利伐沙班口崩片项目信息
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对照品来源中检所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)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%
114.894705354703264699164704314701974702810.06
214.944708174713614710890.09
单位质量响应值RSD%判断
31583.6831532.060.12数据可信
长期6月-供试品溶液-2024122821批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1333479-33347963.15064.123.8363.1564.123.83
2360334-36033468.23568.24
3333215-33321563.10063.10
4335192-33519263.47463.47
5323180-32318061.19961.20
6346324-34632465.58265.58
10min1453155-45315585.81286.941.2585.9287.041.25
2466141-46614188.27188.39
3464659-46465987.99188.10
4455400-45540086.23886.34
5461444-46144487.38287.48
6453759-45375985.92786.04
15min1483181-48318191.49891.151.0391.7591.401.02
2481138-48113891.11191.37
3481845-48184591.24591.50
4477820-47782090.48390.73
5489264-48926492.65092.90
6474851-47485189.92190.17
20min1494771-49477193.69392.351.0694.0992.751.05
2485090-48509091.86092.27
3487823-48782392.37792.78
4484609-48460991.76992.17
5492488-49248893.26193.66
6481149-48114991.11491.52
30min1500442-50044294.76793.291.1295.3293.851.11
2490801-49080192.94193.51
3493123-49312393.38193.94
4486816-48681692.18792.74
5497424-49742494.19594.75
6487227-48722792.26492.82
45min1504211-50421195.48193.841.0496.2094.551.04
2492941-49294193.34794.07
3494090-49409093.56494.28
4490489-49048992.88293.59
5499139-49913994.52095.23
6492339-49233993.23393.94
60min1505115-50511595.65294.080.9696.5394.960.96
2495282-49528293.79094.67
3494509-49450993.64394.51
4492478-49247893.25994.12
5499807-49980794.64795.52
6493842-49384293.51794.38
极限1509725-50972596.52595.630.7897.5696.660.77
2507095-50709596.02797.06
3504610-50461095.55696.58
4498020-49802094.30895.33
5504756-50475695.58496.61
6505751-50575195.77296.79
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
114.894697974691244694464696624701634696380.09
214.944732674731814732240.02
单位质量响应值RSD%判断
31540.5031674.970.31数据可信
长期6月-供试品溶液-2024122921批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1401816-40181675.97173.592.6075.9773.602.60
2391213-39121373.96673.97
3386644-38664473.10273.10
4371307-37130770.20270.20
5392163-39216374.14674.15
6392336-39233674.17874.18
10min1478289-47828990.42986.675.2190.5686.795.21
2462876-46287687.51587.64
3468458-46845888.57188.69
4468992-46899288.67288.79
5460437-46043787.05487.18
6411316-41131677.76777.89
15min1488329-48832992.32890.632.2192.6090.892.21
2475384-47538489.88090.15
3483802-48380291.47291.74
4491031-49103192.83993.10
5475140-47514089.83490.10
6462325-46232587.41187.66
20min1494087-49408793.41691.841.6193.8592.261.61
2481278-48127890.99591.41
3489319-48931992.51592.94
4494314-49431493.45993.88
5478888-47888890.54390.96
6476720-47672090.13390.53
30min1497435-49743594.04993.041.1094.6493.621.10
2486821-48682192.04392.61
3493497-49349793.30593.88
4498844-49884494.31694.89
5485853-48585391.86092.43
6490264-49026492.69393.24
45min1499678-49967894.47393.411.2895.2294.131.27
2489364-48936492.52393.25
3495624-49562493.70794.44
4501562-50156294.83095.56
5484890-48489091.67792.40
6493098-49309893.22993.93
60min1500455-50045594.62093.631.0995.5294.521.09
2492807-49280793.17494.05
3496215-49621593.81994.71
4501852-50185294.88495.77
5487455-48745592.16293.04
6492677-49267793.15094.01
极限1513722-51372297.12995.930.8498.1996.970.84
2507012-50701295.86096.89
3505929-50592995.65596.70
4510040-51004096.43397.48
5501106-50110694.74395.77
