中英文Part1_原辅料包材检验报告书10mg(24版).doc

上海信谊延安药业有限公司 Shanghai Sine Yanan Pharmaceutical Co., Ltd. Page 58 of 58文件编号/ Doc No.：SMPKQA128 版本号/Version No:00外销异维A酸胶丸原辅料、包装材料质量标准及检验报告书(10mg)Specification & CoA for Raw Materials and Packaging Materials(Acnetane 10mg) 目 录/ INDEX序号No.名称Name类别Type全项检验页码Page(All Test)鉴别项检验页码Page(ID or other Test)1异维A酸/ Isotretinoin主药/ Active3-4332明胶/ Gelatin辅药/ Inactive5-6343纯化水/ Purified Water辅药/ Inactive7-8无N/A4大豆油/ Soybean Oil辅药/ Inactive9355甘油/ Glycerin辅药/ Inactive10366叔丁基对羟基茴香醚/ Butylated Hydroxyanisole辅药/ Inactive11377羟苯乙酯/ Ethylparaben辅药/ Inactive12388蜂蜡/ White Wax辅药/ Inactive13399依地酸二钠/ Edetate Disodium辅药/ Inactive144010二氧化钛 Titanium Dioxide辅药/ Inactive154111聚乙二醇400/ Polyethylene Glycol-400辅药/ Inactive164212亮蓝/ Brilliant Blue辅药/ Inactive174313苋菜红/ Amaranth辅药/ Inactive184414乙醇/Alcohol辅药/ Inactive19204515铝箔/ Aluminum Foil包装材料/Packaging Material2122无N/A16PVC包装材料/ Packaging Material23无N/A17聚酯/铝/聚乙烯药品包装用复合袋Pouches (PET/AL/PE) for Pharmaceutical Packaging包装材料/ Packaging Material24无N/A18说明书/ Patient Insert包装材料/ Packaging Material2526无N/A19单盒/ Carton包装材料 Packaging Material2728无N/A20POF热收缩膜 Films (POF) for shrink wrapping包装材料/ Packaging Material29无N/A21纸箱/ Shipper common包装材料/ Packaging Material3031无N/A22衬板Cardboard lining包装材料/ Packaging Material32无N/A上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name异维A酸Isotretinoin用途Using Dept.软胶丸车间Soft Gel Capsule Workshop 来 源Source上海医药集团有限公司Shanghai Pharmaceutical Group Co., Ltd.自编编号In-house No.取样件数Sampling Amount of pieces 取样数量Sampling Quantity 15g取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces. 厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/ USP24检验项目/ Item标准规定/ Specification检验结果/ Result【性状】Character本品为黄色结晶性粉末。Yellow crystal powder.【鉴别】ID(1) 红外光谱 IR(2) 紫外光谱 UV红外吸收图谱应与对照图谱一致The infrared absorption spectrum of the sample should be identical to that of the Reference Standard.在354nm的波长处有最大吸收，本品与对照品在354nm的波长处的紫外吸收差异不得大于3.0%Obtains maximum absorption at 354nm. The absorptions of the sample and the Standard Reference at 354 nm do not differ by more than 3.0%. 检验项目/ Item标准规定/ Specification检验结果/ Result【检查】Test维A酸/ Tretinoin Limits干燥失重/ Loss on Drying炽灼残渣Residual on Ignition重金属/ Heavy Metal1.0%0.5%0.1%0.002%【含量测定】Assay按干燥品计算，含C20H28O2应为98.0102.0%Contains not less than 98.0 percent and not more than 102.0 percent of the labeled amount of Isotretinoin (C20H28O2), calculated on the dried basis.结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials报告书编号/No.:品 名Material Name明胶Gelatin用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source广东罗赛洛明胶有限公司The Rousselot (China) Gelatin Co., Ltd自编编号In-house No.取样件数Sampling Amount of pieces取样数量Sampling Quantity取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces. 厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/ Item标准规定/ Specification检验结果/ Result【性状】Character本品为淡黄色固体Faintly yellow solid【鉴别】IDA化学反应Chemical reactionB化学反应Chemical reaction产生黄色沉淀A yellow precipitate is formed.产生混浊Turbidity is produced.检验项目/ Item标准规定/ Specification检验结果/ Result【检查】Test气味与水不溶物Odor and water-insoluble substance重金属/ Heavy Metal微生物限度检查无异味，铺成2cm厚度薄膜时只显淡乳色Free from any disagreeable odor；Viewed only in a layer 2 cm thick is only slightly opalescent.0.005%1000个/g；沙门氏菌、大肠杆菌不得检出Total Bacterial is not more than 1000 cfu per g; Salmonella and Escherichia coli is absence.结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name纯化水Purified Water用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity650ml取样规则Sampling Protocol500ml用于化学分析，150ml用于微生物检测500ml is used for chemical analysis and 150ml is used for microbial test.厂方批号Batch No.收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP23版/ USP23检验项目/ Item标准规定/ Specification检验结果/ Result【性状】Character应为无色澄清液体；无臭，无味No colour and clear liquid without odor【检查】TestPH氯化物Chloride硫酸盐Sulfate 钙盐Calcium氨AmmoniaCO25.07.0不得发生混浊 Not present turbidity不得发生混浊Not present turbidity不得发生混浊Not present turbidity0.3ppm不得发生混浊Not present turbidity检验项目/ Item标准规定/ Specification检验结果/ Result易氧化物 Oxide重金属 Heavy Metal不挥发物Non-volatile substance微生物限度Microbial Limits粉红色不得完全消失Pink not disappear0.3ppm0.001细菌、霉菌和酵母菌总数100个/ml沙门氏菌、大肠杆菌不得检出Total amount of bacterial, mold and microzyme is not more than 100 cfu per ml. Salmonella and Escherichia coli is absence.结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name大豆油Soybean Oil用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/ Item标准规定/ Specification检验结果/ Result【性状】Character折光率/Refractive Index相对密度/Specific Gravity1.4651.4750.916-0.922【检查】Test过氧化物（ml）/ Peroxide游离脂肪酸（ml）/ Free Fatty碘值/ Iodine Value重金属/ Heavy Metal10.0消耗的0.02mol/L的氢氧化钠2.5mlNot more than 2.5mL of 0.020mol/Lsodium hydroxide consumed120-1410.001%结论/Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manageror Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name甘油Glycerin用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of pieces取样数量Sampling Quantity取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/ Item标准规定/ Specification检验结果/ Result【性状】Character相对密度/Specific Gravity1.249【检查】Test氯化物/Chloride硫酸盐/Sulfate重金属/Heavy Metal炽灼残渣/Residual on Ignition脂肪酸与酯Fatty acid and esters0.001%0.002%5 g/g0.01%消耗的0.5N的盐酸1mlNot more than 1mL of 0.5N sodium hydroxide is consumed.