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%
110.123223653216673221963223793222333221680.10
210.123229143222573225860.15
单位质量响应值RSD%判断
31834.7831876.090.10数据可信
加速6月-供试品溶液-2023073011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%
5min1118111-11811133.23633.375.3333.2433.375.33
2120061-12006133.78533.78
3118926-11892633.46533.47
4125223-12522335.23735.24
5122414-12241434.44734.45
6106818-10681830.05830.06
10min1163231-16323145.93346.054.4246.0146.124.43
2159911-15991144.99845.07
3159894-15989444.99445.07
4175122-17512249.27949.36
5168726-16872647.47947.56
6154950-15495043.60243.67
15min1188008-18800852.90551.994.7953.0852.174.79
2179593-17959350.53750.71
3183675-18367551.68551.86
4195699-19569955.06955.26
5190856-19085653.70653.89
6170775-17077548.05548.22
20min1203580-20358057.28756.563.2157.5856.853.21
2192075-19207554.04954.34
3198377-19837755.82356.11
4209517-20951758.95759.27
5205738-20573857.89458.20
6196663-19666355.34055.61
30min1221949-22194962.45661.602.9162.8862.022.91
2208400-20840058.64359.05
3216336-21633660.87661.29
4226966-22696663.86764.31
5221929-22192962.45062.88
6217790-21779061.28561.68
45min1238902-23890267.22665.065.4967.7965.615.47
2222686-22268662.66363.20
3209749-20974959.02359.57
4242984-24298468.37568.96
5239555-23955567.41067.98
6233301-23330165.65066.18
60min1246735-24673569.43068.252.8970.1468.952.90
2231793-23179365.22665.90
3240811-24081167.76368.44
4250136-25013670.38771.12
5247978-24797869.78070.50
6237874-23787466.93767.61
极限1254007-25400771.47768.395.9672.3469.245.91
2240117-24011767.56868.39
3245160-24516068.98769.82
4256502-25650272.17973.07
5246326-24632669.31570.19
6216196-21619660.83761.66
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%
110.123229403229713229973225443224913227890.08
210.123247923252713250320.11
单位质量响应值RSD%判断
31896.1532117.790.49数据可信
长期6月-供试品溶液-2023073011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%
5min1115621-11562132.38232.465.5232.3832.465.52
2109002-10900230.52830.53
3124183-12418334.78034.78
4122010-12201034.17134.17
5108791-10879130.46930.47
6115721-11572132.41032.41
10min1160853-16085345.05045.083.8945.1245.153.88
2155492-15549243.54843.62
3170222-17022247.67447.75
4165988-16598846.48846.56
5153753-15375343.06143.13
6159495-15949544.66944.74
15min1186095-18609552.11951.992.6852.2952.162.68
2181149-18114950.73450.90
3192975-19297554.04654.23
4189389-18938953.04253.22
5179891-17989150.38250.55
6184353-18435351.63151.80
20min1201808-20180856.52056.441.6256.8156.731.64
2198113-19811355.48555.76
3206486-20648657.83058.13
4203770-20377057.06957.37
5198153-19815355.49655.77
6200807-20080756.23956.53
30min1224279-22427962.81361.851.1463.2362.261.15
2217225-21722560.83861.24
3222560-22256062.33262.76
4221634-22163462.07262.50
5219356-21935661.43461.83
6219989-21998961.61262.02
45min1237231-23723166.44166.500.7366.9967.050.74
2235376-23537665.92166.46
3240647-24064767.39767.97
4237338-23733866.47167.03
5236945-23694566.36166.90
6237163-23716366.42266.97
60min1245139-24513968.65568.770.6369.3669.470.65
2243135-24313568.09468.78
3247861-24786169.41870.14
4246290-24629068.97869.69
5245553-24555368.77169.45
6245325-24532568.70869.40
极限1253087-25308770.88171.100.6571.7371.940.66
2251336-25133670.39171.22
3255866-25586671.66072.53
4255283-25528371.49672.36
5254059-25405971.15471.99
6253480-25348070.99171.84
