National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

A -- STEROID SYNTHESIS-1 TO 3 KG. BATCHES DUE 110199 POC Mr. Paul J. Duska, Contracting Officer, 301-435-6955 WEB: National Institutes of Health, http://www.nih.gov. E-MAIL: National Institutes of Health, pd28n@nih.gov. The Contraception and Reproductive Health Branch, Center for Population Research, National Institute of Child Health and Human Development, National Institutes of Health, is seeking to identify organizations with experience and capabilities in steroid synthesis. The facility must be FDA registered and inspected. Synthesis of 1 to 3 kg batch sizes of cGMP (current Good Manufacturing Practice) levonorgestrel butanoate (>99% purity) for parenteral use in preclinical and clinical studies is desired. The free alcohol, USP levonorgestrel, will be supplied as the starting material. Accordingly, the preparation of the butanoic acid ester is a one step process involving the addition of butyric acid and trifluoracetic anhydride in dry dicholoromethane to the steroid followed by drying and purification. The ester will be recrystallized from ethanol. Organizations should have in house analytical capabilities for the determination of purity and the presence of solvent residues. Organizations interested in performing such work should submit a summary of their capabilities and experience with similar projects, including personnel, and equipment which could be assigned to the project. All organizations would be expected to operate under cGMP guidelines. Any source who thinks they have the capabilities to meet this need, should prepare a short Capability Statement. Three copies should be sent to: Mr. Paul Duska, Contracting Officer, NICHD/OAM/CMB, Executive Blvd., Room 7A07, 6100 Executive Blvd., MSC 7510, Bethesda, Maryland 20892-7510. If sending by overnight carrier, the last two address lines are: 6100 Executive Blvd., Rockville, Maryland 20852. E-mail and FAX responses are acceptable. Responses are due 11/01/99. (See Numbered Note 22) Posted 09/17/99 (W-SN381402). (0260)

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