藥用包裝袋的質(zhì)量標準和方法,僅供參考.doc

- 物料名稱/Name of the product: 聚乙烯袋POLYETHYLENE BAGS- 分子結(jié)構(gòu)式/Structural formula: - 分子式/Molecular formula:( C2H4 ) n- 分子量/Molecular weight: 28 x n- 別名/Synonyms: 不適用N.A.1.- 質(zhì)量標準SPECIFICATIONS1.1.- 性狀Description透明或黑色薄膜。里外表面均應(yīng)光滑平整、無油跡和灰色斑點。Transparent or black film. Both the internal and external surface must be flat, and it must be neither oily nor grayish.1.2.- 紅外鑒別 IR identification: 與USP低密度聚乙烯標準光譜圖一致。It shows the same bands as spectrum of the USP low density polyethylene standard.1.3.- DSC鑒別Identification by DSC: 樣品的熱譜圖應(yīng)與USP低密度聚乙烯標準類似。樣品吸熱（融化）溫度與USP低密度聚乙烯標準之差應(yīng)不超過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.- 重金屬Heavy metals:不超過1ppm。Not more than 1 ppm.1.5.-不揮發(fā)殘留物 Non-volatile residue: 不超過12.0mg。Not more than 12.0 mg.1.6.- 熾灼殘渣Residue on ignition:不超過5mg。Not more than 5 mg.備注：若不揮發(fā)殘留物少于5mg，無需檢測熾灼殘渣。Note: It needs not be determined if the non-volatile residue is lower than 5 mg.1.7.- 酸性和/或堿性Acidity and/or basicity:消耗的體積應(yīng)不超過10mL。The volume used is not more than 10 mL.1.8.- 透光率Transmittance: 290與450nm間10%。 10% between 290 and 450 nm.備注: 僅用于黑色塑料袋 (4133-L, 4134-L).Note: For black bags only (4133-L, 4134-L).2.- 內(nèi)控項目IN-HOUSE PARAMETERS2.1.- 厚度Thickness:名義值的 10%(透明袋400規(guī)格(0.1mm)，黑袋320 規(guī)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.- 熱塑封Thermoseal:應(yīng)連續(xù)完整，沒有撕口。It must be continuous, intact and without loose points.2.3.- 氣孔Pore:應(yīng)無空氣泄漏。There must be no air leak.3.- 程序PROCEDURES3.1.- 性狀Description目視并觸摸檢查。Visual and tactile examination.3.2.- 紅外鑒別Identification by IR從塑料袋剪一圓片，用甲醇清洗并晾干。記錄光譜圖，與USP低密度聚乙烯標準圖譜比較。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鑒別Identification by DSC: 剪取約12mg袋子塑料片。在40至200 C間，升溫速度4C/min，氮氣層下進行熱譜圖測試。然后以同樣的速度降溫至40 C。與USP低密度聚乙烯標準熱譜圖比較。報告獲得的樣品和標準的峰值并進行比較。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.- 重金屬Heavy metals: 量取不揮發(fā)殘留物項下的水浸液20mL，根據(jù)SOPQ-017進行重金屬限度測試。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.- 不揮發(fā)殘留物Non-volatile residue:剪取邊長約24.5cm的正方形塑料樣品(600 cm2/面, 兩面1200 cm2)，再剪成條狀（約35cm），放入500mL錐形瓶中，加250mL水洗，攪拌30秒。倒出洗液，再重復(fù)洗兩次。最后加入200mL水提取，于70保溫24小時。取50mL水浸液，同時取50mL水作空白試驗，減壓蒸餾至干，再在1052干燥至恒重，在干燥器中冷卻。計算水浸液與水空白對照的差值即得。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.- 熾灼殘渣Residue on ignition:備注：若不揮發(fā)殘留物超過5mg。Note: If the non-volatile residue is higher than 5 mg only.加1ml硫酸于獲得的殘渣，轉(zhuǎn)移到事先去皮的石英坩堝中。用1 mL硫酸潤洗瓶子兩次并轉(zhuǎn)移到坩堝中。緩緩加熱至硫酸揮發(fā)，然后用本生燈煅燒，然后放入600 C馬弗爐。同法對水的空白進行測試。稱重，計算不揮發(fā)殘渣物與水空白對照的殘留間差值即得。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/或堿性Acidity and/or basicity:根據(jù)樣品的pH值(用甲基紅指示劑來反映pH值)，用0.01N氫氧化鈉或0.01N鹽酸中和20ml水浸液。計算使用的體積。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: 剪取三個袋子不同部分的圓片，用去離子水清洗，用紙吸干避免摩擦表面。放置于線偏振光束中，測量290nm至450nm間的透光率。每20nm讀取結(jié)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: 報告從不同包裝中取的三個袋子的平均值。Report the average of three bags from different boxes. 把袋子折疊成16層，根據(jù)圖1和圖2用游標卡尺測量其總厚度然后用如下公式計算：Fold the bag to sixteen layers, measure the total thickness with a slide gauge according to the Fig 1 and 2. Fig 1. 用游標卡尺測量折疊成16層塑料袋Bag folded in 16 layers measured using slide gaugeFig 2. 用游標卡尺測量Measure with Slide gauge對齊的數(shù)值是6。所以讀數(shù)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間，讀數(shù)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.- 熱塑封Thermoseal: 從不同的包裝中