Warfarin Sodium is the sodium salt of warfarin, a coumarin-derived anticoagulant and vitamin K antagonist used in pharmaceutical formulations for the prevention and treatment of thromboembolic disorders. It is an established cardiovascular active pharmaceutical ingredient with a well-defined mechanism involving inhibition of the vitamin K cycle and reduction in the synthesis of vitamin K-dependent coagulation factors.
Warfarin Sodium is used in oral anticoagulant medicines and is available in pharmaceutical formulations under different brand names and dosage strengths. The API is particularly important in the development and manufacture of medicines requiring controlled anticoagulant activity.
Warfarin Sodium has the molecular formula C19H15NaO4 and a molecular weight of approximately 330.3 g/mol. Its CAS Number is 129-06-6. PubChem identifies it as the sodium salt form of warfarin and describes its structure as sodium 2-oxo-3-(3-oxo-1-phenylbutyl)chromen-4-olate.
Warfarin Sodium is a synthetic coumarin derivative. The pharmaceutical substance may occur in different physical forms, including the crystalline clathrate form containing 2-propanol. The form of the API is therefore an important consideration when defining material identity, composition and quality specifications.
The active warfarin moiety contains one stereogenic center and clinically used warfarin is a racemic mixture of the R- and S-enantiomers. The two enantiomers have different pharmacological characteristics, but pharmaceutical Warfarin Sodium is generally supplied as the racemic sodium salt.
Warfarin Sodium produces its anticoagulant effect by interfering with the vitamin K cycle. It inhibits vitamin K epoxide reductase, reducing regeneration of the active form of vitamin K required for the synthesis of several coagulation proteins.
As a result, production of functional vitamin K-dependent coagulation factors is reduced. These include Factors II, VII, IX and X, as well as the anticoagulant regulatory proteins C and S.
Because newly synthesized coagulation factors are gradually cleared from circulation, the anticoagulant effect develops over time rather than immediately after administration. The pharmacological effect is monitored clinically using appropriate coagulation testing.
Warfarin Sodium API is relevant to pharmaceutical manufacturers and developers involved in oral anticoagulant formulations and cardiovascular pharmaceutical products.
As a Warfarin Sodium API manufacturer and supplier in India, the product can be positioned for pharmaceutical development and manufacturing applications requiring controlled-quality anticoagulant API material.
Quality control is particularly important for Warfarin Sodium because the substance is sensitive to environmental conditions. The International Pharmacopoeia notes that Warfarin Sodium can become discolored on exposure to light and can gradually degrade in humid conditions, with degradation increasing at higher temperatures.
Warfarin Sodium is an oral anticoagulant used for prevention and treatment of thromboembolic conditions. Its applications include prevention of thromboembolic complications associated with conditions such as atrial fibrillation and certain mechanical heart valve situations, as well as treatment and secondary prevention of venous thromboembolism.
The specific clinical indication, dose and duration of therapy depend on the patient's condition, treatment regimen and coagulation response.
For pharmaceutical manufacturing, Warfarin Sodium can be categorized as an anticoagulant API, cardiovascular API, coumarin API and vitamin K antagonist pharmaceutical ingredient.
Warfarin Sodium has a molecular weight of 330.3 g/mol and is generally described as a crystalline powder. PubChem identifies the substance as a slightly bitter crystalline powder and confirms its molecular formula and CAS Number.
The International Pharmacopoeia describes Warfarin Sodium as a substance that is sensitive to light and humidity. The pharmacopoeial monograph specifies that the substance should meet defined requirements for assay, clarity, water content and pH.
When Warfarin Sodium is acidified during the pharmacopoeial identification procedure, warfarin is precipitated and the resulting material has a melting temperature of approximately 162°C. This value refers to the precipitated warfarin rather than directly to the sodium salt and should therefore not be entered as the melting point of Warfarin Sodium itself.
Warfarin Sodium is substantially more water-compatible than the neutral warfarin form because it is supplied as a sodium salt. Pharmacopoeial procedures use aqueous solutions of Warfarin Sodium for identification, clarity and pH testing.