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%
110.123215513216133213203214073205233212830.14
210.123228843225363227100.08
单位质量响应值RSD%判断
31747.3331888.340.32数据可信
中间条件6月-供试品溶液-2023073011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%
5min1116544-11654432.83432.1310.3432.8332.1310.34
2121509-12150934.23334.23
3112782-11278231.77431.77
4129710-12971036.54336.54
595146-9514626.80526.81
6108667-10866730.61530.61
10min1162085-16208545.66444.417.1345.7444.487.14
2165558-16555846.64346.72
3159305-15930544.88144.95
4169202-16920247.66947.75
5138339-13833938.97439.03
6151370-15137042.64542.71
15min1186585-18658552.56751.384.8752.7451.554.88
2189183-18918353.29953.48
3185307-18530752.20752.38
4188977-18897753.24153.43
5166389-16638946.87747.02
6177794-17779450.09050.25
20min1202969-20296957.18255.953.4557.4756.233.46
2203903-20390357.44657.74
3202154-20215456.95357.24
4202097-20209756.93757.24
5186976-18697652.67752.93
6193384-19338454.48254.76
30min1220916-22091662.23961.571.5962.6661.981.62
2221559-22155962.42062.85
3221434-22143462.38562.80
4218704-21870461.61662.05
5213514-21351460.15360.52
6215101-21510160.60061.00
45min1237569-23756966.93066.400.9467.4966.940.95
2237341-23734166.86667.43
3237943-23794367.03667.59
4233750-23375065.85466.42
5234676-23467666.11566.62
6232817-23281765.59266.12
60min1246605-24660569.47669.010.9270.1869.710.92
2247665-24766569.77570.49
3246266-24626669.38170.08
4242369-24236968.28369.00
5244391-24439168.85269.50
6242485-24248568.31568.99
极限1252916-25291671.25471.270.6872.1172.110.67
2255191-25519171.89572.76
3253350-25335071.37672.23
4250396-25039670.54471.41
5254150-25415071.60272.40
6251729-25172970.92071.75
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%
110.123222523216553215823217043222633218910.11
210.123228203221803225000.15
单位质量响应值RSD%判断
31807.4131867.590.14数据可信
加速6月-供试品溶液-JPS5249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%
5min1154233-15423343.42543.431.8043.4343.431.80
2150091-15009142.25942.26
3152368-15236842.90042.90
4158078-15807844.50844.51
5154981-15498143.63643.64
6155761-15576143.85543.86
10min1194928-19492854.88354.611.8654.9854.711.86
2191556-19155653.93454.03
3187869-18786952.89552.99
4197526-19752655.61455.71
5196022-19602255.19155.29
6195952-19595255.17155.27
15min1213603-21360360.14159.713.0260.3659.933.01
2211774-21177459.62659.84
3199481-19948156.16556.38
4216254-21625460.88761.11
5216133-21613360.85361.07
6215147-21514760.57660.80
20min1224292-22429263.15162.773.9163.5063.123.90
2223816-22381663.01763.36
3205669-20566957.90758.24
4229056-22905664.49264.85
5227587-22758764.07864.43
6227265-22726563.98864.34
30min1239710-23971067.49267.820.8867.9868.300.89
2238792-23879267.23367.72
3238506-23850667.15367.62
4243224-24322468.48168.98
5242941-24294168.40168.90
6241984-24198468.13268.63
45min1250915-25091570.64671.090.7371.2971.730.73
2251655-25165570.85571.49
3250148-25014870.43071.05
4253646-25364671.41572.07
5254640-25464071.69572.34
6253900-25390071.48772.14
60min1257070-25707072.37973.030.6573.1873.830.66
2259446-25944673.04873.84
3257731-25773172.56573.34
4260548-26054873.35974.17
5261381-26138173.59374.40
6260190-26019073.25874.06
极限1261540-26154073.63874.181.0874.6075.151.08
2263218-26321874.11075.07
3259033-25903372.93273.87
4265201-26520174.66975.64
5266753-26675375.10676.08
6265119-26511974.64675.62
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%
