檢驗(yàn)報(bào)告 Certificate of analysis
化工有限公司 chemical CO. , LTD
制藥(藥業(yè))有限公司 Pharmaceutical co. ,Ltd.
化工廠 CHEMICAL PLANT
精細(xì)化工有限公司 FINE CHEMICAL CO., LTD
品名 PRODUCT //title
批號(hào) batch NO.
生產(chǎn)日期 manufacturing date // manu. Date
檢驗(yàn)日期 Analysis date
有效期 Exp date // expiry date
檢驗(yàn)標(biāo)準(zhǔn) quality standard //inspecting basis //Specification
數(shù)量 QUANTITY
報(bào)告日期 report date
包裝規(guī)格 package
企業(yè)標(biāo)準(zhǔn)Company Standard//enterprise standard
檢查項(xiàng)目 test items//analytical items
性狀 appearance // characteristics//description//Character
分子式 molecular formula
分子量 molecular wt
化學(xué)式Chemical formula
鑒別 identification
溶液外觀 appearance of solution
澄清度&顏色clarity & color
白色或類白色結(jié)晶粉末white or almost white crystalline powder
味微苦 a little bitter taste
無(wú)色無(wú)味 odorless,smelless
酸堿度 acidity and alkalinity
鉛鹽Plumbum salts
砷鹽Arsonium salts
有關(guān)物質(zhì) related substances
分為:individual impurity substance NMT….;total impurity substance NMT。。。
干燥失重 loss on drying
熾灼殘?jiān)黵esidue on ignition
重金屬 heavy metals
溶劑殘留 solvent residue
有機(jī)揮發(fā)性物質(zhì) organic volatile impurities
溶解度 solubility
熔點(diǎn) melting point
旋光度 optical rotation
灰分 sulphated ash
水分 water content //moisture
粒度 particles size //MESH。樱桑冢
PH值PH Value
吸收系數(shù)absorption coefficient
氯化物 chloride
硫酸鹽sulphate
農(nóng)藥殘留 residue of pesticide
微生物限度細(xì)菌Microbial Limit bacteria
細(xì)菌總數(shù) total plate count
霉菌和酵母菌yeast & mold //Mildew&Microzyme
大腸桿菌。.coil //Esherichia coli
沙門(mén)氏菌 salmonella
含量 ASSAY
按歸一法計(jì)算 Calculated on the Normalization method
按干燥品計(jì)算 Calculated on the anhydrous substance
應(yīng)符合規(guī)定 complies with the CRS //meet the requirements
不少于 no less than
不多于 no more than //NMT
無(wú) negative
有 positive
歐洲藥典。牛酰颉。校琛
美國(guó)。眨樱小
中國(guó) CH. P ***。.P
80-100目。福埃保埃啊esh
澄清無(wú)色 clear and colorless
紫外燈 Ultraviolet ray lamp
溶于 soluble in ..
易溶于 freely soluble in..
微溶于 sparing soluble in ..
與對(duì)照品圖譜一致 Corresponding to Reference Spectrum
結(jié)果 results
符合規(guī)定 conforms // complies with // pass //meet the requirement
結(jié)論 CONCLUSION
符合英國(guó)藥典2000版。悖铮恚穑欤椋澹蟆ith BP 2000
化驗(yàn)員 Analyst 復(fù)核員。胔ecker
質(zhì)保經(jīng)理 QA manager // QA director