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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062874112874622876132874882880152875980.09
228.022884342885712885020.04
单位质量响应值RSD%判断
10249.3910296.290.33数据可信
供试品溶液-2024032721批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13576-35760.6083.5264.400.613.5264.39
220262-202623.4443.44
325371-253714.3124.31
418097-180973.0763.08
543460-434607.3867.39
613578-135782.3082.31
10min170001-7000111.89713.8521.3211.9013.8621.34
287513-8751314.87414.88
370890-7089012.04812.06
494617-9461716.08116.09
5105937-10593718.00518.02
660080-6008010.21110.21
15min1163661-16366127.81625.9010.0027.8425.939.99
2153694-15369426.12226.15
3144789-14478924.60824.64
4171048-17104829.07129.10
5153600-15360026.10626.15
6127433-12743321.65821.68
20min1203370-20337034.56433.638.2334.6333.708.23
2192421-19242132.70432.78
3196857-19685733.45733.53
4227209-22720938.61638.70
5182354-18235430.99331.08
6185078-18507831.45631.51
30min1231391-23139139.32740.985.6139.4541.105.61
2232552-23255239.52439.65
3249870-24987042.46742.59
4264825-26482545.00945.15
5232286-23228639.47939.62
6235643-23564340.04940.16
45min1264081-26408144.88345.763.9245.0745.953.93
2268209-26820945.58445.78
3275574-27557446.83647.03
4287077-28707748.79149.01
5258433-25843343.92344.13
6261910-26191044.51444.69
60min1279212-27921247.45448.383.3347.7248.653.33
2284487-28448748.35148.62
3291892-29189249.60949.88
4299465-29946550.89751.20
5274046-27404646.57646.85
6278900-27890047.40147.65
90min1295469-29546950.21751.482.3450.5651.842.35
2304104-30410451.68552.04
3307771-30777152.30852.66
4313833-31383353.33953.72
5296488-29648850.39150.74
6299857-29985750.96351.29
120min1309862-30986252.66453.331.8253.0953.761.84
2314172-31417253.39653.83
3317909-31790954.03154.47
4322762-32276254.85655.33
5307743-30774352.30352.74
6310124-31012452.70853.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1316757-31675753.83554.681.6254.3555.211.64
2321165-32116554.58555.11
3325204-32520455.27155.80
4330443-33044356.16256.73
5318411-31841154.11754.64
6318472-31847254.12754.63
极限1319088-31908854.23255.001.2654.8455.621.28
2321223-32122354.59555.21
3326174-32617455.43656.06
4330324-33032456.14156.80
5321319-32131954.61155.23
6323372-32337254.96055.55
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.064975144970854977654976904974574975020.06
228.024985024987564986290.04
单位质量响应值RSD%判断
17729.9417795.470.27数据可信
供试品溶液-2024032721批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14643-46430.4312.4867.160.432.4867.18
225095-250952.3302.33
333342-333423.0963.10
424499-244992.2752.28
557359-573595.3275.33
615305-153051.4211.42
10min189352-893528.2989.6622.478.309.6722.50
2112993-11299310.49310.50
392702-927028.6098.61
4121905-12190511.32111.32
5135214-13521412.55712.57
672161-721616.7016.70
15min1221430-22143020.56318.7911.7820.5818.8111.78
2203822-20382218.92818.95
3191506-19150617.78417.80
4232136-23213621.55721.58
5200945-20094518.66118.69
6164055-16405515.23515.25
20min1282621-28262126.24525.249.6226.2925.299.60
2263634-26363424.48224.54
3270225-27022525.09425.14
4317650-31765029.49829.56
5246249-24624922.86822.93
6250126-25012623.22823.27
30min1335019-33501931.11132.127.0631.2032.217.05
2333253-33325330.94731.04
3362771-36277133.68833.78
4388035-38803536.03536.14
5328050-32805030.46430.56
