Example 13
NLT 80% of batch volume ethanol was transferred into a manufacturing vessel.
Propylene glycol was added to a vessel containing ethanol. Melphalan was added to the above mixture. Check the pH of the sample and if required adjust the pH to 3.5-5.5 using 0.1N NaOH/0.1N HCL. Final batch volume was made up using ethanol. The obtained solution was filtered and filled in vials followed by capping and sealing. The formulation was tested for stability at 2-8° C. for a period of 1 Month. Stability data is summarized 13A.
Although the formulations, compositions, schemes and methods of the present disclosure have been described with reference to exemplary embodiments thereof, the present disclosure is not limited thereby. Indeed, the exemplary embodiments are implementations of the disclosed methods are provided for illustrative and non-limitative purposes. Changes, modifications, enhancements and/or refinements to the disclosed methods may be made without departing from the spirit or scope of the present disclosure. Accordingly, such changes, modifications, enhancements and/or refinements are encompassed within the scope of the present invention. All publications, patent applications, patents, figures and other references mentioned herein are expressly incorporated by reference in their entirety.
