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(also referred to as the "parent guidance") and defines the stability data package in submissions for "existing" drug substances and associated products.

In the interests of international harmonization, wherever possible, this guidance conforms to the principles of the A draft version of this document of the same title was released for Stakeholder consultation in 1997.

DOE experiments to obtain a design space of a unit operation.

Drying and granulation process monitored by Near IR and chemical imaging. Sci., 2006, 95, Group 1A: Products with No Failures ( 10 lots tested) Drug Product Dosage Form Tested Mean Amoxicllin Sodium Tablets Ciprofloxacin Tablets Diphenhydramine HCl Syringe-Needle a Doxycycline Hyclate Capsules b Doxycycline Hyclate Powder b Halothane Liquid Mannitol Injection-Solution Morphine Sulfate Syringe-Needle c Naloxone HCl Injection-Solution Oxacillin Sodium Powder Potassium Iodide Tablets d Sodium Bicarbonate Injection-Solution Sodium Chloride Irrigation e Sodium Nitrite Injection-Solution Sodium Thiosulfate Injection-Solution Cefoperazone Sodium Powder 4 46 Assay Cephapirin Sodium Powder Potency Cimetidine HCl Injection-Solution c 7 42 Assay Dextrose (5%) Injection-Solution Assay; Appearance i Flurazepam HCl Capsules 3 35 Appearance Morphine Sulfate Autoinjector d 3 32 Degradant Ophthalmic Irrigating Solution 6 52 Low ph Pancuronium Bromide Injection-Solution Assay (1) Ringer s, Lactated and Dextrose Injection-Solution Assay k ; Assay, Appearance Sodium Chloride Injection-Solution e Assay; ph Sodium Polystyrene Sulfonate Powder 3 55 Water Content Sulfadiazine Silver Cream High ph & Assay Tetracycline HCl Capsules Dissolution ; Degradant Thiopental Sodium Powder Low ph ; Appearance 18 SLEP Participants Current Do D participants US Army US Air Force US Navy US Marines CDC/Strategic National Stockpile (SNS) since 2004 Dept.

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