Description

Ixabepilone Impurity 2 ((Z)-Ixabepilone) is a specific stereoisomeric impurity of the anti-cancer drug Ixabepilone, identified by CAS No. 1220999-07-4. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control processes. It is primarily needed by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on oncology drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of (Z)-Ixabepilone in Ixabepilone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug stability studies.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Ixabepilone drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH impurity guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Acts as a marker to track the formation of this specific isomer under various stress conditions (e.g., heat, light, pH) as part of forced degradation studies.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this isomer during Ixabepilone manufacturing.

Basic Information

Product Name	Ixabepilone Impurity 2 ((Z)-Ixabepilone)
CAS No.	1220999-07-4
Molecular Formula	C27H41NO6S
Molecular Weight	507.68 g/mol
Synonyms	(Z)-Ixabepilone; Ixabepilone Z-Isomer; Ixabepilone Related Compound Z; BMS-247550 Impurity Z; (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-4,17-dioxabicyclo[14.1.0]heptadecane-5,9-dione; Azaepothilone B Z-Isomer; Ixempra Impurity Z
EINECS	Contact for details

Quality Control

Our Ixabepilone Impurity 2 is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are available upon request, supporting compliance with ICH Q3A/B and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere for long-term stability. This compound is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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