The challenge: Can you improve the yield and impurity levels while streamlining the production process? How we said yes: Baseline Experimentation revealed impurity and yield problems and an R&D program was launched to address the issues.

1. Case Study A:
Virtual Pharma Company,
A Phase II Project
The challenge:
Can you improve the yield and impurity levels while
STEP 3: Reduce impurities:
streamlining the production process?
• The kinetics of the reaction was studied, which allowed
for the reaction time to be reduced by 50%
How we said yes:
Baseline Experimentation revealed impurity and • The parameter study also showed that diluting the
reaction concentration increased the yield by 5-10%,
yield problems and an R&D program was launched
and reduced impurity levels.
to address the issues.
• Crystallization conditions were identified and
STEP 1: Reduce cycle time:
implemented to almost completely remove two
• Reduced extractions from five to three, with no troublesome impurities
yield impact
• Increased the concentration of all extraction operations The yes formula benefits:
to minimize product partitioning, decrease cycle time, Throughout the development and production
and increase throughput
of the project, weekly, and occasionally daily
• Identified a material of construction incompatibility that communications with the customer took place.
caused a 50% reduction in yield, and a corresponding This allowed the customer the opportunity to
increase in impurities
shape the direction of the research, if desired.
STEP 2: Improve yields: Supplied process was not
reproducible; the reaction would not always reach Product was produced at scale. All quality
completion. expectations were met or exceeded.
• Instituted a reverse order of addition that consistently
delivered reaction completion
Project completed at our South Haven facility.
• Added a pH adjustment to the end of the workup that
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significantly increased yield
Fine Chemistry Services

2. SOUTH HAVEN FACILITY
• More than 32 years service in pharmaceutical
and chemical industry
• Substantial R&D and new product
development resources
• cGMP kilo lab and pilot plant to support
customer product development
• Extensive custom manufacturing equipment
and chemistry capabilities
• On-site analytical support and methods
development in a FDA-regulated facility
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.
AMERICAS E U R O P E , M I D D L E E A S T, A F R I C A
Fine Chemistry Services EMA Fine Chemistry Services
Tel: +1 225 388 7402 Tel: +32 10 48 1711
ALBSales@albemarle.com EMASales@albemarle.com
www.albemarle.com
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