Example 7

TABLE 7
IngredientsQty/vial
Melphalan50mg
Povidone5mg
EDTA5mg
PG5ml
Water0.2ml
Ethanol4.8ml
0.1N NaOHQS

EDTA and povidone was dissolved in water and added to a manufacturing vessel containing a mixture of PG and ethanol. Melphalan and povidone were added to the above solution mixture. pH was adjusted to 7.5-9.0 using 0.1 N NaOH. Volume was made up using PG and ethanol. The obtained solution was filtered and filled in vials followed by capping and sealing. The formulation was tested for stability at 25° C./60% RH for a period of 22 days. Stability data is summarized in Table 7A.

Table 7A

TABLE 7A
Stability at Day 22Day 22
Purity92.79
Maximum Individual Impurity1.82
Total Impurities7.21

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