依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.873326713332073331313361783330983336570.43
29.823325723323863324790.04
单位质量响应值RSD%判断
33805.1733857.330.11数据可信
长期6月-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1121364-12136435.87352.6324.4335.8752.6324.43
2210480-21048062.21562.21
3180372-18037253.31553.32
4131542-13154238.88238.88
5230682-23068268.18668.19
6193822-19382257.29157.29
10min1210151-21015162.11782.2713.6462.2382.4313.65
2291305-29130586.10586.29
3267772-26777279.14979.31
4276784-27678481.81381.93
5313576-31357692.68892.89
6310410-31041091.75391.92
15min1245229-24522972.48688.709.8672.7889.109.88
2307850-30785090.99691.44
3289262-28926285.50185.90
4312339-31233992.32392.68
5323392-32339295.59096.07
6322354-32235495.28395.73
20min1263347-26334777.84190.627.7478.3591.297.77
2310005-31000591.63392.35
3297758-29775888.01388.67
4316996-31699693.69994.34
5328045-32804596.96597.73
6323336-32333695.57396.31
30min1277941-27794182.15591.385.5582.9092.325.61
2310771-31077191.85992.85
3302752-30275289.48990.41
4317113-31711393.73494.65
5323396-32339695.59196.65
6322842-32284295.42796.45
45min1287171-28717184.88391.924.3585.8793.144.42
2311601-31160192.10593.37
3304894-30489490.12291.31
4317010-31701093.70394.90
5323195-32319595.53296.88
6321986-32198695.17496.48
60min1290773-29077385.94892.113.8987.1993.603.97
2311759-31175992.15193.70
3305452-30545290.28791.74
4316949-31694993.68595.17
5323358-32335895.58097.21
6321393-32139394.99996.59
极限1332256-33225698.21099.100.9599.71100.871.05
2332878-33287898.394100.21
3334559-33455998.891100.62
4334031-33403198.735100.50
5340699-340699100.705102.63
6337223-33722399.678101.55
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.873323623341303346293324223326353332360.32
29.823330613331393331000.02
单位质量响应值RSD%判断
33762.5133920.570.34数据可信
长期6月-供试品溶液-2024012421批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1181595-18159553.66151.8814.3453.6651.8814.34
2203769-20376960.21360.21
3158565-15856546.85546.86
4167163-16716349.39649.40
5202265-20226559.76959.77
6140016-14001641.37441.37
10min1316905-31690593.64485.786.1293.8185.946.11
2291419-29141986.11386.29
3302976-30297689.52889.67
4287045-28704584.82184.97
5272519-27251980.52880.71
6270882-27088280.04580.17
15min1329547-32954797.38092.034.5097.8292.444.49
2312693-31269392.40092.84
3315994-31599493.37593.78
4314353-31435392.89093.29
5286566-28656684.67985.10
6309522-30952291.46391.83
20min1328748-32874897.14493.093.8997.8893.783.88
2318577-31857794.13894.85
3317391-31739193.78894.48
4315814-31581493.32294.00
5291885-29188586.25186.93
6317697-31769793.87894.52
30min1329424-32942497.34493.713.3898.3794.683.37
2320876-32087694.81895.82
3317838-31783893.92094.89
4317405-31740593.79294.75
5297160-29716087.81088.74
6320016-32001694.56495.48
45min1328976-32897697.21194.293.1398.5395.543.12
2322104-32210495.18196.46
3317570-31757093.84195.09
4323408-32340895.56696.81
5300144-30014488.69189.89
6322395-32239595.26796.47
60min1327865-32786596.88394.832.7798.4996.362.77
2322806-32280695.38896.96
3317063-31706393.69195.22
4328031-32803196.93298.46
5304778-30477890.06191.52
6325031-32503196.04597.54
极限1342693-342693101.26599.401.40103.16101.221.43
2341489-341489100.909102.76
3334009-33400998.698100.51
4334961-33496198.980100.80
5330627-33062797.69999.43
6334545-33454598.857100.63
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.873324123320613329973323583319243323500.13
29.823315643318173316900.06
单位质量响应值RSD%判断
33672.7533776.990.22数据可信
长期6月-供试品溶液-2024012521批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1185268-18526854.93545.6213.0754.9445.6213.08
2159664-15966447.34347.34
3136870-13687040.58440.58
4164094-16409448.65748.66
5130123-13012338.58438.58
6147198-14719843.64743.65
10min1307139-30713991.07288.138.1091.2488.278.10
2325731-32573196.58596.73
3284637-28463784.40084.52
4319631-31963194.77694.92
5264224-26422478.34778.46
6281977-28197783.61183.74
15min1334630-33463099.22497.802.7799.6698.202.79
2341348-341348101.216101.65
3331594-33159498.32498.70
4332909-33290998.71399.14
5315827-31582793.64894.00
6322699-32269995.68696.07
20min1340198-340198100.87599.511.73101.61100.211.75
2342180-342180101.462102.20
3339040-339040100.531101.20
4334409-33440999.15899.88
5328669-32866997.45698.09
6329165-32916597.60398.27
30min1340114-340114100.850100.421.27101.89101.421.28
2343576-343576101.876102.92
3342821-342821101.653102.62
4337932-337932100.203101.23
5333697-33369798.94799.87
6333936-33393699.01899.98
45min1339638-339638100.709100.681.06102.05101.981.08
2343385-343385101.820103.17
3343993-343993102.000103.28
4338854-338854100.476101.80
5335961-33596199.618100.84
6335477-33547799.475100.73
60min1339467-339467100.658100.591.00102.30102.191.02
2343387-343387101.820103.47
3342584-342584101.582103.16
4338631-338631100.410102.04
5334512-33451299.189100.71
6336876-33687699.890101.45
极限1340207-340207100.877100.901.12102.82102.801.13
2346880-346880102.856104.81
3342150-342150101.454103.34
4338067-338067100.243102.17
5336602-33660299.808101.63
6337859-337859100.181102.04
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