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BioSpectra Launches Bulk Mfg. Process

For high purity GMP grades of sodium hydroxide solutions.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

BioSpectra has launched a new, dedicated, bulk manufacturing process for high purity GMP grades of sodium hydroxide solutions made with USP purified and WFI grade water meeting specialty BET specifications that does not rely on the use of pellets.   The new three step manufacturing process is located at BioSpectra’s fully cGMP compliant, 150,000 square foot, FDA registered and inspected facility in Bangor PA. Products became commercially available in April 2019. The overall system is capable of ...

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