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Dexketoprofen trometamol

Dexketoprofen trometamol

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Package and Storage:

Packaging Details: Double polydthylene bags, vacuum and heat vealed, alumium foil outor bag, within a fibre bag
Delivery Detail: 7days

Specifications:
Dexketoprofen Trometamol is an non-steroidal anti-inflammatory drug used for the treatment of mild to moderate pain.

ITEMS SPECIFICATIONS RESULTS
Appearance White or Off-white Powder Off-white Powder
Identification
A. IR
B. HPLC
Corresponding to Reference Spectrum
Retention time of the sample conforms to that of the reference standard
Corresponding to Reference Spectrum
Retention time of the sample conforms to that of the reference standard
pH 5.5-7.0 6.8
Loss on drying ≤0.5% 0.11%
Sulphated Ash ≤0.1% 0.06%
Heavy Metals ≤10ppm <10ppm
Related Substances(HPLC)
Vep
Unidentified impurity
Total impurities

≤0.15%
≤0.10%
≤1.0%

≤RT(0.05%)
≤RT(0.05%)
≤RT(0.05%)
Assay by titration(on dry basis) 98.0%~102.0% 99.4%
Optical purity/HPLC
L-Ketoprofen Trometamol
≤3.0% 1.5%
Conclusion Conform with Enterprise specification

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