Catalog 1 Pinyin 2 English Reference 3 NAPROXEN SODIUM Pharmacopoeia Standard 3.1 Name 3.1.1 Chinese Name 3.1.2 Chinese Pinyin 3.1.3 English Name 3.2 Structural Formula 3.3 Molecular Formula and Molecular Weight 3.4 Source (Name), Content (Potency) 3.5 Properties 3.5.1 Specific Spin 3.6 Identification 3.7 Inspection 3.7.1 Relevant Substances 3.7.2 Free NAPROXEN 3.7. 3.7.4 Heavy Metals 3.8 Determination of Content 3.9 Category 3.10 Storage 3.11 Preparation 3.12 Version Attachment: * NAPROXEN SODIUM PHARMACOLOGICAL INSTRUCTIONAL NOTE 1 Pinyin

nài pǔ shēng nà

2 English Reference

Naproxen Sodium

3 NAPROXEN SODIUM PHARMACOLOGICAL STANDARDS 3.1 Name 3.1.1 Chinese Name

3.1.2 Chinese Pinyin

Naipushengna

3.1.3 English Name

Naproxen Sodium

3.2 Structural Formula 3.3 Molecular Formula and Molecular Weight

C14H13NaO3 252.25

3.4 Source (Name), Content (potency)

This product is (S)αmethyl6methoxy2naphthaleneacetic acid sodium. Calculated according to the dry product, containing C14H13NaO3 should be 98.0% to 102.0%.

3.5 Properties

This product is white or off-white crystalline powder; odorless; slightly moisture-inducing.

The product is soluble in water, soluble in methanol, slightly soluble in ethanol, very slightly soluble in acetone, almost insoluble in trichloromethane or toluene.

3.5.1 Specific rotation

Take 0.5g of this product, add 6ml of water, add 1mol/L hydrochloric acid solution 2.4ml dropwise, shake while dropping and adding, precipitate precipitation precipitation washed with water to neutral, 105 ℃, dry to constant weight, precision weighing, add trichloromethane to make a solution containing about 10mg per 1ml, according to the law to determine (2010 version of the Pharmacopoeia, Appendix VI, Part II, E). The specific rotation is from +63° to +69°.

3.6 Identification

(1) take about 0.25g of this product, add 10ml of water to dissolve, add a few drops of dilute hydrochloric acid, a white precipitate occurs, filtration, the filtrate shows the identification of sodium salts (2010 version of the Pharmacopoeia II Appendix III).

(2) take the precipitate under the identification (1), wash with water to neutral, dry at 105 ℃ for 1 hour, take about 30mg of fine powder, add methanol to make a solution containing 30μg per 1ml, according to the UV-visible spectrophotometry (2010 version of the Pharmacopoeia, Appendix Ⅳ A), at 262nm, 271nm, 317nm and 331nm wavelength. There was maximum absorption at 262nm, 271nm, 317nm and 331nm.

(3) Take the product, after drying at 105 ℃ for 3 hours, its infrared light absorption pattern should be consistent with the pattern of the control (Infrared Spectrum of Pharmaceuticals Collection, 433 charts).

3.7 Check 3.7.1 Related substances

Take this product, add methanol to make a solution containing 20mg per 1ml, as a test solution; take an appropriate amount of precision, quantitatively diluted with methanol into a solution containing 0.1mg per 1ml, as a control solution. According to the thin layer chromatography (2010 version of the Pharmacopoeia II Appendix V B) test, absorb the above two solutions each 10μl, respectively, point in the same silica gel GF254 thin layer plate, with toluene - tetrahydrofuran - glacial acetic acid (30:3:1) as the unfolding agent, unfolding, drying, and placed in the ultraviolet lamp (254nm) under the examination, the test solution if impurities show up, the test solution is not suitable for the test. If the test solution shows impurity spots, compared with the main spot of the control solution, it should not be darker.

3.7.2 Free naproxen

Take 5.0g of this product, precision weighing, placed in a dispensing funnel, add 25ml of water to dissolve, extracted with trichloromethane shaking 3 times, 15ml each time, combined trichloromethane solution, placed in a water bath and evaporated, the residue is dissolved in 75% neutral methanol (phenolphthalein indicator solution shows neutrality) 50 ml, add phenolphthalein indicator solution, 3 drops of titrant with sodium hydroxide (0.1 mol / L), titration, and then the residue is dissolved with 75% neutral methanol (phenolphthalein indicator solution) 50 ml, plus phenolphthalein indicator solution 3 drops, titrate with sodium hydroxide titrant (0.1 mol / L). titration with sodium hydroxide titrant (0.1 mol/L), the consumption of sodium hydroxide titrant (0.1 mol/L) shall not exceed 2.2 ml (1.0%).

3.7.3 Loss of weight on drying

Take the product, dry at 105 ℃ until constant weight, the loss of weight should not be more than 1.0% (2010 version of the Pharmacopoeia II Appendix VIII L).

3.7.4 Heavy metals

Take 1.0g of this product, placed in a dispensing funnel, add 20ml of water to dissolve, add 1 mol / L hydrochloric acid solution 5ml, extracted with dichloromethane 3 times (20ml, 20ml and 10ml), discarding the dichloromethane layer, the aqueous layer according to the law (2010 version of the Pharmacopoeia, Part II, Appendix VIII H, the first method), the content of heavy metals shall not exceed 20 parts per million.

3.8 Determination of content

Take about 0.2g of this product, weigh it precisely, add 30ml of glacial acetic acid to dissolve it, add 1 drop of crystal violet indicator solution, titrate with perchloric acid titrant (0.1 mol/L) until the solution shows blue-green color, and correct the result of the titration with a blank test. Each 1ml of perchloric acid titrant (0.1mol/L) is equivalent to 25.22mg of C14H13NaO3.

3.9 Category

Antipyretic, anti-inflammatory and analgesic.

3.10 Storage

Shielded from light, sealed, stored in a dry place.

3.11 Preparation

Naproxen Sodium Tablets

3.12 Version