Description

Allisartan Isoproxil Impurity 5 is a designated impurity standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API), Allisartan Isoproxil. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Allisartan Isoproxil Impurity 5 in API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods for Allisartan Isoproxil.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports compliance testing against monographs in pharmacopoeias such as USP, EP, or ChP where specified.

Basic Information

Product Name	Allisartan Isoproxil Impurity 5
CAS No.	1131003-59-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Allisartan Isoproxil Related Compound 5; Allisartan Impurity 5; 2-Butyl-5-(hydroxymethyl)-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-4-carboxylic acid 1-methylethyl ester; Allisartan Isoproxil EP Impurity 5; Allisartan Isoproxil USP Impurity 5; Allisartan Isoproxil Process Impurity; (2-Butyl-4-(hydroxymethyl)-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]imidazol-5-yl)methyl isopropyl carbonate derivative
EINECS	Contact for details

Quality Control

Our impurity standards are manufactured and controlled under a strict quality management system. Each batch of Allisartan Isoproxil Impurity 5 undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via MS and NMR, to ensure identity, strength, and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results against comprehensive specifications. Production is aligned with cGMP principles to support its use in regulated pharmaceutical environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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