SAM #75F40126SS131706

FDA Seeks Biopharmaceutics Classification System / Automated Solubility Apparatus

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), is seeking sources for a Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus. - Government Buyer: - Agency: U.S. Food and Drug Administration - Sub-agency: Center for Drug Evaluation and Research (CDER) - Office: Office of Pharmaceutical Quality (OPQ) - Products Requested: - Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus - Quantity: 1 - Must be newly manufactured, latest model, and made in America - Technical requirements: - Maintains sample temperature at 37°C - Adjustable stirring speed - Operates multiple sample containers simultaneously - Withdraws samples at different time points - Filters or centrifuges samples before sampling - Optional features: dilution, pH monitoring, direct HPLC connection - Includes delivery, installation, on-site training for 6 scientists, and minimum one-year warranty (parts and labor) - Services Requested: - Delivery, installation, on-site performance testing, and training for at least 6 scientists - Support for network computer - Unique Requirements: - Apparatus must be made in America - On-site training and warranty included - OEMs and Vendors: - No specific OEMs or vendors are named; opportunity is open to manufacturers meeting requirements

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