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Merck

PHR1216

Dibutyl sebacate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Decanedioic acid dibutyl ester, Sebacic acid dibutyl ester

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About This Item

Linear Formula:
[-(CH2)4CO2(CH2)3CH3]2
CAS Number:
109-43-3
Molecular Weight:
314.46
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823223
EC Number:
203-672-5
Beilstein/REAXYS Number:
1798308
MDL number:
MFCD00027218

Product Name

Dibutyl sebacate, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C18H34O4/c1-3-5-15-21-17(19)13-11-9-7-8-10-12-14-18(20)22-16-6-4-2/h3-16H2,1-2H3

InChI key

PYGXAGIECVVIOZ-UHFFFAOYSA-N

SMILES string

CCCCOC(=O)CCCCCCCCC(=O)OCCCC

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1187091

API family

dibutyl sebacate

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

refractive index

n20/D 1.441 (lit.)

bp

178-179 °C/3 mmHg (lit.)

density

0.936 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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Analysis Note

These secondary standards offer multi-traceability to the US and EP primary standards, where they are available.

Application

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.

General description

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. Dibutyl sebacate is a commonly used plasticizer, which can be synthesized by the reaction of butyl alcohol and sebacyl chloride or by the distillation of sebacic acid with butyl alcohol in the presence of concentrated hydrochloric acid in benzene solution.

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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 LRAA9029 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class

10 - Combustible liquids

wgk

WGK 1

flash_point_f

366.8 °F - open cup

flash_point_c

186 °C - open cup

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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Burdock AG et al.
Encyclopedia of Food & Color Additives, 1 (1997)
T Quinten et al.
Drug development and industrial pharmacy, 37(2), 149-159 (2010-07-10)
It was the aim of the present study to develop sustained-release matrix tablets by means of injection molding of ethylcellulose (EC) and polyethylene oxide (PEO) mixtures and to evaluate the influence of process temperature, matrix composition, and viscosity grade of
Thomas Quinten et al.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 71(1), 145-154 (2008-05-31)
The aim of this study was to develop sustained-release matrix tablets by means of injection moulding and to evaluate the influence of process temperature, matrix composition (EC and HPMC concentration) and viscosity grade of ethylcellulose (EC) and hydroxypropylmethylcellulose (HPMC) on
T Bussemer et al.
Drug development and industrial pharmacy, 29(6), 623-630 (2003-08-02)
The mechanical properties of polymer films used in pharmaceutical coatings of pulsatile drug delivery systems were evaluated in the dry and the wet state by a newly developed puncture test, which allowed the time-dependent measurement of the mechanical properties on
Kangarlou Sogol et al.
International journal of pharmaceutics, 408(1-2), 1-8 (2010-11-26)
The object of this study was to investigate the influence of static and dynamic forces on mechanical properties of the biocompatible polymer ethyl cellulose. Similar polymeric films containing 40% (w/w) of the plasticizer dibutyl sebacate were subjected to tensile forces
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