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%
110.123210833213003210923209813211183211150.04
210.123201593198123199860.08
单位质量响应值RSD%判断
31730.7331619.170.25数据可信
加速6月-供试品溶液-2023072811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%
5min1122036-12203634.53638.355.3734.5438.355.37
2138277-13827739.13239.13
3141219-14121939.96539.97
4133606-13360637.81137.81
5141736-14173640.11140.11
6136204-13620438.54638.55
10min1163061-16306146.14649.584.1446.2249.674.15
2179914-17991450.91651.00
3181365-18136551.32651.42
4172251-17225148.74748.83
5181655-18165551.40851.50
6172981-17298148.95449.04
15min1185002-18500252.35655.353.2252.5355.543.22
2200485-20048556.73756.94
3200934-20093456.86457.07
4192501-19250154.47854.67
5200217-20021756.66256.86
6194347-19434755.00055.19
20min1201236-20123656.95059.142.2457.2559.462.25
2212404-21240460.11060.44
3212680-21268060.18960.52
4206598-20659858.46758.78
5213122-21312260.31460.64
6207897-20789758.83559.15
30min1219856-21985662.21963.641.2862.6464.091.30
2226235-22623564.02564.48
3227338-22733864.33764.80
4223469-22346963.24263.69
5227328-22732864.33464.80
6224967-22496763.66664.11
45min1234992-23499266.50367.180.6767.0667.770.69
2237893-23789367.32467.93
3238919-23891967.61468.22
4236241-23624166.85667.44
5239033-23903367.64668.25
6237234-23723467.13767.73
60min1242727-24272768.69269.431.0469.4070.171.03
2244309-24430969.14069.89
3245779-24577969.55670.31
4249955-24995570.73771.47
5245581-24558169.50070.26
6243703-24370368.96869.71
极限1248227-24822770.24870.600.4871.1171.500.49
2248395-24839570.29671.20
3250952-25095271.02071.93
4250465-25046570.88271.77
5250223-25022370.81371.72
6248639-24863970.36571.26
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%
110.123234623235063233723235143233243234360.03
210.123234743236203235470.04
单位质量响应值RSD%判断
31960.0831971.050.03数据可信
长期6月-供试品溶液-2023072811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%
5min1140417-14041739.37739.570.5539.3839.570.55
2140435-14043539.38239.38
3142324-14232439.91139.91
4140547-14054739.41339.41
5141323-14132339.63139.63
6141603-14160339.70939.71
10min1185127-18512751.91551.460.8452.0051.550.84
2181267-18126750.83250.92
3184003-18400351.59951.69
4183299-18329951.40251.49
5185069-18506951.89851.99
6182301-18230151.12251.21
15min1203975-20397557.20056.740.8757.4056.940.87
2199781-19978156.02456.22
3203450-20345057.05357.26
4202047-20204756.65956.86
5203927-20392757.18757.39
6200885-20088556.33456.54
20min1214777-21477760.22959.760.6360.5660.080.63
2210815-21081559.11859.44
3213979-21397960.00560.34
4213163-21316359.77760.10
5213038-21303859.74260.07
6212794-21279459.67360.00
30min1227559-22755963.81463.540.5964.2864.000.60
2224688-22468863.00963.46
3227347-22734763.75464.22
4226486-22648663.51363.97
5228089-22808963.96264.43
6225382-22538263.20363.66
45min1237080-23708066.48466.420.5067.0967.020.50
2235113-23511365.93266.53
3238634-23863466.91967.52
4236149-23614966.22366.82
5237153-23715366.50467.11
6236885-23688566.42967.03
60min1244511-24451168.56768.250.6069.3269.000.60
2240962-24096267.57268.32
3244750-24475068.63469.39
4242958-24295868.13268.88
5244333-24433368.51869.27
6242753-24275368.07468.82
极限1249354-24935469.92669.680.7070.8370.580.70
2245667-24566768.89269.78
3250442-25044270.23171.14
4247469-24746969.39770.30
5249621-24962170.00070.91
6248335-24833569.64070.54