结论/Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name叔丁基对羟基茴香醚Butylated Hydroxyanisole用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of pieces取样数量Sampling Quantity取样规则Sampling Protocol每批取1件Sample one piece for each batch.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/ Item标准规定/Specification检验结果/ Result【性状】Character本品为白色或微黄色的蜡状固体White or slightly yellow waxy solid【鉴别】ID化学反应Chemical Reaction溶液应呈现蓝色A blue colour is produced【检查】Test炽灼残渣/Residual on Ignition重金属/ Heavy Metal0.01%0.001%结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name羟苯乙酯Ethylparaben用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of pieces取样数量Sampling Quantity取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/Item标准规定/Specification检验结果/Result【性状】Character熔点/Melting Point 115-118oC【检查】Test酸度/Acidity干燥失重/Loss on drying 炽灼残渣/Residual on Ignition溶液应显黄色Appears yellow solution 0.50.05%结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name蜂蜡White Wax用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sample Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces. 厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/Item标准规定/Specification检验结果/Result【性状】Character本品为白色或类白色,块状或板状，薄时透明，具良好晶粒，无光泽，非结晶结构，握手中软并易弯。White or off-white block or plate solid, If it is thin, it is transparent, well crystal, lackluster, soft and easy to curve when holded by hands. 熔程/Melting Range62-65结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name依地酸二钠Edetate Disodium 用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol每批取1件Sample one piece for each batch.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/Item标准规定/Specification检验结果/Result【鉴别】ID化学反应Chemical Reaction溶液由红色变为微黄色The red color is discharged, leaving a yellowish solution.【检查】TestpH钙盐/Calcium重金属/Heavy Metal4.0-6.0不得产生沉淀No precipitate is formed0.005%结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name二氧化钛Titanium Dioxide用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1 Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/Item标准规定/Specification检验结果/Result【鉴别】ID化学反应Chemical Reaction立即生成黄红色至橙红色产物A yellow-red to orange-red color develops immediately.【检查】Test干燥失重/Loss on Drying炽灼残渣Residual on Ignition0.5%（105干燥3小时）Dry it at 105 oC for 3 hours: it loses not more than 0.5% of its weight.0.5%（80025炽灼至恒重）At 80025 oC to constant weight: it loses not more than 0.5% of its weight.结论/Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name聚乙二醇400Polyethylene Glycol-400用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol按批取样，n110，每件取样；n11100，取11件；n100，取+1Sample for each batch. If n is between 1 to 10, sample for each piece; if n is between 11 to 100, sample 11 pieces; if n is more than 100, sample +1 pieces.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据ReferenceUSP24版/USP24检验项目/Item标准规定/Specification检验结果/Result【检查】TestpH炽灼残渣Residual on Ignition重金属/Heavy Metal4.57.50.1%5ppm结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name亮蓝Brilliant Blue用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol每批取1件Sample one piece for each batch.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据Reference厂定标准In-house检验项目/Item标准规定/Specification检验结果/Result【性状】Character本品为蓝紫色粉末。Amethyst powder【鉴别】ID(1) 化学反应Chemical Reaction(2) 紫外光谱/UV应呈蓝色澄清溶液It is a blue clear solution最大吸收波长为6302nmSpectrophotometry, maximum absorbance is 6302nm.【检查】Test砷/Arsenic0.0001%结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name苋菜红Amaranth用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol每批取1件Sample one piece for each batch.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quantity报告日期Report Date年Y月M日D有效期至Expiry Date检验依据Reference厂定标准In-house检验项目/Item标准规定/Specification检验结果/Result【性状】Character本品为红褐色粉末。Brunneus powder【鉴别】ID紫外分光光谱/UV在5202nm的波长处应有最大吸收Obtains maximum absorbance at 5202nm.结论Conclusion检验者：Analyzed by:日期：Date:复核者：Checked by:日期：Date:检验负责人：QC Manager or Authorized person:日期：Date:放行者：Released by:日期：Date:上海信谊延安药业有限公司原辅料质量标准及检验报告书Specifications & CoA for Raw Materials 报告书编号/No.:品 名Material Name乙醇Alcohol用途Using Dept.软胶丸车间Soft Gel Capsule Workshop来 源Source自编编号In-house No.取样件数Sampling Amount of Pieces取样数量Sampling Quantity取样规则Sampling Protocol每批取一件Sample one piece each batch.厂方批号Batch No. of Supplier收样日期Receiving Sample Date年Y月M日D数 量Quan