6506556-50655695.77496.79
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
114.894699094697624693214701414694174697100.08
214.944687864691224689540.06
单位质量响应值RSD%判断
31545.3331389.160.36数据可信
长期6月-供试品溶液-2024123021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1357149-35714967.82766.786.2267.8366.786.22
2352066-35206666.86266.86
3309210-30921058.72358.72
4369052-36905270.08870.09
5367070-36707069.71169.71
6355166-35516667.45167.45
10min1477115-47711590.61089.021.8590.7289.131.85
2455824-45582486.56786.68
3460849-46084987.52187.62
4474548-47454890.12390.24
5475026-47502690.21490.33
6469079-46907989.08489.20
15min1492296-49229693.49392.980.8293.7693.240.82
2484623-48462392.03692.29
3485097-48509792.12692.37
4489804-48980493.02093.29
5494582-49458293.92894.19
6491116-49111693.26993.53
20min1498555-49855594.68294.310.8495.1094.730.84
2494417-49441793.89694.31
3493283-49328393.68194.08
4496888-49688894.36594.79
5503747-50374795.66896.09
6492793-49279393.58894.00
30min1503011-50301195.52895.420.3596.1195.990.36
2502541-50254195.43996.00
3502364-50236495.40595.96
4501640-50164095.26895.85
5505158-50515895.93696.52
6499798-49979894.91895.49
45min1506399-50639996.17296.220.3496.9196.950.34
2506067-50606796.10996.83
3506166-50616696.12796.84
4505528-50552896.00696.74
5510007-51000796.85797.60
6505695-50569596.03896.77
60min1508120-50812096.49996.580.4997.4097.470.49
2508130-50813096.50097.39
3508254-50825496.52497.40
4507267-50726796.33797.23
5513324-51332497.48798.39
6506221-50622196.13897.03
极限1510169-51016996.88897.020.6297.9598.070.62
2510382-51038296.92897.97
3508750-50875096.61897.65
4513524-51352497.52598.58
5515493-51549397.89998.97
6506892-50689296.26597.32
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
114.894714744711614711954712984711584712570.03
214.944763944761384762660.04
单位质量响应值RSD%判断
31649.2331878.580.52数据可信
长期6月-供试品溶液-2024122821批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1322378-32237860.65257.166.4860.6557.166.48
2285666-28566653.74553.75
3308712-30871258.08158.08
4305531-30553157.48357.48
5275651-27565151.86151.86
6324860-32486061.11961.12
10min1423609-42360979.69878.581.8379.8078.681.84
2415563-41556378.18478.27
3419497-41949778.92479.02
4419402-41940278.90779.00
5403565-40356575.92776.01
6424400-42440079.84779.95
15min1448129-44812984.31184.420.8384.5584.650.83
2443896-44389683.51583.73
3447979-44797984.28384.51
4449684-44968484.60484.83
5447539-44753984.20084.41
6455148-45514885.63285.87
20min1460593-46059386.65686.870.7087.0387.240.71
2457489-45748986.07286.43
3462425-46242587.00187.37
4462654-46265487.04487.41
5460242-46024286.59086.94
6467099-46709987.88088.26
30min1471713-47171388.74889.000.7289.2789.510.72
2467705-46770587.99488.50
3473930-47393089.16589.68
4474092-47409289.19689.71
5472814-47281488.95589.45
6478089-47808989.94890.47
45min1478641-47864190.05290.620.9590.7291.280.95
2475291-47529189.42290.07
3481997-48199790.68391.35
4482015-48201590.68791.35
5483352-48335290.93891.58
6488788-48878891.96192.63
60min1481898-48189890.66591.280.9591.4892.090.95
2478501-47850190.02590.82
3485649-48564991.37092.18
4485984-48598491.43392.25
5486823-48682391.59192.39
6492050-49205092.57593.40
极限1495560-49556093.23593.041.1594.2094.001.15
2485760-48576091.39192.34
3495684-49568493.25894.22
4491720-49172092.51293.48
5495327-49532793.19194.14
6503028-50302894.64095.62
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