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%
110.123228093227363229393227283229093228240.04
210.123238393236223237300.05
单位质量响应值RSD%判断
31899.6031989.130.20数据可信
中间条件6月-供试品溶液-2023072811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%
5min1141565-14156539.72537.636.1239.7337.636.13
2139163-13916339.05139.05
3121536-12153634.10534.10
4140051-14005139.30039.30
5126409-12640935.47235.47
6135827-13582738.11538.11
10min1181194-18119450.84550.860.1350.9350.940.13
2181264-18126450.86550.95
3181607-18160750.96151.04
4181167-18116750.83850.93
5180904-18090450.76450.84
6181286-18128650.87150.96
15min1202493-20249356.82256.920.3257.0257.120.32
2202457-20245756.81257.01
3202037-20203756.69456.88
4203449-20344957.09157.29
5203702-20370257.16257.35
6202987-20298756.96157.16
20min1216579-21657960.77559.611.7861.1059.931.78
2214576-21457660.21360.54
3207708-20770858.28658.60
4216032-21603260.62160.95
5210370-21037059.03359.35
6209323-20932358.73959.06
30min1227062-22706263.71763.012.8164.1863.472.79
2228015-22801563.98464.44
3211755-21175559.42159.87
4227244-22724463.76864.23
5226281-22628163.49763.95
6226961-22696163.68864.14
45min1237960-23796066.77567.120.3067.3867.720.29
2240039-24003967.35867.96
3239478-23947867.20167.78
4238988-23898867.06367.67
5239609-23960967.23767.83
6239114-23911467.09967.69
60min1246059-24605969.04769.170.2369.8069.920.21
2246744-24674469.24069.99
3247261-24726169.38570.11
4246088-24608869.05669.81
5246918-24691869.28870.03
6245939-24593969.01469.76
极限1250723-25072370.35670.600.2571.2671.500.23
2252210-25221070.77471.68
3252250-25225070.78571.66
4251162-25116270.47971.39
5251773-25177370.65171.55
6251330-25133070.52771.43
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%
110.123232583231913234343233743231413232800.04
210.123250283252153251220.05
单位质量响应值RSD%判断
31944.6632126.680.41数据可信
加速6月-供试品溶液-2023072911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%
5min1115681-11568132.36932.961.0132.3732.961.01
2118463-11846333.14833.15
3119029-11902933.30633.31
4117344-11734432.83532.83
5117954-11795433.00533.01
6118339-11833933.11333.11
10min1164447-16444746.01546.310.3746.0946.380.37
2165337-16533746.26446.34
3166286-16628646.52946.60
4165625-16562546.34446.42
5165512-16551246.31346.39
6165756-16575646.38146.45
15min1192016-19201653.72953.600.2753.9053.770.27
2191174-19117453.49353.67
3190717-19071753.36653.54
4191985-19198553.72053.90
5191704-19170453.64253.82
6191643-19164353.62553.80
20min1206595-20659557.80857.800.1158.1058.090.11
2206317-20631757.73158.03
3206289-20628957.72358.02
4206874-20687457.88758.18
5206688-20668857.83458.13
6206527-20652757.78958.09
30min1223225-22322562.46262.820.3362.8863.250.33
2225036-22503662.96963.39
3224703-22470362.87563.30
4224277-22427762.75663.18
5224593-22459362.84563.27
6225271-22527163.03463.46
45min1239104-23910466.90566.880.1567.4767.440.15
2238463-23846366.72667.29
3239343-23934366.97267.54
4239378-23937866.98267.55
5238996-23899666.87567.44
6238800-23880066.82067.38
60min1245581-24558168.71768.680.1469.4369.400.15
2245122-24512268.58969.30
3245272-24527268.63169.34
4245959-24595968.82369.54
5245130-24513068.59169.30
6245714-24571468.75569.47
极限1251537-25153770.38470.340.2571.2571.200.25
2251756-25175670.44571.31
3251708-25170870.43271.30
4250622-25062270.12870.99
5250630-25063070.13070.99
6252034-25203470.52371.39
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%