110.123227353227353220783226133227563225830.09
210.123234613230033232320.11
单位质量响应值RSD%判断
31875.7931939.920.15数据可信
长期6月-供试品溶液-JPS5249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%
5min1159341-15934144.76442.935.9744.7642.935.97
2160397-16039745.06145.06
3159579-15957944.83144.83
4153812-15381243.21143.21
5138053-13805338.78438.78
6145723-14572340.93940.94
10min1195503-19550354.92353.943.4055.0254.043.41
2197613-19761355.51655.62
3196241-19624155.13155.23
4194286-19428654.58254.68
5180771-18077150.78550.87
6187569-18756952.69552.79
15min1214937-21493760.38359.462.6060.6059.672.60
2216071-21607160.70260.93
3216396-21639660.79361.02
4212818-21281859.78860.01
5203782-20378257.24957.45
6205815-20581557.82058.03
20min1225834-22583463.44562.901.7563.8063.251.76
2226988-22698863.76964.13
3226590-22659063.65764.01
4226005-22600563.49363.84
5217652-21765261.14661.47
6220361-22036161.90762.24
30min1239755-23975567.35567.011.1167.8567.491.12
2240192-24019267.47867.98
3241960-24196067.97568.47
4238042-23804266.87467.37
5234973-23497366.01266.47
6236146-23614666.34166.82
45min1253136-25313671.11570.630.7471.7671.270.75
2253452-25345271.20371.85
3252667-25266770.98371.63
4249864-24986470.19570.84
5249950-24995070.22070.83
6249428-24942870.07370.69
60min1258118-25811872.51472.370.5573.3273.160.57
2258966-25896672.75273.56
3259213-25921372.82273.63
4257224-25722472.26373.06
5256264-25626471.99372.76
6255789-25578971.86072.64
极限1262860-26286073.84673.780.3974.8174.730.41
2263272-26327273.96274.93
3264158-26415874.21175.18
4261887-26188773.57374.53
5262243-26224373.67374.60
6261316-26131673.41374.35
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%
110.123223873218393224583224193224643223130.09
210.123249523241623245570.18
单位质量响应值RSD%判断
31849.1132070.850.50数据可信
中间条件6月-供试品溶液-JPS5249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%
5min1145407-14540740.78441.244.2140.7841.244.21
2144331-14433140.48240.48
3146605-14660541.12041.12
4158585-15858544.48044.48
5140119-14011939.30039.30
6147209-14720941.28941.29
10min1185924-18592452.14852.652.8352.2452.742.84
2186885-18688552.41752.51
3186030-18603052.17852.27
4197708-19770855.45355.55
5181845-18184551.00451.09
6187830-18783052.68252.77
15min1207496-20749658.19858.501.8158.4058.701.81
2207935-20793558.32158.53
3206847-20684758.01658.22
4215460-21546060.43260.65
5204321-20432157.30857.51
6209304-20930458.70558.91
20min1220557-22055761.86262.261.3262.2062.601.33
2220861-22086161.94762.28
3220262-22026261.77962.12
4227590-22759063.83464.19
5219860-21986061.66661.99
6222654-22265462.45062.79
30min1235626-23562666.08866.550.7866.5667.020.78
2236360-23636066.29466.77
3235507-23550766.05566.53
4240308-24030867.40167.90
5237630-23763066.65067.12
6238147-23814766.79567.27
45min1247587-24758769.44370.171.0870.0670.791.09
2248918-24891869.81670.44
3247159-24715969.32369.94
4253356-25335671.06171.71
5251005-25100570.40271.01
6253029-25302970.96971.60
60min1253885-25388571.20971.900.8271.9872.680.82
2256201-25620171.85972.64
3254151-25415171.28472.06
4259340-25934072.73973.55
5257500-25750072.22372.99
6257048-25704872.09772.88
极限1259687-25968772.83773.210.5873.7774.140.58
2260168-26016872.97273.91
3259166-25916672.69173.62
4262603-26260373.65574.62
5262312-26231273.57374.50
6262088-26208873.51074.45
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