Description

Vitamin B5 Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and method development in the pharmaceutical industry, specifically for the analysis of Pantothenic Acid (Vitamin B5) and its related substances. It is an essential tool for researchers and quality assurance professionals in pharmaceutical development, contract research organizations (CROs), and analytical testing laboratories who require reliable impurity standards to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Pantothenic Acid (Vitamin B5) active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the levels of specified impurities, ensuring batches meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to identify and track degradation products that may form in Vitamin B5 formulations under various stress conditions.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity samples for qualification and toxicological assessment.
• Research and Development: Facilitates metabolic studies, synthesis pathway research, and the development of purer manufacturing processes for Vitamin B5.

Basic Information

Product Name	Vitamin B5 Impurity 1
CAS No.	897045-90-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pantothenic Acid Impurity 1; Pantothenate Impurity 1; Vitamin B5 Related Compound 1; D-Pantothenic Acid Impurity; (R)-Pantothenic Acid Impurity; Provitamin B5 Impurity; 3-[(2,4-Dihydroxy-3,3-dimethylbutanoyl)amino]propanoic acid (related compound); Calcium D-Pantothenate Impurity
EINECS	Contact for details

Quality Control

Our Vitamin B5 Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and impurities is provided with every shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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