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PHR1366

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Dibutyl Phthalate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Dibutyl phthalate, n-Butyl phthalate, DBP, Phthalic acid dibutyl ester
Linear Formula:
C6H4-1,2-[CO2(CH2)3CH3]2
CAS Number:
Molecular Weight:
278.34
Beilstein:
1914064
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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Dibutyl Phthalate Pharmaceutical Secondary Standard; Certified Reference Material

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Dibutyl Phthalate

Dibutyl phthalate certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

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packaging

pkg of 1 g

packaging

-

packaging

-

packaging

-

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

application(s)

cleaning products
cosmetics
environmental
food and beverages
personal care

application(s)

-

application(s)

pharmaceutical (small molecule)

format

neat

format

neat

format

-

format

neat

storage temp.

2-30°C

storage temp.

-

storage temp.

-

storage temp.

2-30°C

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.

Pictograms

Health hazardEnvironment

Signal Word

Danger

Hazard Statements

Hazard Classifications

Aquatic Acute 1 - Aquatic Chronic 2 - Repr. 1B

Storage Class Code

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

WGK

WGK 3

Flash Point(F)

339.8 °F

Flash Point(C)

171 °C


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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)
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)
Phthalic Acid and Derivatives
Ullmann's Encyclopedia of Industrial Chemistry (2007)
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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