Naproxen Sodium is the sodium salt of naproxen, a non-steroidal anti-inflammatory drug (NSAID) active pharmaceutical ingredient used for its analgesic, anti-inflammatory and antipyretic properties. It belongs to the arylpropionic acid derivative group of NSAIDs and is widely used in pharmaceutical formulations for the management of pain and inflammation.
Naproxen Sodium provides the pharmacological activity of naproxen and is used in pharmaceutical formulations where the sodium salt form is selected for its physicochemical and formulation characteristics.
Naproxen Sodium is a well-characterized NSAID pharmaceutical API used in the development and manufacture of medicines for pain and inflammatory conditions.
Important API quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, optical purity and other applicable pharmaceutical quality parameters.
CAS Number: 26159-34-2
Molecular Formula: C14H13NaO3
Molecular Weight: 252.24 g/mol
Chemical Name: Sodium 2-(6-methoxynaphthalen-2-yl)propanoate
Drug Class: Non-Steroidal Anti-Inflammatory Drug (NSAID)
Therapeutic Class: Analgesic / Anti-inflammatory
Therapeutic Area: Pain Management / Musculoskeletal Disorders
Molecule Type: Synthetic Small Molecule
Naproxen Sodium produces its pharmacological effects primarily through inhibition of cyclooxygenase (COX) enzymes, which are involved in the biosynthesis of prostaglandins.
Its pharmacological activity includes:
Naproxen is a non-selective cyclooxygenase inhibitor, and its pharmacological effects are associated with reduced prostaglandin production.
Naproxen Sodium API is relevant to:
Naproxen Sodium is used in pharmaceutical products for the temporary relief and management of mild-to-moderate pain and inflammatory conditions.
Naproxen-containing medicines are associated with conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dysmenorrhea and acute musculoskeletal pain, depending on the approved formulation and regulatory market.
The exact indications, dosage and administration requirements should be determined according to the applicable approved product information.
Naproxen Sodium is generally described as a white or almost white crystalline powder. The sodium salt has different physicochemical characteristics from naproxen free acid, including differences in aqueous solubility.
Physical appearance, particle size, polymorphic characteristics and other physical attributes should be controlled according to the applicable API specification and batch-specific Certificate of Analysis.
Naproxen Sodium contains a chiral center associated with the propionic acid side chain. Pharmaceutical naproxen is used in the S-enantiomeric form, which is pharmacologically active.
Therefore, enantiomeric purity/optical purity can be an important quality attribute for Naproxen Sodium API. The applicable specification should control the stereochemical identity and purity of the pharmaceutical substance.
A controlled Naproxen Sodium API manufacturing process may involve:
The actual commercial manufacturing process should be based on the manufacturer's validated process and regulatory documentation.
Typical Naproxen Sodium API testing may include:
Assay testing determines the content of Naproxen Sodium using a validated analytical method. Related-substance testing controls process-related impurities and degradation products.
Because Naproxen Sodium is a chiral API, control of the undesired enantiomer is particularly important when establishing a pharmaceutical-grade specification.
The final numerical acceptance criteria should be matched to the applicable current pharmacopoeial monograph or approved manufacturer specification.
Store Naproxen Sodium API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
Final storage conditions should be established from validated stability data and the applicable API specification.
Naproxen Sodium is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Melting Point | Approximately 250°C with decomposition |