RS 232 Output Analyzer Readout RS 232 Output
0.0000 0.01033 0.01033 0.05164 0.04082
10
3.3 Specificity
A sample of the bulk drug substance containing a known amount of an

anticipated impurity was analyzed using both the Servomex 5200
Series analyzer and the USP Orsat method. The mixture analyzed
was:
99.04% Oxygen / Argon
The results for each transducer and each readout are provided in
Table 3.3.
The Servomex 5200 Series Oxygen analyzer showed negligible

influence on the accuracy of its reading, from the impurity, equivalent
to the influence obtained with the USP Orsat method. Hence the
method is specific for the drug substance Oxygen.
Conclusion: Method specificity is at least equivalent to the USP

method for both transducers using both outputs, and the analyzer,
therefore, satisfies the requirement for equivalency.
11
Table 3.3: Specificity Data
Transducer 1

Oxygen Oxygen
Analyzer Analyzer
Readout RS 232
Output
99.04% 99.0% -0.04% 99.09% +0.05% 99.09% +0.05%
Transducer 2

Oxygen Oxygen
Analyzer Analyzer
Readout RS 232
Output
99.04% 99.0% -0.04% 99.1% +0.06% 99.1% +0.06%
12
3.4 Linearity
In this study the analytical readings for the Oxygen purity were plotted
against the known value of Oxygen in each mixture. Data was
recorded for the Orsat method and for each output from both
transducers of the Servomex 5200 Series analyzer. The results are
presented in table 3.4A (1 = Transducer 1, and 2 = Transducer 2).
The regression lines were calculated over the range of measurement,

i.e. 98.54 – 99.99%, and that data is presented in Table 3.4B
The graphs show the actual data plotted and the regression lines:
Oxygen - Zoom Regression Orsat
100.20
100.00
99.80
Orsat Reading
99.60
99.40 Actual
99.20 Zoom Regression
99.00
98.80
98.60
98.40
98.00 98.50 99.00 99.50 100.00 100.50
Sample Concentration
13
Oxygen - Zoom Regression Servomex 5200 Series
Transducer 1 - Display
Analyzer Reading 100.50
100.00
99.50 Actual
98.50
98.00
98.00 98.50 99.00 99.50 100.00 100.50

Transducer 1 - RS 232
100.50
Analyzer Reading
100.00
99.50 Actual
98.50
98.00
98.00 98.50 99.00 99.50 100.00 100.50
14
Transducer 2 - Display
100.5
Analyzer Reading 100.0
99.5 Actual
98.5
98.0
98.00 98.50 99.00 99.50 100.00 100.50

Transducer 2 - RS 232
100.5
Analyzer Reading
100.0
99.5 Actual
98.5
98.0
98.00 98.50 99.00 99.50 100.00 100.50
Conclusion: The Servomex 5200 Oxygen analyzer demonstrates

comparable linearity to the USP method, and equivalency has been
demonstrated for both transducers and both outputs.
15
Table 3.4A: Linearity Data
Known USP Orsat Servomex 5200 Oxygen Analyzer Servomex 5200 Oxygen Analyzer
Concentration Method Transducer 1 Transducer 2
Display RS 232 Output Display RS 232 Output
98.54% 98.5% 98.58% 98.59% 98.6% 98.6%
99.00% 99.0% 99.02% 99.02% 99.0% 99.0%
99.42% 99.4% 99.45% 99.45% 99.4% 99.4%
>99.99% 100.0% 100.01% 100.01 100.0% 100.0%
Table 3.4B: Regression Data
USP Orsat Servomex 5200 Oxygen Analyzer Servomex 5200 Oxygen Analyzer
Method Transducer 1 Transducer 2
Display RS 232 Output Display RS 232 Output
Regression
0.9995 0.9999 0.9998 0.9981 0.9981
Coefficient (r2)
Standard Error of
1.5031 0.8139 1.1070 3.1770 3.1770
Intercept (σ)
Slope (S) 0.9750 1.0133 1.0194 1.0350 1.0350
16
3.5 Range
Analytical data over the range of interest for the assay of Oxygen USP
is presented in Table 3.5.
The data confirms that both transducers, with both outputs, of the
Servomex 5200 Oxygen analyzer demonstrate comparable accuracy
to the USP Orsat method, over the range of 98.54 – 99.99% Oxygen.
Conclusion: The Servomex 5200 Oxygen analyzer has acceptable

accuracy over the range of 98.54 – 99.99% Oxygen, the applicable
assay range, and equivalency has been demonstrated.
17
Table 3.5: Range Data
Transducer 1

