PHR1165

Naproxen sodium

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): (S)-6-Methoxy-α-methyl-2-naphthaleneacetic acid sodium salt
• Empirical Formula (Hill Notation): C₁₄H₁₃NaO₃
• CAS Number: 26159-34-2
• Molecular Weight: 252.24
• EC Number: 247-486-2
• MDL number: MFCD00058507
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823182
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1457403
• API family: naproxen
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: [Na+].COc1ccc2cc(ccc2c1)[C@H](C)C([O-])=O
• InChI: 1S/C14H14O3.Na/c1-9(14(15)16)10-3-4-12-8-13(17-2)6-5-11(12)7-10;/h3-9H,1-2H3,(H,15,16);/q;+1/p-1/t9-;/m0./s1
• InChI key: CDBRNDSHEYLDJV-FVGYRXGTSA-M
• Gene Information: human ... PTGS1(5742) , PTGS2(5743)

Description

General description

Naproxen sodium (NS) is a sodium salt of propionic acid derivative and demonstrates analgesic, anti-pyretic, and anti-inflammatory properties. It exhibits efficiency in being used as an indomethacin in the treatment of acute musculoskeletal disorders. It belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDS) and acts by inhibiting the activity of both the cyclooxygenase enzymes, COX-1 & COX-2 and further blocking the synthesis of certain prostaglandins. It is administered in the treatment of ankylosing spondylitis, osteoarthritis, rheumatoid disorders, acute gout, mild to moderate pain, tendonitis, bursitis, dysmenorrhea, fever, and migraine headache. Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Naproxen sodium may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and combined dosage forms by chromatographic and spectrophotometric techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Cyclooxygenase (Prostaglandin H synthase 1 and 2) inhibitor.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Values of analytes vary lot to lot.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA7178 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Statements: H302,H360
• Precautionary Statements: P202 - P264 - P280 - P301 + P312 - P308 + P313 - P405
• Hazard Classifications: Acute Tox. 4 Oral - Repr. 1A
• Storage Class Code: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable