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800
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%
112.044810144795844783054787094795294794280.22
212.064827594800794814190.40
单位质量响应值RSD%判断
39819.6039918.660.18数据可信
供试品溶液-2024010911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%
5min1181425-18142533.99232.484.6533.9932.484.66
2177990-17799033.34933.35
3172617-17261732.34232.34
4172051-17205132.23632.24
5177347-17734733.22833.23
6158535-15853529.70429.70
10min1223050-22305041.79141.511.7041.8741.581.70
2222019-22201941.59841.67
3222336-22233641.65841.73
4223104-22310441.80241.87
5224636-22463642.08942.16
6214090-21409040.11340.18
15min1246449-24644946.17546.100.8246.3446.260.82
2244289-24428945.77145.94
3246864-24686446.25346.42
4247961-24796146.45946.62
5247792-24779246.42746.59
6242957-24295745.52145.68
20min1257535-25753548.25348.420.8148.5248.680.81
2255194-25519447.81448.08
3258773-25877348.48548.75
4260297-26029748.77049.04
5260917-26091748.88649.16
6257755-25775548.29448.55
30min1271606-27160650.88951.040.9151.2751.420.91
2268668-26866850.33950.71
3271897-27189750.94451.32
4274707-27470751.47051.85
5275596-27559651.63752.02
6272092-27209250.98051.34
45min1282783-28278352.98352.502.4953.4752.992.48
2279355-27935552.34152.83
3283293-28329353.07953.57
4284912-28491253.38253.87
5284396-28439653.28553.78
6266543-26654349.94050.42
60min1288863-28886354.12253.822.1954.7354.422.17
2286426-28642653.66654.27
3289523-28952354.24654.85
4292135-29213554.73555.34
5291410-29141054.60055.21
6275126-27512651.54952.14
极限1289062-28906254.16054.251.2054.8954.971.20
2285814-28581453.55154.27
3291384-29138454.59555.32
4293034-29303454.90455.63
5292789-29278954.85855.59
6285125-28512553.42254.12
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800
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%
112.044797484804734798504803374788644798540.14
212.064836484834084835280.04
单位质量响应值RSD%判断
39854.9840093.530.43数据可信
供试品溶液-2024010911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%
5min1171455-17145532.04033.082.3832.0433.082.38
2172248-17224832.18832.19
3181431-18143133.90433.90
4177668-17766833.20133.20
5180464-18046433.72433.72
6178716-17871633.39733.40
10min1224206-22420641.89842.322.2441.9742.402.24
2219149-21914940.95341.02
3225093-22509342.06442.14
4227440-22744042.50242.58
5234316-23431643.78743.86
6228632-22863242.72542.80
15min1250540-25054046.81947.491.5046.9847.651.50
2249639-24963946.65146.81
3258848-25884848.37148.54
4254479-25447947.55547.72
5258096-25809648.23148.40
6253118-25311847.30147.47
20min1270514-27051450.55150.281.8450.8250.561.83
2264852-26485249.49349.76
3262907-26290749.13049.41
4275895-27589551.55751.83
5267470-26747049.98350.26
6272882-27288250.99451.27
30min1279172-27917252.16952.500.9552.5552.880.95
2280229-28022952.36752.74
3277595-27759551.87552.26
4282056-28205652.70853.10
5281166-28116652.54252.93
6285307-28530753.31653.70
45min1290139-29013954.21953.820.8054.7254.330.80
2286039-28603953.45353.95
3284598-28459853.18353.68
4289223-28922354.04854.55
5290136-29013654.21854.73
6288028-28802853.82454.33
60min1291143-29114354.40654.120.7655.0254.740.76
2288611-28861153.93354.54
3285828-28582853.41354.03
4290881-29088154.35754.98
5291783-29178354.52655.15
6289583-28958354.11554.74
极限1295250-29525055.17454.522.1955.9155.272.16
2295089-29508955.14455.88
3290407-29040754.26955.01
4295351-29535155.19355.94
5295165-29516555.15855.91
6279338-27933852.20052.95
