Build a Rock-Solid Analytical

Foundation with Restek Certified

Reference Standards

Dr Dörte Lohrberg

Reference materials are essential in chromatography

• correct identification of the sample components

• accuracy of the analysis values

Reference Standards

customer

business

livelihoodreputation

accreditation

Laboratory cannot stand without a trusted source of high-quality

reference standards

Material or substance used for the calibration of measuring devices, for the

evaluation of measurement procedures and for the internal or external quality control

of measurements and laboratories.

Reference standards play an increasingly important role in national and international

standardizing activities and in the accreditation of laboratories.

• neat compound

• neat compound dissolved in a solvent „single component solution“

• numerous compounds dissolved in a solvent „multi component solution“

Definition Reference Standards

Sources of Reference Standards

• In-house preparation of reference standards

• designated authorities and internationally recognized institutes provide defined

reference material

– National Institute of Standards and Technology (NIST)

– USP-standards (U. S. Pharmacopeial Convention)

– Institute for Reference Materials and Measurements (IRMM)

• Commercial manufacturers like Restek

Reference Materials (RM) vs.

Certified Reference Materials (CRM)

CRM

RM

CRM

• Sufficiently homogeneous and stable with

respect to one or more specific properties

• Has been established to be fit for its intended

use in a measurement process

• Produced in ISO-accredited lab under

documented procedures

• Characterized by a metrologically valid procedure

for one or more specific properties

• Certificate provides

✓ value of specified property

✓ the associated uncertainty

✓ metrological traceability

QUALITY

Trust through ISO Accreditation

• International Organization for Standardization (ISO) developed worldwide quality standards

production of reference standards is regulated by numerous guidelines and is subject to

stringent tests

T Testing laboratory

Calibration laboratory

ISO17025

• analytical testing procedures

provide consistent, valid results

• ensure the highest possible

quality

Reference standard producers

ISO

17034

• Quality system: extensive testing (material purity/identity, homogeneity,

stability)

• determination of uncertainty levels

• statement of metrological traceability

Accreditation allows manufacturers to say that they are making Certified Reference

Materials (CRMs)

Accreditation Restek

The ISO 17034 accreditation - when combined with ISO 17025 accreditation - symbolizes

the highest level of achievement possible for a reference standard provider.

• Scope of accreditation:

– single and multicomponent catalog standards

– custom standards

Updated soon: ISO 17025:2017

Restek’s reference standard manufacturing and quality control testing laboratories in

Bellefonte feature ISO 17034 and ISO 17025 accreditations since 2011.

Review Customer & Method

Requirements

• Forward planning of new standards and custom-made solutions

• Careful evaluation of each method to determine the exact requirements

– ideal mix of compounds

– appropriate concentrations

• formulations are subjected to a thorough review of

accuracy, compatibility, and solubility

Characterize Raw Materials

Thoroughly

• Raw Materials are held to strict purity criteria

• Quality control lab confirms chemical identities and purities with two or more

techniques:

– GC-FID; GC-ECD, GC-MS

– LC-MS, HPLC

– Refractive Index

– Melting Point

• Compounds with a listed purity of less than 99% are weight

corrected

Verify Compatibility & Stability

Formulate stable standards containing ideal mixes of compounds and concentrations

• Examination of individual compounds for their compatibility with one another to

achieve maximum shelf-life

• Checking the homogeneity

Studies ensure reliability and accurate shelf-life reporting

• Long-term storage stability testing

• Short-term shipping stability studies

Calibrate & Deactivate

Calibrate analytical balances

• analytical balances are verified at seven mass levels daily using NIST traceable

weights

• analytical balances are also calibrated yearly by an ISO 17025 accredited provider to

guarantee accurate measurement

Deactivate glassware and ampuls

• Class A volumetric flasks and/or Class A pipettes

• Ampuls and vials are deactivated to prevent loss of

target analytes

Produce according toISO 17034/17025

• Documentation of all work steps

• Processes are reproducible

• Employees are trained and certified

• Compound compatibility is continuously scrutinized

• Correct transfer of all information from the instruments to the certificate is monitored

and documented

Provide documentation

Restek‘s standards come with a certificate that provides:

• The total volume prepared

• Purity of each raw material used

• The exact amount of each raw material used

• Unique Lot numbers (keyword traceability)

• the associated uncertainty and shelf life

• statement of the metrological traceability

• Assigend to the responsible employee

https://www.restek.com/sitesearch/documentation/

• Restek is accredited by the American

Association for Laboratory Accreditation

(A2LA).

• Accreditation bodies that are member of

the ILAC-MRA accept the results of each

other's accredited laboratories and

inspection bodies

• As long as reference materials are

produced under the quality requirements

of ISO 17034 and ISO 17025 they can be

used in any lab all over the world

Provide certificates to pass audits

Offer a Variety of Documentation

Gravimetric Certificate – gravimetric data

✓Purity & amount of all raw materials

✓ Total volumne & calculated concentration

✓Unique lot numbers

Level 1

Certificate of Analysis - quantitative data

✓Gravimetric & qualitative data (QC Analysis Chromatogram )

✓Packaged unit analyzed in triplicate & peak areas compared to 2nd lot

✓ Full production batch reports

Certificate of Composition - qualitative data

✓ gravimetric data

✓Composition confirmed via accredited method

✓Chromatogram included

Level 2

Level 3

Package securely & Label clearly

• durable, high-quality packaging

• labeling provides critical storage, safety, and shelf life

information in an easy-to-read format for added safety

and GHS compliance.

• deactivated screw-top vial with each stock reference

standard for worry-free transfer

Safe Cracker

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• Flexible in concentration

adjustments

• Multiple purchases

necessary for multi-

methods

• Numerous analytes

in one sweep

• Concentration fixed

• Great number of analytes

in one purchase

• Facilitates the preparation

of standards

• Flexible

• Tailored to your needs

Categories of products

Primary source Secondary source

Stock solution

Creation of calibration curves

Validation

primary source standard

Verification of calibration

curves

Requirements – if the secondary

standard is used to internally

validate an externally acquired

primary source standard:

• Different raw material

• Different equipment for production

and validation

• Another staff

The issue with the secondary source…

„I simply buy the secondary source standard from another vendor“

raw

ma

teri

al

2

4

analyst

The issue with the secondary source…

3

1

vendor 1

vendor 2

„I simply buy the secondary source standard from another vendor“

raw

ma

teri

al

2

3

4

analyst

The issue with the secondary source…

1

vendor 1

vendor 2

Better source both standards from the same vendor in compliance

with all requirements for a secondary source standard!ra

wm

ate

rial

2

3

4

analyst

The issue with the secondary source…

1

vendor 1

vendor 2

Environmental Food

Petro

• Semivolatile Organics

• Volatile Organics

• Pesticides

• Phthalates and PCBs

• PAH and petroleum

• Explosives

• Leaking Underground

Storage Tanks (LUST)

• DHA – PiONA and

PONA

• Biodiesel

• Simulated Distillation

Life science

Choose a Restek Reference Standard for Your Next Application

• Pesticides

• QuEChERS

• PAH

• FAME

• MOSH/MOAH

• Fragrance Allergens

• MCPD

Cannabis

• Cannabinoids

• Pesticides

• Terpenes

• Residual Solvents

• Mycotoxins

(coming soon)

• Residual Solvents

• Drugs of abuse

• Ethylene oxide

Tool: Search, Select, and Custom

Request

• Quickly check for stock items

– Compounds can be entered individually or in bulk

– get a list of catalog standards containing your compounds

of interest

– evaluate the list of catalog standards to find the best fit

• Fills out needed custom information if no stock items fit needs

– No loss of information about compounds and concentrations

– Transmit custom standard request online Check out the

step-by-step

walkthrough

video!

Why Restek Reference Standards?

• Reference materials are essential in chromatography to ensure the correct

identification of the sample components and the accuracy of the analysis values.

• ISO quality standards production of reference standards is regulated by numerous

guidelines and is subject to stringent tests.

• A certified reference material from Restek meets the strict criteria

defined under ISO 17034 and ISO 17025.

• benefit from the performance, reliability, and consistency of

certified reference materials.

Turn to Restek for the ISO quality, custom flexibility, and easy-to-find

documentation you require to fit your workflows and trust your results

and build a rock-solid analytical foundation with Restek certified

reference standards!

Thank you foryour attention!