沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132822552813052815752816612824162818420.17
2 28.052818932821272820100.06
单位质量响应值RSD%判断
10019.2710053.830.25数据可信
长期24月-供试品溶液-2024032721批-缬沙坦-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%
5min192818-9281814.97816.6025.7314.9816.6025.72
2129724-12972420.93420.93
377382-7738212.48712.49
469492-6949211.21411.21
5127929-12792920.64420.64
6119754-11975419.32519.32
10min1199808-19980832.24334.1210.3532.2734.1510.36
2235382-23538237.98438.02
3190462-19046230.73530.76
4190262-19026230.70330.72
5213221-21322134.40834.44
6239622-23962238.66838.70
15min1284253-28425345.87046.295.7945.9546.375.79
2300555-30055548.50148.60
3275268-27526844.42044.49
4279071-27907145.03445.10
5269180-26918043.43843.53
6312797-31279750.47650.57
20min1313372-31337250.56951.484.3850.7251.644.38
2326687-32668752.71852.90
3317752-31775251.27651.42
4322767-32276752.08552.23
5296040-29604047.77247.94
6337499-33749954.46254.64
30min1328070-32807052.94152.491.9153.1852.741.91
2326239-32623952.64552.91
3320736-32073651.75751.99
4331881-33188153.55653.79
5315186-31518650.86251.11
6329504-32950453.17253.44
45min1329113-32911353.10953.131.1453.4453.461.14
2331262-33126253.45653.81
3331624-33162453.51453.83
4331177-33117753.44253.76
5321800-32180051.92952.26
6330346-33034653.30853.67
60min1329269-32926953.13452.701.1453.5553.121.14
2325701-32570152.55953.00
3321641-32164151.90352.31
4330684-33068453.36353.77
5322955-32295552.11552.53
6329096-32909653.10653.56
极限1328774-32877453.05452.721.2053.5653.231.20
2329179-32917953.12053.65
3319957-31995751.63252.13
4330111-33011153.27053.77
5324115-32411552.30352.80
6327938-32793852.92053.46
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134868184848914859034850904865284858460.18
2 28.054858664866914862780.12
单位质量响应值RSD%判断
17271.4517336.110.27数据可信
长期24月-供试品溶液-2024032721批-沙库巴曲-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%
5min1156624-15662413.85015.4326.6513.8515.4326.65
2221855-22185519.61919.62
3129786-12978611.47711.48
4115911-11591110.25010.25
5218052-21805219.28219.28
6204889-20488918.11818.12
10min1341928-34192830.23732.0510.5130.2632.0710.52
2403777-40377735.70635.74
3326196-32619628.84528.86
4325245-32524528.76128.78
5365678-36567832.33732.37
6411537-41153736.39236.42
15min1487767-48776743.13343.555.8543.2143.635.86
2516014-51601445.63145.72
3473082-47308241.83541.90
4479391-47939142.39242.46
5461138-46113840.77840.86
6537588-53758847.53947.63
20min1539172-53917247.67948.544.5147.8248.694.51
2561860-56186049.68549.85
3547298-54729848.39748.53
4555655-55565549.13649.27
5507835-50783544.90845.06
6581474-58147451.42051.59
30min1563084-56308449.79349.421.9750.0249.651.97
2560734-56073449.58649.84
3551706-55170648.78749.00
4570092-57009250.41350.63
5540503-54050347.79748.03
6567067-56706750.14650.40
45min1565929-56592950.04550.011.1750.3550.331.17
2569308-56930850.34450.68
3567540-56754050.18750.49
4569249-56924950.33950.64
5552384-55238448.84749.16
6569086-56908650.32450.66
60min1565450-56545050.00349.641.2550.3950.041.25
2559958-55995849.51749.93
3552347-55234748.84449.23
4569587-56958750.36850.75
5554271-55427149.01449.40
6566605-56660550.10550.53
极限1566800-56680050.12249.711.1650.6050.201.17
2564515-56451549.92050.42
3550776-55077648.70549.17
4568012-56801250.22950.70
5558296-55829649.37049.84
6564730-56473049.93950.45
