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 16.347857467857607859687854177859037857590.03
2 16.377929037926007927520.03
单位质量响应值RSD%判断
48088.0748427.120.50数据可信
供试品溶液-3G80SDA2批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1512555-51255563.72862.131.7963.7362.141.79
2492351-49235161.21661.22
3494250-49425061.45261.45
4494417-49441761.47361.47
5495206-49520661.57161.57
6509657-50965763.36863.37
10min1675955-67595584.04483.041.3184.1583.151.31
2671931-67193183.54483.65
3660470-66047082.11982.22
4659063-65906381.94482.05
5661153-66115382.20482.31
6678839-67883984.40384.51
15min1745787-74578792.72791.731.2792.9791.971.26
2741478-74147892.19192.43
3731505-73150590.95191.19
4727132-72713290.40790.65
5730547-73054790.83291.07
6750018-75001893.25393.50
20min1779070-77907096.86595.561.2097.2795.961.20
2773134-77313496.12796.52
3761628-76162894.69695.09
4757457-75745794.17894.57
5762604-76260494.81895.21
6777677-77767796.69297.09
30min1797838-79783899.19997.980.9899.7698.530.99
2793204-79320498.62299.18
3783856-78385697.46098.01
4778670-77867096.81597.36
5781457-78145797.16297.71
6793178-79317898.61999.18
45min1800434-80043499.52198.380.97100.2599.100.98
2795686-79568698.93199.65
3787696-78769697.93898.65
4782197-78219797.25497.96
5783948-78394897.47298.18
6797714-79771499.18399.91
60min1798868-79886899.32798.190.93100.2299.070.94
2794407-79440798.77299.66
3785911-78591197.71698.59
4780442-78044297.03697.91
5783784-78378497.45198.32
6794944-79494498.83999.73
极限1796744-79674499.06397.971.00100.1299.011.00
2793096-79309698.60999.66
3783527-78352797.41998.46
4778447-77844796.78897.82
5781102-78110297.11898.15
6794613-79461398.79899.85
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 16.347946547951367949497942047931427944170.11
2 16.378010728022638016680.11
单位质量响应值RSD%判断
48617.9348971.780.52数据可信
供试品溶液-3G80SDA2批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1547454-54745467.31866.761.5367.3266.761.53
2554517-55451768.18668.19
3540222-54022266.42966.43
4535300-53530065.82365.82
5532809-53280965.51765.52
6547246-54724667.29267.29
10min1709536-70953687.24887.530.9487.3687.650.94
2721491-72149188.71888.83
3716586-71658688.11588.23
4706634-70663486.89287.00
5713586-71358687.74687.86
6703312-70331286.48386.60
15min1764633-76463394.02394.510.8094.2894.760.80
2775056-77505695.30595.57
3774717-77471795.26395.52
4765243-76524394.09894.35
5771566-77156694.87695.13
6760116-76011693.46893.72
20min1789799-78979997.11897.150.6697.5397.560.66
2793428-79342897.56497.98
3796411-79641197.93198.35
4786902-78690296.76297.17
5791924-79192497.37997.79
6781836-78183696.13996.55
30min1799086-79908698.26098.570.4998.8499.140.49
2802535-80253598.68499.27
3806786-80678699.20799.79
4799878-79987898.35798.93
5804912-80491298.97699.55
6796308-79630897.91898.49
45min1801038-80103898.50098.700.5499.2499.440.54
2803100-80310098.75499.50
3807899-80789999.344100.09
4800947-80094798.48999.23
5806763-80676399.20499.94
6796086-79608697.89198.63
60min1799994-79999498.37298.460.5699.2899.360.56
2801055-80105598.50299.41
3806006-80600699.111100.02
4798628-79862898.20499.10
5804819-80481998.96599.87
6793705-79370597.59898.50
极限1797064-79706498.01198.280.6399.0899.350.62
2798627-79862798.20399.28
3804806-80480698.963100.04
4797830-79783098.10599.17
5805027-80502798.990100.06
6792054-79205497.39598.46