114.894705654709024701404706844711144706810.08
214.944702334697414699870.08
单位质量响应值RSD%判断
31610.5431458.300.35数据可信
长期6月-供试品溶液-2024122921批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338204-33820464.09261.827.3964.0961.827.39
2325093-32509361.60861.61
3290800-29080055.10955.11
4360792-36079268.37368.37
5309848-30984858.71958.72
6332601-33260163.03163.03
10min1438789-43878983.15482.772.4283.2682.872.42
2427828-42782881.07781.18
3424111-42411180.37380.46
4451983-45198385.65585.77
5432946-43294682.04782.14
6444764-44476484.28684.39
15min1461596-46159687.47687.451.8787.7287.691.88
2450358-45035885.34785.58
3459516-45951687.08287.31
4473764-47376489.78290.04
5454917-45491786.21186.45
6468538-46853888.79289.04
20min1470193-47019389.10589.371.8689.5089.761.86
2460045-46004587.18287.56
3472931-47293189.62490.00
4483320-48332091.59392.00
5464200-46420087.97088.35
6478767-47876790.73091.12
30min1480103-48010390.98491.271.9491.5291.801.95
2468887-46888788.85889.38
3483560-48356091.63992.16
4493745-49374593.56994.13
5473845-47384589.79890.32
6489388-48938892.74393.29
45min1484578-48457891.83292.492.0092.5293.172.00
2474663-47466389.95390.63
3491355-49135593.11693.79
4499415-49941594.64395.36
5480711-48071191.09991.77
6497435-49743594.26894.97
60min1487489-48748992.38392.981.9693.2393.831.96
2477600-47760090.50991.33
3493935-49393593.60594.43
4501887-50188795.11295.98
5483139-48313991.55992.39
6499936-49993694.74295.60
极限1494968-49496893.80194.481.0694.8095.481.07
2492485-49248593.33094.30
3500790-50079094.90495.89
4503331-50333195.38596.42
5494551-49455193.72294.70
6505233-50523395.74696.76
利伐沙班口崩片项目信息
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对照品来源中检所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)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%
114.894686214681194680814678014685544682350.08
214.944732064744794738420.19
单位质量响应值RSD%判断
31446.2731716.330.61数据可信
长期6月-供试品溶液-2024123021批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338994-33899464.14860.633.9464.1560.633.94
2318951-31895160.35560.35
3305279-30527957.76857.77
4323076-32307661.13561.14
5308035-30803558.28958.29
6328091-32809162.08462.08
10min1438729-43872983.02080.991.6783.1381.091.68
2424058-42405880.24480.34
3422092-42209279.87279.97
4434895-43489582.29582.40
5426460-42646080.69980.80
6421749-42174979.80779.91
15min1460894-46089487.21586.101.0787.4686.331.07
2450328-45032885.21585.45
3455421-45542186.17986.41
4460316-46031687.10587.34
5453358-45335885.78986.02
6449621-44962185.08185.32
20min1473035-47303589.51288.421.1289.9088.801.12
2461281-46128187.28887.66
3468442-46844288.64389.02
4472818-47281889.47189.86
5466378-46637888.25288.63
6461506-46150687.33087.71
30min1483904-48390491.56990.571.0592.1191.101.05
2472164-47216489.34789.87
3480068-48006890.84391.36
4484161-48416191.61792.15
5477515-47751590.36090.88
6473891-47389189.67490.20
45min1495046-49504693.67792.251.2094.3792.931.20
2479937-47993790.81891.49
3488886-48888692.51293.18
4492976-49297693.28693.97
5484860-48486091.75092.42
6483433-48343391.48092.15
60min1497882-49788294.21493.001.1395.0693.831.13
2482738-48273891.34892.17
3493822-49382293.44694.27
4495876-49587693.83494.68
5488686-48868692.47493.30
6489809-48980992.68693.51
极限1507234-50723495.98494.700.9596.9995.680.95
2495936-49593693.84694.82
3497081-49708194.06295.04
4505514-50551495.65896.66
5498244-49824494.28295.26
6498613-49861394.35295.33
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