Simplifying cGMP Crystallization | An Albemarle Fine Chemicals Case Study
2
The challenge: Can you simplify my cGMP crystalization? How we said yes: STEP 1: The crystallization conditions were effective at cleaning up the intermediate to an acceptable purity level. However, the crystallization system was tricky as it consisted of two solvents and the ratio of each relative to product was critical. • Required laboratory use testing when running this step in plant. STEP 2: Quantum mechanics calculations were performed on the structure of the intermediate to determine optimal solvents • Based on the electron density of the intermediate structure, solubility coefficients for various solvents were determined. • This identified two solvents that afforded high recovery and desirable cleanup when impurities were present in the intermediate. • The higher boiling point solvent was the favored azeotrope chosen for its reaction with the solvent mixture. • At the conclusion of the reaction, a solvent exchange was implemented; the batch was then cooled to effect crystallization • All known process impurities were purged to acceptable levels • Yields matched that of the original process. The yes formula benefits: All quality expectations were met or exceeded. Project completed at our South Haven facility. SEE BACK FOR DETAILS Fine Chemistry Services Case Study B: Virtual Pharma Project, Phase III API
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Transcript of Simplifying cGMP Crystallization | An Albemarle Fine Chemicals Case Study
The challenge:Can you simplify my cGMP crystalization?
How we said yes:STEP 1: The crystallization conditions were effective at
cleaning up the intermediate to an acceptable purity level.
However, the crystallization system was tricky as it
consisted of two solvents and the ratio of each relative
to product was critical.
• Required laboratory use testing when running this
step in plant.
STEP 2: Quantum mechanics calculations were
performed on the structure of the intermediate to
determine optimal solvents
• Based on the electron density of the intermediate
structure, solubility coefficients for various solvents
were determined.
• This identified two solvents that afforded high recovery
and desirable cleanup when impurities were present
in the intermediate.
• The higher boiling point solvent was the favored
azeotrope chosen for its reaction with the
solvent mixture.
• At the conclusion of the reaction, a solvent exchange
was implemented; the batch was then cooled to effect
crystallization
• All known process impurities were purged to
acceptable levels
• Yields matched that of the original process.
The yes formula benefits: All quality expectations were met or exceeded.
Project completed at our South Haven facility.SEE BACK FOR DETAILS
Fine Chemistry Services
Case Study B:Virtual Pharma Project, Phase III API
Find out how we say yes to hundreds of fine chemistry projects annually.
Albemarle is experienced and equipped to provide high-quality APIs to pharmaceutical customers worldwide.
To experience the difference of a committed fine chemistry partner, contact your Albemarle Representative.
The information presented herein is believed to be accurate and reliable, but is presented without guarantee or responsibility on the part of Albemarle Corporation. It is the responsibility of the user to comply with all applicable laws and regulations and to provide for a safe workplace. The user should consider any information contained herein, including information about any health or safety hazards, only as a guide, and should take those precautions that are necessary or prudent to instruct employees and to develop work practice procedures in order to promote a safe work environment. Further, nothing contained herein shall be taken as an inducement or recommendation to manufacture or use any of the herein described materials or processes in violation of existing or future patents.
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development in a FDA-regulated facility
