Description

25-Hydroxy-Vitamin-D3 (Antigen) is a crucial metabolite of Vitamin D3, serving as a primary biomarker for assessing Vitamin D status in the body. Its high purity and specificity make it an essential reference standard and immunogen in diagnostic applications. This compound is primarily utilized by manufacturers and research institutions in the in-vitro diagnostics (IVD), pharmaceutical development, and clinical research sectors.

Application

• Immunoassay Development: As a critical antigen for the production of antibodies used in ELISA, CLIA, and other immunoassay kits for 25-Hydroxy-Vitamin D quantification.
• Reference Standard: Serves as a primary or secondary certified reference material (CRM) for calibrating diagnostic equipment and validating assay methods.
• Clinical Research: Used in studies investigating Vitamin D metabolism, deficiency, and its correlation with various health conditions.
• Pharmaceutical R&D: Employed in the research and development of new therapeutic agents targeting Vitamin D pathways.
• Quality Control: Essential for the in-house quality control testing of commercial Vitamin D diagnostic kits to ensure accuracy and reliability.

Basic Information

Product Name	25-Hydroxy-Vitamin-D3 (Antigen)
CAS No.	932023-09-1
Molecular Formula	C27H44O2
Molecular Weight	400.64 g/mol
Synonyms	25-Hydroxycholecalciferol; 25-OH-Vitamin D3; Calcifediol; 25-Hydroxyvitamin D3; 3β,25-Dihydroxycholesta-5,7-dien; Previtamin D3 metabolite; 25(OH)D3; Rocaftor (pharmaceutical form)
EINECS	Contact for details

Quality Control

Our 25-Hydroxy-Vitamin-D3 (Antigen) is manufactured under strict quality management systems to ensure the high purity and batch-to-batch consistency required for diagnostic and research applications. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically determined by HPLC, NMR, and MS. We adhere to relevant quality guidelines suitable for in-vitro diagnostic (IVD) and research use.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). For long-term storage, consider storage under an inert atmosphere. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.