Example 1

TABLE 1
Composition of liquid, ready-to-use
parenteral formulations of carmustine
CompositionFormulation 1
Carmustine100 mg
Polysorbate 80 NFq.s to 1 mL
  • (a) 100 mg of carmustine was dissolved in sufficient quantity (q.s. to 1 mL) of polysorbate 80 NF surfactant, under inert (nitrogen) gas purging.
  • (b) The solution obtained in step (a) was aseptically filtered (sterile 0.22 micron filter) under inert (nitrogen) gas purging to obtain a sterile product.
  • (c) The solution obtained in step (b) was filled into a sterile amber coloured type-I glass vial.

The stability of the formulation was tested after 3 months of storage at 2-8° C. The results are provided in Table 2 below.

TABLE 2
Evaluation of liquid ready-to-use parenteral
formulations of carmustine
Stability data
3 months
TestInitial(2° C.-8° C.)
DescriptionClear pale yellowClear pale yellow
color solutioncolor solution
Assay101.50% 97.21% 
Related substances
Impurity A*0.20%1.80%
Any unspecified impurityBLD**BLD**
Total impurities0.20%1.80%
*Impurity A refers to 1,3-bis(2-chloroethyl)urea
*BLD: below limit of detection

Free full text: Click here