Description

Fimasartan Potassium Trihydrate,Br-A 657 is a high-purity, non-peptide angiotensin II receptor blocker (ARB) active pharmaceutical ingredient (API). This compound is critical for the development and production of antihypertensive medications, offering a targeted mechanism of action. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in cardiovascular drug formulation and advanced therapeutic research.

Application

• Primary Pharmaceutical Ingredient: Core active component in the manufacture of finished dosage forms for the treatment of hypertension (high blood pressure).
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmaceutical laboratories.
• Research & Development: Used in preclinical and clinical studies to investigate pharmacokinetics, pharmacodynamics, and new therapeutic applications of ARBs.
• Formulation Development: Key material for developing various drug delivery systems, including tablets and capsules, optimizing stability and bioavailability.
• Process Chemistry: Employed in scale-up and process optimization studies for efficient and compliant API manufacturing.
• Regulatory Submissions: Supplied as a characterized substance for inclusion in Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.

Basic Information

Product Name	Fimasartan Potassium Trihydrate,Br-A 657
CAS No.	1020110-23-9
Molecular Formula	C27H27KN6O3 · 3H2O
Molecular Weight	582.67 g/mol (Anhydrous basis: 528.65 g/mol)
Synonyms	Fimasartan K; Potassium Fimasartan Trihydrate; BR-A-657; BR-A 657; (2-Butyl-5-dimethylamino-thiocarbonylmethyl-6-methyl-3-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]pyrimidin-4(3H)-one) Potassium Salt Trihydrate; Fimasartan Potassium Salt Hydrate; Kanarb
EINECS	Contact for details

Quality Control

Our Fimasartan Potassium Trihydrate,Br-A 657 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by IR and NMR, to ensure compliance with ICH Q7 guidelines and relevant pharmacopeial standards. A detailed Certificate of Analysis (COA) documenting identity, purity, and impurities is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	8.0% - 10.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	< 20 ppm

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