利伐沙班口崩片项目信息
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2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%
115.224865014863314855974868064855774861620.12
215.144909124911014910060.03
单位质量响应值RSD%判断
31942.3132431.041.08数据可信
供试品溶液-24082701批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1331931-33193161.38563.573.4461.3863.573.44
2365829-36582967.65367.65
3344717-34471763.74963.75
4338799-33879962.65562.65
5344186-34418663.65163.65
6337168-33716862.35362.35
10min1454156-45415683.98883.361.5984.0983.461.60
2462893-46289385.60485.72
3445400-44540082.36982.47
4451142-45114283.43183.53
5442967-44296781.91982.02
6447891-44789182.82982.93
15min1481312-48131289.01088.651.5189.2588.891.51
2488995-48899590.43190.69
3478629-47862988.51488.76
4482233-48223389.18089.42
5466945-46694586.35386.60
6477923-47792388.38388.63
20min1493792-49379291.31890.851.5691.7191.241.56
2500811-50081192.61693.02
3491747-49174790.94091.33
4493907-49390791.33991.73
5477761-47776188.35388.74
6489399-48939990.50590.89
30min1505306-50530693.44792.641.6293.9993.191.62
2511605-51160594.61295.17
3504368-50436893.27493.82
4496044-49604491.73492.28
5488386-48838690.31890.85
6500082-50008292.48193.02
45min1513038-51303894.87794.461.6595.5895.161.64
2519027-51902795.98596.70
3513999-51399995.05595.75
4513719-51371995.00395.70
5494693-49469391.48592.17
6510299-51029994.37195.06
60min1516298-51629895.48095.091.6096.3495.951.60
2522428-52242896.61497.49
3515607-51560795.35296.21
4517944-51794495.78496.64
5498472-49847292.18393.02
6514502-51450295.14896.00
极限1517776-51777695.75395.201.7196.7796.211.70
2523406-52340696.79497.83
3516940-51694095.59996.61
4517124-51712495.63396.65
5497730-49773092.04693.04
6515678-51567895.36596.38
利伐沙班口崩片项目信息
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2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%
115.224867534873724866184860824861804866010.11
215.144870324874734872520.07
单位质量响应值RSD%判断
31971.1632183.090.47数据可信
供试品溶液-24082702批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1378301-37830170.19667.534.3570.2067.544.35
2371923-37192369.01269.01
3363619-36361967.47167.47
4346518-34651864.29864.30
5379928-37992870.49770.50
6343439-34343963.72763.73
10min1487417-48741790.44389.091.8190.5689.201.81
2479415-47941588.95889.07
3478691-47869188.82388.94
4476741-47674188.46288.57
5491679-49167991.23391.35
6466917-46691786.63986.74
15min1510642-51064294.75293.311.7095.0293.571.70
2501743-50174393.10193.36
3499767-49976792.73492.99
4502928-50292893.32193.58
5512983-51298395.18695.46
6489150-48915090.76491.01
20min1515504-51550495.65494.821.5396.0895.231.53
2507963-50796394.25594.67
3508904-50890494.43094.84
4511697-51169794.94895.36
5522533-52253396.95997.39
6499365-49936592.66093.06
30min1522218-52221896.90096.131.6397.4996.711.64
2514690-51469095.50396.08
3515851-51585195.71996.29
4520234-52023496.53297.10
5530393-53039398.41799.01
6505170-50517093.73794.29
45min1527102-52710297.80696.911.8198.5597.641.81
2517464-51746496.01896.75
3519975-51997596.48497.22
4524165-52416597.26197.99
5536373-53637399.527100.28
6508404-50840494.33795.05
60min1525536-52553697.51696.901.7698.4397.801.76
2517472-51747296.01996.91
3520369-52036996.55797.45
4524215-52421597.27198.16
5536620-53662099.572100.49
6509161-50916194.47795.35
极限1522820-52282097.01296.331.7998.0897.381.79
2515763-51576395.70296.76
3517386-51738696.00397.06
4516972-51697295.92796.98
5534859-53485999.246100.33
6506920-50692094.06195.09
利伐沙班口崩片项目信息