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800
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%
112.044812004803764811254807004799564806710.11
212.064793644792034792840.03
单位质量响应值RSD%判断
39922.8439741.630.33数据可信
供试品溶液-JPS5451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%
5min1225769-22576942.34041.512.4342.3441.512.43
2218454-21845440.96840.97
3211831-21183139.72639.73
4223441-22344141.90441.90
5225756-22575642.33842.34
6222793-22279341.78241.78
10min1260256-26025648.80848.151.3048.9048.241.30
2256363-25636348.07848.17
3250542-25054246.98647.07
4257974-25797448.38048.47
5258284-25828448.43848.53
6257036-25703648.20448.30
15min1276141-27614151.78751.370.9451.9951.570.94
2275464-27546451.66051.86
3269105-26910550.46750.66
4274715-27471551.51951.72
5274932-27493251.56051.76
6273127-27312751.22251.42
20min1283997-28399753.26052.760.6453.5853.070.65
2280036-28003652.51752.83
3278970-27897052.31752.62
4281079-28107952.71353.03
5282575-28257552.99353.31
6281221-28122152.73953.05
30min1293624-29362455.06654.400.7155.5054.840.71
2290000-29000054.38654.82
3287384-28738453.89554.32
4290013-29001354.38854.82
5290421-29042154.46554.90
6289103-28910354.21854.65
45min1293345-29334555.01354.940.3755.5755.490.38
2292791-29279154.90955.46
3291630-29163054.69255.23
4294773-29477355.28155.83
5292905-29290554.93155.49
6292160-29216054.79155.34
60min1297895-29789555.86655.840.2756.5556.510.27
2296796-29679655.66056.33
3298525-29852555.98556.65
4298652-29865256.00856.68
5297600-29760055.81156.49
6296906-29690655.68156.35
极限1296808-29680855.66355.640.2956.4756.440.30
2295189-29518955.35956.15
3296501-29650155.60556.39
4297764-29776455.84256.64
5297064-29706455.71156.51
6296953-29695355.69056.49
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800
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%
112.044802274799034798634801984799604800300.04
212.064864204858994861600.08
单位质量响应值RSD%判断
39869.6040311.770.78数据可信
供试品溶液-JPS5451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%
5min1224125-22412541.76241.302.9441.7641.302.94
2227228-22722842.34042.34
3210299-21029939.18639.19
4227860-22786042.45842.46
5221540-22154041.28041.28
6218942-21894240.79640.80
10min1258771-25877148.21847.841.9148.3147.931.91
2258236-25823648.11848.21
3247615-24761546.13946.23
4262255-26225548.86748.96
5256758-25675847.84347.93
6256709-25670947.83347.92
15min1272937-27293750.85750.651.0251.0650.841.02
2272585-27258550.79250.99
3266875-26687549.72849.92
4274957-27495751.23451.44
5272713-27271350.81551.01
6270760-27076050.45250.65
20min1281049-28104952.36952.041.0352.6852.351.03
2278626-27862651.91752.23
3275642-27564251.36151.66
4283690-28369052.86153.18
5279582-27958252.09552.41
6277172-27717251.64651.96
30min1287070-28707053.49153.401.7053.9253.831.70
2286327-28632753.35253.78
3287238-28723853.52253.94
4291526-29152654.32154.76
5289866-28986654.01254.44
6277505-27750551.70852.13
45min1290189-29018954.07254.050.9754.6254.590.97
2288794-28879453.81254.36
3291607-29160754.33654.87
4293004-29300454.59655.15
5291592-29159254.33354.88
6285167-28516753.13653.67
60min1293850-29385054.75455.180.5755.4255.840.56
2294718-29471854.91655.58
3295804-29580455.11855.77
4297392-29739255.41456.09
5296714-29671455.28855.96
6298300-29830055.58356.24
极限1292988-29298854.59355.010.5655.3855.800.55
2293448-29344854.67955.47
3295866-29586655.13055.91
4295618-29561855.08355.88
5296384-29638455.22656.02
6297112-29711255.36256.14
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