Description

Trenbolone Acetate Process Impurity 1 is a specific chemical entity identified during the synthesis and purification of the anabolic steroid Trenbolone Acetate. This compound is critical for pharmaceutical manufacturers and analytical laboratories engaged in quality control and regulatory compliance for steroid-based APIs. It serves as a key reference standard for method development, validation, and impurity profiling to ensure product safety and efficacy. Professionals in pharmaceutical R&D, quality assurance, and contract research organizations require this high-purity impurity to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard to identify, quantify, and monitor this specific impurity in Trenbolone Acetate active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to ensure accurate detection and separation of process-related impurities.
• Quality Control & Assurance (QC/QA): Provides a benchmark for in-house quality control testing to confirm that Trenbolone Acetate API meets specified purity criteria, such as ICH Q3A guidelines.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification in drug master files (DMFs).
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and optimize manufacturing processes to minimize impurity formation.
• Contract Laboratory Testing: Serves as a critical component for third-party testing services offering impurity analysis and certification for the pharmaceutical industry.

Basic Information

Product Name	Trenbolone Acetate Process Impurity 1
CAS No.	22841-97-0
Molecular Formula	C20H24O3
Molecular Weight	312.41 g/mol
Synonyms	Estra-4,9,11-trien-17β-ol-3-one, 17-acetate; 17β-Hydroxy-4,9,11-estratrien-3-one 17-acetate; Trenbolone 17-acetate impurity; δ9,11-Trenbolone Acetate; Trenbolone Acetate Related Compound; 4,9,11-Estratrien-17β-ol-3-one 17-acetate; 17β-Acetoxy-4,9,11-estratrien-3-one
EINECS	Contact for details

Quality Control

Every batch of Trenbolone Acetate Process Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing utilizing advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards for reference materials. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request to support your regulatory and quality needs.

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 light-sensitive and should be handled under appropriate conditions to maintain stability and purity.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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