110.123249803250783252493246393249873249870.07
210.123243523246623245070.07
单位质量响应值RSD%判断
32113.3432065.910.11数据可信
长期6月-供试品溶液-2023072911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%
5min1146780-14678041.00238.854.5341.0038.854.53
2142404-14240439.78039.78
3131339-13133936.68936.69
4142901-14290139.91839.92
5131800-13180036.81736.82
6139205-13920538.88638.89
10min1186379-18637952.06452.011.0752.1552.101.07
2187847-18784752.47452.56
3183684-18368451.31151.39
4187651-18765152.41952.51
5187779-18777952.45552.54
6183761-18376151.33251.42
15min1204931-20493157.24657.410.8457.4557.610.85
2207681-20768158.01458.22
3203676-20367656.89557.09
4206560-20656057.70157.91
5206726-20672657.74757.95
6203555-20355556.86257.06
20min1217919-21791960.87460.900.7761.2161.230.77
2219485-21948561.31261.65
3215869-21586960.30160.62
4218907-21890761.15061.48
5216199-21619960.39460.72
6219741-21974161.38361.71
30min1230524-23052464.39564.720.8664.8665.180.86
2234690-23469065.55966.03
3229565-22956564.12764.58
4233176-23317665.13665.61
5232010-23201064.81065.27
6230133-23013364.28664.75
45min1243134-24313467.91868.190.7768.5368.800.77
2246897-24689768.96969.58
3241215-24121567.38267.98
4244414-24441468.27568.89
5244235-24423568.22568.83
6244754-24475468.37068.98
60min1249303-24930369.64169.830.6470.4070.590.64
2251702-25170270.31171.08
3248236-24823669.34370.09
4251484-25148470.25071.02
5250909-25090970.09070.85
6248287-24828769.35770.12
极限1255104-25510471.26171.511.1072.1872.421.09
2257442-25744271.91572.84
3253669-25366970.86171.76
4261017-26101772.91373.84
5254041-25404170.96571.88
6254664-25466471.13972.05
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%
110.123237163238013238403238443237543237910.02
210.123242213244863243540.06
单位质量响应值RSD%判断
31995.1632050.790.13数据可信
中间条件6月-供试品溶液-2023072911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%
5min1144604-14460440.47838.883.1740.4838.883.17
2135483-13548337.92537.92
3134657-13465737.69437.69
4143455-14345540.15740.16
5135349-13534937.88737.89
6139866-13986639.15239.15
10min1187840-18784052.58151.601.4052.6751.681.40
2180842-18084250.62250.71
3183744-18374451.43451.52
4186298-18629852.14952.24
5182323-18232351.03751.12
6184874-18487451.75151.84
15min1205660-20566057.56957.170.5357.7857.370.54
2202865-20286556.78756.98
3203662-20366257.01057.21
4205361-20536157.48657.69
5203721-20372157.02657.22
6204106-20410657.13457.34
20min1216801-21680160.68860.540.3761.0260.870.38
2215211-21521160.24360.57
3216217-21621760.52460.85
4217287-21728760.82461.16
5215502-21550260.32460.65
6216641-21664160.64360.97
30min1231707-23170764.86064.530.3865.3365.000.39
2230583-23058364.54665.00
3229291-22929164.18464.64
4231244-23124464.73165.20
5229955-22995564.37064.83
6230440-23044064.50664.97
45min1241572-24157267.62267.650.2968.2468.250.28
2240518-24051867.32767.93
3241393-24139367.57268.17
4242459-24245967.87068.48
5242136-24213667.78068.38
6241878-24187867.70868.31
60min1246818-24681869.09069.131.1269.8569.891.11
2241630-24163067.63868.39
3247896-24789669.39270.14
4248540-24854069.57270.34
5249296-24929669.78470.54
6247586-24758669.30570.06
极限1253484-25348470.95670.860.3971.8771.770.38
2253542-25354270.97371.87
3254020-25402071.10672.01
4252927-25292770.80071.72
5251323-25132370.35171.26
6253617-25361770.99471.91
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