Parecoxib Sodium 198470-85-8

Product Information

COA

ANALYSIS

SPECIFICATION

RESULTS

Appearance

White to almost white crystalline powder

Conform

Identification

A: The retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.

Conform

B: Comparing with the spectrum obstained with CRS

Conform

C: Reaction of sodium

Conform

Clarity and color solution

Meets the requirements

Conform

pH

7.5-9.0

8.3

Chlorides

≤ 0.02%

< 0.02%

Ammonium

≤ 0.02%

< 0.02%

Sulfate

≤ 0.02%

< 0.02%

Water

≤ 2.0%

0.4%

Heavy metals

≤ 0.002%

< 0.002%

Propionic acid

≤ 0.15%

Not detected

Related substance

Impurity I ≤ 0.15%

Not detected

Impurity II ≤ 0.15%

Not detected

Impurity III ≤ 0.15%

Not detected

Impurity IV ≤ 0.15%

Not detected

Impurity V ≤ 0.15%

Not detected

Impurity VI ≤ 0.15%

Not detected

Other single impurity ≤ 0.10%

Not detected

Total impurities ≤ 0.50%

Not detected

Residual solvent

Ethanol ≤ 5000ppm

45.3ppm

Acetone ≤ 5000ppm

317.5ppm

Dichloromethane ≤ 600ppm

Not detected

Ethyl acetate ≤ 5000ppm

59.6ppm

Triethylamine ≤ 320ppm

1.0ppm

Toluene ≤ 890ppm

7.7ppm

Endotoxin

≤ 2.9EU/mg

< 2.9EU/mg

Microbial limit

TAMC ≤ 100cfu/g

< 1cfu/g

TYMC ≤ 10cfu/g

< 10cfu/g

E.Coli: Not detected

Not detected

Assay

(anhydrous substance)

98.0%-102.0%

100.8%

Conclusion

The product meets the specification

Usage