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%
114.894711464708114708244708694706544708610.04
214.944721904715234718560.10
单位质量响应值RSD%判断
31622.6331583.400.09数据可信
加速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%
5min1351263-35126366.42264.884.8966.4264.884.89
2328512-32851262.12062.12
3354655-35465567.06467.06
4331379-33137962.66262.66
5326001-32600161.64561.65
6366840-36684069.36869.37
10min1444559-44455984.06485.551.8384.1885.661.83
2445029-44502984.15384.26
3461292-46129287.22887.34
4456971-45697186.41186.52
5445457-44545784.23484.34
6461200-46120087.21187.33
15min1464957-46495787.92190.181.4088.1790.431.40
2474962-47496289.81390.06
3483805-48380591.48691.74
4479441-47944190.66090.91
5476713-47671390.14490.39
6481590-48159091.06791.33
20min1471652-47165289.18791.681.4389.5892.081.43
2484242-48424291.56891.96
3491738-49173892.98693.40
4486279-48627991.95392.35
5486545-48654592.00492.40
6488402-48840292.35592.77
30min1475886-47588689.98892.731.5190.5393.281.51
2490511-49051192.75493.30
3496028-49602893.79794.36
4491440-49144092.92993.48
5494009-49400993.41593.96
6494337-49433793.47794.04
45min1478630-47863090.50793.271.5091.2093.981.50
2494523-49452393.51294.21
3498897-49889794.33995.06
4494186-49418693.44994.16
5496845-49684593.95194.65
6496436-49643693.87494.60
60min1479940-47994090.75593.551.5291.6094.421.52
2496340-49634093.85694.71
3500292-50029294.60395.48
4494890-49489093.58294.45
5498058-49805894.18195.04
6498889-49888994.33895.22
极限1493246-49324693.27195.251.2194.2796.271.21
2502206-50220694.96595.98
3506705-50670595.81696.85
4501872-50187294.90295.92
5509550-50955096.35497.37
6508727-50872796.19897.23
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%
114.894736464739954734554735924738734737120.05
214.944721504720414720960.02
单位质量响应值RSD%判断
31814.1031599.460.48数据可信
加速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%
5min1356920-35692067.27267.854.3767.2767.854.38
2375061-37506170.69170.69
3344146-34414664.86464.86
4346745-34674565.35465.35
5353918-35391866.70666.71
6383165-38316572.21972.22
10min1463134-46313487.29187.841.6187.4087.951.61
2473826-47382689.30689.42
3455395-45539585.83285.94
4461634-46163487.00887.12
5467566-46756688.12688.24
6474686-47468689.46889.59
15min1480313-48031390.52991.231.0890.7991.491.08
2485934-48593491.58891.86
3477761-47776190.04890.30
4480604-48060490.58490.84
5489219-48921992.20892.47
6490282-49028292.40892.68
20min1486495-48649591.69492.311.0992.1092.731.09
2492666-49266692.85793.28
3483462-48346291.12391.52
4485413-48541391.49091.90
5495081-49508193.31293.72
6495616-49561693.41393.84
30min1490540-49054092.45793.171.1093.0293.741.11
2494945-49494593.28793.86
3488639-48863992.09892.65
4490730-49073092.49293.05
5498536-49853693.96494.53
6502678-50267894.74495.32
45min1493624-49362493.03893.661.0393.7594.381.03
2497913-49791393.84694.58
3490659-49065992.47993.19
4493847-49384793.08093.79
5501740-50174094.56895.29
6503722-50372294.94195.68
60min1494254-49425493.15794.021.1594.0394.901.16
2499864-49986494.21495.10
3491581-49158192.65393.51
4497256-49725693.72294.59
5502677-50267794.74495.63
6507330-50733095.62196.52
极限1506418-50641895.44996.101.0496.4797.131.04
2504197-50419795.03196.07
3510327-51032796.18697.20
4506389-50638995.44496.47
5513962-51396296.87197.91
6517987-51798797.63098.68
