Menadiol Sodium Phosphate is a water-soluble synthetic vitamin K analogue used as a pharmaceutical source of vitamin K activity. It is the sodium phosphate derivative of menadiol and was developed to provide a more water-soluble form of the vitamin K-related compound.
Vitamin K-related compounds play an important role in the hepatic synthesis of several coagulation factors, including factors II, VII, IX and X. Menadiol Sodium Phosphate has therefore been used in pharmaceutical preparations associated with vitamin K deficiency and coagulation disorders.
Menadiol Sodium Phosphate is a phosphorylated derivative of menadiol. It is designed to have improved water solubility compared with poorly water-soluble vitamin K-related compounds.
The compound is commonly associated with the molecular formula C11H11Na2O5P and a molecular weight of approximately 300.16 g/mol for the anhydrous disodium salt.
Menadiol Sodium Phosphate provides vitamin K-related activity after conversion to active vitamin K forms in the body. Vitamin K is required as a cofactor for gamma-carboxylation of specific glutamate residues on coagulation proteins.
This process enables the normal biological activity of several vitamin K-dependent coagulation factors, helping support normal blood coagulation.
Menadiol Sodium Phosphate has been used in pharmaceutical preparations as a vitamin K-related agent, particularly in situations associated with vitamin K deficiency and impaired coagulation.
Its historical pharmaceutical applications include:
Use and regulatory status can vary by country and formulation.
Menadiol Sodium Phosphate API can be evaluated using validated analytical methods for identification, assay, related substances, water content, inorganic phosphate, residual solvents, elemental impurities and other applicable quality attributes.
HPLC, infrared spectroscopy and other validated analytical techniques may be used for identity, assay and impurity determination.
Final acceptance criteria should follow the applicable manufacturer's approved drug-substance specification and Certificate of Analysis.
Menadiol Sodium Phosphate should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. The material should be protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Menadiol Sodium Phosphate API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Menadiol Sodium Phosphate API is available for qualified pharmaceutical development and manufacturing requirements. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 7.0 – 9.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 5.0% |