6328128-32812830.47130.55
45min1401680-40168037.30237.595.3737.4537.735.37
2404408-40440837.55537.70
3419038-41903838.91439.06
4438544-43854440.72540.89
5383226-38322635.58835.74
6381583-38158335.43535.56
60min1438652-43865240.73541.054.5440.9441.264.55
2443376-44337641.17441.38
3458400-45840042.56942.78
4470568-47056843.69943.93
5419828-41982838.98739.20
6421434-42143439.13639.32
90min1480308-48030844.60345.543.0944.8845.823.10
2493223-49322345.80346.08
3504265-50426546.82847.11
4511625-51162547.51247.82
5475980-47598044.20244.48
6476745-47674544.27344.53
120min1510241-51024147.38348.202.6547.7348.552.67
2522136-52213648.48848.84
3532179-53217949.42049.78
4537520-53752049.91650.30
5505467-50546746.94047.29
6506379-50637947.02447.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1532920-53292049.48950.422.4449.9250.852.46
2543299-54329950.45350.89
3553400-55340051.39151.83
4563466-56346652.32652.80
5534527-53452749.63850.06
6529737-52973749.19449.60
极限1540128-54012850.15951.021.7750.6751.541.79
2545324-54532450.64151.16
3557673-55767351.78852.32
4564969-56496952.46553.02
5542959-54295950.42150.93
6545464-54546450.65451.14
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062885442883062885742888952892002887040.13
228.022879612883302881460.10
单位质量响应值RSD%判断
10288.8110283.580.04数据可信
供试品溶液-2024032821批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123540-235403.9964.0758.674.004.0858.67
241643-416437.0687.07
32751-27510.4670.47
435986-359866.1086.11
525221-252214.2814.28
614872-148722.5242.52
10min1113876-11387619.32916.2632.0719.3416.2632.09
2123731-12373121.00221.01
341063-410636.9706.97
4116283-11628319.73719.75
597829-9782916.60516.61
681955-8195513.91113.91
15min1182226-18222630.93027.5313.3630.9727.5613.40
2184042-18404231.23931.29
3125974-12597421.38221.39
4169579-16957928.78428.83
5158531-15853126.90926.94
6152773-15277325.93125.96
20min1225330-22533038.24735.557.2938.3435.637.32
2231712-23171239.33039.43
3194308-19430832.98133.03
4200091-20009133.96334.05
5200791-20079134.08234.16
6204503-20450334.71234.78
30min1261140-26114044.32541.257.2944.4841.397.28
2266178-26617845.18045.34
3245481-24548141.66741.77
4222969-22296937.84637.99
5228588-22858838.80038.94
6233742-23374239.67539.80
45min1281270-28127047.74244.806.5047.9745.006.49
2282815-28281548.00448.24
3269328-26932845.71545.89
4241155-24115540.93341.14
5248008-24800842.09642.30
6260980-26098044.29844.49
60min1296547-29654750.33547.246.1450.6447.526.13
2296254-29625450.28550.60
3282547-28254747.95948.21
4254132-25413243.13643.41
5264361-26436144.87245.14
6276019-27601946.85147.12
90min1312997-31299753.12750.365.4053.5250.725.40
2315127-31512753.48953.89
3297480-29748050.49350.82
4272772-27277246.29946.65
5286701-28670148.66449.01
6295022-29502250.07650.42
120min1320126-32012654.33752.353.9954.8252.804.02
2326291-32629155.38455.88
3305848-30584851.91452.33
4294811-29481150.04050.47
5298681-29868150.69751.12
6304846-30484651.74452.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1325418-32541855.23553.773.0255.8154.313.05
2331119-33111956.20356.79
3312935-31293553.11753.62
4305968-30596851.93452.45
5310361-31036152.68053.19
6315017-31501753.47053.99
极限1326268-32626855.38054.482.1156.0455.102.14
2330188-33018856.04556.72
3322150-32215054.68155.27
4312115-31211552.97753.58
5314998-31499853.46754.07
6320164-32016454.34454.95
