Description

Tribenoside Ep Impurity B is a high-purity chemical reference standard, specifically identified as a process-related impurity of Tribenoside. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily utilized by research institutions, quality assurance laboratories, and API manufacturers involved in the development and production of Tribenoside-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tribenoside Ep Impurity B in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Tribenoside to understand degradation pathways.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in synthetic chemistry R&D to study the formation and fate of this specific impurity during the manufacturing process.

Basic Information

Product Name	Tribenoside Ep Impurity B
CAS No.	28713-39-5
Molecular Formula	C29H34O10
Molecular Weight	542.58 g/mol
Synonyms	Ethyl 3,5-Bis-O-(2,4-di-O-benzyl-α-L-rhamnopyranosyl)-β-D-galactofuranoside; Tribenoside Impurity B; Tribenoside Related Compound B; 3,5-Bis-O-(2,4-di-O-benzyl-α-L-rhamnopyranosyl)-β-D-galactofuranoside ethyl ester; Glyvenol Impurity B
EINECS	Contact for details

Quality Control

Every batch of Tribenoside Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and chromatographic data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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