Vitamin K being a fat-soluble vitamin has two forms available naturally. Vitamin K is involved in the production of different proteins that are needed for blood clotting and the building of bones. Common indications of vitamin K include hemorrhagic disease of newborn, malabsorption syndrome, cystic fibrosis, biliary atresia, antidote to warfarin and hepatic failure. The problems associated with Vitamin K deficiency can significantly contribute to bleeding, poor bone development, osteoporosis, and increased risk of cardiovascular disease. Only 2 mg of Vitamin K injection is available in Pakistan, and if adults experience internal bleeding, other hemorrhagic diseases, or other vitamin K deficiency-related conditions, 5 injections of the typical 2 mg neonate dose are required to be given. Therefore, the primary goal of this study was to reduce the cost of injections and introduce the adult dose (10 mg) of injections, which had previously only been available internationally. Following many trials, an optimized adult dosage was created. A six-month stability study was performed using different instruments including HPLC, UV, FTIR etc. Different parameters like pH, assay, physical appearance, sterility and others are checked and verified according to British Pharmacopeia.

Keywords: Vitamin K, Injection, Formulation, Accelerated Stability