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Merck

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:
Molecular Weight:
278.34
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
201-557-4
Beilstein/REAXYS Number:
1914064
MDL number:
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Quality Segment

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

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

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.


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pictograms

Health hazardEnvironment

signalword

Danger

Hazard Classifications

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

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


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

84-74-2

CAS No.

84-74-2

CAS No.

84-74-2

CAS No.


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Certificates of Analysis (COA)

Lot/Batch Number

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