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Potassium Cyanide-COA

This document provides a certificate of analysis for a certified reference material of potassium cyanide. It details the product information, certified purity of 99.98% via mass balance analysis, metrological traceability, analytical methods used, and packaging details.

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Deepthi R
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0% found this document useful (0 votes)
75 views4 pages

Potassium Cyanide-COA

This document provides a certificate of analysis for a certified reference material of potassium cyanide. It details the product information, certified purity of 99.98% via mass balance analysis, metrological traceability, analytical methods used, and packaging details.

Uploaded by

Deepthi R
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Certificate of Analysis - Certified Reference Material

POTASSIUM CYANIDE
Product no.: PHR2214-1G
Lot no.: LRAC8507
Description of CRM: White powder
Expiry date: June 2025
Storage: ROOM TEMPERATURE
Certificate version: LRAC8507.01 (Note: Certificates may be updated due
to the availability of new data. Check our website at:
www.sigma-aldrich.com for the most current version.)
Chemical formula: KCN
Molecular mass: 65.12
CAS No. 151-50-8

Analyte Purity (Mass Balance/basis)

Potassium Cyanide 99.98 % UCRM = ± 0.54 %, k = 2 (Mass Balance/as is basis)

Metrological traceability: Traceable to the SI and higher order standards from NIST through an
unbroken chain of comparisons. When applicable, additional traceability to
Primary Standards is established through comparative assay determinations.
See "Details on metrological traceability“ on page 2.
Measurement method: Where applicable, the certified value is based on a purity determination by
mass balance. See section “Certification process details”.
Intended use: Intended for Laboratory Use only. Not for drug, household or other uses
Minimum sample size: 40 mg
Health and safety All chemical reference materials should be considered potentially hazardous
information: and should be used only by qualified laboratory personnel. Please refer to the
Safety Data Sheet for detailed information about the nature of any hazard
and appropriate precautions to be taken.
Accreditation: Sigma-Aldrich RTC is accredited by the US accreditation authority ANAB as a
registered reference material producer AR-1470 in accordance with ISO
17034.
Certificate issue date: 17-Jun-2021

[Andy Ommen - Quality Control] [Mark Pooler - Quality Assurance]

Sigma-Aldrich RTC, 2931 Soldier Springs Rd. Laramie, WY 82070, USA;


Tel. 1 307-742-5452; Fax 1 307-855-831-9211; www.sigmaaldrich.com
Sigma-Aldrich RTC is a subsidiary of Merck KGaA, Darmstadt, Germany.
Certificate Page 1 of 4 Certificate version 01
Instructions for handling The internal pressure of the container may be slightly different from the
and correct use: atmospheric pressure at the user`s location. Open slowly and carefully to
avoid dispersion of the material. All values reported on the CoA are for the
contents of the unopened standard and apply to the initial use of the
standard. Any unused portions remaining after the container has been opened
should be carefully stored in accordance with prudent laboratory procedures.
Many variables are outside of the control of MilliporeSigma. Therefore,
MilliporeSigma makes no warranties concerning the continued suitability of
previously opened CRMs. Decisions concerning the proper use of previously
opened CRMs are the responsibility of the user.
Expiration is at end of month given on certificate and label.

Packaging: 1 g in amber vial

Details on metrological This standard has been gravimetrically prepared using balances that have
traceability: been fully qualified and calibrated to ISO 17025 requirements. All
calibrations utilize NIST traceable weights which are calibrated externally by a
qualified ISO 17025 accredited calibration laboratory to NIST standards.
Qualification of each balance includes the assignment of a minimum weighing
by a qualified and ISO 17025 accredited calibration vendor taking into
consideration the balance and installed environmental conditions to ensure
compliance with USP tolerances of NMT 0.10% relative error. Fill volume to
predetermined specifications is gravimetrically verified throughout the
dispensing process using qualified and calibrated balances. Further
traceability to a corresponding Primary Standard may be achieved through a
direct comparison assay. Where a Primary Standard is available, the assay
value will be included in the specified section of the COA.
Associated uncertainty: Uncertainty values in this document are expressed as Expanded Uncertainty
(UCRM) corresponding to the 95% confidence interval. UCRM is derived from
the combined standard uncertainty multiplied by the coverage factor k, which
is obtained from a t-distribution and degrees of freedom. The components of
combined standard uncertainty include the uncertainties due to
characterization, homogeneity, long term stability, and short term stability
(transport). The components due to stability are generally considered to be
negligible unless otherwise indicated by stability studies.
TRACEABILITY ASSAY
Comparative assay demonstrates direct traceability to Pharmacopeial Standards

