1187080

Dibutyl phthalate

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): 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
• UNSPSC Code: 41116107
• NACRES: NA.24
• PubChem Substance ID: 329749370
• MDL number: MFCD00009441
• Beilstein/REAXYS Number: 1914064
• eCl@ss: 25140904

Properties

• grade: pharmaceutical primary standard
• agency: USP
• vapor density: 9.6 (vs air)
• vapor pressure: 1 mmHg ( 147 °C)
• API family: dibutyl phthalate
• form: liquid
• autoignition temp.: 756 °F
• expl. lim.: 0.47 %, 236 °F
• manufacturer/tradename: USP
• 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): USP Biologics; pharmaceutical; pharmaceutical (small molecule)
• format: neat
• 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

Find answers to frequently asked questions on USP products in USP FAQs.

Dibutyl phthalate (DBP) is a plasticizer commonly used in the formulation of biologics to improve the flexibility and stability of polymeric materials. It plays an essential role in the production of drug delivery devices and packaging for biologics. By enhancing the physical properties of polymers, DBP contributes to the reliability and performance of biologic products, particularly those in extended-release or controlled-release systems.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

This compound is listed in the SVHC (Substances of very high concern) candidate list of ECHA (European Chemicals Agency)

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.
For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Plasticizer

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

This compound is listed in the SVHC (Substances of very high concern) candidate list of ECHA (European Chemicals Agency)This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

This product is part of USP Biologics Program.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pha

Safety Information

• Pictograms: GHS08,GHS09
• Signal Word: Danger
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Flash Point (°F): 367.7 °F - open cup
• Flash Point (°C): 186.5 °C - open cup
• Hazard Codes: H360Df,H400,EUH380,EUH430
• Precautionary Statements: P201 - P202 - P263 - P273 - P280 - P308 + P313 - P391 - P405 - P501
• Hazard Classifications: Aquatic Acute 1 - ED ENV 1 - ED HH 1 - Repr. 1B