Seeded Trenbolone Acetate Crystallization for Defined Particle Size

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Solution Overview

Problem

Existing methods for preparing Trenbolone Acetate suffer from low yield, poor reproducibility, and difficulty in achieving a defined particle size distribution, leading to low-quality and inefficient production.

Innovation Solution

A process involving crystallization of Trenbolone Acetate using a seed with a defined particle size distribution, which includes seeding a solution of Trenbolone Acetate in a solvent, cooling to form a suspension, and filtering to achieve a specific particle size range, allowing for high yield and reproducible production.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional crystallization methods are used for Trenbolone Acetate preparation, then the process is simple to operate, but the particle size distribution is undefined and product quality is low

Engineering Contradiction:
Improveparticle size distributionVSAvoidcrystallization process complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by introducing seeds with a predefined particle size distribution before the crystallization process. These seeds serve as nucleation sites that guide the crystal growth, ensuring the final product achieves the desired particle size distribution (D10: 15-40 μm, D50: 67-130 μm, D90: ≤350 μm) without requiring complex post-processing equipment.

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If multi-step synthesis routes are used to improve chemical purity, then the purity increases, but the yield decreases and production efficiency deteriorates

Engineering Contradiction:
Improvechemical purityVSAvoidproduction efficiency
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent employs parameter changes by optimizing the crystallization conditions including temperature range (0°C to 30°C), solvent selection (isopropanol), and seeding parameters. These controlled parameter changes enable the simultaneous achievement of high chemical purity (>99.50%) and high molar yield (85-95%) in a single crystallization step, eliminating the need for multiple purification steps that would reduce productivity.

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If seed crystallization with defined particle size is implemented, then the solid density increases and active ingredient utilization improves, but the crystallization process becomes more complex

Engineering Contradiction:
Improvesolid densityVSAvoidcrystallization process complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent applies local quality by using seeds with specific particle size characteristics (D50: 8-90 μm) to locally control the nucleation and growth process. This localized control at the seed level propagates through the entire crystallization process, resulting in a final product with enhanced solid density and defined particle size distribution, while keeping the overall process relatively simple.

Inventive Principle:
Principle #3Local quality

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The process achieves a molar yield of 85-95% and high chemical purity (>99.50%), with a defined particle size distribution that enhances solid density and facilitates more efficient use of active ingredient per volume, improving the quality and efficiency of Trenbolone Acetate production.

Implementation Method 1

crystallization of Trenbolone Acetate by means of addition of a seed having a define median value (D50) of the particle size distribution

Methodology Applied
Scientific EffectCrystallization: Crystallisation

Implementation Method 2

seeding said solution with a Trenbolone Acetate seed

Methodology Applied
Scientific EffectNucleation: Nucleation

Implementation Method 3

cooling until the obtainment of a suspension

Methodology Applied
Scientific EffectCooling: Cooling

Implementation Method 4

cooling until the obtainment of a suspension

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Data Source

PatentEP4000688B1Process for the preparation of trenbolone acetate having a definite particle size distribution
Publication Date: 2025.11.05 F I S FAB ILTALIANA SINTETICI SPA
  • EP4000688B1 patent drawingFigure 1
  • EP4000688B1 patent drawingFigure 2
  • EP4000688B1 patent drawingFigure 3

AI summary

Object of the present invention is related to a process for the preparation of Trenbolone Acetate of formula (I): having a median value (D50) of the particle size distribution comprised in the range from 50 µm to 80 µm, or from 60 µm to 90 µm, or from 90 µm to 250 µm, by means of addition of a seed having a median value (D50) of the particle size distribution comprised respectively in the range from 8 µm to 15 µm, or from 15 µm to 20 µm, or from 20 µm to 90 µm, to a solution of Trenbolone Acetate in a solvent.