ASSAY vs. NIST REFERENCE STANDARD NIST3141a (as is basis)

ASSAY VALUE vs. USP LOT


99.5 % 32192
Labeled Content = assume 100.0 %
METHOD: ICP (ICP-OES Inhouse Method 0726 )

Instrument: Optima 2100 DV PerkinElmer


Flow Rate: 1.00 mL/min with a flush time of 60 sec
Wavelength: 769.896 nm
Plasma View: Radial
Sample Matrix: 2.0 % Ammonium Hydroxide, 1.0 wt. % EDTA, 1.0 wt. % Triton X-100 in water

ADDITIONAL ASSAYS

Titration Assay
Method: Titrated by Silver nitrate 0.1 N

Mean of measurements: 100.1 %

Certificate Page 2 of 4 Certificate version 01 LRAC8507


MASS BALANCE ANALYSIS
Certification process The certified purity is determined by mass balance and calculated as
details:
𝟏𝟎𝟎 𝑻𝑪𝑰
% 𝑃𝑢𝑟𝑖𝑡𝑦 𝟏𝟎𝟎 𝐑𝐎𝐈 𝐋𝐎𝐃 𝐇𝟐 𝐎 𝐑𝐒 ∗
𝟏𝟎𝟎
 TCI = Total Chromatographic Impurities
 LOD = Loss on Drying
 H₂O = Water content determined by Karl Fischer analysis
 ROI = Residue on Ignition
 RS = Residual Solvents

Methods for impurity determination may be added or deleted as required.

ANALYSIS BY ICP-MS
Method: ICP-MS
Sample Size: 13 mg
Mean of three measurements, Residue = None

WATER DETERMINATION
Method: Karl Fischer Titration (ref.: Current Compendial Monographs)
Mean of three measurements, Water Content = None

LOSS ON DRYING/VOLATILES
Method: Oven at 280 °C for 3 hrs
Sample Size: ~ 1 g
Mean of three measurements, Loss = 0.021 %

CERTIFIED PURITY BY MASS BALANCE

99.98 % UCRM = ± 0.54 %, k = 2 (Mass Balance/as is basis)

Homogeneity Homogeneity was assessed in accordance with ISO Guide 35. Completed units
assessment: were sampled using a random stratified sampling protocol. The results of
chemical analysis were then compared by Single Factor Analysis of Variance
(ANOVA). The uncertainty due to homogeneity was derived from the ANOVA.
Heterogeneity was not detected under the conditions of the ANOVA.
Analytical method: ICP
Sample size: 40 mg
Stability assessment: Significance of the stability assessment will be demonstrated if the analytical
result of the study and the range of values represented by the Expanded
Uncertainty do not overlap the result of the original assay and the range of its
values represented by the Expanded Uncertainty. The method employed will
usually be the same method used to characterize the assay value in the initial
evaluation.
Long Term Stability Evaluation - An assessment, or re-test, versus a
Compendial Reference Standard may be scheduled, within the 3 year
anniversary date of a release of a Secondary Standard. The re-test interval
will be determined on a case-by-case basis. Short Term Stability Study - It is
useful to assess stability under reasonably anticipated, short term transport
conditions by simulating exposure of the product to humidity and temperature
stress. This type of study is conducted under controlled conditions of elevated
temperature and humidity.

Certificate Page 3 of 4 Certificate version 01 LRAC8507


Certificate of analysis revision history:
Certificate version Date Reason for version

LRAC8507.01 17-Jun-2021 Original Release Date

Disclaimer: The purchaser is required to determine the suitability of this product for
any particular application. Sigma-Aldrich RTC makes no warranty of any kind, express
or implied, other than its products meet all quality control standards set by
Sigma-Aldrich RTC. We do not guarantee that the product can be used for any
particular application.
The vibrant M, Supelco, TraceCERT and Sigma-Aldrich are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates.
All other trademarks are the property of their respective owners. Detailed information on trademarks is available via
publicly accessible resources. © 2018 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.

Certificate Page 4 of 4 Certificate version 01 LRAC8507

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