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PHR1366

Dibutyl Phthalate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Dibutyl phthalate, n-Butyl phthalate, DBP, Phthalic acid dibutyl ester

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About This Item

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:
329823345
EC Number:
201-557-4
Beilstein/REAXYS Number:
1914064
MDL number:
MFCD00009441

Key Documents

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InChI key

DOIRQSBPFJWKBE-UHFFFAOYSA-N

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

SMILES string

CCCCOC(=O)c1ccccc1C(=O)OCCCC

grade

certified reference material, pharmaceutical secondary standard

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

Quality Level

300

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

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.
Plasticizer
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 and EP 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.
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.

pictograms

Health hazardEnvironment
GHS08,GHS09

signalword

Danger

Storage Class

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

flash_point_f

339.8 °F

flash_point_c

171 °C

Hazard Classifications

Aquatic Acute 1 - ED ENV 1 - ED HH 1 - Repr. 1B

Regulatory Information

农药列管产品
This item has

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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Qing Ye et al.
Toxicology, 443, 152573-152573 (2020-08-30)
Maternal exposure to di-n-butyl phthalate (DBP) can cause renal fibrosis in adult offspring rats. However, its underlying mechanisms have not yet been fully understood. In this study, we investigated whether the RhoA/ROCK pathway plays an important role in offspring renal
Identification of phthalates in medications and dietary supplement formulations in the United States and Canada
Kelley KE, et al.
Engineering in Medicine and Biology Society (EMBC), 2014 36th Annual International Conference of the IEEE., 120(3), 379-384 (2011)
Phthalic Acid and Derivatives
Ullmann's Encyclopedia of Industrial Chemistry (2007)
Determination of plasticizers commonly used in pharmaceutical dosage forms by high performance liquid chromatography
Bodmeier R and Paeratakul O
Journal of Liquid Chromatography, 14(2), 365-375 (1991)
Analysis of consumer cosmetic products for phthalate esters.
Hubinger JC and Havery DC
Journal of Cosmetic Science, 57(2), 127-137 (2006)

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