PHR1366

Dibutyl Phthalate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Dibutyl phthalate, n-Butyl phthalate, DBP, Phthalic acid dibutyl ester
• Linear Formula: C₆H₄-1,2-[CO₂(CH₂)₃CH₃]₂
• CAS Number: 84-74-2
• Molecular Weight: 278.34
• Beilstein/REAXYS Number: 1914064
• EC Number: 201-557-4
• MDL number: MFCD00009441
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823345
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. D1010000; traceable to USP 1187080
• vapor density: 9.6 (vs air)
• vapor pressure: 1 mmHg ( 147 °C)
• API family: dibutyl phthalate
• CofA: current certificate can be downloaded
• autoignition temp.: 756 °F
• expl. lim.: 0.47 %, 236 °F
• packaging: pkg of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• refractive index: n20/D 1.492 (lit.)
• bp: 340 °C (lit.)
• mp: −35 °C (lit.)
• density: 1.043 g/mL at 25 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: CCCCOC(=O)c1ccccc1C(=O)OCCCC
• InChI: 1S/C16H22O4/c1-3-5-11-19-15(17)13-9-7-8-10-14(13)16(18)20-12-6-4-2/h7-10H,3-6,11-12H2,1-2H3
• InChI key: DOIRQSBPFJWKBE-UHFFFAOYSA-N

Description

General description

Dibutyl Phthalate is a diester of phthalate, commonly synthesized by the condensation of the carboxy groups of phthalic acid with two molecules of 1-butanol. It is used as a plasticizer and film coating agent in solid pharmaceutical dosage forms.
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

Dibutyl Phthalate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and dietary supplements by chromatography.

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.

Plasticizer

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 LRAA1470 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS08,GHS09
• signalword: Danger
• hcodes: H360FD,H410
• pcodes: P202 - P273 - P280 - P308 + P313 - P391 - P405
• Hazard Classifications: Aquatic Acute 1 - Aquatic Chronic 2 - Repr. 1B
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: 339.8 °F
• flash_point_c: 171 °C