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%
110.413288143287353288213287813287763287850.02
210.483282593283493283040.02
单位质量响应值RSD%判断
31583.5731326.720.58数据可信
供试品溶液-2024010612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%
5min1100431-10043128.62128.958.9428.6228.958.94
295666-9566627.26327.26
386876-8687624.75824.76
4108204-10820430.83630.84
5109335-10933531.15931.16
6109002-10900231.06431.06
10min1146752-14675241.82241.264.4241.8941.324.43
2134042-13404238.20038.26
3139997-13999739.89739.95
4148857-14885742.42242.49
5150326-15032642.84042.91
6148660-14866042.36542.43
15min1171592-17159248.90147.903.9749.0648.053.98
2156824-15682444.69244.84
3162918-16291846.42946.57
4171538-17153848.88549.05
5173310-17331049.39049.55
6172229-17222949.08249.25
20min1186423-18642353.12752.163.5153.3952.433.51
2171768-17176848.95149.20
3178966-17896651.00251.25
4186109-18610953.03853.31
5188252-18825253.64853.92
6186737-18673753.21753.49
30min1205157-20515758.46657.533.0358.8557.903.04
2191049-19104954.44654.80
3198060-19806056.44456.80
4205035-20503558.43158.82
5206696-20669658.90559.30
6205144-20514458.46258.85
45min1221563-22156363.14162.152.6363.6562.662.64
2208081-20808159.29959.77
3214279-21427961.06661.55
4221009-22100962.98463.50
5222403-22240363.38163.91
6221257-22125763.05463.57
60min1229478-22947865.39764.662.5066.0565.312.51
2217272-21727261.91962.52
3222775-22277563.48764.11
4229739-22973965.47166.13
5231664-23166466.02066.69
6230454-23045465.67566.34
极限1236841-23684167.49566.922.1368.2967.712.14
2225744-22574464.33365.08
3232376-23237666.22366.99
4237113-23711367.57368.38
5239151-23915168.15468.97
6237683-23768367.73568.54
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%
110.413292103292843291233291233292493291980.03
210.483299873300883300380.03
单位质量响应值RSD%判断
31623.2531492.180.30数据可信
供试品溶液-2024010612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%
5min1103760-10376029.47329.220.5229.4729.220.51
2102547-10254729.12929.13
3102982-10298229.25229.25
4103004-10300429.25929.26
5102278-10227829.05229.05
6102551-10255129.13029.13
10min1147476-14747641.89141.640.4241.9641.710.43
2147040-14704041.76741.83
3146857-14685741.71541.78
4146341-14634141.56841.63
5146036-14603641.48241.55
6145905-14590541.44541.51
15min1171395-17139548.68548.280.5248.8448.440.52
2170525-17052548.43848.60
3170006-17000648.29148.45
4169520-16952048.15348.31
5169172-16917248.05448.21
6169186-16918648.05848.21
20min1186365-18636552.93752.560.5053.2052.830.50
2185754-18575452.76453.03
3185325-18532552.64252.91
4184480-18448052.40252.67
5184323-18432352.35752.62
6184029-18402952.27452.54
30min1204919-20491958.20857.820.5858.5958.200.57
2204757-20475758.16258.54
3204026-20402657.95458.34
4202433-20243357.50257.88
5202889-20288957.63158.01
6202317-20231757.46957.85
45min1220769-22076962.71062.170.5663.2262.680.55
2219181-21918162.25962.77
3219671-21967162.39862.91
4218029-21802961.93262.44
5217848-21784861.88062.39
6217789-21778961.86362.37
60min1227908-22790864.73864.460.4665.3965.110.46
2227767-22776764.69865.35
3227763-22776364.69765.35
4226147-22614764.23864.88
5226462-22646264.32764.97
6225495-22549564.05264.70
极限1236381-23638167.14566.760.4367.9467.550.43
2235306-23530666.83967.63
3235844-23584466.99267.79
4233964-23396466.45867.25
5234604-23460466.64067.43
6234017-23401766.47367.26
