药用包装袋的质量标准和方法,仅供参考.doc

- 物料名称/Name of the product: 聚乙烯袋POLYETHYLENE BAGS- 分子结构式/Structural formula: - 分子式/Molecular formula:( C2H4 ) n- 分子量/Molecular weight: 28 x n- 别名/Synonyms: 不适用N.A.1.- 质量标准SPECIFICATIONS1.1.- 性状Description透明或黑色薄膜。里外表面均应光滑平整、无油迹和灰色斑点。Transparent or black film. Both the internal and external surface must be flat, and it must be neither oily nor grayish.1.2.- 红外鉴别 IR identification: 与USP低密度聚乙烯标准光谱图一致。It shows the same bands as spectrum of the USP low density polyethylene standard.1.3.- DSC鉴别Identification by DSC: 样品的热谱图应与USP低密度聚乙烯标准类似。样品吸热（融化）温度与USP低密度聚乙烯标准之差应不超过8.0 C。The thermogram obtained with the sample is similar to that of the USP low density polyethylene standard and the endotherm (melting) temperature of the thermogram obtained with the sample does not differ by more than 8.0 C from that of the USP low density polyethylene standard. 1.4.- 重金属Heavy metals:不超过1ppm。Not more than 1 ppm.1.5.-不挥发残留物 Non-volatile residue: 不超过12.0mg。Not more than 12.0 mg.1.6.- 炽灼残渣Residue on ignition:不超过5mg。Not more than 5 mg.备注：若不挥发残留物少于5mg，无需检测炽灼残渣。Note: It needs not be determined if the non-volatile residue is lower than 5 mg.1.7.- 酸性和/或碱性Acidity and/or basicity:消耗的体积应不超过10mL。The volume used is not more than 10 mL.1.8.- 透光率Transmittance: 290与450nm间10%。 10% between 290 and 450 nm.备注: 仅用于黑色塑料袋 (4133-L, 4134-L).Note: For black bags only (4133-L, 4134-L).2.- 内控项目IN-HOUSE PARAMETERS2.1.- 厚度Thickness:名义值的 10%(透明袋400规格(0.1mm)，黑袋320 规格 (0.08mm) 10% of the nominal value (400 gauge (0.1mm) for transparent bags and 320 gauge (0.08mm) for black bags).2.2.- 热塑封Thermoseal:应连续完整，没有撕口。It must be continuous, intact and without loose points.2.3.- 气孔Pore:应无空气泄漏。There must be no air leak.3.- 程序PROCEDURES3.1.- 性状Description目视并触摸检查。Visual and tactile examination.3.2.- 红外鉴别Identification by IR从塑料袋剪一圆片，用甲醇清洗并晾干。记录光谱图，与USP低密度聚乙烯标准图谱比较。Cut a circular section of the bag, wash it with methanol, and allow to dry. Record and compare with the USP low density polyethylene standard spectrum.3.3.- DSC鉴别Identification by DSC: 剪取约12mg袋子塑料片。在40至200 C间，升温速度4C/min，氮气层下进行热谱图测试。然后以同样的速度降温至40 C。与USP低密度聚乙烯标准热谱图比较。报告获得的样品和标准的峰值并进行比较。Cut a section of the bag of about 12 mg. Carry out the thermogram under nitrogen blanket between 40 and 200C, and at a warming-up rate of 4C/min. Then cool down to 40C at the same speed. Compare with the reference USP low density polyethylene standard thermogram. Report peak value obtained by the sample and the standard and compare both values. 3.4.- 重金属Heavy metals: 量取不挥发残留物项下的水浸液20mL，根据SOPQ-017进行重金属限度测试。With 20 mL of the aqueous extract from the non-volatile residue, carry out the limit test for heavy metals according to SOPQ-017.3.5.- 不挥发残留物Non-volatile residue:剪取边长约24.5cm的正方形塑料样品(600 cm2/面, 两面1200 cm2)，再剪成条状（约35cm），放入500mL锥形瓶中，加250mL水洗，搅拌30秒。倒出洗液，再重复洗两次。最后加入200mL水提取，于70保温24小时。取50mL水浸液，同时取50mL水作空白试验，减压蒸馏至干，再在1052干燥至恒重，在干燥器中冷却。计算水浸液与水空白对照的差值即得。Cut a plastic square of 24.5 cm per side (600 cm2/side, 1200 cm2 of surface). Cut the square into strips of about 3 x 5 mm with a cutter. Place the strips into a 500-mL conical flask, wash with 250 mL of water and stir for 30 sec. Decant the cleaning water and repeat twice. Finally, add 200 mL of water for the extraction. Keep at 70C for 24 h.Determine the residue with 50 mL extract. At the same time, perform a blank determination of the extraction water (50mL). Evaporate at reduced pressure almost to dryness, and evaporate to dryness in an oven at 105C until constant weight. Cool in a desiccator. Determine the residue by difference between the extract and the corresponding blank of water.3.6.- 炽灼残渣Residue on ignition:备注：若不挥发残留物超过5mg。Note: If the non-volatile residue is higher than 5 mg only.加1ml硫酸于获得的残渣，转移到事先去皮的石英坩埚中。用1 mL硫酸润洗瓶子两次并转移到坩埚中。缓缓加热至硫酸挥发，然后用本生灯煅烧，然后放入600 C马弗炉。同法对水的空白进行测试。称重，计算不挥发残渣物与水空白对照的残留间差值即得。Add 1 mL of sulfuric acid to the residue obtained, and transfer to a quartz crucible, previously tared. Wash the flask twice with 1 mL of sulfuric acid, and transfer to the crucible. Heat mildly until the sulfuric acid evaporates, finish calcinating in the Bunsen burner, and place it in the muffle at 600C. Proceed in the same way with the blank of water. Weigh, determine the residue by difference between the non-volatile residue and the corresponding blank of water.3.7.- 酸性和/或碱性Acidity and/or basicity:根据样品的pH值(用甲基红指示剂来反映pH值)，用0.01N氢氧化钠或0.01N盐酸中和20ml水浸液。计算使用的体积。Neutralize 20mL of aqueous extract with either 0.01N sodium hydroxide or 0.01N hydrochloric acid, depending on the samples pH (using methyl red indicator to know the pH). Measure the mL used. 3.8.- 透光率Transmittance: 剪取三个袋子不同部分的圆片，用去离子水清洗，用纸吸干避免摩擦表面。放置于线偏振光束中，测量290nm至450nm间的透光率。每20nm读取结果。Cut three circular sections of different parts of the bag. Wash them with deionized water, and dry with paper without grating the surface. Measure the transmittance between 290 and 450 nm, placing them under a light beam. Read every 20 nm.3.9.- 厚度Thickness: 报告从不同包装中取的三个袋子的平均值。Report the average of three bags from different boxes. 把袋子折叠成16层，根据图1和图2用游标卡尺测量其总厚度然后用如下公式计算：Fold the bag to sixteen layers, measure the total thickness with a slide gauge according to the Fig 1 and 2. Fig 1. 用游标卡尺测量折叠成16层塑料袋Bag folded in 16 layers measured using slide gaugeFig 2. 用游标卡尺测量Measure with Slide gauge对齐的数值是6。所以读数是6（120.05mm=0.6mm）Number coincident with the scale is the 6. Then, lecture is 6 (12 lines0.05 mm = 0,6 mm)0位于1和2mm间，读数是1mmZero is between 1 and 2 mm. Lecture is 1 mmCalculate the thickness by the following formula：薄膜厚度Thickness of film(gauge)= 3.10.- 热塑封Thermoseal: 从不同的包装中