Formulation and Stability of Melphalan Injection

Example 5

TABLE 5

IngredientsQty/vial

Melphalan50mg

Povidone5mg

EDTA5mg

PEG5ml

Water0.2ml

Ethanol4.8ml

0.1N HClQS

EDTA was dissolved in water and added to a manufacturing vessel containing a mixture of PEG and ethanol. Melphalan and povidone were added to the above solution mixture. pH was adjusted to 3.5-5.5 using 0.1N HCl. Volume was made up using mixture of PEG 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 5A.

TABLE 5A

Stability at Day 22Day 22

Purity92.04

Maximum Individual Impurity1.76

Total Impurities7.96

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US11857677B2. Ready to use injectable formulations of melphalan and processes for preparation thereof (2024-01-02). RK Pharma Solutions LLC [US]. Inventors: Ravishanker Kovi [US], Jayaraman Kannappan [IN], Thupalli Ajeykumar Reddy [IN], Vamshi Yekkanti [IN], Raghu Kasu [US].

Patent 2024

Edta Ethanol Melphalan Povidone Vessel

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Variable analysis

independent variables

Melphalan concentration
Povidone concentration
EDTA concentration
PEG concentration
Ethanol concentration
PH adjustment using 0.1N HCl

dependent variables

Purity
Maximum Individual Impurity
Total Impurities

control variables

Temperature (25°C)
Relative Humidity (60% RH)
Storage duration (22 days)

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