Chromatography Standards and Solutions V1
Chromatography Standards and Solutions V1
Chromatography Standards and Solutions V1
Conductivity Standards
About Reagecon 04
______________________________________________________________________________________________
Dissolution Media 08
______________________________________________________________________________________________
pH Buffer Solutions 09
______________________________________________________________________________________________
Conductivity Standards 16
______________________________________________________________________________________________
All Reagecon manufactured products are underpinned by and demonstrate our position as a centre of excellence in the
science of Metrology. Product is manufactured, tested, and certified under the applicable ISO/IEC 17025
(A2LA Ref: 6739.03) or ISO/IEC 17034 (A2LA Ref: 6739.01) accreditation or ISO/IEC 17025 (A2LA Ref: 6739.02) for
Calibration, in one of our 20 specially equipped laboratories.
The resulting product is classified within one of 54 product families, these families are then grouped and promoted under
7 main product headings, as listed below:-
Electrochemistry Standards
Cation and Anion Standards
Pharmacopoeia Reagents and Standards
Physicochemical Standards
Total Organic and Inorganic Carbon Standards
Volumetric Solutions for Titration
Customised Standards and Reagents
The products presented are suitable for use as Ensure consistency of products (independent,
buffering systems in either solvent or aqueous traceable, certified)
mobile phases.
Manufactured under controlled processes and batch
Significant reduction in the amount of time and certified to ensure lot-to-lot consistency and
expense required to prepare them in house - “lean reproducibility of results
labs”
Certificates of Analysis and Safety Data Sheets
available online
Frees up resources for other core activities
Reagecon’s produces a range of ready to use Buffered Eluents for Liquid Chromatography for the control of Mobile
Phase pH, when analysing ionisable compounds using HPLC and for the use of pH control when working with field
samples of non-ionisable compounds due to the presence of ionisable impurities or contaminants.
The use of Reagecon’s high quality buffer systems will minimise variations of mobile phase pH, leading to dramatically
improved selectivity, retention factor, peak shape, resolution and reproducibility. These Buffered Eluents, which are not
available from any other manufacturer, bring you multiple benefits as outlined above.
Reagecon has selected 19 most commonly recommended buffering systems from scientific literature and from the
currently published 2,400 monographs of the USP. However, there are several hundred other buffering systems
contained in the monographs and we are happy to quote for these also. The products offered are suitable for use as
buffering systems in either solvent or aqueous mobile phases.
At least 18 anion and 18 cation standards available Uncertainties of measurement are calculated
according to Eurachem/CITAC guidelines and reported
Many Multi Element mixes available as expanded uncertainties at the 95% confidence level.
Manufactured to exacting specifications with an Suitable for any make or model or instrument
extended shelf life & stability
Manufactured to exacting specifications with an
This product is produced in a highly controlled extended shelf life & stability
cleanroom (ISO 7) environment, using ultra-pure
water (specially treated for the production of Ion Consistency of product - Independent, Traceable,
Chromatography Standards) and triple leached pre- Certified
cleaned bottles.
Certificates of Analysis and Safety Data Sheets
The titrimetry and spectroscopy are controlled and available online
calibrated using separate standards, so the product
comes with two layers of traceability including NIST
Standards, where available.
These standards are prepared, tested, certified and verified by following the exact same regime as already presented
for ICP-MS Standards. The raw material specifications are in most cases identical to the materials used for ICP-MS.
Additionally, the elemental cations are also analysed by ICP-MS. All results are verified on a state of the art Ion
Chromatograph, which is calibrated using high purity ISO 17034 accredited standards, similar in concentration to the
products listed below.
Controlled Environment
Reagecon’s standards are manufactured in a highly controlled clean room environment using:
Certification
Reagecon’s Ion Chromatography Standards are prepared gravimetrically on a weight/weight basis from the purest
available raw materials on the market. Both solute and solvent are weighed on balances calibrated by Reagecon’s
engineers using OIML traceable weights. Reagecon holds ISO/IEC 17025 accreditation for calibration of laboratory
balances. The resulting Balance Certificate of Calibration is issued in accordance with the requirements of ISO/IEC
17025.
