Certificate of Analysis: Benzoic Acid

Certificate of Analysis
Benzoic acid
TRACEABLE REFERENCE MATERIAL
CERTIFIED PURITY: 99.92%

Ucrm=±0.1% k=2.228
Mass Balance/as is basis
Catalog Number: PH541 Lot Number: 020619

Manufacture Date: 02/06/2019 Expiration Date: 2/28/2024
Physical Description: White Powder in amber vial CAS# 65-85-0
Chemical Formula: C₇H₆O₂ Molecular Weight: 122.12
Packaging, Storage, Instructions For Use:

This RM is packaged in an amber glass container and must be stored at room temperature (15°C to 30°C). Carefully
open the container to avoid dispersion of the material. Withdraw an aliquot appropriate for you application. Do not
dry, use on the as is basis. Keep the container tightly closed by attching a 20mm stopper and seal. Store in the
aluminumized zip bag when not in use.
Hazards:
This material is intended for Laboratory Use only. Not for drug, household or other uses. Read Safety Data Sheet
before using. All chemical reference materials should be considered potentially hazardous and should be used only
by qualified laboratory personnel.
Purity Determination by Mass Balance:
Certified Purity by Mass Balance = 99.92%

Ucrm=±0.1% k=2.228
ISO 9001:2015 UL Registered Firm - Certificate # 10002343 QM15
Page 1 of 4
Chromatographic Impurity Analysis by GCMS (Modified from Benzoic Acid Current Compendial Monograph)
Column: RXI-5MS W/Integra-guard
Carrier gas: He
Flow Rate: 1.7mL/min
Split Ratio: 11:1
Injection: 1ul/230°C
Temperature: 70°C for 2min, 8°C/min to 220°C
Impurities Detected: NONE
Representative Traceability Chromatograph of Benzoic Acid
Residual Solvents Impurity Analysis by GC-FID Headspace (Modified from Residual Solvents USP34 <467>)
Column: RTX-624
Carrier gas: He
Flow Rate: 1.2mL/min
Split Ratio: 10:1
Injection: 1ul/250°C
Temperature: 40°C for 20min, 15°C/min to 230°C, hold 5min
Solvents Detected: None
Water Determination Imputity Analysis by Karl Fisher Titration (Current Compendial Monograph)
Mean of three measurements - Water Content = 0.0150%
Residue Impurity Analysis by Sulfated Ash (Current Compendial Monograph)

Mean of three 1g measurements - Residue = 0.0014%
Loss on Drying Impurity Analysis by Oven

Mean of three 1g measurements - Loss = 0.6222%
Identification Tests:
Comparative identification analysis demonstrates direct traceability to Pharmacopeial standards
Page 2 of 4
Fourier-transform infrared spectroscopy (FTIR)
Melting Point
Mean of three measurements = 122.8°C
Results are consistant with Current Compendial Monograph, NIST Standard Reference
Database or comparative analysis of USP Standard.
Homogeneity Assessment :
This compound is guaranteed homogenous. Homogeneity was assessed in accordance with ISO Guide 35.
Completed units were sampled using a random sampling protocol.
Uncertainty Statement:
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 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.
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.
Page 3 of 4
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.
Kenneth Grzybowski
________________________________________________
Kenneth Grzybowski, Organics Department Manager
Mark Hammersla
________________________________________________
Mark Hammersla, President
Page 4 of 4

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Certificate of Analysis

CERTIFIED PURITY: 99.92%

Catalog Number: PH541 Lot Number: 020619

Packaging, Storage, Instructions For Use:

Purity Determination by Mass Balance:

Certified Purity by Mass Balance = 99.92%

ISO 9001:2015 UL Registered Firm - Certificate # 10002343 QM15

Impurities Detected: NONE

Representative Traceability Chromatograph of Benzoic Acid

Solvents Detected: None

Residue Impurity Analysis by Sulfated Ash (Current Compendial Monograph)

Loss on Drying Impurity Analysis by Oven

ISO 9001:2015 UL Registered Firm - Certificate # 10002343 QM15

ISO 9001:2015 UL Registered Firm - Certificate # 10002343 QM15

ISO 9001:2015 UL Registered Firm - Certificate # 10002343 QM15

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