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 16.343961993966593969743971003961283966120.12
2 16.373951933962643957280.20
单位质量响应值RSD%判断
24272.4624173.980.29数据可信
供试品溶液-2025032921批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1297194-29719473.61473.782.6973.6173.782.69
2310239-31023976.84576.85
3296988-29698873.56373.56
4288562-28856271.47671.48
5303287-30328775.12375.12
6290825-29082572.03772.04
10min1383531-38353195.00094.960.5995.1295.080.60
2385998-38599895.61195.74
3385732-38573295.54595.67
4380024-38002494.13194.25
5382904-38290494.84494.97
6382095-38209594.64494.76
15min1396394-39639498.18698.400.4498.4798.690.44
2397227-39722798.39298.68
3400359-40035999.16899.45
4395225-39522597.89698.17
5396881-39688198.30698.59
6397575-39757598.47898.76
20min1397775-39777598.52898.710.4898.9799.160.48
2398048-39804898.59599.05
3402161-40216199.614100.06
4396725-39672598.26898.71
5397583-39758398.48098.93
6398807-39880798.78399.23
30min1398171-39817198.62698.700.4199.2399.310.41
2397571-39757198.47799.09
3401650-40165099.488100.10
4397044-39704498.34798.95
5398050-39805098.59699.21
6398339-39833998.66799.27
45min1397012-39701298.33998.550.4699.1199.320.45
2398426-39842698.68999.47
3400824-40082499.283100.06
4395437-39543797.94998.72
5397305-39730598.41199.19
6398163-39816398.62499.39
60min1397304-39730498.41198.410.3799.3599.350.37
2395873-39587398.05799.00
3399896-39989699.053100.00
4396045-39604598.09999.03
5397545-39754598.47199.41
6397086-39708698.35799.29
极限1395471-39547197.95798.080.5299.0699.180.51
2394859-39485997.80598.91
3399736-39973699.014100.12
4394596-39459697.74098.83
5394416-39441697.69698.80
6396752-39675298.27499.37
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 16.343947403950503955913954783963003954320.15
2 16.374043924040154042040.07
单位质量响应值RSD%判断
24200.2424691.751.43数据可信
供试品溶液-2025032921批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312285-31228576.65573.2610.2076.6573.2610.20
2265275-26527565.11565.12
3345133-34513384.71884.72
4267005-26700565.54065.54
5291582-29158271.57371.57
6309541-30954175.98175.98
10min1387473-38747395.11191.973.3495.2492.093.35
2364748-36474889.53289.64
3389988-38998895.72895.87
4357942-35794287.86287.97
5375361-37536192.13892.26
6372579-37257991.45591.58
15min1394472-39447296.82997.160.5797.1197.430.57
2399745-39974598.12398.38
3395805-39580597.15697.46
4393451-39345196.57896.83
5396758-39675897.39097.66
6394605-39460596.86197.14
20min1395384-39538497.05297.761.3897.5098.201.37
2406735-40673599.839100.26
3395957-39595797.19397.66
4394085-39408596.73497.15
5403506-40350699.04699.48
6393875-39387596.68297.12
30min1393933-39393396.69697.651.3897.3198.251.37
2407288-40728899.974100.56
3395700-39570097.13097.75
4394323-39432396.79297.37
5401598-40159898.57899.18
6394010-39401096.71597.32
45min1392985-39298596.46497.741.5097.2398.501.48
2408899-408899100.370101.12
3395276-39527697.02697.81
4396516-39651697.33098.07
5401153-40115398.46999.23
6394325-39432596.79297.56
60min1394268-39426896.77897.441.6197.7198.361.59
2408038-408038100.159101.08
3393816-39381696.66897.62
4392685-39268596.39097.29
5401110-40111098.45899.39
6391758-39175896.16297.09
极限1392486-39248696.34197.311.5197.4398.401.50
2406035-40603599.667100.76
3393809-39380996.66697.78
4394388-39438896.80897.87
5401369-40136998.52299.61
6390474-39047495.84796.93
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