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PHR1156

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Tributyl 2-acetylcitrate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Acetyl tributyl citrate
Linear Formula:
CH3CO2C[CO2(CH2)3CH3][CH2CO2(CH2)3CH3]2
CAS Number:
77-90-7
Molecular Weight:
402.48
Beilstein:
2303316
EC Number:
201-067-0
MDL number:
MFCD00043554
UNSPSC Code:
41116107
PubChem Substance ID:
329823174
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001055
traceable to USP 1009901

vapor pressure

0.26 psi ( 20 °C)
0.8 psi ( 55 °C)

description

API family: acetyltributyl citrate

API family

acetyltributyl citrate

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

refractive index

n20/D 1.443 (lit.)

density

1.05 g/mL at 25 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CCCCOC(=O)CC(CC(=O)OCCCC)(OC(C)=O)C(=O)OCCCC

InChI

1S/C20H34O8/c1-5-8-11-25-17(22)14-20(28-16(4)21,19(24)27-13-10-7-3)15-18(23)26-12-9-6-2/h5-15H2,1-4H3

InChI key

QZCLKYGREBVARF-UHFFFAOYSA-N

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General description

Tributyl 2-acetylcitrate is a hydrophobic biodegradable plasticizer, that is usually synthesized by esterification of citric acid. Pharmaceutically, it is used as an excipient, which is generally applied as a thin film over the tablets or capsules.
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

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.
Tributyl 2-acetylcitrate may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by gas chromatography.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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.
Values of analytes vary lot to lot.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA8991 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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.

WGK

WGK 2

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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Study of the migration behavior of acetyl tributyl citrate from PVDC/PVC film into fish fillets as affected by intermediate doses of electron beam radiation
Zygoura PD, et al.
European Food Research and Technology, 232(6), 1017-1025 (2011)
Acetyltributyl Citrate
Pharmacopeia, US
United States Pharmacopeia/National Formulary, 35(6)(4), 5555-5555 (2018)
Migration of di-(2-ethylhexyl) adipate (DEHA) and acetyl tributyl citrate (ATBC) plasticizers from PVC film into the food stimulant of isooctane: Weichmacherwanderung von Di-(2-ethylhexyl) Adipate (DEHA) und Acetyl Tributyl Zitrate (ATBC) von PVC-Folien in das Genussmittel Isooctan
Lajqi MV, et al.
Materials Science and Engineering Technology, 46(1), 16-23 (2015)
Pharmacokinetic Properties of Acetyl Tributyl Citrate, a Pharmaceutical Excipient
Kim H, et al.
Pharmaceutics, 10(4), 177-177 (2018)
Acetyltributyl Citrate
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 35(6)(4), 3833-3834 (2017)
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