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%
110.413301773298503302593297193298263299660.08
210.483309093310453309770.03
单位质量响应值RSD%判断
31697.0231581.770.26数据可信
供试品溶液-JPS6768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%
5min1145601-14560141.25140.761.4541.2540.761.44
2146804-14680441.59241.59
3142549-14254940.38740.39
4144406-14440640.91340.91
5141400-14140040.06140.06
6142540-14254040.38440.38
10min1181462-18146251.41251.071.1551.5051.161.15
2183414-18341451.96552.06
3178600-17860050.60150.69
4180918-18091851.25751.35
5177891-17789150.40050.49
6179301-17930150.79950.89
15min1199832-19983256.61656.091.0756.8256.291.08
2201011-20101156.95057.16
3196534-19653455.68255.88
4198259-19825956.17056.38
5195692-19569255.44355.64
6196431-19643155.65355.86
20min1209547-20954759.36959.130.9859.7059.460.98
2212149-21214960.10660.44
3208100-20810058.95959.28
4208998-20899859.21359.54
5206894-20689458.61758.94
6206635-20663558.54458.87
30min1222727-22272763.10362.910.7763.5763.370.78
2224835-22483563.70064.17
3220464-22046462.46262.92
4222585-22258563.06263.52
5220284-22028462.41162.87
6221393-22139362.72563.18
45min1233292-23329266.09666.050.7066.7066.650.70
2235877-23587766.82867.44
3231912-23191265.70566.30
4233972-23397266.28966.89
5231752-23175265.66066.25
6231983-23198365.72566.32
60min1240069-24006968.01667.970.7168.7768.720.72
2243086-24308668.87169.63
3238965-23896567.70368.44
4240161-24016168.04268.79
5238543-23854367.58468.32
6238699-23869967.62868.37
极限1243664-24366469.03568.980.6569.9469.880.66
2245854-24585469.65570.57
3242113-24211368.59569.49
4244728-24472869.33670.24
5241977-24197768.55769.45
6242406-24240668.67869.57
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%
110.413334643332373332243329823321053330020.16
210.483318743320013319380.03
单位质量响应值RSD%判断
31988.6631673.470.71数据可信
供试品溶液-JPS6768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%
5min1139587-13958739.31039.851.7939.3139.851.79
2137369-13736938.68638.69
3142248-14224840.06040.06
4143999-14399940.55340.55
5142586-14258640.15540.15
6143332-14333240.36540.36
10min1176303-17630349.65050.441.9649.7450.531.95
2173402-17340248.83348.92
3180883-18088350.94051.03
4182567-18256751.41451.50
5180777-18077750.91051.00
6180771-18077150.90851.00
15min1193604-19360454.52255.361.7454.7255.561.74
2191131-19113153.82654.02
3197933-19793355.74255.94
4199762-19976256.25756.46
5198538-19853855.91256.11
6198597-19859755.92956.13
20min1203922-20392257.42858.271.7357.7558.601.73
2201147-20114756.64756.96
3208313-20831358.66558.99
4210292-21029259.22259.55
5209208-20920858.91759.24
6208682-20868258.76959.10
30min1217629-21762961.28861.941.5061.7362.391.50
2214354-21435460.36660.81
3221367-22136762.34162.80
4223031-22303162.81063.27
5221912-22191262.49562.95
6221319-22131962.32862.79
45min1229285-22928564.57164.911.3265.1565.501.33
2224912-22491263.33963.91
3231535-23153565.20565.80
4233252-23325265.68866.29
5232435-23243565.45866.05
6231570-23157065.21465.81
60min1234813-23481366.12866.771.3066.8567.501.30
2231889-23188965.30466.02
3238532-23853267.17567.91
4239519-23951967.45368.20
5239139-23913967.34668.09
6238697-23869767.22267.96
极限1238724-23872467.22967.981.2868.1068.871.29
2236601-23660166.63167.49
3241751-24175168.08268.97
4243777-24377768.65269.55
5244186-24418668.76769.66
6243366-24336668.53669.43
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