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PHR1313

m-Xylene

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

1,3-Dimethylbenzene

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About This Item

Linear Formula:
C6H4(CH3)2
CAS Number:
108-38-3
Molecular Weight:
106.17
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823299
EC Number:
203-576-3
Beilstein/REAXYS Number:
605441
MDL number:
MFCD00008536
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to NIST 3004, traceable to USP 1601849

vapor density

3.7 (vs air)

CofA

current certificate can be downloaded

autoignition temp.

982 °F

expl. lim.

7 %

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

refractive index

n20/D 1.497 (lit.)

bp

138-139 °C (lit.)

mp

−48 °C (lit.)

density

0.868 g/mL at 25 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Cc1cccc(C)c1

InChI

1S/C8H10/c1-7-4-3-5-8(2)6-7/h3-6H,1-2H3

InChI key

IVSZLXZYQVIEFR-UHFFFAOYSA-N

General description

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. m-Xylene is widely used as a residual solvent (RS) or organic volatile impurity (OVI) in pharmaceutical formulations.

Application

m-Xylene may be used as a pharmaceutical reference standard for the determination of the analyte in tablet formulations by chromatography. It can also be used as a residual solvent standard for the quantification of the analyte in tablet formulations by headspace gas chromatography (HS-GC) with flame ionization detection (FID) technique.
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.

Analysis Note

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

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 LRAB3625 in the slot below. This is an example certificate only and may not be the lot that you receive.

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Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Aquatic Chronic 3 - Asp. Tox. 1 - Eye Irrit. 2 - Flam. Liq. 3 - Skin Irrit. 2 - STOT SE 3

target_organs

Respiratory system

Storage Class

3 - Flammable liquids

wgk

WGK 2

flash_point_f

80.6 °F - closed cup

flash_point_c

27 °C - closed cup

Regulatory Information

危险化学品

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Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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m-Xylene
USP43-NF38
United States Pharmacopeia/National Formulary, 6218-6218 (2013)
Determination of Organic Volatile Impurities in Twenty-Three Different Coated Tablet Formulations Using Headspace Gas Chromatography with Flame Ionization Detection Technique
Latif A, et al.
Pharmaceutica Analytica Acta, 8, 553-553 (2017)
Dragana Bozinovski et al.
FEMS microbiology ecology, 81(1), 134-144 (2012-03-01)
A sulfate-reducing consortium maintained for several years in the laboratory with m-xylene as sole source of carbon and energy was characterized by terminal restriction fragment length polymorphism (T-RFLP) fingerprinting of PCR-amplified 16S rRNA genes and stable isotope probing of proteins
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Global Trade Item Number

SKUGTIN
PHR1313-1G04061834415855