沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.535904975898085908075907825915105906810.11
228.435956485973425964950.21
单位质量响应值RSD%判断
20703.8620981.180.95数据可信
供试品溶液-2024032421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%
5min130006-300062.3753.6269.762.373.6269.80
211722-117220.9280.93
315326-153261.2131.21
492475-924757.3197.32
559564-595644.7144.71
665555-655555.1885.19
10min1209281-20928116.56413.9932.6816.5714.0032.68
265025-650255.1465.15
3164572-16457213.02513.03
4218269-21826917.27517.29
5197946-19794615.66615.68
6205187-20518716.24016.25
15min1303883-30388324.05122.2415.3424.0922.2815.37
2207035-20703516.38616.40
3267058-26705821.13621.17
4333738-33373826.41426.47
5276456-27645621.88021.93
6298206-29820623.60223.65
20min1358534-35853428.37627.9314.4728.4728.0214.50
2291224-29122423.04923.10
3329806-32980626.10326.18
4439512-43951234.78534.90
5325250-32525025.74225.84
6372831-37283129.50829.61
30min1416284-41628432.94733.6210.5933.1133.7810.62
2381564-38156430.19930.30
3413698-41369832.74232.88
4499806-49980639.55739.75
5384515-38451530.43330.58
6453147-45314735.86436.03
45min1456071-45607136.09637.189.3336.3337.419.35
2428805-42880533.93834.11
3475851-47585137.66137.87
4540242-54024242.75843.04
5423653-42365333.53033.75
6494259-49425939.11839.36
60min1485825-48582538.45139.699.4638.7640.009.47
2454490-45449035.97136.21
3525118-52511841.56141.85
4571217-57121745.20945.58
5448217-44821735.47435.77
6524327-52432741.49841.83
极限1593641-59364146.98447.641.9347.3848.032.01
2588024-58802446.53946.86
3599068-59906847.41347.80
4616847-61684748.82149.29
5598794-59879447.39247.76
6614984-61498448.67349.10
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.531010283101040610112791010502101177710108490.07
228.431020370102341010218900.22
单位质量响应值RSD%判断
35431.0935944.071.02数据可信
供试品溶液-2024032421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%
5min130820-308201.5082.6473.751.512.6473.74
215416-154160.7540.75
314207-142070.6950.70
4111515-1115155.4565.46
571453-714533.4963.50
680401-804013.9343.93
10min1267619-26761913.09310.9534.5313.1010.9634.54
274571-745713.6483.65
3206399-20639910.09810.10
4277512-27751213.57713.59
5252134-25213412.33612.34
6264759-26475912.95312.96
15min1402657-40265719.70018.0516.5219.7318.0816.57
2264790-26479012.95512.96
3346259-34625916.94116.96
4441618-44161821.60621.65
5362334-36233417.72717.76
6396127-39612719.38119.42
20min1486956-48695623.82523.1815.6623.9023.2515.69
2378743-37874318.53018.57
3436959-43695921.37821.44
4594910-59491029.10629.20
5438814-43881421.46921.54
6506194-50619424.76624.85
30min1585744-58574428.65829.0412.1228.7929.1612.14
2516424-51642425.26625.35
3570211-57021127.89828.01
4711833-71183334.82734.98
5537263-53726326.28626.41
6639674-63967431.29631.43
45min1663440-66344032.45933.4510.9032.6533.6410.93
2604389-60438929.57029.71
3682935-68293533.41333.58
4804815-80481539.37639.61
5617781-61778130.22530.41
6728979-72897935.66635.87
60min1723150-72315035.38136.7511.0335.6537.0111.05
2660089-66008932.29532.50
3779170-77917038.12138.37
4878829-87882942.99743.32
5671619-67161932.85933.11
6793672-79367238.83139.12
极限1936934-93693445.84046.442.9846.1846.783.06
2913381-91338144.68844.96
3936313-93631345.81046.14
4988274-98827448.35248.77
5942449-94244946.11046.43
6977797-97779747.83948.21
