利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
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%
110.673339193343113337003330523329193335800.18
210.743355673351833353750.09
单位质量响应值RSD%判断
31263.3631226.720.09数据可信
供试品溶液-2024010511批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1270163-27016377.50872.863.7177.5172.863.71
2250053-25005371.73971.74
3247061-24706170.88070.88
4248236-24823671.21771.22
5247663-24766371.05371.05
6260591-26059174.76274.76
10min1314372-31437290.19186.862.4090.3687.022.40
2293503-29350384.20484.36
3307428-30742888.19988.36
4299693-29969385.98086.14
5302085-30208586.66686.82
6299579-29957985.94786.11
15min1330535-33053594.82891.512.3495.2091.862.34
2311734-31173489.43589.78
3324310-32431093.04293.40
4316435-31643590.78391.13
5319245-31924591.58991.94
6311499-31149989.36789.72
20min1331985-33198595.24493.141.6395.8393.701.63
2317442-31744291.07291.62
3329248-32924894.45995.02
4321851-32185192.33792.89
5324712-32471293.15893.71
6322607-32260792.55493.11
30min1337451-33745196.81393.871.7497.6194.631.74
2321238-32123892.16192.91
3325620-32562093.41894.19
4324778-32477893.17793.93
5324635-32463593.13693.90
6329398-32939894.50295.26
45min1338103-33810397.00094.771.6098.0195.741.61
2322801-32280192.61093.56
3333678-33367895.73096.71
4327330-32733093.90994.87
5329053-32905394.40395.37
6330952-33095294.94895.92
60min1338864-33886497.21894.701.7598.4495.881.75
2322166-32216692.42793.59
3333680-33368095.73196.92
4326626-32662693.70794.88
5329588-32958894.55795.73
6329525-32952594.53995.72
极限1343110-34311098.43695.261.9599.8896.661.95
2324705-32470593.15694.52
3334583-33458395.99097.39
4327181-32718193.86695.25
5331899-33189995.22096.61
6330860-33086094.92296.31
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
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%
110.673351433350453349903349803347543349820.05
210.743366463367433366940.03
单位质量响应值RSD%判断
31394.7531349.530.11数据可信
供试品溶液-2024010511批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1254740-25474072.78772.534.6372.7972.544.63
2257577-25757773.59873.60
3255220-25522072.92472.92
4246883-24688370.54270.54
5271992-27199277.71777.72
6236709-23670967.63567.64
10min1303206-30320686.63585.482.7086.8085.642.70
2302482-30248286.42986.59
3301949-30194986.27686.44
4284742-28474281.36081.52
5307358-30735887.82287.99
6295208-29520884.35084.50
15min1316012-31601290.29590.250.4390.6590.600.43
2318068-31806890.88291.24
3316571-31657190.45490.81
4315326-31532690.09990.44
5314361-31436189.82390.19
6314842-31484289.96090.30
20min1320432-32043291.55791.910.3692.1192.460.35
2321986-32198692.00192.56
3321160-32116091.76592.32
4323469-32346992.42592.96
5322275-32227592.08492.65
6320705-32070591.63592.17
30min1323599-32359992.46292.980.6293.2293.740.62
2324451-32445192.70693.47
3323962-32396292.56693.32
4324994-32499492.86193.60
5328853-32885393.96494.74
6326629-32662993.32894.07
45min1323995-32399592.57693.050.4293.5494.010.42
2325642-32564293.04694.01
3325962-32596293.13894.10
4325621-32562193.04093.99
5327938-32793893.70294.68
6324678-32467892.77193.72
60min1324424-32442492.69892.980.6093.8794.150.60
2324618-32461892.75493.93
3324317-32431792.66893.84
4324762-32476292.79593.95
5329321-32932194.09795.29
6325024-32502492.87094.02
极限1325727-32572793.07093.530.7094.4594.910.69
2326752-32675293.36394.74
3325871-32587193.11294.49
4327950-32795093.70695.07
5331650-33165094.76396.16
6326104-32610493.17894.54
