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%
112.044788934787224785324783544785454786090.05
212.064807714806724807220.02
单位质量响应值RSD%判断
39751.5839860.860.20数据可信
供试品溶液-2024010711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%
5min1134444-13444425.23025.666.1425.2325.666.13
2132656-13265624.89424.89
3124846-12484623.42923.43
4142444-14244426.73126.73
5149220-14922028.00328.00
6136912-13691225.69325.69
10min1185475-18547534.80634.432.7734.8634.492.78
2179388-17938833.66433.72
3175842-17584232.99833.05
4185367-18536734.78634.85
5190190-19019035.69135.75
6184610-18461034.64434.70
15min1212114-21211439.80539.311.8239.9439.451.83
2205754-20575438.61238.74
3204114-20411438.30438.43
4209870-20987039.38439.52
5213985-21398540.15640.30
6211089-21108939.61339.75
20min1226456-22645642.49742.001.4442.7242.221.44
2220630-22063041.40341.62
3219489-21948941.18941.40
4223682-22368241.97642.20
5227490-22749042.69142.92
6225260-22526042.27242.49
30min1242165-24216545.44544.961.1245.7645.281.13
2236474-23647444.37744.68
3236403-23640344.36344.67
4239295-23929544.90645.22
5242246-24224645.46045.79
6240957-24095745.21845.53
45min1254251-25425147.71347.270.8748.1347.680.89
2249308-24930846.78547.19
3249451-24945146.81247.21
4251386-25138647.17547.59
5253917-25391747.65048.08
6253079-25307947.49347.91
60min1257893-25789348.39647.940.8048.9248.460.81
2252908-25290847.46147.97
3253304-25330447.53548.04
4255208-25520847.89248.41
5257007-25700748.23048.76
6256613-25661348.15648.68
极限1264661-26466149.66649.390.6450.3050.020.65
2261034-26103448.98649.60
3261604-26160449.09249.70
4262975-26297549.35049.98
5265265-26526549.77950.42
6263617-26361749.47050.10
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%
112.044787714792784788244789014786474788840.05
212.064794604792454793520.04
单位质量响应值RSD%判断
39774.4239747.260.05数据可信
供试品溶液-2024010711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%
5min1133277-13327725.03926.844.8925.0426.844.89
2139559-13955926.21926.22
3139584-13958426.22426.22
4152103-15210328.57628.58
5149537-14953728.09428.09
6143174-14317426.89926.90
10min1185891-18589134.92435.371.7934.9835.431.80
2184504-18450434.66334.72
3185488-18548834.84834.91
4192593-19259336.18336.25
5190983-19098335.88135.94
6190031-19003135.70235.76
15min1214708-21470840.33840.421.7340.4740.561.73
2209738-20973839.40439.54
3212098-21209839.84839.98
4217551-21755140.87241.02
5217100-21710040.78740.93
6219696-21969641.27541.41
20min1229518-22951843.12043.021.6143.3443.241.61
2222385-22238541.78042.00
3227292-22729242.70242.93
4232008-23200843.58843.82
5232004-23200443.58743.82
6230619-23061943.32743.56
30min1245512-24551246.12546.001.3646.4446.321.36
2239427-23942744.98245.30
3242297-24229745.52145.84
4247602-24760246.51846.85
5246543-24654346.31946.65
6247740-24774046.54446.87
45min1254764-25476447.86347.621.3348.2848.041.33
2248122-24812246.61647.03
3250657-25065747.09247.51
4255354-25535447.97448.41
5257031-25703148.28948.72
6254888-25488847.88748.32
60min1262344-26234449.28749.021.0349.8249.551.03
2256727-25672748.23248.75
3259020-25902048.66349.19
4260670-26067048.97349.51
5263480-26348049.50150.04
6263357-26335749.47850.01
极限1264508-26450849.69449.590.8350.3350.240.84
2260044-26004448.85549.48
3262935-26293549.39850.03
4265156-26515649.81650.47
5265610-26561049.90150.55
6265616-26561649.90250.55
