Description

Ascorbic Acid Ep Impurity G (L-Threo-Hex-2-Eneric Acid, 1-4-Lactone) is a specified impurity used in the analytical profiling and quality control of ascorbic acid (Vitamin C) pharmaceutical substances. This compound matters significantly for manufacturers and regulatory bodies as it is a critical reference standard for ensuring the purity and safety of ascorbic acid products according to stringent pharmacopeial monographs. It is essential for pharmaceutical R&D, quality assurance laboratories, and manufacturers of active pharmaceutical ingredients (APIs) who must comply with EP, USP, and ICH guidelines for impurity identification and quantification.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity G in ascorbic acid as per European Pharmacopoeia (EP) and other pharmacopeial specifications.
• Method Development and Validation: Critical for developing, validating, and calibrating analytical methods such as HPLC, UPLC, and LC-MS in quality control laboratories.
• Pharmaceutical Quality Control (QC): Used in routine batch testing of ascorbic acid API to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of ascorbic acid formulations to track impurity profiles over time.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Used in academic and industrial research focused on the synthesis, degradation pathways, and metabolism of ascorbic acid and related compounds.

Basic Information

Product Name	Ascorbic Acid Ep Impurity G (L-Threo-Hex-2-Eneric Acid, 1-4-Lactone)
CAS No.	66757-69-5
Molecular Formula	C6H8O6
Molecular Weight	176.12 g/mol
Synonyms	L-Threo-Hex-2-Eneric Acid, 1,4-Lactone; (5R)-5-[(1R)-1,2-Dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one; Ascorbic Acid Impurity G (EP); Vitamin C Impurity G; 2,3-Didehydro-L-threo-hexono-1,4-lactone; L-Threo-2-hexenonic acid γ-lactone; L-Ascorbic acid related compound G
EINECS	Contact for details

Quality Control

Every batch of Ascorbic Acid EP Impurity G is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and NMR to ensure it meets the exacting standards required for a pharmacopeial reference impurity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment supports your regulatory and GMP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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