Description

Tandolone Impurity 4 CAS NO 1374000-99-3 is a high-purity chemical reference standard specifically identified as a process-related impurity of Tandolone. This compound is critical for pharmaceutical research and development, enabling precise analytical method development and validation. It is primarily required by analytical chemists and quality control laboratories in the pharmaceutical industry to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Tandolone impurities during API synthesis.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods for Tandolone analysis.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical QC labs to monitor impurity levels against regulatory specifications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Tandolone to track impurity formation over time.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize purification processes for Tandolone.

Basic Information

Product Name	Tandolone Impurity 4
CAS No.	1374000-99-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tandolone Related Compound 4; Tandolone Impurity D; Tandolone EP Impurity D; Tandolone USP Impurity 4; 1374000-99-3; Tandolone Process Impurity; Tandolone Degradant
EINECS	Contact for details

Quality Control

Every batch of Tandolone Impurity 4 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC, NMR, and MS to confirm identity and purity. We adhere to relevant ICH guidelines for impurity standards, ensuring data integrity and traceability for regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single major peak
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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