PHR1549

1,4-Dioxane

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 1,4-Dioxane, Diethylene oxide, Dioxane
• Empirical Formula (Hill Notation): C₄H₈O₂
• CAS Number: 123-91-1
• Molecular Weight: 88.11
• Beilstein: 102551
• EC Number: 204-661-8
• MDL number: MFCD00006571
• PubChem Substance ID: 329823458
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1601521
• vapor density: 3 (vs air)
• vapor pressure: 27 mmHg ( 20 °C); 40 mmHg ( 25 °C)
• CofA: current certificate can be downloaded
• autoignition temp.: 356 °F
• expl. lim.: 22 %
• packaging: ampule of 3x1.2 mL each
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• refractive index: n20/D 1.422 (lit.)
• bp: 100-102 °C (lit.)
• mp: 10-12 °C (lit.)
• density: 1.034 g/mL at 25 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: C1COCCO1
• InChI: 1S/C4H8O2/c1-2-6-4-3-5-1/h1-4H2
• InChI key: RYHBNJHYFVUHQT-UHFFFAOYSA-N

Description

General description

1,4-Dioxane belongs to the class of volatile organic compounds (VOCs).[1]
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

1,4-Dioxane may be used as a pharmaceutical reference standard for the determination of the analyte in bulk pharmaceuticals, and cosmetic raw materials and finished products by chromatography.[2][3][4]

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 USP, EP 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 LRAC0289 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS02,GHS07,GHS08
• Signal Word: Danger
• Hazard Statements: H225 - H319 - H335 - H350
• Precautionary Statements: P202 - P210 - P233 - P240 - P305 + P351 + P338 - P308 + P313
• Hazard Classifications: Carc. 1B - Eye Irrit. 2 - Flam. Liq. 2 - STOT SE 3
• Target Organs: Respiratory system
• Supplementary Hazards: EUH019 - EUH066
• Storage Class Code: 3 - Flammable liquids
• WGK: WGK 2
• Flash Point(F): 51.8 °F - closed cup
• Flash Point(C): 11 °C - closed cup