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.535980235974625981595996665979985982620.14
228.436144966139986142470.06
单位质量响应值RSD%判断
20969.5821605.592.12数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032421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%
5min18202-82020.6362.39109.740.642.40109.61
297905-979057.5887.59
321268-212681.6481.65
48459-84590.6560.66
530154-301542.3372.34
619220-192201.4901.49
10min1123428-1234289.56612.9928.679.5713.0028.69
2229454-22945417.78417.80
3220397-22039717.08217.09
4117575-1175759.1139.11
5145817-14581711.30111.31
6169064-16906413.10313.11
15min1239101-23910118.53121.7520.1318.5521.7920.16
2357592-35759227.71527.77
3335651-33565126.01426.06
4228683-22868317.72417.75
5231082-23108217.91017.94
6292024-29202422.63322.67
20min1314150-31415024.34827.2917.5724.4127.3817.60
2421825-42182532.69332.81
3406148-40614831.47831.58
4299307-29930723.19823.26
5278342-27834221.57321.64
6393227-39322730.47730.56
30min1389102-38910230.15732.9115.2630.2833.0615.27
2481629-48162937.32837.52
3461827-46182735.79435.96
4378292-37829229.31929.43
5338277-33827726.21826.34
6498669-49866938.64938.80
45min1441565-44156534.22336.6913.0334.4136.9113.05
2522071-52207140.46340.74
3500705-50070538.80739.06
4428266-42826633.19333.37
5393664-39366430.51130.69
6553940-55394042.93343.17
60min1470156-47015636.43938.7712.1036.7039.0712.13
2548475-54847542.50942.87
3526309-52630940.79141.13
4456307-45630735.36635.62
5421039-42103932.63232.88
6578898-57889844.86745.20
极限1592935-59293545.95546.572.7546.3046.962.85
2617274-61727447.84148.30
3608185-60818547.13747.56
4585006-58500645.34145.67
5581904-58190445.10045.42
6619946-61994648.04948.48
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.531020815102042010215871023565101986610212510.15
228.431037201103733410372680.01
单位质量响应值RSD%判断
35795.6936484.981.35数据可信
供试品溶液-2024032421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%
5min17310-73100.3531.69124.820.351.68125.11
2121252-1212525.8585.86
321970-219701.0611.06
46493-64930.3140.31
534455-344551.6651.66
617857-178570.8630.86
10min1152933-1529337.38910.2831.667.3910.2831.67
2296159-29615914.30914.32
3290721-29072114.04614.05
4142630-1426306.8916.89
5179064-1790648.6518.66
6214779-21477910.37710.38
15min1308801-30880114.92017.7122.5314.9417.7422.56
2477761-47776123.08323.13
3447589-44758921.62521.66
4290143-29014314.01814.03
5291220-29122014.07014.09
6384251-38425118.56518.59
20min1416107-41610720.10422.8320.0120.1522.8920.04
2578754-57875427.96228.06
3559827-55982727.04827.13
4389795-38979518.83318.88
5360708-36070817.42717.48
6529504-52950425.58325.65
30min1537617-53761725.97528.6617.7126.0728.7817.72
2688668-68866833.27333.43
3665080-66508032.13332.27
4513870-51387024.82724.92
5452654-45265421.87021.96
6701505-70150533.89334.02
45min1636080-63608030.73233.2915.3330.8833.4715.35
2777109-77710937.54637.78
3746468-74646836.06536.28
4605078-60507829.23429.38
5552931-55293126.71526.86
6816797-81679739.46339.66
60min1695434-69543433.60036.3014.4133.8236.5514.45
2843718-84371840.76441.08
3810290-81029039.14939.44
4665117-66511732.13532.34
5612529-61252929.59429.79
6880781-88078142.55542.84
极限1929195-92919544.89445.924.1545.1946.254.24
2993950-99395048.02248.43
3973879-97387947.05347.43
4912891-91289144.10644.39
5904924-90492443.72143.99