Reduce preparation time, expense and free up Certificates of Analysis and Safety Data Sheets
resources for core activities available online
Ready to use Dissolution Media takes out all preparation steps, allowing you to run your dissolution test without
delay and at a reduced cost, the following graphic demonstrates the number of steps to be saved by using our ready to use
Dissolution Media
Media Preparation Weighing Mixing
• Consult relevant • Weigh ingredients • Dissolve chemicals
pharmacopoeia • Measured dangerous • Make up to Volume
• Produce BOM concentrates • Adjust to volume Ready for Testing
• Calculate quantities of • Verify Weights • Measure pH & adjust if
ingredients • Calibrate pH Meter or required
• Calibrate Balance other equipment • Mix
Dissolution Media Concentrates take out all preparation steps up to the final mixing, simply add purified water and
mix, allowing you to run your dissolution test without delay and at a reduced cost.
We are delighted to add several new offerings that include buffers to calibrate
Antimony Electrodes
Sterile Buffers
Colour Coded pH Buffers with a three decimal place specification.
Various packaging options are offered for ease of use e.g. Colour Coded, Twin Neck Bottles, Bag-in Box.
All are manufactured to exacting specifications with an extended shelf life and cover the pH range of pH 1.00 to pH 13.00
inclusive. All are supplied with a detailed Certificate of Analysis which outlines traceability to N.I.S.T (the N.I.S.T SRM(s) Lot
No. is stated on the certificate). Temperature dependence data is printed on the label as are lot numbers and expiry dates.
For proof of traceability, all of these comparisons must be made in a technically - valid manner and the accuracy of each
step must be quantified by calculating the associated Uncertainty of Measurement. Reagecon’s pH buffer standards
meet the ISO definition of traceability: “The ability to relate measurements back to a stated reference (usually an
international standard) through an unbroken chain of comparisons, each having stated uncertainties of measurement.”
Reagecon’s traceability claims are guaranteed by our accreditation to ISO/IEC 17025.
Traceable analysis is necessary for consistency and universal acceptance of your pH results - including acceptance by
regulatory bodies.
Fully Accredited
Reagecon’s pH analysis is accredited to ISO/IEC 17025 “General requirements for the competence of testing and
calibration laboratories”. Reagecon’s accreditation to ISO/IEC 17025 gives independent proof of three key areas:
Our pH analysis is technically valid and is carried out in a thoroughly controlled manner by highly - qualified
staff.
Our claims over the accuracy of our pH analysis are valid and we have properly quantified our accuracy in our
Uncertainty of Measurement calculations.
Our pH analysis is traceable to NIST SRMs. It is important to note that NIST do not police claims of traceability
to their SRMs.
Why take chances with your pH buffer supplier’s traceability? By using buffers from a manufacturer that holds ISO/IEC
17025 accreditation you have a guarantee of traceability.
Stability
Reagecon’s pH buffers have been specially formulated to ensure their stability. The packaging bottles that we use have
also been selected and tested to provide maximum stability. We have conducted stability trials on both freshly-opened
and part-full bottles of our pH buffers to validate their shelf-life - an example is given in Figure 2. This demonstrates
that Reagecon’s pH buffers will stay within their specification limits up to the stated expiry date regardless of when the
bottle was first opened (provided that the pH buffer is stored in accordance with good laboratory practice). Most of
Reagecon’s pH buffers have an expiry date of either 2 years or 3 years from the date of manufacture.
Calibration Buffers
Reagecon pH Buffers are pre-programmed into the instruments of most major manufacturers.
Control Buffers
For increased confidence in their test measurements, analysts should regularly measure the pH of a Control Standard. If
an acceptable value is obtained from the Control Standard measurement then the analysts, can have improved confidence
that their test measurements will be correct. Reagecon’s extensive range of pH buffers means that there will be a
Reagecon pH buffer which can be used as a control buffer for all pH applications.
Capsules. The presentation of pH buffers in capsule format is an innovative concept developed by Reagecon,
and offers several advantages
RECAL Buffers. RECAL is a range of pH Buffers in a wide mouth disposable container which can be used for direct
calibration of the electrode and then discarded on completion.
