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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.344938714934404935384930474929234933640.08
215.224934284934554934420.01
单位质量响应值RSD%判断
32161.9332420.630.57数据可信
供试品溶液-1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%
5min1116942-11694221.64218.7716.8121.6418.7716.81
278502-7850214.52814.53
3103354-10335419.12819.13
4124422-12442223.02723.03
593167-9316717.24217.24
692207-9220717.06517.06
10min1169260-16926031.32529.535.9831.3629.565.99
2147126-14712627.22827.25
3164590-16459030.46030.49
4169662-16966231.39931.44
5153189-15318928.35028.38
6153419-15341928.39328.42
15min1199044-19904436.83735.323.4836.9335.403.50
2183658-18365833.98934.06
3194395-19439535.97636.06
4196655-19665536.39536.49
5185957-18595734.41534.49
6185298-18529834.29334.37
20min1220187-22018740.75039.292.7940.9039.432.81
2207009-20700938.31138.44
3216153-21615340.00340.15
4216278-21627840.02640.18
5206389-20638938.19638.33
6207880-20788038.47238.60
30min1245949-24594945.51744.521.8845.7344.731.89
2237677-23767743.98744.18
3244265-24426545.20645.42
4243456-24345645.05645.27
5235062-23506243.50343.70
6237107-23710743.88144.08
45min1269809-26980949.93349.221.3450.2349.501.36
2264749-26474948.99749.26
3268803-26880349.74750.03
4268473-26847349.68649.98
5261407-26140748.37848.65
6262487-26248748.57848.85
60min1285093-28509352.76252.171.0053.1452.531.02
2280909-28090951.98752.33
3283950-28395052.55052.92
4283779-28377952.51952.89
5278038-27803851.45651.81
6279507-27950751.72852.08
极限1298393-29839355.22354.810.7755.6955.260.78
2296675-29667554.90555.34
3298052-29805255.16055.62
4297129-29712954.98955.45
5292811-29281154.19054.63
6293999-29399954.41054.85
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.344947034941644941784947754944634944570.06
215.224943764937164940460.10
单位质量响应值RSD%判断
32233.1832460.320.50数据可信
供试品溶液-1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%
5min1179600-17960033.18133.135.5433.1833.135.54
2181560-18156033.54333.54
3193381-19338135.72735.73
4168538-16853831.13731.14
5185347-18534734.24334.24
6167638-16763830.97130.97
10min1237396-23739643.85944.592.7843.9144.652.78
2242464-24246444.79544.85
3249808-24980846.15246.21
4232289-23228942.91542.97
5248028-24802845.82345.88
6238285-23828544.02344.07
15min1266370-26637049.21249.391.3249.3449.521.33
2266639-26663949.26249.39
3271779-27177950.21150.35
4261927-26192748.39148.51
5270676-27067650.00750.14
6266597-26659749.25449.38
20min1281569-28156952.02052.010.8552.2352.220.86
2280210-28021051.76951.98
3284806-28480652.61852.84
4278144-27814451.38751.59
5283521-28352152.38152.60
6280798-28079851.87852.08
30min1297550-29755054.97254.810.4355.2755.110.43
2296230-29623054.72955.03
3298071-29807155.06955.38
4294498-29449854.40954.70
5297063-29706354.88255.19
6296566-29656654.79155.08
45min1309190-30919057.12356.900.3957.5157.280.39
2307266-30726656.76857.16
3309687-30968757.21557.61
4306716-30671656.66657.05
5307482-30748256.80757.20
6307402-30740256.79357.18
60min1314827-31482758.16457.900.2858.6558.380.29
2313043-31304357.83558.32
3314065-31406558.02458.52
4312561-31256157.74658.22
5312876-31287657.80458.29
6312995-31299557.82658.31
极限1318737-31873758.88758.690.2559.4759.280.26
2318399-31839958.82459.41
3317956-31795658.74259.33
4316900-31690058.54759.12
5316994-31699458.56559.15
6317135-31713558.59159.17