6987403-98740347.70648.09
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.536023396016486030806030656042256028710.16
228.436110456116616113530.08
单位质量响应值RSD%判断
21131.1321503.801.24数据可信
供试品溶液-2024032521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%
5min16948-69480.5381.4398.800.541.4298.72
216078-160781.2441.24
38427-84270.6520.65
454975-549754.2544.25
510947-109470.8470.85
613166-131661.0191.02
10min1116357-1163579.00411.7030.909.0111.7130.89
2174531-17453113.50613.51
3171488-17148813.27113.27
4200903-20090315.54715.56
5170011-17001113.15613.16
674224-742245.7445.75
15min1283248-28324821.91922.508.5021.9422.538.54
2286276-28627622.15322.19
3303736-30373623.50423.54
4325607-32560725.19725.24
5294835-29483522.81622.85
6251031-25103119.42619.44
20min1358417-35841727.73628.965.0327.8129.045.06
2370078-37007828.63828.72
3366567-36656728.36728.45
4402009-40200931.10931.21
5392544-39254430.37730.46
6355950-35595027.54527.60
30min1434873-43487333.65236.307.6133.7836.447.60
2461262-46126235.69535.84
3429085-42908533.20533.35
4521171-52117140.33140.50
5470393-47039336.40136.55
6497772-49777238.52038.64
45min1478990-47899037.06639.627.5237.2739.847.50
2503856-50385638.99139.22
3468406-46840636.24736.47
4565020-56502043.72443.98
5504800-50480039.06439.29
6550495-55049542.60042.80
60min1509849-50984939.45441.836.5039.7442.146.49
2532178-53217841.18241.49
3505859-50585939.14639.45
4588782-58878245.56345.92
5527846-52784640.84741.16
6578666-57866644.78045.08
极限1608343-60834347.07647.781.5347.4548.191.55
2617635-61763547.79548.20
3611326-61132647.30747.69
4626064-62606448.44848.90
5610230-61023047.22247.63
6631368-63136848.85849.26
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.531027194102797210284891027986102901410281310.07
228.431032011103453310332720.18
单位质量响应值RSD%判断
36036.8436344.420.61数据可信
供试品溶液-2024032521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%
5min110459-104590.5051.2086.030.501.1986.11
228498-284981.3751.37
314252-142520.6880.69
466430-664303.2053.20
514795-147950.7140.71
614283-142830.6890.69
10min1147453-1474537.1149.4432.707.119.4432.71
2233635-23363511.27111.27
3223708-22370810.79310.79
4255877-25587712.34512.35
5224569-22456910.83410.84
688696-886964.2794.28
15min1377763-37776318.22518.718.6618.2418.738.69
2387628-38762818.70118.73
3407622-40762219.66519.69
4429033-42903320.69820.73
5394915-39491519.05219.08
6329580-32958015.90015.91
20min1489288-48928823.60524.665.1823.6624.725.21
2509534-50953424.58224.65
3503967-50396724.31324.38
4544796-54479626.28326.36
5539956-53995626.05026.12
6479534-47953423.13523.18
30min1617534-61753429.79232.137.3629.9032.257.35
2659410-65941031.81231.94
3611039-61103929.47929.60
4741500-74150035.77335.91
5671088-67108832.37632.50
6695461-69546133.55233.65
45min1708047-70804734.15936.587.7934.3436.777.77
2744241-74424135.90536.10
3693388-69338833.45233.64
4844226-84422640.72940.95
5746622-74662236.02036.22
6812685-81268539.20739.38
60min1769960-76996037.14639.737.2437.4040.007.22
2811268-81126839.13939.41
3767352-76735237.02037.28
4910883-91088343.94544.25
5799809-79980938.58638.86
6881530-88153042.52842.79
极限1962178-96217846.41947.432.1646.7547.792.18
2983544-98354447.45047.81
3966771-96677146.64146.99
41007062-100706248.58548.99
5968845-96884546.74147.10
61010893-101089348.76949.12
