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 Inj

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 Inj
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.

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 Inj
盐酸Caution-Gemcitabine是一种强有力的细胞毒性的代理. 伟大的应注意防止吸入粒子和裸露的皮肤.
包装与贮存:保存在容器下固体如前所述,无菌注射
不要放入切入后.
识别——
答:紫外吸收a197Un.
方法:16µg每毫升.
中等:0.14 Mphosphate缓冲与pHof 2.5,准备如下. 增加13.8克的一代磷酸盐和2.5 mLof钠磷酸1000 mLof纯水.
乙:保留时间的主要顶峰的preparationcorresponds色谱测定的色谱标准的准备,得出在检测.
清晰的解决方案:溶解在溶剂和集中推荐标签:不要超过10吨(见分光光度法、光散射,由turbidimetry 15分钟内的比例为稀释剂,纠正了切入空白.
——它包含细菌内毒素不超过0.05毫克单位/ USP内毒素吉西他滨.
不育-它符合要求的测试时,对膜过滤指示下的产品测试不育进行检查.
统一的用量变化符合要求在减肥.
微粒要求:满足了对台小额注射.
纯度-色谱
流动相,系统适应性的标准溶液,解决方案,进行色谱系统——直接在测试色谱purityfor盐酸吉西他滨.
望采纳!