Sodium Ascorbate → Mannitol

Participants

Reaction Steps

A formulation with 1.5% of the freeze-dried NOE powder from Example 1, 0.05% sodium ascorbate and 0.02% ascorbic acid as antioxidants, 0.1% methylparaben sodium and 0.01% propylparaben sodium as preservatives (Table 5) was prepared under aseptic conditions following the method given in Example 2A. A 2000 mL glass cylinder was weighed and tarred, and the following ingredients (Table 5) except water were weighed and added directly into the glass cylinder. Type I water was added to the mixture and the volume of the mixture was adjusted to 1000 mL. The pH of the solution was approximately 6.49. The freeze-dried powder in 10 mL vials with the ingredients in Table 5 was reconstituted with 10 mL sterile water forming a clear solution within a minute.

Provenance & Evidence