Oxygen Oxygen
Analyzer Analyzer
Readout RS 232
Output
98.54% 98.5% -0.04% 98.58% +0.04% 98.59% +0.05%
99.00% 99.0% 0% 99.02% +0.02% 99.02% +0.02%
99.42% 99.4% -0.02% 99.45% +0.03% 99.45% +0.03%
>99.99% 100.0% +0.01% 100.01% +0.02% 100.01 +0.02%
Transducer 2

Oxygen Oxygen
Analyzer Analyzer
Readout RS 232
Output
98.54% 98.5% -0.04% 98.6% +0.06% 98.6% +0.06%
99.00% 99.0% 0% 99.0% 0% 99.0% 0%
99.42% 99.4% -0.02% 99.4% -0.02% 99.4% -0.02%
>99.99% 100.0% +0.01% 100.0% +0.01% 100.0 +0.01%
18
4. SUMMARY
The assay of Oxygen USP was carried out by analysis of Oxygen content by
a Servomex 5200 paramagnetic Oxygen analyzer equipped with transducers
reading respectively to 2 and 1 decimal place. The analyzer response was
recorded both from the analyzer display and a RS 232 output. In all
requirements of the “Validation of Compendial Methods”, the Servomex 5200
Oxygen analyzer performed at a level equivalent to that of the USP Orsat
method.
Conclusion: These results demonstrate that the Servomex 5200 Oxygen

analyzer is equivalent to the USP method and provides results
acceptable to the demands of the US Pharmacopeia.
Dr Derek F Gill
Technical Director
Acknowledgments:
1. The analytical work was carried out with the assistance of Steven Shook,
Laboratory Manager, Airgas Intermountain.
Attachments
1. “Validation of Compendial Methods”, USP 25, Section 1225.

2. Certificate of Analysis for Nitrogen Research Grade (zero gas).
3. Certificate of Analysis for Oxygen Research Grade (calibration gas).
4. Certificates of Analysis for sample mixtures of Oxygen in Nitrogen.
19
Airgas Airgas Specialty Gases
12722SouthWentworth Avenue
Chicago.
Il 60628
773.785.3000
Fax:773.785.1928
WM'I.airgas.com
CERTIFICATE OF PURE GAS ANALYSIS
PURE GASPRODUCT: Nitrogen

Date: 08/14/03 Reference Number: 54-03224-01
Customer Name:
Address:
Purchase Order #:
Grade of Product: Research
Cvlinder Number: Impuritv Specification Actual Level

(Analyzed Cylinder)
343182
Oxygen <0.5 ppm 0.30 ppm
H20 <0.5 ppm <0.1 ppm
THC <0.2 ppm <0.2 ppm
Carbon Monoxide <0.5 ppm <0.2 ppm
Carbon Dioxide <0.5 ppm <0.2 ppm
Hydrogen <2.0 ppm <2.0 ppm
Argon <25 ppm <25 ppm
Product Purity: >99.9997%
Note: Product composition verified by direct comparison to calibration standards traceable to NIST Weights and/or
NIST Gas Mixture Reference Material
Approval Signature
Airgas~
Alrgas SpecialtyGases
11711 S. Alameda Street
LosAngeles,
CA90059-2130
323.357.6891
fax:323.567.3686
www.airgas.com
CERTIFICATE OF ANALYSIS
Customer Name: Airgas Intermountain

Address: 3415 South 700 West
Salt Lake City, UT 84119
Purchase Order #: 104 397855
Grade of Product: Oxygen, Research Grade 5.0
Cvlinder Number: Component Required Actual