The British Pharmacopoeia/Ph. Eur. description of the clathrate form characterizes Warfarin Sodium as very soluble in water, freely soluble in ethanol and soluble in acetone.
Because solubility can depend on the exact physical form, clathrate state, temperature and test conditions, a single numerical mg/mL value should not be presented as a universal API specification unless it is supported by the applicable validated specification.
Quality control of Warfarin Sodium should include identity, assay, related substances, water content, pH and other applicable quality attributes.
The International Pharmacopoeia defines Warfarin Sodium as containing 98.0–102.0% of C19H15NaO4, calculated with reference to the anhydrous and 2-propanol-free substance.
The monograph also specifies that the pH of a 10 mg/mL aqueous solution should be 7.2–8.3 and that water content should be not more than 45 mg/g, equivalent to NMT 4.5%.
Identity testing includes infrared comparison after precipitation of the warfarin component and a characteristic identification test for sodium. These tests help confirm both the warfarin component and sodium counterion.
Warfarin Sodium is a defined synthetic pharmaceutical substance, and control of related substances is important for API quality. Chromatographic methods can be used to determine assay and monitor organic impurities and degradation products.
The presence of 2-propanol is particularly relevant for clathrate forms of Warfarin Sodium. The pharmacopoeial clathrate specification defines the relationship between warfarin sodium and propan-2-ol, so the physical form should be clearly identified in pharmaceutical documentation.
For a commercial API specification, assay, water, residual 2-propanol, related substances and other applicable parameters should be controlled according to the selected pharmacopoeial standard or registered product specification.
Warfarin Sodium is an established cardiovascular API with extensive pharmaceutical use. Its well-defined vitamin K antagonist mechanism makes it an important ingredient for oral anticoagulant formulations.
During pharmaceutical development, control of the API's chemical identity, salt form, assay, water content, residual solvent profile and degradation products is important. Protection from excessive humidity, heat and light is also relevant because the substance can degrade under unfavorable environmental conditions.
Warfarin Sodium can therefore be categorized as an oral anticoagulant API, vitamin K antagonist API, cardiovascular API, coumarin derivative API and pharmaceutical active ingredient.
Warfarin Sodium should be stored according to the applicable API specification and validated stability data. Protection from excessive humidity and light is particularly important because the International Pharmacopoeia identifies both factors as contributing to degradation or discoloration.
Appropriate moisture-protective packaging and controlled environmental conditions should therefore be used. Storage temperature and container-closure requirements should be established from stability studies and the applicable pharmaceutical specification.
Manufacturing facilities should also use suitable procedures for sampling, weighing and handling to prevent contamination and preserve API quality.
Warfarin Sodium remains an important pharmaceutical ingredient for oral anticoagulant products. Its established mechanism through inhibition of the vitamin K cycle and its long history in cardiovascular medicine make it a significant API for pharmaceutical manufacturing.
For pharmaceutical manufacturers and developers, accurate control of assay, salt form, water content, pH, related substances and residual 2-propanol is important for consistent API quality.
As a specialized pharmaceutical ingredient, Warfarin Sodium can be positioned for applications involving anticoagulant medicines, cardiovascular formulations, thromboembolic disease therapies and vitamin K antagonist products.
Warfarin Sodium is the sodium salt of warfarin and is an established vitamin K antagonist and oral anticoagulant API. It has the molecular formula C19H15NaO4, molecular weight 330.3 g/mol and CAS Number 129-06-6.
The International Pharmacopoeia specifies an assay range of 98.0–102.0%, a pH range of 7.2–8.3 for a 10 mg/mL aqueous solution and water content of NMT 4.5%.
Warfarin Sodium should be protected from excessive light and humidity during storage and handling. With its established use in oral anticoagulant formulations, it is an important cardiovascular API, anticoagulant API, coumarin API and pharmaceutical active ingredient.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| pH (1% Solution) | 7.2–8.3 |
| Water Content | NMT 4.5% |
| Melting Point | 162°C |