PHR1883

Docetaxel

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Docetaxel trihydrate
• Empirical Formula (Hill Notation): C₄₃H₅₃NO₁₄ · 3H₂O
• CAS Number: 148408-66-6
• Molecular Weight: 861.93
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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

Description

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.

Safety Information

• Pictograms: GHS07,GHS08
• Signal Word: Danger
• Hazard Statements: H319 - H360F
• Precautionary Statements: P202 - P264 - P280 - P305 + P351 + P338 - P308 + P313 - P337 + P313
• Hazard Classifications: Eye Irrit. 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): Not applicable
• Flash Point(C): Not applicable