药用包装袋的质量标准和方法,仅供参考

1、一 物料名称/name of the product:聚乙烯袋polyethylene bags-分子结构式/structural formula:(ch2ch2)n- 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 specifications11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 mu

2、st be flat, and it must be neither oily nor grayish.12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 standard1.3. - 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 °cothe thermogram obtained with

3、 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lppmonot more than

4、1 ppm.15不挥发残留物 nonvolatile residue:不超过12.0mgonot more than 12.0 mg.1.6. -炽灼残渣 residue on ignition:不超过5mgonot 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 mg1.7. -酸性和/或碱性 acidity and/or basicity:消耗的体积应不超过lomlothe volume used is n

5、ot 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 parameters21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

6、mm) for transparent bags and 320 gauge (0.08mm) for black bags).22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procedures31性状descriptionfl视并触摸检查。visual and tactile examination.32红外鉴别identification by ir从塑料袋剪一圆片，用甲醇清洗

7、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.33 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4°c/min,氮气层下进行热谱图测试。 然后以同样的速度降温至40°co与usp低密度聚

8、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 200°c，and at a warming-up rate of 4°c/min. then cool down to 40°c at the same speed. compare with the reference usp low density polyethylene standard t

9、hermogram. 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 no

10、n-volatile residue:剪取边长约24.5cm的正方形塑料样品(600 cm2/®,两面1200 cm2),再剪成条状(约3x 5cm),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°c保温24小时。取50ml水浸液，同时取50ml水作空白试验，减压蒸憾至干，再在105±2°c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 cnr/side, 1200 cm of s

11、urface). cut the square into strips of about 3x5 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 70°c for 24 h.determine the residue

12、 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 105°c until constant weight. cool in a desiccator. determine the residue by difference between the extract

13、 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lml硫酸于获得的残渣，转移到事先去皮的石英圮烟中。用1 ml硫酸润洗瓶子两次并转移 到圮埸屮。缓缓加热至硫酸挥发，然后用本生灯锻烧，然后放入600七马弗炉。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 resi

14、due 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 600°c. proceed in the same way

15、 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 0.0in sodium hy

16、droxide or 0.0in hydrochloric acid, depending on the sample's 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

17、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：

18、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 gauge0位于1和2mm间，读数是1mmzero is between 1 and 2 mm. lecture is 1 mm对齐的数值是6。所以读数是6 (12±x0.05mm 二 06mm)number coincident with the scale is the 6. then, lecture is 6 (12 lines x ().05 mm = (),6 mm)calculate the thickness by the following foimula：薄膜厚度thickness of film(gauge)=血。皿伽伽心4x1000163.10. -热塑封 thermoseal: