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In this brochure, Roquette presents its approach to the development of pyrogen-free dextrose monohydrate: reliability based on decades of expertise and compliance with the most stringent quality and regulatory requirements.
The documentation provides information on LYCADEX®’s production, compliance with Good Industrial Manufacturing Practice, traceability, records, and the double control of pyrogenic substances.
Individual technical bulletins are available at the end of the brochure with more details on batch identification and packaging, the manufacturing flow sheet, physico-chemical analysis, suitability and ICH Q7A certification, and biological controls.
Request this documentation
· In English version (March 2001)
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· In English version
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