Description

Triamterene Related Compound B (2,7-Diamino-4-Hydroxy-6-Phenylpteridine) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound is critical for ensuring the accuracy and reliability of analytical methods used to assess the purity and stability of the diuretic drug Triamterene. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Triamterene Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for quality control.
• Stability Testing: Employed in forced degradation studies to monitor the formation of related substances under various stress conditions (light, heat, humidity).
• Pharmacopoeial Compliance: Supports testing to meet the stringent specifications outlined in pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Utilized in metabolic and pharmacokinetic studies to understand the drug's behavior and degradation pathways.

Basic Information

Product Name	Triamterene Related Compound B (50 Mg)
CAS No.	19375-89-4
Molecular Formula	C12H11N7O
Molecular Weight	269.26 g/mol
Synonyms	2,7-Diamino-4-hydroxy-6-phenylpteridine; 6-Phenyl-2,4,7-pteridinetriamine; 4-Hydroxy-2,7-diamino-6-phenylpteridine; Triamterene Impurity B; Triamterene Related Substance B; Triamterene EP Impurity B; 6-Phenyl-2,4,7-triaminopteridine
EINECS	Contact for details

Quality Control

Every batch of Triamterene Related Compound B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and support your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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