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%
110.153387163382033402633402323377513390330.35
210.113438233453483445860.32
单位质量响应值RSD%判断
33402.2734083.681.43数据可信
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%
5min1109987-10998732.59948.2518.8332.6048.2618.83
2179968-17996853.34053.34
3144506-14450642.83042.83
4166626-16662649.38649.39
5189810-18981056.25756.26
6185954-18595455.11555.11
10min1226263-22626367.06278.3111.6567.1678.4611.66
2279006-27900682.69482.85
3236479-23647970.09070.22
4257562-25756276.33876.49
5275629-27562981.69381.86
6310351-31035191.98492.15
15min1262491-26249177.79986.376.9078.1086.756.93
2300040-30004088.92889.34
3276596-27659681.98082.32
4290956-29095686.23686.61
5297791-29779188.26288.68
6320560-32056095.01095.45
20min1277855-27785582.35389.695.2582.8990.335.29
2303410-30341089.92790.60
3290730-29073086.16986.75
4313206-31320692.83193.47
5309098-30909891.61392.29
6321359-32135995.24795.97
30min1293927-29392787.11791.274.0187.9092.184.03
2297285-29728588.11289.06
3302448-30244889.64290.49
4322932-32293295.71396.63
5309036-30903691.59592.55
6321932-32193295.41796.43
45min1304309-30430990.19492.573.1391.2393.753.15
2300698-30069889.12390.33
3309045-30904591.59792.71
4324925-32492596.30497.51
5312222-31222292.53993.77
6322683-32268395.63996.94
60min1306340-30634090.79692.632.9492.1194.092.95
2299861-29986188.87590.35
3310758-31075892.10593.49
4324151-32415196.07597.56
5312433-31243392.60194.11
6321623-32162395.32596.91
极限1328527-32852797.37297.910.6598.9699.640.63
2329682-32968297.71499.46
3333540-33354098.857100.52
4330256-33025697.88499.66
5332055-33205598.417100.20
6327904-32790497.18799.06
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%
110.153454323442443442193430153457973445410.33
210.113455813446423451120.20
单位质量响应值RSD%判断
33944.9334135.710.40数据可信
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%
5min1126259-12625937.09140.459.0137.0940.459.01
2156409-15640945.94945.95
3128705-12870537.81037.81
4149939-14993944.04844.05
5132933-13293339.05239.05
6131821-13182138.72538.73
10min1264510-26451077.70679.087.1777.8279.207.17
2307175-30717590.23990.38
3259979-25997976.37476.49
4268982-26898279.01979.15
5260394-26039476.49676.61
6254001-25400174.61874.73
15min1310966-31096691.35390.552.8291.7090.912.83
2318234-31823493.48893.90
3310697-31069791.27491.62
4314231-31423192.31292.68
5296803-29680387.19287.54
6298427-29842787.66988.01
20min1320231-32023194.07592.661.9794.6993.291.95
2311154-31115491.40892.10
3321868-32186894.55695.17
4320889-32088994.26894.91
5308347-30834790.58491.19
6310059-31005991.08791.69
30min1320030-32003094.01692.581.9494.9293.491.91
2305127-30512789.63890.60
3320391-32039194.12295.02
4319812-31981293.95294.88
5312051-31205191.67292.55
6313446-31344692.08292.96
45min1316200-31620092.89191.542.0094.0792.721.97
2301086-30108688.45189.68
3316839-31683993.07894.26
4316580-31658093.00294.21
5309683-30968390.97692.13
6309152-30915290.82091.97
60min1309994-30999491.06789.921.9092.5391.381.86
2295546-29554686.82388.32
3309643-30964390.96492.43
4311136-31113691.40392.89
5305828-30582889.84491.27
6304345-30434589.40890.83
极限1304619-30461989.48889.630.6691.2291.360.68
2304655-30465589.49991.26
3305585-30558589.77291.51
4308860-30886090.73492.50
5303345-30334589.11490.81
6303577-30357789.18290.88
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%
110.153429903445293435783440883443793439130.19
210.113427063420873423960.13
单位质量响应值RSD%判断
33883.0533867.060.04数据可信
供试品溶液-2024012321批-sds3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1197331-19733158.25352.1011.5758.2552.1011.57
2204411-20441160.34360.34
3176940-17694052.23352.23
4165613-16561348.88948.89
5154792-15479245.69545.69
6159781-15978147.16847.17
10min1298503-29850388.11985.316.4288.2985.466.43
2321277-32127794.84295.02
3282978-28297883.53683.69
4271288-27128880.08580.23
5286033-28603384.43884.57
6273879-27387980.85080.99
15min1309670-30967091.41592.702.4991.8593.112.50
2325940-32594096.21896.68
3308608-30860891.10291.51
4306965-30696590.61791.00
5321613-32161394.94195.33
6311397-31139791.92592.31
20min1308201-30820190.98294.142.0491.7094.842.02
2325048-32504895.95596.71
3315810-31581093.22893.91
4318560-31856094.04094.70
5325681-32568196.14296.82
6320195-32019594.52295.18
30min1309165-30916591.26695.252.3092.2596.222.27
2325370-32537096.05097.09
3319138-31913894.21095.17
4325793-32579396.17597.12
5328976-32897697.11598.08
6327493-32749396.67797.62
45min1309296-30929691.30595.512.5092.5796.772.46
2324485-32448595.78997.12
3319808-31980894.40895.65
4329043-32904397.13498.36
5331536-33153697.87099.13
6327133-32713396.57097.80
60min1308771-30877191.15095.672.4992.6897.212.45
2325257-32525796.01797.63
3322486-32248695.19996.72
4327856-32785696.78498.30
5329620-32962097.30598.85
6330488-33048897.56199.08
极限1328197-32819796.88598.031.2198.6999.861.21
2337345-33734599.585101.49
3331630-33163097.89899.71
4333185-33318598.357100.17
5326906-32690696.50398.34
6335117-33511798.927100.74
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