Concentration Concentration
CC53141 Moisture < 0.50ppm < 0.20ppm

THC (as Methane) < 0.20ppm < 0.05ppm
Argon < 3.00ppm < 3.00ppm
Krypton < 2.00ppm < 0.50ppm
Nitrogen < 5.00ppm < 5.00ppm
Carbon Dioxide < 0.50ppm < 0.05ppm
Carbon Monoxide < 0.50ppm < 0.05ppm
Oxygen 99.999:!: % 99.999:!: %
Uncertainty of Analytical Result: ::!: 5.0 %
Method of-Analysis: HID, FID, Aluminum Oxide
Volume: 156c.f.
Pressure: 2200psig @ 88° F
Delivery Ticket #: 650359-00
Approval Signature
Airgas AirgasSpecialty Gases
12722SouthWentworthAvenue
Chicago,
IL 60628
773.785.3000
Fax:773.785.1928
lWvW.airgas.com
Certificate of Analysis
Date of Analysis: 9/27/2004 Reference Number: 54-124023142-4

Customer Name: Part Number: X02N11P200COW3
Grade of Product: PRIMARY STANDARD
Cylinder Number ComDonent Reauested Actual Concentration

Concentration
14421 OXYGEN 98.50 % 98.54 %
NITROGEN BaiaiIG6 Balance
Notes:
Relative Uncertaintv of Analytical Value: +/-1% of component or +/- 0.02% of absolute,

which ever is lower.
Primary Standard gas mixtures are traceable to ~.I.S.T weights and/or N.I.S.T gas mixture
reference materials.
Approval Signature
Page 1
Airgas~ Airgas SpeciallyGases
11711 S. AlamedaStreet
LosAngeles.
CA90059-2130
323.357.6891
fax:323.567.3686
www.airgas.com
CERTIFICATE OF ANALYSIS
Customer Name: VALLEY OXYGEN
3415 S 700 WEST
Grade Of Product: Primary Standard
Cylinder Number Component Reauested Actual Concentration

Concentration
8G-47678 Oxygen 99.00 % 99.00 %
Nitrogen Balance Balance
Note:
Relative Uncertainty of Analvtical Value: +/-1% of component or +/- 0.02% of absolute, which
ever is lower.
Primary Standard gas mixtures are traceable to N.I.S.Tweights and/or N.I.S.Tgas mixture
reference materials
....
Approval Signature
Airgas AirgasSpecialty Gases
Chicago,
IL 60628
773.785.3000
Fax:773.785.1928
WM'I.airgas.com

Customer Name: Part Number: X02NI1P200COW4
Grade of Product: PRIMARY STANDARD
Cvlinder Number ComDonent Reauested Actual Concentration

ConcentratioQ
1365165 OXYGEN 99.49 % 99.42 %
NITROGEN 8a!anr.:e Balance
Notes:
Relative Uncertainty of Analvtical Value: +/-1% of component or +/- 0.02% of absolute,

Primary Standard gas mi~re tracea~le to N.I.S.Tweights and/or N.I.S.T gas mixture
Approval Signature
Page 1
AirgaS Airgas SpecialtyGases
Chicago.
Il 60628
CERTIFICATE OF ANALYSIS 773.785.3000
Fax:773.785.1928
lWNI.airgas.com
Date Of Analysis: 8/17/2004 Reference Number: 54-124021377-4
Customer Name: Part Number: OX UHP300SRVCT
Lot #: 54-124021377-4 Product: Oxygen UHP GR 4.4 Size

300CGA 540
Grade of Product: U.H.P. Grade 4.4
Cvlinder Tested: Required Actual

80084 79, 99.994 % 99.994 %
Analvtical Results
Component Required . Actual

Moisture < 0.00020 % < 0.00001 %:1: 0.0000010 %
THC < 0.00005 % < 0.00001 % :I:0.0000005 %
Argon < 0.00350 % < 0.00001 % :I: 0.0000025 %
Nitrogen < 0.00150 % < 0.00003 % :I: 0.0000050 %
Carbon Dioxide + < 0.00010 % < 0.00001 %:1: 0.0000010 %
Carbon Monoxide < 0.00010 % < 0.00001 %:1: 0.0000010 %
Oxygen 99.994 % 99.994 % :I: 0.00050 %
Method of Analysis: TCD, FTIR, THC Analyzer, Panametrics Moisture Analyzer
Expiration Date: 8/17/06

