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Key Documents

PHR1883

Supelco

Docetaxel

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

Docetaxel trihydrate

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About This Item

Fórmula empírica (notación de Hill):
C43H53NO14 · 3H2O
Número de CAS:
Peso molecular:
861.93
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to Ph. Eur. Y0001133
traceable to USP 1224551

API family

docetaxel

CofA

current certificate can be downloaded

packaging

pkg of 200 mg

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

InChI

1S/C43H53NO14.3H2O/c1-22-26(55-37(51)32(48)30(24-15-11-9-12-16-24)44-38(52)58-39(3,4)5)20-43(53)35(56-36(50)25-17-13-10-14-18-25)33-41(8,34(49)31(47)29(22)40(43,6)7)27(46)19-28-42(33,21-54-28)57-23(2)45;;;/h9-18,26-28,30-33,35,46-48,53H,19-21H2,1-8H3,(H,44,52);3*1H2/t26-,27-,28+,30-,31+,32+,33-,35-,41+,42-,43+;;;/m0.../s1

InChI key

XCDIRYDKECHIPE-QHEQPUDQSA-N

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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.
Docetaxel is a taxoid anticancer agent that binds to β tubulin and promotes tubulin assembly into microtubles inducing cell-cycle arrest and apoptosis.

Application

Docetaxel may be used as a pharmaceutical reference standard for the determination of the analyte in plasma samples by various chromatography techniques.
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, 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 LRAB0750 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazardExclamation mark

signalword

Danger

Hazard Classifications

Eye Irrit. 2 - Repr. 1B

Storage Class

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

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificados de análisis (COA)

Lot/Batch Number

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Visite la Librería de documentos

Sensitive determination of docetaxel in human plasma by liquid--liquid extraction and reversed-phase high-performance liquid chromatography
Loos WJ, et al.
Journal of Chromatography. B, Biomedical Sciences and Applications, 693(2), 437-441 (1997)
Simultaneous determination of docetaxel and ketoconazole in rat plasma by liquid chromatography/electrospray ionization tandem mass spectrometry
Huang Q, et al.
Rapid Communications in Mass Spectrometry, 21(6), 1009-1018 (2007)

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