Merck
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PHR1311

Supelco

Toluene

Pharmaceutical Secondary Standard; Certified Reference Material

Linear Formula:
C6H5CH3
CAS Number:
Molecular Weight:
92.14
Beilstein:
635760
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

Agency

traceable to USP 1601805

vapor density

3.2 (vs air)

vapor pressure

22 mmHg ( 20 °C)
26 mmHg ( 25 °C)

CofA

current certificate can be downloaded

autoignition temp.

997 °F

expl. lim.

7 %

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

refractive index

n/D 1.496 (lit.)

bp

110-111 °C (lit.)

mp

-93 °C (lit.)

density

0.865 g/mL at 25 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Cc1ccccc1

InChI

1S/C7H8/c1-7-5-3-2-4-6-7/h2-6H,1H3

InChI key

YXFVVABEGXRONW-UHFFFAOYSA-N

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General description

Toluene is a non-polar organic solvent and methyl derivative of benzene. As per USP and EP, it belongs to the Class 2 category of organic solvents and has limited application in the synthesis of pharmaceuticals, due to its moderate toxicity.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Toluene may be used as a pharmaceutical solvent reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by gas chromatography.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC2115 in the slot below. This is an example certificate only and may not be the lot that you receive.

Signal Word

Danger

Hazard Classifications

Aquatic Chronic 3 - Asp. Tox. 1 - Flam. Liq. 2 - Repr. 2 - Skin Irrit. 2 - STOT RE 2 - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

3 - Flammable liquids

WGK

WGK 2

Flash Point(F)

39.2 °F

Flash Point(C)

4.0 °C

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Origin

Enter Lot Number to search for Certificate of Origin (COO).

5.4 Residual Solvents
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 5553-5560 (2018)
?467? Residual Solvents
USP43/NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 45(3), 6712-6712 (2019)
A generic static headspace gas chromatography method for determination of residual solvents in drug substance.
Cheng, et al.
Journal of Chromatography A, 1217(41), 6413-6421 (2010)
Organic solvents in the pharmaceutical industry
Grodowska K and Parczewski A
Acta Poloniae Pharmaceutica, 67(1), 3-12 (2010)
Liang Guo et al.
Journal of chromatography. A, 1286, 9-15 (2013-03-19)
For the first time, a novel one-step sample preparation method that combines microwave assisted extraction and solvent bar microextraction (MAE-SBME) with analysis by gas chromatography-mass spectrometry (GC-MS), was developed for the fast and efficient determination of polycyclic aromatic hydrocarbons (PAHs)

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