Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) belonging to the oxicam class. It is used for its anti-inflammatory, analgesic and antipyretic properties and acts primarily by inhibiting cyclooxygenase-mediated prostaglandin synthesis.
Tenoxicam is a chemically synthesized small-molecule pharmaceutical API with the molecular formula C13H11N3O4S2 and molecular weight 337.4 g/mol. The European Pharmacopoeia identifies Tenoxicam under CAS 59804-37-4 and specifies a content of 99.0% to 101.0% on an anhydrous basis.
The API is described in the European Pharmacopoeia as a yellow crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride and very slightly soluble in anhydrous ethanol, while it dissolves in acidic and alkaline solutions. Tenoxicam also exhibits polymorphism, making solid-state characterization important during pharmaceutical manufacturing and quality control.
| Parameter | Value |
|---|---|
| Product Name | Tenoxicam |
| CAS No. | 59804-37-4 |
| Molecular Formula | C13H11N3O4S2 |
| Molecular Weight | 337.4 g/mol |
| API Class | Small-Molecule NSAID |
| Therapeutic Class | Non-Steroidal Anti-Inflammatory Drug |
| Pharmacological Class | Oxicam NSAID |
| Physical Form | Yellow crystalline powder |
| Storage | Protected from light |
The British Pharmacopoeia currently lists a Tenoxicam chemical reference standard under CAS 59804-37-4, while the European Pharmacopoeia monograph gives the molecular formula and molecular mass as C13H11N3O4S2 and 337.4, respectively.
Tenoxicam is an oxicam derivative characterized by a thienothiazine ring system containing sulfonamide functionality. Its chemical structure contributes to its anti-inflammatory and analgesic activity.
The API has a molecular weight of 337.4 g/mol and is supplied as a crystalline material. Because Tenoxicam shows polymorphism, control of its solid-state form can be important for consistent pharmaceutical quality. The European Pharmacopoeia specifically notes its polymorphic behavior.
Tenoxicam is practically insoluble in water. It is sparingly soluble in methylene chloride and very slightly soluble in anhydrous ethanol, while acidic and alkaline solutions can dissolve the compound.
Tenoxicam produces its pharmacological effects primarily through inhibition of cyclooxygenase (COX) enzymes involved in the synthesis of prostaglandins.
Reduced prostaglandin production decreases inflammatory signaling and contributes to the analgesic and anti-inflammatory effects of the drug.
As an oxicam NSAID, Tenoxicam is particularly associated with treatment of inflammatory and painful musculoskeletal conditions.
Tenoxicam API is used in the manufacture of pharmaceutical products intended for anti-inflammatory and analgesic therapy.
Its pharmaceutical applications include:
The specific indication, dosage and route of administration depend on the finished pharmaceutical product and applicable regulatory approval.
Tenoxicam has established pharmacopoeial analytical controls.
The European Pharmacopoeia identifies Tenoxicam using infrared absorption spectrophotometry with Tenoxicam CRS as the reference. Related substances are determined by liquid chromatography, with the test performed protected from light.
The current accessible BP/Ph. Eur. monograph information specifies:
The pharmacopoeial related-substance limits include 0.15% for each specified impurity A and B, 0.10% for each unspecified impurity, and 0.30% total impurities. The disregard limit is 0.05%.
Tenoxicam is a synthetic small-molecule API manufactured through controlled chemical synthesis followed by purification and crystallization.
A pharmaceutical-grade manufacturing process should control:
Because Tenoxicam exhibits polymorphism, appropriate solid-state characterization can be important when establishing consistent API quality.
According to the European Pharmacopoeia monograph, Tenoxicam is:
Tenoxicam API should be packaged in suitable pharmaceutical-grade containers that protect the material from contamination, moisture and excessive environmental exposure.
The European Pharmacopoeia specifically states that Tenoxicam should be protected from light.
For commercial pharmaceutical API, the exact container-closure system, retest period and storage temperature should follow the manufacturer's validated stability data and approved specification.
A pharmaceutical Tenoxicam API manufacturer should provide appropriate documentation such as:
Tenoxicam is an established oxicam-class NSAID requiring controlled chemical synthesis, impurity management and solid-state quality control.
A qualified Tenoxicam API manufacturing program should provide consistent assay, controlled related substances, appropriate water and inorganic impurity control, validated analytical methods and reliable batch-to-batch quality.
For pharmaceutical companies sourcing Tenoxicam API from India, compliance with applicable pharmacopoeial requirements and appropriate analytical documentation is important for pharmaceutical development and commercial manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.15% |
| Total Impurities | NMT 0.30% |
| Water Content | NMT 0.50% |