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.064984784982644987834989584999994988960.14
228.024975524985564980540.15
单位质量响应值RSD%判断
17779.6217774.950.02数据可信
供试品溶液-2024032821批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124169-241692.2432.3967.892.242.3967.89
248908-489084.5384.54
3-0.0000.00
439854-398543.6983.70
526849-268492.4912.49
614611-146111.3561.36
10min1143734-14373413.33711.1433.6213.3411.1433.63
2156231-15623114.49614.50
348627-486274.5124.51
4148392-14839213.76913.78
5122299-12229911.34811.35
6101028-1010289.3749.38
15min1240421-24042122.30819.6714.1422.3319.7014.17
2241311-24131122.39122.42
3162686-16268615.09515.10
4224149-22414920.79820.83
5206081-20608119.12219.14
6197601-19760118.33518.35
20min1309014-30901428.67326.357.8128.7426.407.83
2314901-31490129.21929.29
3262703-26270324.37624.41
4271993-27199325.23825.30
5270035-27003525.05625.11
6274945-27494525.51225.56
30min1375089-37508934.80431.968.1334.9132.068.12
2379392-37939235.20335.32
3349716-34971632.44932.52
4315308-31530829.25729.36
5320400-32040029.72929.83
6327044-32704430.34630.44
45min1423967-42396739.33936.377.3039.5136.527.29
2421673-42167339.12639.30
3402141-40214137.31437.44
4356412-35641233.07133.23
5364869-36486933.85534.00
6382795-38279535.51935.66
60min1465333-46533343.17739.687.2743.4139.907.26
2458118-45811842.50842.75
3435857-43585740.44240.63
4388344-38834436.03436.24
5399601-39960137.07837.28
6418848-41884838.86439.06
90min1513008-51300847.60144.366.2347.9144.646.24
2513913-51391347.68548.00
3474989-47498944.07344.33
4442627-44262741.07041.34
5453919-45391942.11842.38
6469914-46991443.60243.87
120min1534805-53480549.62346.905.5850.0147.255.59
2544239-54423950.49950.89
3499041-49904146.30546.64
4474135-47413543.99444.33
5482650-48265044.78445.12
6497602-49760246.17146.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1551519-55151951.17449.024.2051.6449.454.23
2558972-55897251.86652.34
3519634-51963448.21648.62
4502942-50294246.66747.08
5512509-51250947.55547.96
6524443-52444348.66249.08
极限1553711-55371151.37850.143.0551.9350.653.07
2563533-56353352.28952.85
3540234-54023450.12750.62
4519747-51974748.22648.72
5525925-52592548.79949.29
6538819-53881949.99650.49
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062900032897532898912897552898132898430.04
228.022903702900032901860.09
单位质量响应值RSD%判断
10329.4010356.390.19数据可信
供试品溶液-2024032921批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11898-18980.3202.4269.650.322.4269.62
218741-187413.1643.16
317743-177432.9953.00
425875-258754.3684.37
519671-196713.3213.32
62061-20610.3480.35
10min142441-424417.16415.2635.487.1615.2635.50
296154-9615416.23116.24
3108229-10822918.27018.27
4123689-12368920.88020.89
5111757-11175718.86518.87
659999-5999910.12810.13
15min1121682-12168220.54126.9717.4420.5527.0017.46
2154857-15485726.14126.17
3173371-17337129.26629.30
4189156-18915631.93131.97
5185804-18580431.36531.40
6133689-13368922.56822.59
20min1171460-17146028.94434.2311.4228.9934.3011.46
2189263-18926331.94932.02
3222222-22222237.51337.60
4229854-22985438.80138.90
5216032-21603236.46836.56
6187645-18764531.67631.73
30min1220048-22004837.14640.707.3537.2440.837.38
2224278-22427837.86037.99
3251268-25126842.41642.56
4267036-26703645.07745.24
5247712-24771241.81541.97
6236344-23634439.89640.00
45min1243677-24367741.13444.506.1141.2944.706.14
