利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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400
标示量(mg)30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%
112.339781059760849800039803239773929783810.19
212.319785999788189787080.02
单位质量响应值RSD%判断
79349.6479505.120.14数据可信
供试品溶液-2024010612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%
5min1232900-23290021.90421.272.8021.9021.282.79
2229207-22920721.55721.56
3221122-22112220.79620.80
4216446-21644620.35620.36
5231233-23123321.74721.75
6226227-22622721.27621.28
10min1285436-28543626.84526.341.6626.8826.371.66
2283207-28320726.63526.67
3276799-27679926.03226.07
4273321-27332125.70525.74
5283172-28317226.63226.67
6278347-27834726.17826.21
15min1303366-30336628.53128.530.6328.6128.610.63
2305924-30592428.77228.85
3303907-30390728.58228.66
4300220-30022028.23528.31
5304181-30418128.60828.69
6302769-30276928.47528.55
20min1311674-31167429.31229.420.5129.4429.550.51
2314942-31494229.62029.75
3314344-31434429.56429.69
4310813-31081329.23129.36
5312651-31265129.40429.53
6312457-31245729.38629.51
30min1319397-31939730.03930.360.6830.2230.540.67
2325442-32544230.60730.78
3323939-32393930.46630.64
4324357-32435730.50530.68
5321550-32155030.24130.42
6322287-32228730.31130.49
45min1326721-32672130.72831.060.7430.9631.290.73
2332672-33267231.28731.52
3331806-33180631.20631.43
4332260-33226031.24831.47
5328112-32811230.85831.09
6329937-32993731.03031.26
60min1329672-32967231.00531.380.9431.2831.660.94
2337907-33790731.78032.06
3335006-33500631.50731.78
4336020-33602031.60231.88
5331275-33127531.15631.43
6332285-33228531.25131.53
极限1332310-33231031.25331.480.4531.5831.810.46
2336033-33603331.60331.94
3335959-33595931.59631.93
4335791-33579131.58131.91
5333873-33387331.40031.73
6334179-33417931.42931.76
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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400
标示量(mg)30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%
112.339772409775059787739770299771799775450.08
212.319814919812809813860.02
单位质量响应值RSD%判断
79281.8379722.660.40数据可信
供试品溶液-2024010612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%
5min1230541-23054121.66221.202.6321.6621.202.63
2225231-22523121.16321.16
3223235-22323520.97520.98
4226446-22644621.27721.28
5215831-21583120.28020.28
6232617-23261721.85721.86
10min1281883-28188326.48625.961.4726.5225.991.48
2277658-27765826.08926.12
3276481-27648125.97826.01
4274948-27494825.83425.87
5269488-26948825.32125.35
6277323-27732326.05726.09
15min1302124-30212428.38828.110.9928.4728.180.99
2302667-30266728.43928.52
3297760-29776027.97828.06
4299427-29942728.13428.21
5294891-29489127.70827.78
6297882-29788227.98928.07
20min1314563-31456329.55629.260.8329.6829.380.84
2313651-31365129.47129.60
3310645-31064529.18829.31
4312278-31227829.34229.47
5308775-30877529.01329.13
6308288-30828828.96729.09
30min1324398-32439830.48130.351.0130.6630.521.01
2326319-32631930.66130.84
3324044-32404430.44730.62
4324895-32489530.52730.70
5320939-32093930.15630.33
6317460-31746029.82930.00
45min1331293-33129331.12831.001.0131.3631.231.00
2332822-33282231.27231.50
3332191-33219131.21331.44
4331109-33110931.11131.34
5328298-32829830.84731.07
6323998-32399830.44330.67
60min1333649-33364931.35031.300.9431.6331.580.94
2335772-33577231.54931.83
3335957-33595731.56731.84
4334518-33451831.43131.71
5331131-33113131.11331.39
6327901-32790130.81031.08
极限1335062-33506231.48331.470.9131.8131.790.91
2337855-33785531.74532.08
3337845-33784531.74432.07
4335930-33593031.56431.89
5332251-33225131.21831.54
6330373-33037331.04231.37