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.536089156087126088766089936071576085310.13
228.436191866183286187570.10
单位质量响应值RSD%判断
21329.5121764.231.43数据可信
供试品溶液-2024032521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%
5min1114214-1142148.7455.2360.918.745.2360.87
219074-190741.4601.46
322801-228011.7461.75
4101842-1018427.7977.80
555886-558864.2794.28
696260-962607.3707.37
10min1253034-25303419.37313.8345.7719.3913.8445.80
274202-742025.6815.68
388045-880456.7416.74
4222484-22248417.03417.05
5180295-18029513.80413.81
6266035-26603520.36820.38
15min1365637-36563727.99423.1019.3228.0623.1419.38
2230941-23094117.68117.70
3239900-23990018.36718.39
4329169-32916925.20225.26
5287007-28700721.97422.01
6357311-35731127.35727.42
20min1411655-41165531.51729.279.4831.6429.369.55
2343986-34398626.33626.39
3339823-33982326.01826.08
4400581-40058130.66930.78
5371078-37107828.41128.50
6426718-42671832.67132.79
30min1461849-46184935.36035.483.7435.5635.643.78
2468260-46826035.85135.96
3434114-43411433.23733.35
4487358-48735837.31337.49
5460417-46041735.25135.40
6468802-46880235.89336.09
45min1499446-49944638.23939.244.8638.5139.484.85
2534361-53436140.91241.11
3475413-47541336.39936.59
4544400-54440041.68141.94
5515438-51543839.46339.69
6505891-50589138.73239.01
60min1526208-52620840.28841.464.6140.6541.784.59
2561787-56178743.01243.30
3505783-50578338.72439.00
4572459-57245943.82944.18
5552033-55203342.26542.58
6530814-53081440.64041.00
极限1614265-61426547.03046.911.3547.4847.331.39
2613434-61343446.96647.35
3598804-59880445.84646.20
4619089-61908947.39947.85
5621922-62192247.61648.03
6608732-60873246.60647.06
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.531030889103149510309441031354103207010313500.05
228.431046160104567010459150.04
单位质量响应值RSD%判断
36149.6736789.131.24数据可信
供试品溶液-2024032521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%
5min1152381-1523817.2964.1963.227.304.1963.24
224064-240641.1521.15
326976-269761.2921.29
4129930-1299306.2216.22
568864-688643.2973.30
6123299-1232995.9035.90
10min1336968-33696816.13311.1548.6116.1511.1648.62
290007-900074.3094.31
3106460-1064605.0975.10
4288787-28878713.82713.84
5225626-22562610.80310.81
6349870-34987016.75116.76
15min1501906-50190624.03019.1821.5624.0819.2221.60
2300226-30022614.37414.39
3311732-31173214.92514.94
4437473-43747320.94520.99
5369976-36997617.71417.75
6482807-48280723.11623.17
20min1578025-57802527.67524.9411.1527.7825.0211.23
2465872-46587222.30522.35
3453914-45391421.73221.78
4546691-54669126.17426.27
5492634-49263423.58623.66
6588942-58894228.19728.30
30min1672511-67251132.19831.444.3732.3731.574.43
2656940-65694031.45331.55
3610718-61071829.24029.34
4689956-68995633.03433.18
5637069-63706930.50230.62
6672840-67284032.21432.38
45min1756111-75611136.20136.294.8736.4436.494.87
2787385-78738537.69837.86
3698747-69874733.45533.62
4805392-80539238.56138.78
5745635-74563535.69935.89
6754269-75426936.11336.35
60min1818707-81870739.19839.504.8039.5239.784.80
2853923-85392340.88441.13
3762315-76231536.49836.73
4878795-87879542.07542.38
5822668-82266839.38839.66
6813847-81384738.96539.28
极限1990843-99084347.44046.691.6647.8547.061.71
2982383-98238347.03447.37
3946115-94611545.29845.61
4986324-98632447.22347.63
5975443-97544346.70247.06
6969791-96979146.43246.83
