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PHR1165

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Naproxen sodium

Pharmaceutical Secondary Standard; Certified Reference Material

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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

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)

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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.

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Description
Pricing

PHR1040

Naproxen, Pharmaceutical Secondary Standard; Certified Reference Material

1457301

Naproxen, United States Pharmacopeia (USP) Reference Standard

N0250000

Naproxen, European Pharmacopoeia (EP) Reference Standard

Y0000399

Naproxen (racemic), European Pharmacopoeia (EP) Reference Standard

Y0000631

Naproxen impurity L, European Pharmacopoeia (EP) Reference Standard

1457403

Naproxen sodium, United States Pharmacopeia (USP) Reference Standard

1457312

Naproxen Related Compound A, United States Pharmacopeia (USP) Reference Standard

1457425

Naproxen Related Compound L, United States Pharmacopeia (USP) Reference Standard

08129

6-Methoxy-2-naphthol, pharmaceutical impurity standard

79584

2-Ethyl-6-methoxynaphthalene, pharmaceutical impurity standard

80713

(1RS)-1-(6-Methoxynaphthalen-2-yl)ethanol, pharmaceutical impurity standard

82170

(R)-Naproxen, pharmaceutical impurity standard

07506

(S)-Naproxen ethyl ester, pharmaceutical impurity standard

80822

(S)-Naproxen methyl ester, pharmaceutical impurity standard

80816

(2S)-2-(5-Chloro-6-methoxynaphthalen-2-yl)propanoic acid, pharmaceutical impurity standard

80821

(2S)-2-(5-Iodo-6-methoxynaphthalen-2-yl)propanoic acid, pharmaceutical impurity standard

80818

(2S)-2-(5-Bromo-6-methoxynaphthalen-2-yl)propanoic acid, pharmaceutical impurity standard

07503

2-Bromo-6-methoxynaphthalene, pharmaceutical impurity standard

07499

2-Methoxynaphthalene, pharmaceutical impurity standard

07547

6-Methoxy-2-naphthoic acid, pharmaceutical impurity standard

BP435

Naproxen, British Pharmacopoeia (BP) Reference Standard

1457436

Naproxen Related Compound G, United States Pharmacopeia (USP) Reference Standard

PHR2254

Naproxen 1,2,3 Propanetriol Esters, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2256

Naproxen 1,3-Butylene Glycol Esters, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2219

Naproxen 1,2 Propylene Glycol Esters, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2248

Naproxen 2,3-Butylene Glycol Ester, pharmaceutical secondary standard

PHR2257

Naproxen Isopropyl Ester, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2524

Naproxen Impurity N, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2525

Naproxen Impurity M, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2527

Naproxen Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2526

Naproxen Impurity H, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2520

Naproxen Impurity B, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2519

Naproxen Impurity C, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2518

Naproxen Related Compound G, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2523

Naproxen Related Compound L, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2530

rac-Naproxen, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2517

Naproxen Related Compound K, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2521

Naproxen Impurity A, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2522

Naproxen Impurity I, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2528

Naproxen Impurity F, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2529

Naproxen Impurity E, Pharmaceutical Secondary Standard; Certified Reference Material

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H302,H360

Hazard Classifications

Acute Tox. 4 Oral - Repr. 1A

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Simultaneous determination of naproxen sodium and acetaminophen in fixed-dose combinations formulations by first-order derivative spectroscopy: application to dissolution studies
Medina JR, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 7(3), 183-188 (2015)
Effects of preoperative ibuprofen and naproxen sodium on orthodontic pain
Polat O, et al.
The Angle Orthodontist, 75(5), 791-796 (2005)
Rapid simultaneous determination of sumatriptan succinate and naproxen sodium in combined tablets by validated ultra performance liquid chromatographic method
Reddy YR, et al.
Journal of Analytical and Bioanalytical Techniques , 2(3), 1-6 (2011)
Simultaneous Estimation of Sumatrirtan succinate and Naproxen Sodium in bulk drug and Pharmaceutical dosage form by RP-HPLC Method
Gondalia R and Dharamsi A
Journal of Drug Delivery and Therapeutics, 3(2), 1-6 (2013)
Naproxen sodium, diflunisal, and placebo in the treatment of chronic back pain.
Berry H, et al.
Annals of the Rheumatic Diseases, 41(2), 129-132 (1982)
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