Carglumic Acid DMSO Solvate Purification for High Yield

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Solution Overview

Problem

Existing methods for purifying carglumic acid are time-consuming, costly, and result in high waste generation with low yield, achieving only up to 99% purity, which is insufficient for commercial viability.

Innovation Solution

A method involving the formation of a carglumic acid solvate with dimethyl sulfoxide, followed by precipitation and subsequent release using solvents or acids, allowing for high-purity carglumic acid production through simple and cost-effective procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If repeated precipitation and crystallizations are used to purify carglumic acid, then purity increases to 99%, but processing time increases and yield decreases

Engineering Contradiction:
ImprovepurityVSAvoidprocessing time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The invention changes the chemical parameter by forming a solvate complex with dimethyl sulfoxide, which fundamentally alters the purification mechanism. Instead of relying on repeated precipitation and crystallization steps, the solvate formation allows for direct filtration to achieve high purity (99.5-99.7%) in a single operation, dramatically reducing processing time while maintaining high yield

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention introduces dimethyl sulfoxide as an intermediary substance that forms a solvate complex with carglumic acid. This intermediary enables the purification process to work through a different mechanism - the solvate complex precipitates selectively from the reaction mixture, allowing direct filtration to obtain high-purity product without requiring multiple repeated purification cycles

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If repeated precipitation and crystallizations are used to purify carglumic acid, then purity increases to 99%, but waste generation increases

Engineering Contradiction:
ImprovepurityVSAvoidwaste generation
Core Design Contradiction:
Manufacturing precisionVSLoss of substance

Solution Approach 1:

The invention changes the purification approach by utilizing solvate formation with dimethyl sulfoxide, which enables single-step filtration to achieve 99.5-99.7% purity. This eliminates the need for multiple repeated purification cycles, thereby significantly reducing waste generation while maintaining high product purity and yield

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If repeated precipitation and crystallizations are used to purify carglumic acid, then purity increases to 99%, but yield decreases

Engineering Contradiction:
ImprovepurityVSAvoidyield
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The invention changes the purification mechanism through solvate formation with dimethyl sulfoxide, enabling direct filtration to achieve high purity (99.5-99.7%) in one step. This approach avoids the yield loss associated with multiple repeated purification cycles, maintaining high productivity while delivering superior purity

Inventive Principle:
Principle #35Parameter changes

4Manufacturing precision

If conventional purification methods are used, then 99% purity is achieved, but the process is complex and costly

Engineering Contradiction:
ImprovepurityVSAvoidprocess complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The invention introduces dimethyl sulfoxide as an intermediary that forms a solvate complex with carglumic acid, enabling purification through simple filtration. This single-step process replaces complex multi-step procedures involving repeated precipitation and crystallization, dramatically simplifying the overall process while achieving 99.5-99.7% purity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention changes the fundamental approach to purification by utilizing solvate formation, which transforms a complex multi-step process into a simple single-step filtration operation. This parameter change in the purification mechanism reduces process complexity and cost while maintaining high purity levels

Inventive Principle:
Principle #35Parameter changes

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 method achieves high yields and purities exceeding 99.5%, reducing processing time and waste, while maintaining operational efficiency.

Implementation Method 1

when the raw carglumic acid is dissolved in dimethyl sulfoxide and solvate of carglumic acid and dimethyl sulfoxide is formed

Methodology Applied
Scientific EffectSolvation: Solvation

Implementation Method 2

A solvent, in which the solvate of carglumic acid with dimethyl sulfoxide is insoluble, is then added to the generated solution, thereby precipitating the solvate of carglumic acid with dimethyl sulfoxide

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Data Source

PatentEP4110756B1Process for the purification of carglumic acid and intermediate of this process
Publication Date: 2025.08.13 SCALE UP LAB SRO
  • EP4110756B1 patent drawingFigure 1
  • EP4110756B1 patent drawingFigure 2
  • EP4110756B1 patent drawingFigure 3

AI summary

Method of purification of carglumic acid, substance formula I, contains the following steps: a) Dissolution of carglumic acid in dimethyl sulfoxide; b) Addition of a precipitation solvent; c) Isolation of the precipitated solvate of carglumic acid with dimethyl sulfoxide; d) Release of carglumic acid from the solvate by the help of water, possibly a mixture of water and an organic solvent, possibly a mixture of water and an organic or mineral acid, possibly a mixture of water, an organic acid and a mineral acid, possibly by an activity of an organic acid, possibly by an activity of mixture of water, a mineral acid and an organic solvent.