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%
114.894709174706174710274708624711274709100.05
214.944725224720524722870.08
单位质量响应值RSD%判断
31625.9231612.250.04数据可信
加速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%
5min1358201-35820167.70065.148.3667.7065.148.36
2288142-28814254.45954.46
3348088-34808865.78965.79
4345349-34534965.27165.27
5362389-36238968.49168.49
6365739-36573969.12569.12
10min1458141-45814186.58987.421.7386.7087.531.73
2455158-45515886.02586.12
3477707-47770790.28790.40
4463782-46378287.65587.76
5461293-46129387.18487.30
6459200-45920086.78986.90
15min1476831-47683190.12191.611.1390.3891.861.13
2483305-48330591.34591.58
3493909-49390993.34993.61
4484336-48433691.53991.79
5485495-48549591.75892.02
6484251-48425191.52391.78
20min1482348-48234891.16493.031.1791.5793.441.17
2492123-49212393.01193.40
3500135-50013594.52594.94
4491685-49168592.92893.34
5494113-49411393.38793.80
6492878-49287893.15493.57
30min1487121-48712192.06693.941.1592.6394.501.14
2497995-49799594.12194.66
3504375-50437595.32795.90
4495938-49593893.73294.29
5499741-49974194.45195.02
6497113-49711393.95494.52
45min1489291-48929192.47694.521.1693.1995.241.16
2502121-50212194.90195.60
3506043-50604395.64296.37
4498707-49870794.25694.97
5502419-50241994.95795.68
6502081-50208194.89395.62
60min1491494-49149492.89294.761.1893.7695.641.18
2506026-50602695.63996.50
3507351-50735195.88996.78
4498017-49801794.12595.00
5504240-50424095.30196.18
6501086-50108694.70595.59
极限1501297-50129794.74596.401.0195.7797.431.01
2511498-51149896.67397.69
3515694-51569497.46698.52
4510812-51081296.54397.58
5513647-51364797.07998.12
6507316-50731695.88396.92
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%
114.894699924697184700034697044702824699400.06
214.944721184720244720710.02
单位质量响应值RSD%判断
31560.7831597.790.09数据可信
加速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%
5min1301567-30156757.06859.314.9257.0759.314.92
2326031-32603161.69761.70
3336451-33645163.66963.67
4295271-29527155.87755.88
5312702-31270259.17559.18
6308442-30844258.36958.37
10min1418120-41812079.12479.910.6479.2280.010.64
2425108-42510880.44780.55
3422773-42277380.00580.11
4420199-42019979.51879.61
5422985-42298580.04580.14
6424583-42458380.34780.44
15min1448633-44863384.89885.170.3185.1385.400.31
2450945-45094585.33685.57
3449347-44934785.03485.27
4448481-44848184.87085.10
5451524-45152485.44685.68
6451336-45133685.41085.64
20min1459909-45990987.03287.400.6287.4087.770.62
2462634-46263487.54887.93
3458827-45882786.82887.21
4459851-45985187.02187.39
5466403-46640388.26188.64
6463433-46343387.69988.07
30min1470859-47085989.10489.510.8089.6290.030.79
2473307-47330789.56890.09
3469826-46982688.90989.43
4469771-46977188.89989.41
5479412-47941290.72391.24
6474888-47488889.86790.39
45min1477298-47729890.32391.010.7390.9891.670.73
2480025-48002590.83991.51
3479029-47902990.65191.32
4480293-48029390.89091.55
5487398-48739892.23492.91
6481405-48140591.10091.77
60min1480868-48086890.99991.630.7891.8192.450.78
2484205-48420591.63092.46
3481320-48132091.08491.91
4483551-48355191.50692.32
5491320-49132092.97693.80
6483970-48397091.58692.41
极限1488596-48859692.46192.850.5293.4393.820.52
2493490-49349093.38794.37
3489869-48986992.70293.68
4488065-48806592.36093.32
5494051-49405193.49394.47
6489798-48979892.68893.66
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%
