氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.683347653344983351203350163349763348750.08
214.573358173361143359660.07
单位质量响应值RSD%判断
22811.6523058.750.77数据可信
供试品溶液-2025011421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1173725-17372543.95543.417.1943.9543.407.19
2170341-17034143.09943.10
3148231-14823137.50537.50
4177192-17719244.83244.83
5184225-18422546.61246.61
6175622-17562244.43544.43
10min1351307-35130788.88686.123.7988.9686.203.79
2344784-34478487.23587.31
3316312-31631280.03180.09
4338134-33813485.55385.63
5350712-35071288.73588.81
6341064-34106486.29486.37
15min1395166-39516699.983100.181.85100.20100.401.85
2404822-404822102.426102.64
3393895-39389599.66199.86
4385747-38574797.59997.82
5403977-403977102.212102.44
6392037-39203799.19199.41
20min1395311-395311100.019100.791.82100.41101.171.81
2400041-400041101.216101.60
3401290-401290101.532101.89
4385450-38545097.52497.90
5406110-406110102.752103.15
6401988-401988101.709102.09
30min1394657-39465799.854100.411.99100.41100.961.98
2404821-404821102.425102.98
3399832-399832101.163101.69
4385195-38519597.46098.00
5405063-405063102.487103.05
6391528-39152899.06299.61
45min1393929-39392999.670100.281.95100.39100.991.94
2404233-404233102.277103.00
3399540-399540101.089101.79
4385000-38500097.41098.12
5404180-404180102.263103.00
6391066-39106698.94599.66
极限1392915-39291599.413100.422.35100.30101.302.34
2403095-403095101.989102.89
3407304-407304103.054103.92
4384147-38414797.19598.06
5404273-404273102.287103.20
6389582-38958298.57099.45
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.683365343362453363363363343360993363100.05
214.573348963345343347150.08
单位质量响应值RSD%判断
22909.4022972.890.20数据可信
供试品溶液-2025011421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1161667-16166740.89242.836.3540.8942.826.35
2162848-16284841.19141.19
3168714-16871442.67542.67
4160128-16012840.50340.50
5174011-17401144.01544.01
6188542-18854247.69047.69
10min1320896-32089681.16882.333.9781.2482.403.97
2306706-30670677.57977.65
3321219-32121981.25081.32
4325046-32504682.21882.29
5344470-34447087.13187.20
6334522-33452284.61584.69
15min1380607-38060796.27196.951.3096.4797.161.30
2378802-37880295.81596.01
3383871-38387197.09797.30
4381870-38187096.59196.80
5392838-39283899.36599.58
6381755-38175596.56296.78
20min1381541-38154196.50897.761.3996.8798.131.39
2389759-38975998.58698.94
3392023-39202399.15999.53
4381782-38178296.56996.93
5392203-39220399.20599.59
6381753-38175396.56196.94
30min1380772-38077296.31397.591.3396.8498.121.32
2388956-38895698.38398.91
3391065-39106598.91799.45
4381311-38131196.44996.98
5391173-39117398.94499.49
6381556-38155696.51197.05
45min1380776-38077696.31497.411.3397.0098.101.33
2388271-38827198.21098.90
3390420-39042098.75499.45
4380024-38002496.12496.81
5390441-39044198.75999.47
6380665-38066596.28696.99
极限1379882-37988296.08897.261.4296.9398.121.42
2388191-38819198.19099.04
3389574-38957498.54099.40
4379208-37920895.91896.76
5390562-39056298.78999.67
6379705-37970596.04396.91
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.683356863363303362583362003362313361410.08
214.573361263362373361820.03
单位质量响应值RSD%判断
22897.8923073.580.55数据可信
供试品溶液-2025011521批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1167983-16798342.40842.901.3842.4142.901.38
2171726-17172643.35343.35
3170455-17045543.03243.03
4168144-16814442.44942.45
5167770-16777042.35442.35
6173413-17341343.77943.78
10min1329444-32944483.17084.081.2383.2484.151.23
2330799-33079983.51283.58
3328099-32809982.83082.90
4336058-33605884.83984.91
5337593-33759385.22785.30
6336381-33638184.92184.99
15min1397038-397038100.23498.711.56100.4498.921.56
2393406-39340699.31799.53
3383691-38369196.86497.07
4393815-39381599.42099.63
5395031-39503199.72799.94
6382935-38293596.67496.89
20min1386631-38663197.60798.921.4597.9899.301.45
2398598-398598100.628101.00
3388354-38835498.04298.41
4398083-398083100.498100.88
5393459-39345999.33099.71
6385952-38595297.43597.81
30min1390960-39096098.70099.671.3399.24100.211.32
2403292-403292101.813102.36
3391025-39102598.71699.25
4398668-398668100.645101.19
5394431-39443199.576100.12
6390357-39035798.54799.09
45min1385785-38578597.39398.181.2298.1098.891.21
2389936-38993698.44199.16
3385442-38544297.30698.01
4396551-396551100.111100.82
5391600-39160098.86199.57
6384152-38415296.98197.68
极限1394485-39448599.58999.590.99100.46100.461.00
2397368-397368100.317101.20
3388240-38824098.01398.87
4399626-399626100.887101.77
5394274-39427499.536100.41
6392986-39298699.211100.07
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.683355003356123353253351833349303353100.09
214.573341693347213344450.12
单位质量响应值RSD%判断
22841.2822954.360.35数据可信
供试品溶液-2025011521批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159566-15956640.43741.734.9240.4441.734.92
2158761-15876140.23340.23
3177528-17752844.98944.99
4162965-16296541.29941.30
5171590-17159043.48543.48
6157549-15754939.92639.93
10min1314892-31489279.80082.422.2079.8782.492.20
2324902-32490282.33782.40
3332754-33275484.32784.40
4324772-32477282.30482.37
5333550-33355084.52984.60
6320477-32047781.21681.28
15min1387852-38785298.29098.441.4298.4998.651.42
2381056-38105696.56896.77
3390010-39001098.83799.05
4386539-38653997.95798.16
5397903-397903100.837101.05
6387381-38738198.17198.37
20min1391445-39144599.20199.321.9399.5699.691.92
2380211-38021196.35496.72
3389735-38973598.76799.15
4394128-39412899.880100.25
5392286-39228699.41499.80
6403646-403646102.293102.66
30min1390725-39072599.01898.931.5599.5599.471.55
2379811-37981196.25296.78
3388521-38852198.46099.00
4397147-397147100.646101.18
5391164-39116499.12999.68
6394955-394955100.090100.63
45min1390302-39030298.91198.921.5199.6199.621.51
2380684-38068496.47397.16
3387920-38792098.30799.02
4397674-397674100.779101.48
5390470-39047098.95399.67
6394865-394865100.067100.77
极限1403405-403405102.231100.431.91103.09101.291.88
2402375-402375101.970102.82
3398019-398019100.867101.74
4392808-39280899.546100.42
5398106-398106100.889101.77
6382955-38295597.04997.92
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