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132827692840012837422828462832482833210.20
2 28.052817422830002823710.32
单位质量响应值RSD%判断
10071.8510066.700.04数据可信
长期24月-供试品溶液-2024032821批-缬沙坦-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%
5min176917-7691712.37216.0216.4312.3716.0216.43
289843-8984314.45114.45
3123776-12377619.90919.91
498047-9804715.77015.77
597714-9771415.71715.72
6111343-11134317.90917.91
10min1194360-19436031.26234.857.2031.2834.887.21
2206010-20601033.13633.16
3231271-23127137.19937.23
4212577-21257734.19234.22
5220108-22010835.40335.43
6235725-23572537.91537.95
15min1270527-27052743.51344.652.1943.5944.732.19
2281792-28179245.32545.40
3274293-27429344.11944.21
4287514-28751446.24546.33
5275905-27590544.37844.46
6275406-27540644.29844.39
20min1317217-31721751.02350.293.5751.1750.453.54
2323443-32344352.02452.18
3300096-30009648.26948.44
4326419-32641952.50352.66
5303967-30396748.89249.05
6304905-30490549.04349.21
30min1323100-32310051.96952.051.0052.2052.290.99
2324546-32454652.20252.44
3318622-31862251.24951.50
4328165-32816552.78453.03
5325088-32508852.28952.53
6321922-32192251.78052.03
45min1322233-32223351.83052.260.9252.1552.590.92
2325631-32563152.37652.70
3322931-32293151.94252.28
4326441-32644152.50752.84
5329851-32985153.05553.38
6322417-32241751.85952.19
60min1321214-32121451.66652.150.9152.0752.570.91
2324740-32474052.23352.65
3323124-32312451.97352.39
4325767-32576752.39852.82
5329020-32902052.92153.34
6321486-32148651.71052.13
极限1320984-32098451.62952.221.1252.1252.721.11
2324134-32413452.13652.64
3328304-32830452.80653.31
4324696-32469652.22652.74
5329257-32925752.96053.46
6320446-32044651.54252.05
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134862934890124869434874324869744873310.22
2 28.054856964873394865180.24
单位质量响应值RSD%判断
17324.2417344.670.09数据可信
长期24月-供试品溶液-2024032821批-沙库巴曲-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%
5min1128400-12840011.33414.8717.1311.3314.8717.13
2151769-15176913.39713.40
3211003-21100318.62618.63
4164329-16432914.50614.51
5165755-16575514.63214.63
6189450-18945016.72316.72
10min1331924-33192429.30032.747.3729.3232.777.38
2352392-35239231.10731.13
3395990-39599034.95534.99
4363535-36353532.09032.11
5376884-37688433.26933.29
6404836-40483635.73635.76
15min1463791-46379140.94042.042.2241.0142.122.22
2482670-48267042.60742.68
3470056-47005641.49341.58
4493840-49384043.59343.67
5474172-47417241.85741.94
6473169-47316941.76841.86
20min1545418-54541848.14647.403.7148.2847.553.70
2556161-55616149.09449.24
3514569-51456945.42345.58
4561494-56149449.56549.72
5521038-52103845.99446.14
6523330-52333046.19646.35
30min1555911-55591149.07249.121.0149.2949.351.00
2558759-55875949.32349.55
3546986-54698648.28448.52
4564046-56404649.79050.02
5558073-55807349.26349.49
6555110-55511049.00149.24
45min1553409-55340948.85149.280.9649.1549.600.96
2559358-55935849.37649.69
3554162-55416248.91849.23
4562022-56202249.61149.93
5566711-56671150.02550.33
6554234-55423448.92449.24
60min1552690-55269048.78849.250.9149.1749.640.90
2558913-55891349.33749.73
3555934-55593449.07449.47
4560103-56010349.44249.84
5566213-56621349.98150.37
6553396-55339648.85049.25
极限1552204-55220448.74549.341.1849.2149.811.17
2558325-55832549.28549.76
3566286-56628649.98850.47
4558548-55854849.30549.79
5566584-56658450.01450.49
6551408-55140848.67449.15