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.535951705961045951465948005945275951490.11
228.436073296083946078620.13
单位质量响应值RSD%判断
20860.4621381.011.75数据可信
供试品溶液-2024032621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%
5min111214-112140.8764.2375.470.884.2375.38
2112210-1122108.7658.76
354658-546584.2694.27
46736-67360.5260.53
583558-835586.5276.53
656193-561934.3894.39
10min1146956-14695611.47915.1622.4611.4815.1622.48
2255184-25518419.93319.95
3172394-17239413.46613.48
4152991-15299111.95011.95
5228344-22834417.83617.85
6208316-20831616.27216.28
15min1305501-30550123.86324.9911.8723.8925.0311.91
2373050-37305029.13929.20
3293100-29310022.89422.93
4271327-27132721.19421.22
5352774-35277427.55627.61
6323880-32388025.29925.34
20min1392954-39295430.69431.539.1230.7731.639.15
2453014-45301435.38535.51
3378359-37835929.55429.64
4350818-35081827.40327.48
5424585-42458533.16533.28
6422132-42213232.97333.08
30min1456599-45659935.66537.519.2335.8137.689.26
2554823-55482343.33843.55
3454325-45432535.48835.64
4433025-43302533.82433.96
5474624-47462437.07337.26
6507877-50787739.67139.85
45min1492920-49292038.50340.968.2838.7341.218.31
2591135-59113546.17446.48
3505027-50502739.44839.68
4481035-48103537.57437.79
5512117-51211740.00240.27
6564062-56406244.06044.32
60min1530501-53050141.43843.536.7441.7543.886.78
2612339-61233947.83048.24
3536333-53633341.89442.22
4519740-51974040.59740.89
5550092-55009242.96843.33
6594778-59477846.45946.82
极限1609499-60949947.60948.372.2148.0148.812.29
2643620-64362050.27450.79
3611187-61118747.74148.16
4608837-60883747.55747.94
5615502-61550248.07848.53
6626895-62689548.96749.43
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.531018310102013010180311018375101766310185020.10
228.431030282103073310305080.04
单位质量响应值RSD%判断
35699.3336247.201.08数据可信
供试品溶液-2024032621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%
5min114866-148660.7223.4776.200.723.4776.22
2152028-1520287.3797.38
369071-690713.3533.35
410283-102830.4990.50
5108342-1083425.2595.26
673917-739173.5883.59
10min1189875-1898759.21612.2323.869.2212.2423.88
2340282-34028216.51616.53
3218880-21888010.62410.63
4196939-1969399.5599.56
5296520-29652014.39214.40
6269374-26937413.07513.08
15min1411382-41138219.96720.7813.2219.9920.8113.25
2512202-51220224.86124.91
3384389-38438918.65718.69
4359223-35922317.43617.46
5472868-47286822.95223.00
6428399-42839920.79320.83
20min1543672-54367226.38826.8410.2426.4526.9210.28
2632866-63286630.71830.83
3509844-50984424.74624.82
4473704-47370422.99223.05
5584689-58468928.37928.47
6572621-57262127.79327.88
30min1656382-65638231.85933.2010.3931.9833.3410.42
2805952-80595239.11939.30
3636664-63666430.90231.03
4606354-60635429.43129.54
5678466-67846632.93133.09
6719734-71973434.93435.08
45min1736483-73648335.74737.899.3535.9438.109.38
2897314-89731443.55343.82
3740333-74033335.93436.13
4706351-70635134.28434.46
5762960-76296037.03237.26
6840637-84063740.80241.02
60min1810482-81048239.33941.518.1539.6141.818.17
2960373-96037346.61446.97
3815296-81529639.57239.85
4783353-78335338.02238.28
5841247-84124740.83241.15
6920394-92039444.67344.99
极限1968142-96814246.99148.013.2647.3548.403.33
21045647-104564750.75351.22
3967809-96780946.97547.34
4963106-96310646.74747.08
5981576-98157647.64348.05
61008434-100843448.94749.36