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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400
标示量(mg)30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%
112.339901159921459914379904479917419911770.09
212.319904449926729915580.16
单位质量响应值RSD%判断
80387.4380548.980.15数据可信
供试品溶液-2024010911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%
5min1236426-23642621.94821.642.6721.9521.642.67
2229603-22960321.31421.31
3228393-22839321.20221.20
4232049-23204921.54221.54
5227928-22792821.15921.16
6244026-24402622.65322.65
10min1281664-28166426.14725.821.4626.1825.861.46
2278936-27893625.89425.93
3276488-27648825.66725.70
4275541-27554125.57925.61
5272712-27271225.31625.35
6283557-28355726.32326.36
15min1300001-30000127.85027.710.8127.9327.780.81
2300902-30090227.93328.01
3298888-29888827.74627.82
4296025-29602527.48127.56
5294992-29499227.38527.46
6300011-30001127.85127.93
20min1308696-30869628.65728.640.7328.7828.760.73
2312350-31235028.99629.12
3309412-30941228.72328.85
4307786-30778628.57228.70
5306089-30608928.41528.54
6306707-30670728.47228.60
30min1317020-31702029.43029.630.6229.6029.800.61
2322422-32242229.93130.10
3320146-32014629.72029.89
4319023-31902329.61529.79
5318843-31884329.59929.77
6317457-31745729.47029.65
45min1323705-32370530.05030.240.5130.2730.460.51
2327314-32731430.38530.61
3326984-32698430.35530.58
4325977-32597730.26130.48
5326804-32680430.33830.56
6323648-32364830.04530.27
60min1326196-32619630.28130.520.5830.5530.790.58
2331302-33130230.75531.03
3329980-32998030.63330.90
4329115-32911530.55230.82
5328957-32895730.53830.81
6326998-32699830.35630.63
极限1326245-32624530.28630.590.5630.6130.910.55
2331655-33165530.78831.11
3330144-33014430.64830.97
4329206-32920630.56130.88
5330399-33039930.67230.99
6329462-32946230.58530.91
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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400
标示量(mg)30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%
112.339872989884369897709875499876519881410.11
212.319839829842159840980.02
单位质量响应值RSD%判断
80141.2079942.970.18数据可信
供试品溶液-2024010911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%
5min1237112-23711222.12920.944.7722.1320.944.76
2231745-23174521.62821.63
3228663-22866321.34021.34
4220725-22072520.59920.60
5221521-22152120.67420.67
6206652-20665219.28619.29
10min1275508-27550825.71225.422.6525.7525.452.66
2275892-27589225.74825.78
3276800-27680025.83325.87
4272749-27274925.45525.49
5275299-27529925.69325.73
6257923-25792324.07124.10
15min1299020-29902027.90627.661.6427.9927.741.65
2297634-29763427.77727.86
3298904-29890427.89627.97
4296940-29694027.71227.79
5299073-29907327.91127.99
6286634-28663426.75026.82
20min1309741-30974128.90728.740.7929.0328.860.80
2308826-30882628.82228.95
3309269-30926928.86328.99
4307994-30799428.74428.87
5308776-30877628.81728.94
6303210-30321028.29728.41
30min1319165-31916529.78629.720.2529.9629.890.25
2318120-31812029.68929.86
3318485-31848529.72329.90
4317152-31715229.59929.77
5319313-31931329.80029.97
6318488-31848829.72329.89
45min1323589-32358930.19930.340.3330.4230.560.32
2324575-32457530.29130.51
3324493-32449330.28430.51
4325936-32593630.41830.64
5325332-32533230.36230.58
6326446-32644630.46630.68
60min1326597-32659730.48030.570.3130.7530.840.29
2326619-32661930.48230.76
3328520-32852030.65930.93
4327836-32783630.59630.87
5327130-32713030.53030.80
6328956-32895630.70030.96
极限1329466-32946630.74830.670.3131.0730.990.29
2327997-32799730.61130.93
3328457-32845730.65430.98
4327730-32773030.58630.91
5327726-32772630.58530.91
6330118-33011830.80931.12
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