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%
115.154769444771094767504768694774384770220.06
215.144804084786424795250.27
单位质量响应值RSD%判断
31486.6031672.720.42数据可信
供试品溶液-JPS8079批-pH1.2(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%
5min1279659-27965952.92253.602.4052.9253.602.40
2274131-27413151.87651.88
3290936-29093655.05655.06
4291328-29132855.13055.13
5283103-28310353.57453.57
6280224-28022453.02953.03
10min1359263-35926367.98668.901.2868.0768.991.29
2362927-36292768.67968.77
3370381-37038170.09070.18
4369468-36946869.91770.01
5361535-36153568.41668.51
6361109-36110968.33568.42
15min1384781-38478172.81573.961.0573.0274.161.05
2389039-38903973.62173.82
3396406-39640675.01575.22
4394277-39427774.61274.82
5389664-38966473.73973.94
6390678-39067873.93174.13
20min1399650-39965075.62976.841.3575.9577.161.35
2404196-40419676.48976.81
3411890-41189077.94578.28
4413261-41326178.20478.54
5401795-40179576.03576.36
6405442-40544276.72577.05
30min1414326-41432678.40679.561.2178.8580.021.21
2419926-41992679.46679.92
3427476-42747680.89481.36
4425267-42526780.47680.94
5416352-41635278.78979.24
6419356-41935679.35879.81
45min1423558-42355880.15381.401.2680.7381.991.26
2430230-43023081.41682.00
3437671-43767182.82483.42
4435333-43533382.38182.98
5427038-42703880.81281.40
6427139-42713980.83181.42
60min1427860-42786080.96782.121.1881.6882.841.18
2433679-43367982.06882.79
3441041-44104183.46184.20
4438948-43894883.06583.80
5430931-43093181.54882.27
6431174-43117481.59482.31
极限1429341-42934181.24782.511.3182.1083.381.31
2436984-43698482.69483.55
3443389-44338983.90684.78
4441789-44178983.60384.48
5431369-43136981.63182.49
6433296-43329681.99682.85
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%
115.154767564780144773234770504779724774230.12
215.144782264784074783160.03
单位质量响应值RSD%判断
31513.0731592.870.18数据可信
供试品溶液-JPS8079批-pH1.2(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%
5min1281146-28114653.24852.463.3953.2552.463.39
2273774-27377451.85251.85
3260666-26066649.36949.37
4275589-27558952.19552.20
5285942-28594254.15654.16
6284919-28491953.96353.96
10min1359893-35989368.16267.901.0568.2567.981.05
2357716-35771667.75067.84
3351244-35124466.52466.61
4361321-36132168.43368.52
5360467-36046768.27168.36
6360266-36026668.23368.32
15min1385286-38528672.97273.181.0273.1773.381.03
2387349-38734973.36273.56
3379896-37989671.95172.14
4390547-39054773.96874.17
5390102-39010273.88474.09
6385050-38505072.92773.13
20min1399161-39916175.60075.881.0575.9276.201.05
2400368-40036875.82876.15
3394881-39488174.78975.10
4405797-40579776.85677.18
5405158-40515876.73577.06
6398447-39844775.46475.79
30min1414130-41413078.43578.731.0078.8879.181.00
2415241-41524178.64579.09
3409853-40985377.62578.06
4421035-42103579.74280.19
5419851-41985179.51879.97
6413977-41397778.40678.86
45min1423623-42362380.23380.551.0980.8181.131.09
2425269-42526980.54481.12
3419799-41979979.50880.08
4431040-43104081.63782.22
5430527-43052781.54082.13
6421669-42166979.86280.44
60min1426813-42681380.83781.271.2381.5581.991.23
2428888-42888881.23081.94
3423304-42330480.17280.87
4436152-43615282.60583.33
5434662-43466282.32383.05
6424833-42483380.46281.18
极限1428624-42862481.18081.721.1782.0382.571.17
2431781-43178181.77882.63
3423977-42397780.30081.13
4436254-43625482.62583.48
5437688-43768882.89683.76
6430525-43052581.54082.39
