Description

Ascorbic Acid Impurity 6 (L-Xylo-2-Hexulopyranosonic Acid) is a high-purity chemical reference standard, specifically identified as an impurity of ascorbic acid (Vitamin C). This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of final drug products. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies focused on developing and producing ascorbic acid-based formulations and injectables.

Application

• Pharmaceutical Reference Standard: Used for the identification, qualification, and quantification of Ascorbic Acid Impurity 6 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Vitamin C synthesis and formulations.
• Quality Control & Assurance: Serves as a system suitability standard and for preparing calibration curves in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3B).
• Stability Studies: Employed to track the formation of this specific degradation product in ascorbic acid under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Used in metabolic pathway studies and to understand the degradation profile of ascorbic acid in novel drug delivery systems.

Basic Information

Product Name	Ascorbic Acid Impurity 6 (L-Xylo-2-Hexulopyranosonic Acid)
CAS No.	2073888-75-0
Molecular Formula	C6H10O7
Molecular Weight	194.14 g/mol
Synonyms	L-Xylo-2-Hexulopyranosonic Acid; Ascorbic Acid Impurity F; Vitamin C Impurity 6; 2-Keto-L-gulonic acid derivative; 2-Oxo-L-gulono-1,4-lactone isomer; (5R)-5-[(1S)-1,2-Dihydroxyethyl]-3,4-dihydroxy-5H-furan-2-one
EINECS	Contact for details

Quality Control

Every batch of Ascorbic Acid Impurity 6 is manufactured and controlled under a strict quality management system. It undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (NMR, IR, MS), to ensure it meets the exacting standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
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.