Description

Paclitaxel impurity 19/Taxol E/(αR,βS)-α-Hydroxy-β-[[(2S)-2-methyl-1-oxobutyl]amino]benzenepropanoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-Bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetr is a structurally defined chemical impurity and a key reference standard for the quality control of the anticancer drug Paclitaxel. This compound is critical for ensuring the pharmaceutical purity, safety, and efficacy of Paclitaxel formulations by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams involved in the development and manufacturing of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Paclitaxel impurity 19 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating stability-indicating HPLC/UPLC methods for Paclitaxel analysis.
• Stability Studies & Forced Degradation: Used to monitor impurity profiles and establish degradation pathways during drug substance and product stability testing.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Pharmaceutical Research: Serves as a tool in metabolic and pharmacokinetic studies to understand the behavior of Paclitaxel and its related compounds.
• Quality Control Testing: Routinely used in in-process control and release testing of Paclitaxel API to ensure compliance with pharmacopeial specifications (USP, EP).

Basic Information

Item	Details
Product Name	Paclitaxel impurity 19/Taxol E/(αR,βS)-α-Hydroxy-β-[[(2S)-2-methyl-1-oxobutyl]amino]benzenepropanoic Acid (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-Bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetr
CAS No.	158948-96-0
Molecular Formula	C47H51NO14
Molecular Weight	853.91 g/mol
Synonyms	Taxol Impurity E; Paclitaxel Related Compound E; 7-Epitaxol; 7-epi-Paclitaxel; (2'R,3S)-N-Benzoyl-3-phenylisoserine Paclitaxel Ester; 10-Deacetyl-7-epipaclitaxel; NSC 716088; Paclitaxel EP Impurity E
EINECS	Contact for details

Quality Control

Our Paclitaxel impurity 19 is manufactured under strict quality systems to ensure it meets the exacting requirements for use as a pharmaceutical reference standard. Each batch is characterized and tested using advanced analytical techniques including HPLC, NMR, and Mass Spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability. Our quality commitment aligns with the standards expected for materials used in GMP-compliant pharmaceutical development and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.