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%
112.044785544786234791214784354784584786380.06
212.064875334878894877110.06
单位质量响应值RSD%判断
39753.9940440.381.22数据可信
供试品溶液-2024010811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%
5min1159430-15943029.70428.406.1229.7028.406.12
2160996-16099629.99530.00
3161341-16134130.06030.06
4148218-14821827.61527.61
5140029-14002926.08926.09
6144635-14463526.94726.95
10min1200746-20074637.40136.342.6937.4736.402.70
2198034-19803436.89636.96
3200197-20019737.29937.37
4191307-19130735.64335.70
5188554-18855435.13035.19
6191421-19142135.66435.72
15min1219865-21986540.96340.091.6841.1140.241.68
2216489-21648940.33440.48
3218568-21856840.72240.87
4212640-21264039.61739.76
5211127-21112739.33539.47
6212535-21253539.59839.74
20min1231556-23155643.14142.421.4543.3842.651.46
2228286-22828642.53242.77
3231500-23150043.13143.37
4224840-22484041.89042.12
5224062-22406241.74541.97
6225859-22585942.08042.31
30min1246295-24629545.88745.211.1646.2245.541.17
2242441-24244145.16945.50
3245848-24584845.80446.14
4239744-23974444.66744.99
5240111-24011144.73545.05
6241622-24162245.01745.34
45min1256224-25622447.73747.340.7148.1847.770.72
2254450-25445047.40747.84
3256222-25622247.73748.17
4252782-25278247.09647.52
5252216-25221646.99147.41
6252805-25280547.10047.52
60min1262327-26232748.87448.430.8349.4248.960.84
2259221-25922148.29648.83
3262588-26258848.92349.47
4257353-25735347.94848.47
5258213-25821348.10848.63
6259790-25979048.40248.93
极限1267227-26722749.78749.470.6350.4450.110.64
2265698-26569849.50250.15
3267726-26772649.88050.53
4263579-26357949.10849.74
5264153-26415349.21549.84
6264867-26486749.34849.98
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%
112.044830234834344819574823764826854826950.12
212.064785354782664784000.04
单位质量响应值RSD%判断
40090.9539668.330.75数据可信
供试品溶液-2024010811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%
5min1144338-14433827.03728.536.0227.0428.536.01
2140151-14015126.25326.25
3148504-14850427.81827.82
4160819-16081930.12430.12
5160978-16097830.15430.15
6159091-15909129.80129.80
10min1191347-19134735.84336.512.7835.9036.582.78
2187795-18779535.17835.24
3191437-19143735.86035.92
4200078-20007837.47837.55
5198154-19815437.11837.18
6200678-20067837.59137.66
15min1212481-21248139.80240.261.6139.9440.411.63
2210862-21086239.49839.63
3212515-21251539.80839.95
4217316-21731640.70740.86
5216912-21691240.63240.78
6219602-21960241.13641.29
20min1226035-22603542.34142.661.4842.5742.891.49
2224079-22407941.97442.20
3224991-22499142.14542.38
4231785-23178543.41843.66
5227679-22767942.64942.89
6231798-23179843.42043.66
30min1241295-24129545.19945.381.0845.5245.711.10
2239791-23979144.91745.23
3240335-24033545.01945.34
4245244-24524445.93946.28
5241006-24100645.14545.48
6245839-24583946.05046.39
45min1252641-25264147.32447.590.8947.7548.020.90
2252087-25208747.22147.64
3252133-25213347.22947.65
4256799-25679948.10348.54
5253911-25391147.56248.00
6256868-25686848.11648.56
60min1258564-25856448.43448.600.8648.9649.130.87
2257356-25735648.20848.73
3257444-25744448.22448.75
4262102-26210249.09749.64
5258884-25888448.49449.03
6262259-26225949.12649.67
极限1263873-26387349.42849.670.6750.0650.310.68
2263924-26392449.43850.07
3263143-26314349.29249.93
4267248-26724850.06150.72
5265714-26571449.77350.42
6267037-26703750.02150.68
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