Description

Telmisartan Impurity G-D3 CAS NO 1794883-47-8 is a high-purity, deuterated reference standard used for analytical and research purposes. This compound is critically important for ensuring the quality, safety, and regulatory compliance of Telmisartan, a widely prescribed antihypertensive API. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this impurity standard for method development, validation, and precise quantification in drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Telmisartan Impurity G in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS/MS methods in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure drug product specifications are met.
• Stability Studies: Employed to track the formation and level 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 data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Metabolic and Pharmacokinetic Research: The deuterated form (D3) can be utilized as an internal standard in mass spectrometry for more accurate bioanalytical assays.

Basic Information

Product Name	Telmisartan Impurity G-D3
CAS No.	1794883-47-8
Molecular Formula	C33H27D3N4O2
Molecular Weight	~518.62 g/mol
Synonyms	Deuterated Telmisartan Impurity G; Telmisartan-d3 Impurity G; 4'-[(1,7'-Dimethyl-2'-propyl[2,5'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic Acid-d3; 2-(4-{[2'-Propyl-4'-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2H,4'H-1,1'-bibenzo[d]imidazol-1'-yl]methyl}biphenyl-2-yl)acetic Acid-d3; Telmisartan Related Compound G-D3; Telmisartan Deuterated Impurity G.
EINECS	Contact for details

Quality Control

Every batch of Telmisartan Impurity G-D3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and isotopic enrichment testing to ensure compliance with the highest standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses, along with chromatographic traces.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
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.