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2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%
115.224863784863104858854857304854924859590.08
215.144858034848904853460.14
单位质量响应值RSD%判断
31928.9832057.200.29数据可信
供试品溶液-24082701批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1162069-16206930.15129.705.5630.1529.705.55
2150372-15037227.97527.98
3175616-17561632.67232.67
4159998-15999829.76629.77
5153832-15383228.61928.62
6156094-15609429.04029.04
10min1228297-22829742.47342.152.7242.5242.202.72
2221026-22102641.12041.17
3237672-23767244.21744.27
4227321-22732142.29142.34
5222484-22248441.39141.44
6222644-22264441.42141.47
15min1255878-25587847.60447.441.7147.7247.561.72
2255328-25532847.50147.62
3262537-26253748.84348.97
4254554-25455447.35747.48
5251691-25169146.82546.94
6249927-24992746.49746.61
20min1270921-27092150.40250.341.4850.6050.541.49
2272728-27272850.73950.93
3276927-27692751.52051.73
4269987-26998750.22950.43
5266659-26665949.60949.80
6266190-26619049.52249.72
30min1285853-28585353.18053.311.1953.4653.601.19
2289610-28961053.87954.16
3291166-29116654.16954.46
4286187-28618753.24253.53
5284781-28478152.98153.26
6281753-28175352.41852.70
45min1297938-29793855.42955.530.8955.8055.900.90
2301591-30159156.10856.48
3301609-30160956.11256.50
4298151-29815155.46855.84
5296178-29617855.10155.47
6295345-29534554.94655.31
60min1304364-30436456.62456.540.9157.0957.010.92
2307799-30779957.26357.73
3305013-30501356.74557.22
4304619-30461956.67257.14
5302176-30217656.21756.67
6299651-29965155.74756.20
极限1306720-30672057.06257.240.8557.6257.800.85
2311561-31156157.96358.52
3309546-30954657.58858.16
4307896-30789657.28157.84
5305946-30594656.91857.47
6304318-30431856.61657.16
利伐沙班口崩片项目信息
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2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%
115.224853964864374866224856664866704861580.13
215.144911434908854910140.04
单位质量响应值RSD%判断
31942.0532431.571.08数据可信
供试品溶液-24082702批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1150690-15069027.86732.138.4427.8732.148.43
2170498-17049831.53031.53
3167243-16724330.92830.93
4176477-17647732.63632.64
5185216-18521634.25234.25
6192446-19244635.58935.59
10min1214982-21498239.75742.594.2239.8042.644.22
2243109-24310944.95845.01
3227237-22723742.02342.07
4227963-22796342.15742.21
5230531-23053142.63242.69
6237900-23790043.99544.05
15min1243882-24388245.10147.142.6445.2147.272.65
2263532-26353248.73548.86
3253849-25384946.94547.07
4254450-25445047.05647.18
5253743-25374346.92547.05
6260111-26011148.10348.24
20min1261803-26180348.41649.901.8148.6050.101.82
2275671-27567150.98051.19
3270626-27062650.04750.25
4268951-26895149.73749.94
5268106-26810649.58149.79
6273790-27379050.63250.85
30min1280729-28072951.91653.051.3052.1853.331.32
2290866-29086653.79054.08
3289651-28965153.56553.85
4285965-28596552.88453.17
5285002-28500252.70652.99
6288816-28881653.41153.71
45min1296891-29689154.90455.750.9855.2656.120.99
2304377-30437756.28956.67
3303850-30385056.19156.56
4301859-30185955.82356.20
5298902-29890255.27655.65
6302758-30275855.98956.38
60min1306507-30650756.68357.360.8757.1357.830.88
2311992-31199257.69758.17
3313314-31331457.94258.41
4310222-31022257.37057.84
5307397-30739756.84757.32
6311575-31157557.62058.10
极限1314459-31445958.15358.640.6658.6959.200.67
2318278-31827858.86059.43
3319216-31921659.03359.60
4315911-31591158.42258.98
5315452-31545258.33758.90
6319175-31917559.02559.60
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