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430060-202303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)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%
110.103217263218983220723222743221973220330.07
210.093226003220573223280.12
单位质量响应值RSD%判断
31884.4631945.290.14数据可信
供试品溶液-2024122521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%
5min180470-8047022.60222.218.3322.6022.218.33
291390-9139025.66925.67
376842-7684221.58321.58
476614-7661421.51921.52
572141-7214120.26220.26
677088-7708821.65221.65
10min1135679-13567938.10837.203.5838.1537.243.59
2140116-14011639.35539.40
3130253-13025336.58436.62
4131195-13119536.84936.88
5126625-12662535.56535.60
6130773-13077336.73136.77
15min1162008-16200845.50444.792.6345.6044.892.64
2166357-16635746.72546.83
3157593-15759344.26444.36
4159328-15932844.75144.85
5154594-15459443.42143.51
6156925-15692544.07644.17
20min1181510-18151050.98150.072.1851.1650.252.19
2183764-18376451.61451.80
3176795-17679549.65749.83
4178927-17892750.25650.43
5173660-17366048.77648.94
6174986-17498649.14949.32
30min1205509-20550957.72257.051.5257.9857.311.52
2207094-20709458.16758.44
3203573-20357357.17857.43
4203318-20331857.10657.36
5198926-19892655.87356.12
6200317-20031756.26456.52
45min1229416-22941664.43763.861.3164.7964.211.32
2230069-23006964.62064.99
3229399-22939964.43264.78
4228077-22807764.06164.41
5223406-22340662.74963.09
6223842-22384262.87163.22
60min1242640-24264068.15168.271.0668.6268.721.07
2245891-24589169.06469.54
3245087-24508768.83869.29
4244529-24452968.68169.14
5240721-24072167.61268.06
6239425-23942567.24867.70
极限1257323-25732372.27572.591.1272.8573.161.12
2260560-26056073.18473.78
3260908-26090873.28273.85
4261411-26141173.42374.00
5255378-25537871.72972.29
6255074-25507471.64372.21
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430060-202303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)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%
110.103220863218203216943229703214883220120.18
210.093210283217463213870.16
单位质量响应值RSD%判断
31882.3831852.030.07数据可信
供试品溶液-2024122521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%
5min1139440-13944039.22337.014.7739.2237.014.76
2134489-13448937.83137.83
3125485-12548535.29835.30
4122926-12292634.57834.58
5131748-13174837.06037.06
6135334-13533438.06838.07
10min1196827-19682755.36653.981.6655.4354.051.66
2189693-18969353.35953.42
3193146-19314654.33154.39
4189127-18912753.20053.26
5188980-18898053.15953.22
6193728-19372854.49454.56
15min1218618-21861861.49660.800.8961.6560.950.89
2213745-21374560.12560.28
3217640-21764061.22061.37
4215564-21556460.63760.78
5214378-21437860.30360.45
6216961-21696161.02961.18
20min1233534-23353465.69164.890.8665.9565.140.86
2228165-22816564.18164.43
3231861-23186165.22165.47
4230635-23063564.87665.12
5228853-22885364.37564.63
6231026-23102664.98665.24
30min1249937-24993770.30569.650.8170.6870.010.81
2244620-24462068.81069.17
3249046-24904670.05570.41
4247703-24770369.67770.03
5245939-24593969.18169.54
6248407-24840769.87570.24
45min1263615-26361574.15373.720.7274.6474.200.72
2259256-25925672.92773.40
3264149-26414974.30374.78
4263000-26300073.98074.45
5260624-26062473.31273.79
6261800-26180073.64274.12
60min1271338-27133876.32576.110.6676.9476.710.66
2268772-26877275.60476.20
3272656-27265676.69677.30
4271489-27148976.36876.96
5268050-26805075.40076.00
6271097-27109776.25876.86
极限1277799-27779978.14378.010.4378.8878.740.43
2275261-27526177.42978.15
3277840-27784078.15478.88
4278459-27845978.32879.05
5276656-27665677.82178.54
6277916-27791678.17678.91
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430060-202303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)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%
110.103218133217353218433204203215123214650.19
210.093225383218753222060.15
单位质量响应值RSD%判断
31828.2231933.200.24数据可信
供试品溶液-2024122521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%
5min195757-9575726.92425.946.8926.9225.946.89
293954-9395426.41726.42
393360-9336026.25026.25
484066-8406623.63723.64
585596-8559624.06724.07
6100865-10086528.36128.36
10min1148259-14825941.68741.143.0341.7341.183.03
2147602-14760241.50241.55
3148599-14859941.78241.83
4139229-13922939.14839.19
5142864-14286440.17040.21
6151327-15132742.54942.60
15min1173992-17399248.92248.071.9849.0448.181.99
2169664-16966447.70547.82
3171870-17187048.32548.44
4165769-16576946.61046.71
5169437-16943747.64147.75
6174953-17495349.19249.31
20min1190009-19000953.42652.751.5953.6252.941.59
2186494-18649452.43752.63
3188515-18851553.00653.20
4182709-18270951.37351.56
5186839-18683952.53452.72
6191021-19102153.71053.91
30min1210348-21034859.14458.621.1959.4358.901.21
2206959-20695958.19158.47
3208552-20855258.63958.92
4204986-20498657.63757.90
5208125-20812558.51958.79
6212027-21202759.61659.91
45min1230711-23071164.87064.241.1265.2564.621.13
2227254-22725463.89864.27
3227188-22718863.87964.26
4225151-22515163.30763.67
5228451-22845164.23464.61
6232136-23213665.27165.66
60min1242980-24298068.32067.870.9568.8168.350.95
2240138-24013867.52168.00
3239696-23969667.39667.88
4238903-23890367.17367.64
5241529-24152967.91268.39
6244944-24494468.87269.37
极限1255456-25545671.82871.330.7472.4371.920.75
2253055-25305571.15271.75
3252578-25257871.01871.62
4250841-25084170.53071.11
5254378-25437871.52472.12
6255735-25573571.90672.52
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