Description

Dexpanthenol Impurity F is a specified impurity of Dexpanthenol, a key pharmaceutical intermediate and provitamin of B5. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and fine chemical industries who require precise impurity profiling to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dexpanthenol Impurity F in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling of Dexpanthenol.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure Dexpanthenol meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to identify and track the formation of this specific impurity during forced degradation and shelf-life studies of Dexpanthenol formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Research & Development: Utilized in synthetic chemistry R&D to study the formation pathways and minimization strategies for this impurity.

Basic Information

Item	Details
Product Name	Dexpanthenol Impurity F
CAS No.	124402-18-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	D-Panthenol Impurity F; (R)-2,4-Dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide Impurity F; Pantothenol Impurity F; Dexpanthenol Related Compound F; Provitamin B5 Impurity F; (R)-N-(3-Hydroxypropyl)-2,4-dihydroxy-3,3-dimethylbutyramide Impurity F
EINECS	Contact for details

Quality Control

Our Dexpanthenol Impurity F is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the high standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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%
Related Substances (HPLC)	Specification available upon request
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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