114.894703764710524708984708884712464708920.07
214.944713904715944714920.04
单位质量响应值RSD%判断
31624.7131559.040.15数据可信
加速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%
5min1323370-32337061.17059.812.8861.1759.802.89
2317135-31713559.99059.99
3323295-32329561.15561.16
4300443-30044356.83356.83
5321969-32196960.90560.90
6310727-31072758.77858.78
10min1437570-43757082.77281.351.0682.8781.451.06
2431925-43192581.70481.80
3430290-43029081.39581.50
4423993-42399380.20480.30
5427711-42771180.90781.01
6428844-42884481.12181.22
15min1453320-45332085.75186.270.5685.9986.500.56
2460088-46008887.03287.27
3457842-45784286.60786.84
4453835-45383585.84986.08
5455272-45527286.12186.36
6456001-45600186.25886.49
20min1465157-46515787.99088.370.5588.3788.740.56
2470837-47083789.06589.45
3469998-46999888.90689.29
4465894-46589488.13088.50
5465495-46549588.05488.43
6465454-46545488.04788.42
30min1474207-47420789.70290.310.5890.2390.840.58
2481184-48118491.02291.55
3479177-47917790.64291.17
4475580-47558089.96290.48
5478946-47894690.59991.13
6475395-47539589.92790.45
45min1481321-48132191.04891.270.7791.7391.940.77
2487918-48791892.29692.98
3486259-48625991.98292.66
4480476-48047690.88891.56
5480274-48027490.85091.53
6478619-47861990.53791.21
60min1484874-48487491.72091.780.7892.5592.610.78
2490003-49000392.69093.53
3489665-48966592.62693.46
4482548-48254891.28092.10
5482533-48253391.27792.11
6481466-48146691.07591.90
极限1497821-49782194.16994.050.7695.1595.030.76
2500543-50054394.68495.67
3501503-50150394.86695.85
4492144-49214493.09594.07
5497768-49776894.15995.14
6493380-49338093.32994.31
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%
114.894735314729134734134728484722774729960.11
214.944770024768964769490.02
单位质量响应值RSD%判断
31766.0231924.300.36数据可信
加速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%
5min1314140-31414058.95158.066.4058.9558.066.41
2295441-29544155.44255.44
3340865-34086563.96663.97
4284410-28441053.37253.37
5318636-31863659.79559.79
6302890-30289056.84056.84
10min1426237-42623779.98779.892.3180.0979.992.32
2431289-43128980.93581.03
3436493-43649381.91282.02
4407437-40743776.45976.55
5426563-42656380.04880.15
6426272-42627279.99480.09
15min1451833-45183384.79185.551.1685.0285.781.16
2461422-46142286.59086.82
3462846-46284686.85787.10
4449822-44982284.41384.63
5453446-45344685.09385.33
6455946-45594685.56285.79
20min1463258-46325886.93588.171.6887.3188.551.68
2483050-48305090.64991.02
3475369-47536989.20789.60
4463079-46307986.90187.26
5466081-46608187.46487.84
6468359-46835987.89288.26
30min1475375-47537589.20890.231.2189.7390.751.21
2487835-48783591.54792.07
3487889-48788991.55792.09
4475356-47535689.20589.71
5477863-47786389.67590.20
6480471-48047190.16590.68
45min1483602-48360290.75291.771.1091.4292.441.11
2495779-49577993.03793.71
3493485-49348592.60793.30
4484191-48419190.86391.51
5484954-48495491.00691.68
6492111-49211192.34993.02
60min1487530-48753091.48992.651.2992.3193.471.29
2502418-50241894.28395.11
3498155-49815593.48394.33
4488426-48842691.65892.46
5488370-48837091.64792.47
6497239-49723993.31194.13
极限1494608-49460892.81893.981.4093.7994.961.39
2510251-51025195.75396.74
3507586-50758695.25396.25
4494727-49472792.84093.79
5495364-49536492.96093.93
6502293-50229394.26095.24
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