.
Airgas Airgas Specialty Gases
12722 SouthWentworthAvenue
Chicago,IL 60628
773.785.3000Fax:773.785.1928
WWvV.airgas.com

Customer Name: Part Number: X02AROP200COW5
Grade of Product: PRIMARY
STANDARD
Cvlinder Number ComDonent Requested Actual Concentration

Concentration
.JK0015060 OXYGEN 99.10 % 99.04 %
ARGON Balance Balance
Notes:
Relative Uncertainty of AnalvticalValue: +/-1% of component or +/-0.02%of absolute,

Primary Standard gas mixtures are traceable to N.I.S.Tweights and/or N.I.S.T gas mixture
Approval Signature
Page 1

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Airgas

Validation (Equivalency) Study

Comparison of a Modified Method Utilizing a

Report prepared by:

Dr Derek F Gill – Technical Director, Airgas

The USP method determines product purity by the chemical absorption of

The alternative method proposed relies on the measurement of Oxygen content

As stated in this document, “Validation of an analytical method is the process by

Compendial assay procedures vary from highly exacting analytical

Category I – Analytical methods for quantitation of major components of bulk

Category II – Analytical methods for determination of impurities in bulk drug

Accuracy Yes Yes *

* May be required, depending on the nature of the specific test.

The USP method requires assay of Oxygen by the chemical absorption of

Problems encountered when using the USP method include:

The use of a gas analyzer offers a number of advantages:

• Rapid set up.

1.1 Routine Method

1.1.1 Operational Conditions

1.1.3 Sample Analysis

1.1.4 System Suitability

2.1 Instrument Set Up

Instrument panel display

2.3 Sample Analysis

The analytical samples were prepared gravimetrically to produce

The mixtures were as follows:

98.54% Oxygen in Nitrogen

99.04% Oxygen in Argon for the specificity test

Certificates of Analysis are provided for all sample mixtures as

3. Validation Study Data Elements

The assay of Oxygen, the bulk drug substance, is determined directly by

The determination of the Oxygen concentration is, therefore, a Category I

Accuracy was determined by performing at least three measurements

Conclusion: Both transducers, with each readout method, of the

Known USP Orsat Absolute Servomex Absolute Servomex Absolute

99.00% 99.0% 0% 99.02% +0.02% 99.02% +0.02%

99.42% 99.4% -0.02% 99.45% +0.03% 99.45% +0.03%

>99.99% 100.0% +0.01% 100.01% +0.02% 100.01 +0.02%

Known USP Orsat Absolute Servomex Absolute Servomex Absolute

99.00% 99.0% 0% 99.0% 0% 99.0% 0%

99.42% 99.4% -0.02% 99.4% -0.02% 99.4% -0.02%

>99.99% 100.0% +0.01% 100.0% +0.01% 100.0 +0.01%

(y1 −y)2 +(y2 −y)2 +(y3−y)2 +...+(yn −y)2

Where y1, y2, y3. = Analyzer reading

USP Orsat Method

s = √ [(99.4-99.4)2 + (99.4-99.4)2 + (99.4-99.4)2 + (99.4-99.4)2 +

The standard deviation for the Servomex outputs were similarly

Conclusion: The precision of both transducers, with each of the

Standard Deviation Data

0.0000 0.01033 0.01033 0.05164 0.04082

A sample of the bulk drug substance containing a known amount of an

99.04% Oxygen / Argon

The Servomex 5200 Series Oxygen analyzer showed negligible

Conclusion: Method specificity is at least equivalent to the USP

Known USP Orsat Absolute Servomex Absolute Servomex Absolute

Known USP Orsat Absolute Servomex Absolute Servomex Absolute

The regression lines were calculated over the range of measurement,

Oxygen - Zoom Regression Orsat

Analyzer Reading 100.50

Oxygen - Zoom Regression Servomex 5200 Series

Analyzer Reading 100.0

Oxygen - Zoom Regression Servomex 5200 Series

Conclusion: The Servomex 5200 Oxygen analyzer demonstrates