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Merck

PHR1311

Toluène

Pharmaceutical Secondary Standard; Certified Reference Material

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A propos de cet article

Formule linéaire :
C6H5CH3
Numéro CAS:
108-88-3
Poids moléculaire :
92.14
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823297
EC Number:
203-625-9
Beilstein/REAXYS Number:
635760
MDL number:
MFCD00008512

Principaux documents

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Nom du produit

Toluène, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

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

InChI key

YXFVVABEGXRONW-UHFFFAOYSA-N

SMILES string

Cc1ccccc1

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

Quality Level

300

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Catégories apparentées

Analysis Note

These secondary standards offer multi-traceability to the US and EP primary standards, where they are available.

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.

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.

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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.
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.

signalword

Danger

Hazard Classifications

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

target_organs

Central nervous system

Classe de stockage

3 - Flammable liquids

wgk

WGK 3

flash_point_f

39.9 °F - closed cup

flash_point_c

4.4 °C - closed cup

Certificats d'analyse (COA)

Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".

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Consulter la Bibliothèque de documents

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)
Organic solvents in the pharmaceutical industry
Grodowska K and Parczewski A
Acta Poloniae Pharmaceutica, 67(1), 3-12 (2010)
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)
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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