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132826422830232832872819852825382826950.18
2 28.052816432814632815530.05
单位质量响应值RSD%判断
10049.5910037.540.09数据可信
长期24月-供试品溶液-2024032921批-缬沙坦-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%
5min189589-8958914.44716.6323.5114.4516.6323.52
298920-9892015.95215.95
3107497-10749717.33517.33
4145843-14584323.51823.52
573247-7324711.81211.81
6103631-10363116.71116.71
10min1178844-17884428.84032.4610.8028.8632.4810.81
2221532-22153235.72435.75
3210540-21054033.95133.98
4212943-21294334.33934.38
5168982-16898227.25027.27
6214771-21477134.63334.66
15min1248294-24829440.03942.748.2940.1142.828.29
2280042-28004245.15945.25
3292824-29282447.22047.31
4255780-25578041.24641.34
5235398-23539837.96038.02
6277993-27799344.82844.91
20min1295825-29582547.70448.636.8947.8448.786.89
2320173-32017351.63051.79
3330443-33044353.28653.45
4282896-28289645.61945.78
5277228-27722844.70544.83
6302723-30272348.81648.98
30min1322980-32298052.08351.552.5952.3051.792.59
2324185-32418552.27752.52
3332171-33217153.56553.82
4309348-30934849.88550.13
5315209-31520950.83051.03
6314336-31433650.68950.93
45min1324783-32478352.37452.121.7952.6852.441.80
2326062-32606252.58052.91
3332095-33209553.55353.90
4315215-31521550.83151.16
5320757-32075751.72452.01
6320407-32040751.66851.99
60min1325765-32576552.53252.121.6852.9252.521.68
2324280-32428052.29352.71
3331686-33168653.48753.92
4315942-31594250.94851.36
5321365-32136551.82352.20
6320055-32005551.61152.02
极限1326473-32647352.64652.061.6453.1352.551.63
2324239-32423952.28652.80
3329869-32986953.19453.71
4314970-31497050.79151.29
5321810-32181051.89452.35
6319498-31949851.52152.02
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134869164869184872044849274868254865580.19
2 28.054849984857404853690.11
单位质量响应值RSD%判断
17296.7717303.710.03数据可信
长期24月-供试品溶液-2024032921批-沙库巴曲-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%
5min1150361-15036113.29915.4224.3813.3015.4224.37
2166946-16694614.76614.77
3182725-18272516.16216.16
4248886-24888622.01322.01
5121682-12168210.76210.76
6175740-17574015.54415.54
10min1304341-30434126.91830.3911.0126.9430.4111.01
2378773-37877333.50233.53
3359937-35993731.83631.86
4363706-36370632.16932.21
5287524-28752425.43125.45
6367070-36707032.46632.49
15min1423622-42362237.46840.128.4537.5440.208.45
2479175-47917542.38242.46
3502234-50223444.42144.50
4438429-43842938.77838.87
5401808-40180835.53935.60
6476253-47625342.12342.20
20min1506227-50622744.77545.747.0144.9045.887.00
2548684-54868448.53048.68
3568031-56803150.24150.39
4484749-48474942.87543.03
5474722-47472241.98842.11
6520303-52030346.02046.17
30min1553423-55342348.94948.542.7149.1548.762.71
2557022-55702249.26749.50
3571542-57154250.55150.79
4530047-53004746.88147.11
5540063-54006347.76747.96
6540555-54055547.81148.04
45min1558063-55806349.35949.111.8749.6449.411.88
2559345-55934549.47349.79
3571605-57160550.55750.88
4541065-54106547.85648.16
5550258-55025848.66948.94
6550930-55093048.72849.04
60min1560394-56039449.56549.171.7549.9349.551.75
2557372-55737249.29849.69
3571738-57173850.56950.98
4543646-54364648.08448.47
5551681-55168148.79549.15
6550730-55073048.71149.10
极限1560876-56087649.60849.131.6350.0649.591.63
2557059-55705949.27149.75
3568704-56870450.30050.79
4542751-54275148.00548.47
5554093-55409349.00849.44
6549275-54927548.58249.05