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
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%
110.673362583363163359013356753351903358680.14
210.743367323366793367060.02
单位质量响应值RSD%判断
31477.7931350.650.29数据可信
供试品溶液-2024010611批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1256210-25621073.10971.2810.0673.1171.2810.06
2242705-24270569.25669.26
3212039-21203960.50560.51
4290234-29023482.81882.82
5249134-24913471.09071.09
6248495-24849570.90870.91
10min1308119-30811987.92285.634.1888.0885.794.18
2278572-27857279.49079.64
3305755-30575587.24787.38
4314258-31425889.67389.86
5295788-29578884.40384.56
6298012-29801285.03885.20
15min1324690-32469092.65092.021.9093.0192.371.90
2325995-32599593.02393.35
3311764-31176488.96289.29
4328816-32881693.82894.21
5319254-31925491.09991.44
6324381-32438192.56292.91
20min1331478-33147894.58794.011.4595.1594.561.46
2330793-33079394.39294.93
3319942-31994291.29591.82
4333196-33319695.07795.67
5330858-33085894.41094.96
6330399-33039994.27994.83
30min1335465-33546595.72595.550.3596.5096.310.37
2334398-33439895.42096.17
3333946-33394695.29196.02
4336438-33643896.00296.81
5335474-33547495.72796.49
6333339-33333995.11895.88
45min1336685-33668596.07396.580.8797.0697.560.85
2335797-33579795.82096.78
3343876-34387698.12599.07
4337349-33734996.26297.28
5339684-33968496.92997.90
6337484-33748496.30197.27
60min1338478-33847896.58596.670.8297.7897.850.80
2335867-33586795.84097.01
3343610-34361098.04999.21
4337054-33705496.17897.41
5337508-33750896.30897.49
6340060-34006097.03698.22
极限1337886-33788696.41696.710.7897.8398.110.76
2337336-33733696.25997.64
3343478-34347898.01199.39
4336631-33663196.05897.50
5337432-33743296.28697.69
6340654-34065497.20598.61
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
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%
110.673364343365653366223366613367313366030.04
210.743365343363513364420.04
单位质量响应值RSD%判断
31546.6731326.070.50数据可信
供试品溶液-2024010611批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255585-25558572.88071.119.9272.8871.119.92
2242518-24251869.15469.15
3212135-21213560.49060.49
4289147-28914782.45182.45
5248382-24838270.82670.83
6248545-24854570.87370.87
10min1307991-30799187.82485.474.1987.9985.624.19
2278324-27832479.36479.52
3304748-30474886.89987.03
4314293-31429389.62189.80
5295709-29570984.32284.48
6297255-29725584.76384.92
15min1324553-32455392.54791.881.9492.9092.231.95
2325451-32545192.80393.13
3311055-31105588.69889.03
4328617-32861793.70594.09
5319232-31923291.02991.37
6324411-32441192.50692.85
20min1331197-33119794.44193.881.5495.0094.421.55
2330786-33078694.32494.86
3319160-31916091.00991.53
4333277-33327795.03495.62
5330833-33083394.33794.88
6330024-33002494.10794.66
30min1335525-33552595.67595.480.3596.4596.240.36
2334672-33467295.43296.18
3333798-33379895.18395.91
4336352-33635295.91196.71
5335333-33533395.62196.38
6333262-33326295.03095.79
45min1336770-33677096.03096.530.9197.0297.500.88
2335846-33584695.76796.72
3344185-34418598.14599.08
4337456-33745696.22697.24
5339696-33969696.86597.83
6337242-33724296.16597.14
60min1338740-33874096.59296.640.8997.7997.820.87
2335626-33562695.70496.87
3344212-34421298.15299.31
4337361-33736196.19997.43
5337429-33742996.21897.40
6340022-34002296.95898.14
极限1338070-33807096.40196.680.7897.8198.080.75
2337621-33762196.27397.66
3343563-34356397.96799.34
4336659-33665995.99997.44
5337616-33761696.27297.67
6340836-34083697.19098.59
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