问题描述：
英语翻译
Caution—Gemcitabine Hydrochloride is a potent cytotoxic agent.Great care should be taken to prevent inhaling particles and exposing the skin to it.
Packaging and storage— Preserve in Containers for Sterile Solids,as described under Injections
Do not refrigerate after reconstitution.
Identification—
A:Ultraviolet Absorption 197U.
Solution:16µg per mL.
Medium:0.14Mphosphate buffer with a pHof 2.5,prepared as follows.Add 13.8g of monobasic sodium phosphate and 2.5mLof phosphoric acid to 1000mLof purified water.
B:The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Clarity of solution— Dissolve it in the solvent and at the concentration recommended in the labeling:not more than 10(see Spectrophotometry and Light-Scattering ,determined by ratio turbidimetry within 15minutes of reconstitution,corrected for a diluent blank.
Bacterial endotoxins — It contains not more than 0.05USP Endotoxin Unit per mg of gemcitabine.
Sterility — It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product To Be Examined.
Uniformity of dosage meets the requirements for Weight Variation.
Particulate matter :meets the requirements for small-volume injections.
Chromatographic purity—
Mobile phase,System suitability solution,Standard solution,and Chromatographic system— Proceed as directed in the test for Chromatographic purityfor Gemcitabine Hydrochloride.
Caution—Gemcitabine Hydrochloride is a potent cytotoxic agent.Great care should be taken to prevent inhaling particles and exposing the skin to it.
Packaging and storage— Preserve in Containers for Sterile Solids,as described under Injections
Do not refrigerate after reconstitution.
Identification—
A:Ultraviolet Absorption 197U.
Solution:16µg per mL.
Medium:0.14Mphosphate buffer with a pHof 2.5,prepared as follows.Add 13.8g of monobasic sodium phosphate and 2.5mLof phosphoric acid to 1000mLof purified water.
B:The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Clarity of solution— Dissolve it in the solvent and at the concentration recommended in the labeling:not more than 10(see Spectrophotometry and Light-Scattering ,determined by ratio turbidimetry within 15minutes of reconstitution,corrected for a diluent blank.
Bacterial endotoxins — It contains not more than 0.05USP Endotoxin Unit per mg of gemcitabine.
Sterility — It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product To Be Examined.
Uniformity of dosage meets the requirements for Weight Variation.
Particulate matter :meets the requirements for small-volume injections.
Chromatographic purity—
Mobile phase,System suitability solution,Standard solution,and Chromatographic system— Proceed as directed in the test for Chromatographic purityfor Gemcitabine Hydrochloride.
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