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132837612826792830602834992827112831420.17
2 28.052827152824082825620.08
单位质量响应值RSD%判断
10065.4810073.510.06数据可信
长期24月-供试品溶液-SDR926批-缬沙坦-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%
5min191643-9164314.74014.158.6714.7414.148.65
285503-8550313.75213.75
385552-8555213.76013.76
477750-7775012.50512.51
5100559-10055916.17416.17
686691-8669113.94413.94
10min1195321-19532131.41631.827.1631.4431.857.16
2207310-20731033.34433.37
3191448-19144830.79330.82
4180456-18045629.02529.05
5220808-22080835.51535.54
6191810-19181030.85130.87
15min1287141-28714146.18444.239.7746.2644.319.76
2289075-28907546.49546.57
3242404-24240438.98939.06
4276098-27609844.40844.48
5310704-31070449.97450.06
6244680-24468039.35539.43
20min1320265-32026551.51248.138.8251.6748.288.81
2317900-31790051.13251.29
3262121-26212142.16042.30
4305918-30591849.20549.35
5319237-31923751.34751.52
6269802-26980243.39643.54
30min1321329-32132951.68349.266.6551.9249.496.65
2318674-31867451.25651.50
3273868-27386844.05044.26
4317422-31742251.05551.28
5318908-31890851.29451.55
6287378-28737846.22346.44
45min1321670-32167051.73849.875.2452.0650.185.24
2319696-31969651.42151.75
3283470-28347045.59445.88
4320759-32075951.59251.90
5318542-31854251.23551.58
6296131-29613147.63047.92
60min1321189-32118951.66150.224.1152.0750.624.12
2319497-31949751.38951.80
3290550-29055046.73347.09
4322330-32233051.84452.24
5317160-31716051.01351.44
6302712-30271248.68949.06
极限1321493-32149351.71051.261.0152.2151.741.04
2320022-32002251.47351.97
3313386-31338650.40650.84
4322000-32200051.79152.27
5317216-31721651.02251.53
6317978-31797851.14451.59
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134880644873634874284881094869534875830.11
2 28.054867594863464865520.07
单位质量响应值RSD%判断
17333.2017345.880.06数据可信
长期24月-供试品溶液-SDR926批-沙库巴曲-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%
5min1150534-15053413.28412.759.4513.2812.759.46
2139428-13942812.30412.30
3140020-14002012.35612.36
4126919-12691911.20011.20
5167663-16766314.79614.80
6142546-14254612.57912.58
10min1328868-32886829.02229.467.7829.0429.487.78
2351630-35163031.03031.05
3321477-32147728.36928.39
4302254-30225426.67326.69
5375805-37580533.16433.19
6323029-32302928.50628.53
15min1490255-49025543.26441.3110.3843.3341.3810.37
2491729-49172943.39443.47
3408436-40843636.04336.11
4470735-47073541.54141.60
5533534-53353447.08347.16
6414303-41430336.56136.63
20min1549816-54981648.52045.079.5648.6645.219.55
2544236-54423648.02748.17
3442484-44248439.04839.18
4522530-52253046.11246.24
5549161-54916148.46248.62
6456037-45603740.24440.37
30min1551785-55178548.69346.147.5348.9246.367.52
2546638-54663848.23948.46
3459532-45953240.55240.75
4543938-54393848.00148.21
5547852-54785248.34648.59
6487462-48746243.01743.21
45min1553025-55302548.80346.706.1849.1146.996.19
2547803-54780348.34248.65
3476128-47612842.01742.28
4549925-54992548.52948.82
5547809-54780948.34348.66
6500211-50021144.14244.41
60min1552060-55206048.71847.075.0249.1047.445.03
2548325-54832548.38848.77
3488448-48844843.10443.43
4552747-55274748.77849.15
5546335-54633548.21248.61
6512432-51243245.22145.56
极限1552401-55240148.74848.371.0449.2148.821.07
2551142-55114248.63749.10
3538659-53865947.53547.94
4554132-55413248.90149.35
5545305-54530548.12248.60
6547263-54726348.29448.71
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