2248433-24843341.93742.13
3271221-27122145.78446.00
4287779-28777948.57948.81
5268350-26835045.29945.52
6262303-26230344.27844.45
60min1262772-26277244.35847.155.7044.5847.425.73
2260146-26014643.91444.18
3284275-28427547.98748.28
4303249-30324951.19051.51
5284331-28433147.99748.29
6280997-28099747.43447.68
90min1285746-28574648.23650.164.7648.5450.514.79
2278167-27816746.95647.29
3297233-29723350.17550.55
4318772-31877253.81154.21
5303046-30304651.15651.53
6299793-29979350.60750.93
120min1297701-29770150.25452.074.3750.6352.504.40
2290833-29083349.09549.51
3306524-30652451.74352.20
4329234-32923455.57756.07
5312823-31282352.80753.27
6313598-31359852.93753.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1311364-31136452.56053.972.8053.0254.492.84
2311663-31166352.61153.11
3315612-31561253.27753.82
4335082-33508256.56457.15
5322489-32248954.43854.99
6321923-32192354.34354.84
极限1314840-31484053.14754.422.6253.7055.032.66
2312183-31218352.69953.28
3319775-31977553.98054.61
4334815-33481556.51957.20
5325116-32511654.88255.52
6327498-32749855.28455.87
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.065010855000675009945001925008685006410.10
228.025018955014945016940.06
单位质量响应值RSD%判断
17841.8017904.850.25数据可信
供试品溶液-2024032921批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0001.5475.720.001.5475.66
222094-220942.0392.04
322413-224132.0682.07
430978-309782.8592.86
522988-229882.1222.12
61917-19170.1770.18
10min151018-510184.70810.6437.264.7110.6437.26
2120069-12006911.08111.08
3139149-13914912.84212.85
4161655-16165514.91914.92
5143774-14377413.26913.27
676038-760387.0187.02
15min1156736-15673614.46519.4618.9614.4719.4818.99
2200258-20025818.48218.50
3231991-23199121.41021.44
4252025-25202523.25923.29
5249620-24962023.03723.06
6174771-17477116.13016.14
20min1228832-22883221.11925.4113.0421.1525.4613.07
2251235-25123523.18623.24
3306182-30618228.25728.32
4315293-31529329.09829.17
5299239-29923927.61727.68
6251292-25129223.19223.23
30min1306350-30635028.27331.498.9828.3431.599.01
2310365-31036528.64328.73
3362371-36237133.44333.55
4383173-38317335.36335.48
5355010-35501032.76432.87
6330233-33023330.47730.55
45min1355727-35572732.83036.047.4632.9436.187.50
2361601-36160133.37233.51
3408907-40890737.73837.90
4432266-43226639.89440.07
5399586-39958636.87837.04
6384875-38487535.52035.65
60min1395850-39585036.53339.497.0336.7039.707.06
2393098-39309836.27936.47
3443006-44300640.88541.11
4472726-47272643.62843.87
5434751-43475140.12340.35
6428155-42815539.51439.70
90min1450161-45016141.54543.925.9841.7744.206.01
2440792-44079240.68040.94
3480800-48080044.37344.67
4521317-52131748.11248.43
5483066-48306644.58244.87
6479524-47952444.25544.51
120min1482115-48211544.49446.665.6044.7947.015.62
2470762-47076243.44643.77
3503341-50334146.45346.82
4551573-55157350.90451.30
5511968-51196847.24947.62
6513968-51396847.43447.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1516197-51619747.64049.363.8848.0149.783.91
2518233-51823347.82748.22
3527578-52757848.69049.14
4573010-57301052.88353.36
5536663-53666349.52849.97
6537409-53740949.59750.00
极限1528433-52843348.76950.223.4549.2250.723.48
2523114-52311448.27848.75
3539403-53940349.78150.31
4575410-57541053.10453.67
5546391-54639150.42650.95
6552097-55209750.95351.44
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