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%
115.154839224826274835614815274819534827180.22
215.144805524798944802230.10
单位质量响应值RSD%判断
31862.5731718.820.32数据可信
供试品溶液-JPS8079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%
5min1326332-32633261.34461.282.8261.3461.282.82
2317750-31775059.73159.73
3314058-31405859.03759.04
4325892-32589261.26161.26
5333763-33376362.74162.74
6338285-33828563.59163.59
10min1407788-40778876.65677.091.6176.7677.191.61
2402195-40219575.60575.70
3403697-40369775.88775.99
4415640-41564078.13278.23
5418352-41835278.64278.75
6412928-41292877.62277.73
15min1435267-43526781.82282.021.1982.0582.251.19
2428192-42819280.49280.72
3432904-43290481.37781.60
4441383-44138382.97183.20
5441080-44108082.91483.15
6438995-43899582.52282.76
20min1449329-44932984.46584.671.1284.8385.041.12
2442777-44277783.23383.59
3448583-44858384.32584.69
4457624-45762486.02486.39
5450324-45032484.65285.03
6453908-45390885.32685.70
30min1465067-46506787.42487.591.0787.9388.101.07
2457929-45792986.08286.58
3463793-46379387.18487.69
4472479-47247988.81789.33
5468386-46838688.04788.56
6467934-46793487.96288.48
45min1476258-47625889.52789.681.1990.1890.331.20
2468608-46860888.08988.73
3473459-47345989.00189.65
4484603-48460391.09691.76
5478189-47818989.89090.55
6481271-48127190.47091.13
60min1481002-48100290.41990.521.1191.2291.321.11
2473133-47313388.94089.73
3478673-47867389.98190.78
4488745-48874591.87592.69
5484100-48410091.00191.81
6483540-48354090.89691.71
极限1486688-48668891.48891.711.2192.4492.671.21
2479508-47950890.13891.08
3484733-48473391.12092.06
4496815-49681593.39294.36
5488567-48856791.84192.80
6491050-49105092.30893.27
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%
115.154735344752864728214747374742614741280.21
215.144817154819774818460.04
单位质量响应值RSD%判断
31295.5831826.021.19数据可信
供试品溶液-JPS8079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%
5min1320881-32088160.76358.303.5960.7658.303.59
2312814-31281459.23559.24
3300114-30011456.83056.83
4294023-29402355.67755.68
5300961-30096156.99156.99
6318616-31861660.33460.33
10min1403767-40376776.45875.331.4576.5675.431.46
2400178-40017875.77975.88
3400202-40020275.78375.88
4387720-38772073.42073.51
5394605-39460574.72374.82
6400506-40050675.84175.94
15min1431710-43171081.75080.551.2381.9880.781.23
2428802-42880281.19981.42
3426988-42698880.85581.08
4416669-41666978.90179.12
5423049-42304980.10980.33
6425123-42512380.50280.73
20min1445944-44594484.44583.441.1184.8183.801.11
2444116-44411684.09984.46
3443574-44357483.99684.35
4432878-43287881.97182.32
5437785-43778582.90083.25
6439611-43961183.24683.61
30min1462080-46208087.50086.451.1988.0186.941.20
2460365-46036587.17687.68
3459963-45996387.10087.60
4447511-44751184.74285.22
5453839-45383985.94086.43
6455368-45536886.22986.73
45min1473428-47342889.64988.611.2790.3089.251.27
2470619-47061989.11789.76
3471312-47131289.24989.89
4457410-45741086.61687.24
5470064-47006489.01289.65
6464674-46467487.99288.64
60min1479966-47996690.88789.441.3391.6990.221.33
2475756-47575690.09090.88
3474752-47475289.90090.69
4461632-46163287.41688.18
5469939-46993988.98989.77
6471750-47175089.33290.12
极限1485366-48536691.91090.441.6692.8691.381.66
2479767-47976790.85091.79
3487141-48714192.24693.19
4467153-46715388.46189.38
5475114-47511489.96990.90
6471090-47109089.20790.15
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