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Whitepaper: Techniques for developing Raw Material Libraries – sampling and scanning

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Posted: 3 October 2016 | | No comments yet

In this whitepaper, find out more about the techniques for developing Raw Material Libraries…

For many years the pharmaceutical industry has utilized Near Infrared (NIR) spectroscopy to identify raw materials as they are received by a manufacturing facility. This is because NIR is highly specific for most organic compounds used in the formulation of tablets, capsules, crèmes, suspensions etc. The development of portable instrumentation has allowed organizations to become more mobile and use the technology at point of receipt and storage.

 

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This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

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Background…

Near infrared offers many practical advantages over mid-infrared spectroscopy for raw material identification, mainly due to ease of sampling and robustness of instrumentation. NIR is also complimentary to Raman Spectroscopy and both methods should be used in tandem to maximize synergies.

Where to start…

Plan your development based on the 80:20 rule, i.e. what are the 20% of materials that come in 80% of the time. It is easy then to find the materials that will provide the most benefits up front in terms of quality assessment and efficiency.

Make a list of raw materials incoming to the facility and assess their history for past failures or deviations. Also seek materials that don’t come in as often, but require lengthy and tedious laboratory analyses. For materials that come in only once or twice a year, these will not typically give you the benefits upfront, so schedule those materials for second or even third phase library developments.

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