| 摘要 |
<p>A process for freeze drying an aqueous solution of a dosage amount of cyclophosphamide to yield a hydrate of cyclophosphamide ("CPA") comprises, in a first stage, freeze drying a solution of CPA with an excipient until the moisture content of the freeze-dried material is less than 2% by weight, based on anhydrous CPA present; and, in a second stage, rehydrating the freeze-dried material using live steam for a relative humidity of about 80-85% until the moisture content of the product is from about 2% to 7% by weight, based on the net weight of CPA product. The preferred CPA product provides a dosage amount of CPA and at least an equivalent amount by weight, and up to 5 times as much, of mannitol.</p> |
