Description

Dexpanthenol Impurity E is a high-purity chemical reference standard, specifically identified as a known impurity of Dexpanthenol (Provitamin B5). This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Dexpanthenol. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and routine quality control testing to monitor and control impurity profiles.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Dexpanthenol Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to separate and analyze impurities in Dexpanthenol.
• Quality Control & Assurance: Employed in routine QC testing to ensure Dexpanthenol batches meet stringent pharmacopoeial specifications (e.g., USP, EP, ICH Q3A/B) for impurity limits.
• Stability Studies: Used to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of Dexpanthenol formulations.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Serves as a key material in pharmaceutical R&D for studying the degradation pathways and chemistry of Dexpanthenol.

Basic Information

Product Name	Dexpanthenol Impurity E
CAS No.	96305-22-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Panthenol Impurity E; D-Panthenol Impurity E; (R)-2,4-Dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide Impurity E; Provitamin B5 Impurity E; Dexpanthenol Related Compound E; Dexpanthenol EP Impurity E; Dexpanthenol USP Impurity E
EINECS	Contact for details

Quality Control

Every batch of Dexpanthenol Impurity E is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support compliance with major pharmacopoeias (USP, EP).

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
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.