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Chiral Separation by Crystallization
Economical & Environmentally Favorable Purification

More than 70% of drug candidates worldwide are chiral. Typically, only one enantiomer or diastereomer is biologically active or desirable — making the production of enantiopure compounds imperative. For small molecule drugs, separation via crystallization is often vastly more economical and environmentally favorable than traditional chromatography, particularly at early and commercial manufacturing scales.

Our Chiral Separation Approaches

Classical Chiral Resolution

A highly effective and widely used approach to separating a desired enantiomer from a racemic mixture via diastereomeric salt formation and selective crystallization. We provide comprehensive, tailored resolution programs including:

  • Screening for the optimal resolving agent from a diverse library of chiral acids and bases
  • Identifying the ideal polymorph and solvent system for selective crystallization
  • Full design and optimization of the crystallization process for yield and purity
  • Scale-up from milligram screening quantities to pilot and commercial scale

Preferential Crystallization

Conventional chiral resolution methods are theoretically limited to a 50% maximum yield per cycle. Crystal Pharmatech surpasses this limitation by combining active racemization with the targeted, continuous crystallization of a single enantiomer directly from its racemic mixture — a strategy known as deracemization or dynamic resolution.

  • Identification of the proper racemizing agent and reaction conditions
  • Design and optimization of the preferential crystallization process parameters
  • Integration of racemization and crystallization into a single, efficient process

Our Systematic Advantage: Ternary Phase Diagrams

Crystal Pharmatech does not rely on trial and error. We have established a highly systematic method for chiral purification based on Ternary Phase Diagrams — a powerful predictive tool that provides a fundamental understanding of the thermodynamics governing your chiral system.

Based on these diagrams, the exact feasibility of purifying a chiral drug molecule by crystallization can be immediately determined — guiding us directly to optimal process conditions and eliminating guesswork from your development program.

Ternary Phase Diagram — Chiral Separation by Crystallization
Ternary phase diagram example

Why Choose Crystallization Over Chromatography?

Crystallization-Based Separation Chromatographic Separation
Lower cost per kilogram at scale High solvent and resin costs at scale
Readily scalable to commercial volumes Scale-up complexity and equipment constraints
Minimal solvent waste; more sustainable High solvent consumption and waste generation
Integrates naturally with API crystallization workflow Requires separate downstream processing step
No chiral stationary phase — no IP/supply constraints Dependence on specialized chiral stationary phases

Achieve Your Success with Our Expertise

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Our capabilities span three specialized platforms:

  • Small Molecule

  • Crystal Bio Solutions

  • Crystal NAX


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Small Molecule Crystal Bio Solutions
Biologics Characterization and CMC Analytics Bioanalytical and Biomarker Services Quantitative Clinical Pharmacology (QCP)
Crystal NAX
DNA Synthesis RNA Synthesis LNP Formulation Services Analytical & Characterization Services Early-Phase Manufacturing Catalogue Products
Contact Us
bd_global@crystalpharmatech.com (925) 558-5040
U.S
NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512

2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512

CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
Canada
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
No. 288, Jiangyun Road, Suzhou Industrial Park, Suzhou, China 215123

Floor 1, Bldg. 3, 68 Chunpu Road, Suzhou Industrial Park, Suzhou, China 215123
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NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512

2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512

CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
bd_global@crystalpharmatech.com (925) 558-5040