托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.453964023950723928933959513949633950560.35
2 16.523979353938113958730.74
单位质量响应值RSD%判断
24015.5623963.260.16数据可信
供试品溶液-24102501批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150663-5066312.67113.073.7112.6713.073.72
249534-4953412.38912.39
353078-5307813.27513.28
452386-5238613.10213.10
552836-5283613.21513.21
655052-5505213.76913.77
10min195742-9574223.94624.413.6223.9724.443.61
293302-9330223.33623.36
3100242-10024225.07225.09
4100435-10043525.12025.14
594419-9441923.61523.64
6101509-10150925.38825.41
15min1132560-13256033.15534.023.8133.2234.083.81
2130312-13031232.59232.65
3139920-13992034.99535.06
4139976-13997635.00935.07
5131232-13123232.82332.88
6142012-14201235.51935.58
20min1162695-16269540.69241.603.5140.8141.723.51
2160038-16003840.02740.14
3170106-17010642.54542.67
4171983-17198343.01543.14
5160598-16059840.16740.28
6172499-17249943.14443.27
30min1201974-20197450.51651.673.0550.7051.863.05
2200312-20031250.10050.28
3210905-21090552.75052.94
4210377-21037752.61852.81
5200904-20090450.24850.43
6215073-21507353.79253.99
45min1242204-24220460.57861.822.8260.8562.102.82
2240921-24092160.25760.52
3250001-25000162.52862.81
4251732-25173262.96163.24
5240650-24065060.18960.46
6257503-25750364.40464.69
60min1268514-26851467.15868.862.7567.5369.242.76
2268677-26867767.19967.56
3280531-28053170.16470.55
4279796-27979669.98070.37
5268729-26872967.21267.58
6285589-28558971.42971.82
90min1299798-29979874.98376.542.9275.4677.042.92
2300272-30027275.10175.58
3309408-30940877.38677.89
4312441-31244178.14578.65
5295510-29551073.91074.39
6318770-31877079.72880.24
120min1321017-32101780.29081.602.9980.9082.232.99
2314278-31427878.60479.21
3334729-33472983.71984.35
4331912-33191283.01583.65
5318000-31800079.53580.14
6337708-33770884.46485.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1329821-32982182.49283.862.6183.2384.622.62
2326121-32612181.56682.30
3339131-33913184.82085.59
4341539-34153985.42386.19
5327513-32751381.91482.65
6347689-34768986.96187.75
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.453990583951723953623995803975173973380.52
2 16.523991583959373975480.58
单位质量响应值RSD%判断
24154.2924064.650.27数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131726-317267.8968.283.177.908.283.18
232642-326428.1238.12
333674-336748.3808.38
432928-329288.1958.19
534582-345828.6068.61
634153-341538.5008.50
10min161952-6195215.41815.341.6515.4315.361.64
261034-6103415.18915.20
361101-6110115.20615.22
463412-6341215.78115.79
560538-6053815.06615.08
661883-6188315.40115.41
15min191609-9160922.79822.571.2622.8422.611.26
290126-9012622.42922.47
389824-8982422.35422.39
492426-9242623.00223.04
589450-8945022.26122.30
690794-9079422.59622.64
20min1117083-11708329.13828.761.1529.2128.831.15
2115682-11568228.78928.87
3114416-11441628.47428.55
4117207-11720729.16929.25
5114366-11436628.46228.54
6114546-11454628.50728.58
30min1156391-15639138.92038.341.1539.0538.471.15
2154836-15483638.53338.66
3152924-15292438.05838.18
4155516-15551638.70338.83
5151855-15185537.79237.92
6152935-15293538.06038.19
45min1198651-19865149.43748.840.9549.6349.030.96
2197132-19713249.05949.25
3195812-19581248.73148.92
4196909-19690949.00449.20
5193091-19309148.05448.24
6195828-19582848.73548.92
60min1228567-22856756.88256.350.7757.1656.620.77
2226863-22686356.45856.73
3226512-22651256.37156.64
4227640-22764056.65256.92
5223669-22366955.66455.93
6225389-22538956.09256.36
90min1266690-26669066.37065.960.5966.7466.320.59
2266044-26604466.20966.57
3265255-26525566.01366.38
4265902-26590266.17466.54
5262805-26280565.40365.76
6263464-26346465.56765.93
120min1293061-29306172.93372.210.5873.4172.690.58
2289718-28971872.10172.58
3290213-29021372.22472.70
4289951-28995172.15972.64
5287872-28787271.64172.11
6290220-29022072.22672.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1308848-30884876.86275.311.8677.4675.901.85
2304208-30420875.70776.30
3304310-30431075.73276.33
4305885-30588576.12476.72
5299364-29936474.50175.09
6292994-29299472.91673.51
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.453990613951383960783970593945283963730.45
2 16.523958803969533964160.20
单位质量响应值RSD%判断
24095.6223996.130.30数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132393-323938.0838.804.798.088.804.78
234488-344888.6068.61
336287-362879.0549.05
437120-371209.2629.26
536195-361959.0329.03
635106-351068.7608.76
10min166615-6661516.62217.112.5016.6417.132.49
268666-6866617.13417.15
368983-6898317.21317.23
468201-6820117.01817.03
567410-6741016.82016.84
671600-7160017.86617.88
15min197396-9739624.30324.721.3424.3424.761.35
2100046-10004624.96425.01
399567-9956724.84424.89
498713-9871324.63124.68
597862-9786224.41924.46
6100866-10086625.16825.21
20min1122733-12273330.62531.112.2630.7131.202.26
2125051-12505131.20331.29
3124744-12474431.12731.21
4122630-12263030.59930.68
5122935-12293530.67530.76
6130006-13000632.44032.53
30min1159272-15927239.74240.662.3339.8740.802.32
2163777-16377740.86641.00
3163429-16342940.77940.92
4161120-16112040.20340.34
5160385-16038540.02040.15
6169818-16981842.37442.51
45min1200018-20001849.90950.682.2550.1150.892.25
2204048-20404850.91551.12
3202120-20212050.43450.64
4200834-20083450.11350.32
5199853-19985349.86850.07
6211867-21186752.86653.08
60min1230137-23013757.42557.961.8857.7158.251.88
2234118-23411858.41858.71
3231118-23111857.67057.96
4228630-22863057.04957.34
5229380-22938057.23657.52
6240258-24025859.95060.25
90min1265350-26535066.21167.152.2066.5967.532.20
2270394-27039467.47067.86
3267172-26717266.66667.05
4265944-26594466.35966.74
5265230-26523066.18166.56
6280518-28051869.99670.40
120min1289953-28995372.35072.811.6872.8473.301.67
2291553-29155372.75073.25
3291132-29113272.64473.14
4290141-29014172.39772.89
5286772-28677271.55772.05
6301117-30111775.13675.65
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1303916-30391675.83476.251.7276.4476.861.72
2306005-30600576.35676.98
3303727-30372775.78776.40
4302835-30283575.56576.18
5301152-30115275.14575.75
6315768-31576878.79279.43
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