Introduction
pH is one of the most frequently and universally made measurements in science. Despite the number of people
involved in pH measurement, the practical fundamentals governing it are not widely understood. The literature
sometimes offers conflicting advice on how it is best measured and there is often uncertainty about the correct option
available to deal with individual measurement applications. What is often not fully appreciated is that the vast majority
of pH problems are related to the correct selection, care or maintenance of the electrode with particular emphasis on
the reference electrode.
This brief technical note deals specifically with the correct choice of reference Electrode Filling Solution and the
compatibility of the filling solution with the sample being measured. It is important to keep two key considerations in
mind as part of the selection process of the Electrode Filling Solution. Firstly, the issue of the compatibility between the
filling solution and the sample relates not only to direct pH measurement but also direct Ion and Redox measurement.
It is also relevant to the use of all three sensors when performing potentiometric titrations. Secondly, the direct
experience of the analyst, the operating instructions of the electrode or the detail contained within the test method
being followed, may be of most value in the selection of the correct filling solution.
Concentrated or saturated Potassium Chloride (KCl) fulfils all of these conditions to a greater or lesser extent and is
the filling solution of choice in either potentiometric titrations or direct pH, redox or ion measurements where
silver/silver chloride or calomel reference electrodes are used.
Introduction
Reagecon is the largest producer of Conductivity Standards and is credited with the invention of low level aqueous
standards. The company is still the only producer worldwide with the capability to manufacture and stabilise these
products at such low levels of conductivity. This low range of standards includes 1.3 µS ±0.05 µS/cm - the lowest
aqueous Conductivity Standard available. The following summary details the principle features and benefits of this
exciting range of products.
Matrix Matched
The matrix of a solution is defined as “the components of the sample other than the analyte”. In all analytical
measurements, it is of utmost importance that the matrix of the standard and the sample are the same. As
conductivity measurement is, in the main, a water quality measurement, the standard used should also have an
aqueous matrix. Reagecon’s Conductivity Standards are all aqueous based, thereby eliminating any errors attributable
to matrix mismatch.
Ease and cost of shipping, without the need to provide hazardous goods’ paperwork
Reduced Health & Safety requirements for storage and use
Ease and cost of disposal - solvent-based Conductivity Standards require expensive, specialised disposal to
comply with environmental regulations.
Guaranteed Stability
As a result of the extensive R&D that led to our innovative manufacturing process, Reagecon can guarantee the stability
of their complete range of Conductivity Standards over their entire shelf life. The stability offered by Reagecon’s
Conductivity Standards varies from that of their competitors in one vital area. We can guarantee that our Conductivity
Standards will remain within specification, (up to their expiry date), right through their working life, regardless of when
the bottle was first opened provided Good Laboratory Practise is adhered to. This eliminates the need to open a fresh
bottle of standard every time the product is used. (The 1.30 µS/cm Conductivity Standard is packaged in single-dose
bottles and each bottle when opened can only be used once.) The shelf life of the products from their date of
manufacture are given below.
Accuracy
All standards have a specification of ± 1%, except 1.30 µS/cm, which has a specification of 1.25 - 1.35 µS/cm. This high
level of accuracy enables the standards to be used as calibrators and/or controls in fulfilment of the most exacting
industrial statutory requirements, for example the United States Pharmacopoeia Monograph for Water for Injection.
Accreditation
Reagecon’s conductivity measurement has been covered in the scope of our accreditation to ISO 17025 “General
Requirements for the competence of Calibration and Testing Laboratories” and its predecessor, EN 45001, since 1990.
ISO/IEC 17025. Achieving accreditation involves fulfilling many highly technical criteria, including fully validating our test
methods and instrumentation systems and characterising our measurement uncertainty. Reagecon’s accreditation
proves the technical competence of our personnel, the technical validity of our test procedures and the traceability of
our measurements. Therefore, in purchasing a Conductivity Standard from us, not only do you have transparent
traceability to primary standards, but you also have confidence that our standards are of a well-defined and tightly
controlled specification.
Product Number
Lot Number
Expiry Date
Mean specific conductance
Date of Measurement
Assay Limits
Test Method Used
Uncertainty of Measurement and Traceability Data
Our Technical Services team is always on hand to answer any questions regarding the selection and use of conductivity
instruments, sensors and standards.