Piroxicam BP

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Piroxicam is a monocarboxylic acid amide resulting from the formal condensation of the carboxy group of 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylic acid 1,1-dioxide with the exocyclic nitrogen of 2-aminopyridine. It is a commonly used nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class with anti-inflammatory, antipyretic and analgesic properties.

It was patented in 1968 by Pfizer and approved for medical use in 1979. It became generic in 1992 and is marketed worldwide under many brand names. Piroxicam works by preventing the production of endogenous prostaglandins which are involved in the mediation of pain, stiffness, tenderness and swelling. It is used in the treatment of inflammatory conditions like rheumatoid and osteoarthritis, and primary dysmenorrhoea. It also acts as an analgesic in postoperative pain.

Macsen Laboratories is the supplier of high-quality Piroxicam BP API.
PRODUCT SPECIFICATIONS
Name of Product Piroxicam BP
IUPAC Name 4-hydroxy-2-methyl-1,1-dioxo-N-pyridin-2-yl-1λ6,2-benzothiazine-3-carboxamide
Synonyms Feldene, Piroxicamum, Pyroxycam
CAS No 36322-90-4
Molecular Formula C15H13N3O4S
Molecular Weight 331.3

TECHNICAL SPECIFICATIONS

SR. No Criteria Limit/Specification
1 Appearance White or slightly yellow crystalline powder
2 Solubility Practically insoluble in water, soluble in methylene chloride, slightly soluble in anhydrous ethanol
3 Identification
IR spectrum

The sample spectrum should be concordant with working standards.
4 Related Substances
Impurity A
Impurity B
Impurity D
Impurity G
Impurity J
Unspecified Impurity
Total Impurities

-NMT 0.2 %
-NMT 0.2 %
-NMT 0.2 %
-NMT 0.2 %
-NMT 0.2 %
-NMT 0.10 %
-NMT 0.4 %
5 Loss on drying NMT 0.5%
6 Sulphated Ash NMT 0.I %
7 Assay (By Potentiometric Titration) NLT 98.5% and NMT 101.0 % (Calculated on dried basis)
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