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.344930344930864928724928104927294929060.04
215.224935004941734938360.10
单位质量响应值RSD%判断
32132.0732446.520.69数据可信
供试品溶液-1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142306-14230626.33826.433.7826.3426.443.79
2141054-14105426.10626.11
3152293-15229328.18728.19
4137020-13702025.36025.36
5145115-14511526.85826.86
6139141-13914125.75225.75
10min1187974-18797434.79034.142.4434.8334.182.44
2181546-18154633.60133.64
3191946-19194635.52635.57
4181586-18158633.60833.65
5180874-18087433.47633.52
6182743-18274333.82233.87
15min1210515-21051538.96238.461.5039.0638.561.50
2205487-20548738.03238.13
3212539-21253939.33739.44
4206209-20620938.16538.26
5204541-20454137.85737.96
6207571-20757138.41738.52
20min1227329-22732942.07441.571.6342.2441.731.64
2221733-22173341.03941.20
3230311-23031142.62642.80
4223618-22361841.38741.55
5220431-22043140.79840.96
6224152-22415241.48641.65
30min1247232-24723245.75845.330.8245.9945.560.82
2243603-24360345.08645.32
3246430-24643045.61045.85
4244499-24449945.25245.48
5241813-24181344.75544.99
6245882-24588245.50845.74
45min1264949-26494949.03748.680.7149.3548.990.71
2261555-26155548.40948.72
3264113-26411348.88249.20
4263545-26354548.77749.08
5259999-25999948.12148.43
6263830-26383048.83049.14
60min1274655-27465550.83350.660.3551.2351.050.35
2272265-27226550.39150.78
3273508-27350850.62151.02
4273533-27353350.62651.01
5274909-27490950.88051.27
6273492-27349250.61851.01
极限1284333-28433352.62552.320.4753.1052.800.48
2282291-28229152.24752.72
3283267-28326752.42752.91
4282517-28251752.28952.76
5280435-28043551.90352.37
6283381-28338152.44852.92
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.344958174960704962174957324959044959480.04
215.224969794966934968360.05
单位质量响应值RSD%判断
32330.3832643.630.69数据可信
供试品溶液-1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%
5min1349911-34991164.36860.358.6964.3760.358.70
2348737-34873764.15264.15
3340590-34059062.65362.65
4320157-32015758.89458.89
5334717-33471761.57361.57
6274268-27426850.45350.45
10min1456330-45633083.94481.802.3784.0581.902.38
2446511-44651182.13882.24
3453922-45392283.50183.61
4440536-44053681.03981.14
5443812-44381281.64181.74
6427024-42702478.55378.64
15min1481455-48145588.56687.730.9788.8187.960.98
2476595-47659587.67287.92
3482268-48226888.71588.96
4475967-47596787.55687.79
5475504-47550487.47187.71
6469521-46952186.37186.59
20min1493341-49334190.75290.050.8091.1590.430.81
2489865-48986590.11390.50
3493724-49372490.82391.21
4490169-49016990.16990.55
5485985-48598589.39989.78
6483985-48398589.03189.39
30min1506000-50600093.08192.380.8393.6392.910.84
2502614-50261492.45893.00
3507833-50783393.41893.96
4500734-50073492.11292.64
5498257-49825791.65792.19
6497547-49754791.52692.03
45min1516933-51693395.09294.010.9895.7994.700.99
2511753-51175394.13994.83
3516278-51627894.97295.67
4509724-50972493.76694.45
5507404-50740493.33994.03
6504152-50415292.74193.40
60min1517111-51711195.12594.360.9195.9895.200.92
2514084-51408494.56895.42
3518624-51862495.40396.26
4512596-51259694.29495.13
5508464-50846493.53494.38
6506892-50689293.24594.06
极限1526457-52645796.84495.820.8197.8696.820.82
2519106-51910695.49296.50
3525330-52533096.63797.65
4518387-51838795.36096.36
5520280-52028095.70896.71
6515648-51564894.85695.83
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