Description

Trenbolone Acetate Process Impurity 4 is a specific chemical reference standard used in the analytical profiling of the anabolic steroid Trenbolone Acetate. This compound is critical for pharmaceutical quality control, enabling manufacturers to identify, quantify, and control this specific by-product during synthesis. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in steroid API development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for analytical method development and validation (HPLC, GC-MS) in API manufacturing.
• Quality Control & Assurance: Essential for setting impurity limits, conducting stability studies, and ensuring batch-to-batch consistency of Trenbolone Acetate.
• Regulatory Compliance: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.
• Forensic Analysis: Serves as a reference marker in the analysis of pharmaceutical preparations and related substances.

Basic Information

Product Name	Trenbolone Acetate Process Impurity 4
CAS No.	5218-51-9
Molecular Formula	C20H24O3
Molecular Weight	312.41 g/mol
Synonyms	Estra-4,9,11-trien-3-one, 17-(acetyloxy)-13-methyl-, (8R,9S,13S,14S)-; 17β-Hydroxy-4,9,11-estratrien-3-one 17-acetate; δ9,11-Trenbolone acetate; Trenbolone Acetate δ9(11) Impurity; 4,9,11-Trien-3-one-17β-ol acetate; Related Substance A of Trenbolone Acetate
EINECS	Contact for details

Quality Control

Every batch of Trenbolone Acetate Process Impurity 4 is produced and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, and relevant pharmacopoeial guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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