Description

2-Desethoxy-2-Hydroxy-1H-1-Ethyl Candesartan Cilexetil-D5 is a deuterated impurity standard and a key synthetic intermediate used in the development and quality control of the antihypertensive drug Candesartan Cilexetil. This high-purity compound is essential for ensuring the accuracy and reliability of analytical methods, including mass spectrometry and HPLC, by serving as a critical reference material. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the synthesis, validation, and regulatory filing of advanced pharmaceutical ingredients.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Candesartan Cilexetil active pharmaceutical ingredient (API) and finished drug products.
• Metabolite Studies: Used as a stable isotope-labeled internal standard in bioanalytical methods for the precise measurement of Candesartan and its metabolites in pharmacokinetic and pharmacodynamic studies.
• Process Chemistry R&D: Acts as a crucial intermediate or reference compound in the research and development of novel synthetic pathways for sartan-class pharmaceuticals.
• Quality Control & Assurance: Integral to method development and validation protocols to comply with ICH Q2(R1), Q3A(R2), and Q3B(R2) guidelines for impurities in new drug substances and products.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing characterized impurity data required for drug approval.
• Stability Testing: Employed in forced degradation studies and long-term stability testing programs to monitor impurity profiles over time.

Basic Information

Product Name	2-Desethoxy-2-Hydroxy-1H-1-Ethyl Candesartan Cilexetil-D5
CAS No.	1246819-36-2
Molecular Formula	C33H29D5N6O6
Molecular Weight	Contact for details
Synonyms	1H-1-Ethyl Candesartan Cilexetil-D5 Impurity; Candesartan Cilexetil Deuterated Impurity D; 2-Desethoxy-2-hydroxy Candesartan Cilexetil-D5; (2-((2'-(2H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-methyl-6-oxo-1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1,6-dihydropyrimidin-5-yl)oxy)methyl 2-ethoxy-3-((4-(2H5)ethyl)phenyl)propanoate; Candesartan Cilexetil EP Impurity D-D5; Candesartan Cilexetil Related Compound D-D5; Deuterated Candesartan Impurity
EINECS	Contact for details

Quality Control

Our 2-Desethoxy-2-Hydroxy-1H-1-Ethyl Candesartan Cilexetil-D5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and Mass Spectrometry, to confirm identity, chemical purity, and isotopic enrichment. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data and traceability. Our quality standards are designed to support compliance with ICH, USP, and EP guidelines for reference standards and pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere to ensure stability.

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%
Isotopic Purity (D-content)	≥ 95 atom % D
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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