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REFERENCE STANDARDS
10 Critical Steps
10 CRITICAL STEPS
World-Class Certified
Verify Compatibility & Stability
All raw materials used in our reference standards are held to strict purity criteria,
and compound compatibility is scrutinized during both formulation and review.
We also conduct on-going, long-term stability and short-term shipping stability
studies in accordance with ISO Guide 34 and ISO Guide 35 to ensure reliability
and accurate shelf-life reporting.
2
Characterize Raw Materials Thoroughly
Restek’s Quality Control (QC) lab confirms the chemical identity and purity of
mixture components and solvents using one or more of the following techniques:
GC-FID, HPLC, GC-ECD, GC-MS, LC-MS, refractive index, and melting point.
3
Review Customer & Method Requirements
To determine which organic reference standards we should develop as stock prod-
ucts, Restek experts closely monitor government regulations and methods from
around the globe and also actively engage with our customers and distributors. Once
a product is chosen based on regulatory changes, customer needs, and our 20+ years
of experience, a veteran Restek chemist formulates a stable standard containing an
ideal mix of compounds and concentrations. All formulations are then subjected to
a thorough review of accuracy, compatibility, and solubility by a second chemist.
1
Deactivate Glassware & Ampuls
Restek® reference standards are prepared using Class A volumetric flasks and/
or Class A pipettes. Ampuls and vials used in preparation and packaging are
deactivated to prevent the loss of target analytes.
5
4 Calibrate Analytical Balances
All analytical balances are verified at seven mass levels daily using NIST* traceable
weights and are also calibrated yearly by an ISO/IEC 17025:2005–accredited provider
to guarantee accurate measurement.
Whether it’s a stock, off-the-shelf reference standard or a one-of-a-kind,
custom-formulated solution, there are 10 critical steps that Restek takes to
separate our certified reference materials (CRMs) from the competition.
For every CRM produced in Restek’s ISO-accredited labs, we always:
6 Maintain ISO Accreditation
In 2011, the reference standard manufacturing and
QC testing laboratories in Restek’s state-of-the-art
Bellefonte, PA, facility earned ISO Guide 34 and
ISO/IEC 17025 accreditation. These accreditations—in
addition to ISO 9001 registration, which we have maintained since 1994—serve
as recognition that Restek and our labs meet the world-class quality standards
established by the International Organization for Standardization (ISO). On-site
manufacturing as well as raw material, qualitative, and quantitative analyses are
completed in these ISO-accredited labs. Restek’s ISO-accredited labs offer a full
line of both stock and custom CRMs.
* National Institute of Standards and Technology
What are Certified
Reference Materials
(CRMs)?
A CRM from Restek is in an
exclusive subset of reference
standards that meets the
following set of strict criteria
defined under ISO Guide 34 and
ISO/IEC 17025:
• Made of raw materials
characterized via qualified
methods on qualified
instruments.
• Produced in an ISO-accredited
lab under documented
procedures.
• Falls under the manufacturer’s
scopes of accreditation.
To learn more about Restek’s
ISO quality credentials and to
view our certificates (including
scopes of accreditation), visit