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.536105656096576103546094656095246099130.09
228.436002005993275997640.11
单位质量响应值RSD%判断
21377.9521096.170.94数据可信
供试品溶液-2024032621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%
5min195773-957737.4394.1967.917.444.1967.85
243748-437483.3983.40
312202-122020.9480.95
489406-894066.9456.94
568587-685875.3275.33
613613-136131.0571.06
10min1236583-23658318.37714.4525.8918.3914.4625.91
2197474-19747415.33915.35
399571-995717.7347.74
4214252-21425216.64216.66
5201854-20185415.67915.69
6166360-16636012.92212.92
15min1340701-34070126.46424.329.7326.5224.369.76
2334964-33496426.01826.06
3259146-25914620.12920.15
4331630-33163025.75925.81
5311265-31126524.17724.22
6301292-30129223.40323.43
20min1412293-41229332.02531.733.1332.1431.833.15
2422383-42238332.80932.91
3397507-39750730.87630.94
4417052-41705232.39432.50
5388655-38865530.18930.29
6413252-41325232.09932.18
30min1482362-48236237.46737.504.8037.6537.674.76
2510883-51088339.68339.86
3507612-50761239.42939.56
4470044-47004436.51136.69
5450275-45027534.97535.14
6475709-47570936.95137.11
45min1533905-53390541.47141.034.9041.7441.284.85
2553963-55396343.02943.29
3561112-56111243.58443.80
4507605-50760539.42839.69
5497023-49702338.60638.85
6515512-51551240.04240.28
60min1565920-56592043.95843.403.6144.3243.743.59
2582409-58240945.23945.59
3577951-57795144.89245.21
4541284-54128442.04442.39
5532112-53211241.33241.66
6552932-55293242.94943.27
极限1619265-61926548.10148.301.3048.5648.741.30
2634278-63427849.26749.72
3624342-62434248.49648.91
4621318-62131848.26148.70
5609297-60929747.32747.75
6622457-62245748.34948.77
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
128.531042376104188210415291042113104174310419290.04
228.431021187102139710212920.02
单位质量响应值RSD%判断
36520.4735923.041.17数据可信
供试品溶液-2024032621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%
5min1122776-1227765.9183.3864.265.923.3864.31
254955-549552.6492.65
320625-206250.9940.99
4113526-1135265.4735.47
588288-882884.2564.26
620365-203650.9820.98
10min1308189-30818914.85611.6025.9414.8711.6025.95
2256013-25601312.34112.35
3128500-1285006.1946.20
4273368-27336813.17813.19
5261146-26114612.58912.60
6216201-21620110.42210.42
15min1454328-45432821.90120.129.7521.9520.159.78
2450609-45060921.72221.75
3346324-34632416.69416.71
4438833-43883321.15421.20
5412530-41253019.88619.92
6401150-40115019.33719.36
20min1563799-56379927.17826.983.4227.2727.063.43
2583450-58345028.12528.21
3547881-54788126.41126.46
4567108-56710827.33727.43
5528348-52834825.46925.55
6567917-56791727.37627.44
30min1687557-68755733.14433.255.4333.3033.395.39
2735727-73572735.46635.61
3729868-72986835.18335.29
4668975-66897532.24832.40
5637336-63733630.72330.86
6679629-67962932.76132.89
45min1796042-79604238.37337.915.5238.6038.125.49
2832137-83213740.11340.34
3838238-83823840.40740.60
4752459-75245936.27236.49
5730847-73084735.23035.44
6769255-76925537.08237.28
60min1869414-86941441.91041.314.4742.2241.604.46
2904546-90454643.60343.92
3890463-89046342.92543.20
4824462-82446239.74340.04
5805716-80571638.83939.12
6847111-84711140.83541.12
极限1990234-99023447.73447.871.7848.1448.261.79
21017459-101745949.04649.46
31004737-100473748.43348.81
4985735-98573547.51747.91
5965484-96548446.54146.91
6994588-99458847.94448.32
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