Pravastatin Sodium is a pharmaceutical active ingredient belonging to the statin class of medicines. It is the sodium salt of pravastatin and is primarily used in the development and manufacture of pharmaceutical formulations for cholesterol management. Pravastatin Sodium acts as an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoA reductase), an important enzyme involved in cholesterol biosynthesis.
Pravastatin Sodium is identified by CAS Number 81131-70-6, with the molecular formula C₂₃H₃₅NaO₇ and molecular weight 446.52 g/mol. The API is characterized by its controlled assay, related substances, water content, pH, heavy-metal content and optical rotation requirements.
Pravastatin Sodium API is used by pharmaceutical manufacturers for the production of statin-based medicines. The API is generally supplied as a white to almost white powder or crystalline solid and is soluble in water and methanol.
The USP-NF monograph specifies an assay of 97.5% to 102.0%, calculated on an anhydrous and solvent-free basis. Quality testing also includes identification, chromatographic purity, water content, heavy metals, pH and specific rotation.
Pravastatin Sodium should be manufactured and tested according to an established pharmaceutical-quality specification suitable for the intended regulatory market.
Pravastatin Sodium is the sodium salt form of pravastatin and belongs to the HMG-CoA reductase inhibitor class. Its chemical and physical properties make it suitable for incorporation into pharmaceutical dosage forms designed for oral administration.
Chemical Name: Pravastatin Sodium
CAS Number: 81131-70-6
Molecular Formula: C₂₃H₃₅NaO₇
Molecular Weight: 446.52 g/mol
Pharmaceutical Class: Statin
Mechanism Class: HMG-CoA Reductase Inhibitor
Physical Form: White to almost white powder/crystalline solid
Solubility: Soluble in water; soluble in methanol
Pravastatin Sodium inhibits HMG-CoA reductase, thereby reducing cholesterol biosynthesis and supporting the pharmacological management of elevated cholesterol levels.
Pravastatin Sodium API is used in pharmaceutical manufacturing for formulations intended for the management of cholesterol and cardiovascular risk.
Its major pharmaceutical applications include:
The API can be incorporated into appropriate pharmaceutical formulations following applicable formulation, quality and regulatory requirements.
Quality control is an important part of Pravastatin Sodium API manufacturing. Analytical testing helps confirm the identity, potency, purity and consistency of each batch.
Typical quality evaluation includes IR identification, chromatographic assay, related-substance analysis, water determination, heavy-metal testing, pH determination and specific-rotation testing.
USP quality requirements include an assay of 97.5–102.0%, water content of NMT 4.0%, heavy metals of NMT 20 ppm, and pH of 7.2–9.0 under the applicable test conditions. The USP related-substances procedure controls specified and unspecified impurities, with total impurities controlled at NMT 0.60%.
These analytical controls help maintain consistent API quality and support pharmaceutical manufacturing requirements.
A pharmaceutical-grade Pravastatin Sodium API manufacturing process requires controlled production conditions and comprehensive analytical testing. Manufacturing controls should cover raw-material quality, process parameters, impurity formation, water content and final API quality.
A reliable manufacturing program should use validated analytical methods and appropriate quality-control procedures to ensure batch-to-batch consistency. Pravastatin Sodium API can be manufactured and tested against applicable pharmacopoeial and customer-specific requirements for pharmaceutical applications.
Quality systems should support appropriate documentation, traceability and analytical evaluation throughout the manufacturing process.
Pravastatin Sodium API should be packed in suitable pharmaceutical-grade, tightly closed containers that protect the material from moisture and environmental exposure.
The API should be stored under controlled conditions according to validated stability data and the applicable product specification. Exposure to excessive heat, moisture and unsuitable storage conditions should be avoided.
Appropriate packaging and storage practices help maintain the chemical and physical quality of Pravastatin Sodium during transportation and storage.
Pharmaceutical customers may require comprehensive documentation for Pravastatin Sodium API, including:
Documentation should correspond to the actual manufacturing batch and applicable quality specification.
Pravastatin Sodium is an established statin API requiring consistent control of assay, related substances, water content, pH, elemental impurities and stereochemical characteristics. Appropriate analytical testing and controlled manufacturing processes are therefore essential for maintaining reliable API quality.
Pravastatin Sodium API manufactured under a robust pharmaceutical quality system can support the production of consistent statin formulations and pharmaceutical development programs. Controlled manufacturing, validated analytical testing and comprehensive documentation help provide the quality assurance expected for pharmaceutical API applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Assay (HPLC) | 97.5–102.0% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 7.2–9.0 |
| Total Impurities | NMT 0.60% |
| Water Content | NMT 4.0% |
| Specific Rotation | +150° to +160° |
| Melting Point | 171–173°C |