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%
128.065890815888695871425883155868765880570.18
228.025914885898605906740.20
单位质量响应值RSD%判断
20957.1321080.440.42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%
5min113128-131281.0903.5968.661.093.5968.69
278663-786636.5346.53
315067-150671.2521.25
458610-586104.8694.87
571094-710945.9065.91
622546-225461.8731.87
10min1147531-14753112.25515.6231.4212.2615.6331.42
2210323-21032317.47117.48
3163676-16367613.59613.60
4272956-27295622.67422.68
5224449-22444918.64418.65
6109409-1094099.0889.09
15min1273473-27347322.71626.0914.1622.7426.1214.17
2298961-29896124.83424.87
3298012-29801224.75524.78
4398147-39814733.07333.12
5325129-32512927.00727.05
6290631-29063124.14224.16
20min1395656-39565632.86632.156.3732.9332.226.37
2362432-36243230.10630.19
3382544-38254431.77731.84
4431989-43198935.88435.98
5376733-37673331.29431.38
6372770-37277030.96531.02
30min1483993-48399340.20438.176.1940.3238.296.18
2420880-42088034.96135.09
3452921-45292137.62337.74
4487308-48730840.47940.64
5432264-43226435.90736.04
6479346-47934639.81839.93
45min1529925-52992544.01941.875.6644.2042.065.63
2480824-48082439.94040.13
3491452-49145240.82341.00
4519771-51977143.17643.40
5466179-46617938.72438.92
6535859-53585944.51244.69
60min1554424-55442446.05443.845.5346.3144.105.50
2506234-50623442.05142.31
3517667-51766743.00143.25
4544236-54423645.20845.51
5485561-48556140.33440.60
6558188-55818846.36746.62
90min1586344-58634448.70646.165.5049.0446.505.47
2535297-53529744.46544.79
3540969-54096944.93645.26
4568092-56809247.19047.57
5513843-51384342.68343.01
6590014-59001449.01049.34
120min1599832-59983249.82647.495.0650.2447.905.04
2553666-55366645.99146.39
3555899-55589946.17746.57
4581521-58152148.30548.76
5532983-53298344.27344.67
6606510-60651050.38150.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1615269-61526951.10849.014.6151.6049.504.58
2575354-57535447.79348.27
3572881-57288147.58748.06
4598090-59809049.68150.22
5554202-55420246.03646.51
6624537-62453751.87852.37
极限1637323-63732352.94051.822.6353.5252.392.64
2611757-61175750.81751.37
3615084-61508451.09351.65
4634170-63417052.67853.30
5601969-60196950.00450.55
6642470-64247053.36853.95
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%
128.061005853100617910023191004209100174110040600.21
228.021010138100789410090160.16
单位质量响应值RSD%判断
35782.6136010.560.45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%
5min119546-195460.8982.5069.490.902.5069.39
299832-998324.5884.59
316721-167210.7680.77
473766-737663.3903.39
590606-906064.1644.16
626462-264621.2161.22
10min1188423-1884238.65811.2132.998.6611.2233.01
2272966-27296612.54312.55
3208725-2087259.5919.59
4359733-35973316.53116.54
5295519-29551913.58013.59
6138407-1384076.3606.36
15min1361635-36163516.61819.3315.1316.6319.3615.15
2399297-39929718.34918.38
3395351-39535118.16718.18
4540352-54035224.83024.86
5438843-43884320.16620.20
6388827-38882717.86717.88
20min1539746-53974624.80324.346.9624.8524.396.97
2492770-49277022.64422.70
3521350-52135023.95724.00
4597556-59755627.45927.53
5519977-51997723.89423.96
6506390-50639023.27023.31
30min1691433-69143331.77330.016.6531.8630.116.63
2592740-59274027.23827.33
3647190-64719029.74029.83
4698786-69878632.11132.23
5612440-61244028.14328.25
6676058-67605831.06631.15
45min1787696-78769636.19634.276.0936.3334.426.07
2701710-70171032.24532.39
3732563-73256333.66333.80
4776616-77661635.68735.86
5686430-68643031.54331.69
6790044-79004436.30436.44
60min1852423-85242339.17136.995.9739.3737.205.95
2763488-76348835.08435.28
3796143-79614336.58536.78
4833378-83337838.29638.53
5735940-73594033.81834.02
6848740-84874039.00239.20
90min1932328-93232842.84340.366.1343.1140.626.11
2832496-83249638.25538.51
3860415-86041539.53839.79
4904807-90480741.57841.88
5805449-80544937.01237.27
6934273-93427342.93243.19
120min1972319-97231944.68042.305.7445.0242.635.71
2876291-87629140.26840.59
3899483-89948341.33341.65
4938515-93851543.12743.49
5852961-85296139.19639.52
6983324-98332445.18645.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11012223-101222346.51444.175.4446.9244.575.42
2924861-92486142.49942.88
3933973-93397342.91843.31
4976238-97623844.86045.30
5893561-89356141.06141.45
61025945-102594547.14547.55
极限11058915-105891548.66047.323.8249.1547.803.83
2996796-99679645.80546.26
31011481-101148146.48046.94
41062064-106206448.80449.32
5978181-97818144.95045.40
61071493-107149349.23849.72
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%
128.065880785870065881005873675872335875570.09
228.025855855864165860000.11
单位质量响应值RSD%判断
20939.3120913.630.09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%
5min191702-917027.6512.91100.167.652.91100.12
28231-82310.6870.69
35368-53680.4480.45
452957-529574.4184.42
545333-453333.7823.78
65654-56540.4720.47
10min1200351-20035116.71614.0324.4116.7314.0324.43
2147293-14729312.28912.29
3116371-1163719.7099.71
4203352-20335216.96616.97
5209473-20947317.47717.48
6131888-13188811.00411.00
15min1274262-27426222.88223.4415.9422.9223.4715.96
2258573-25857321.57321.59
3219655-21965518.32618.34
4327579-32757927.33127.37
5338821-33882128.26928.30
6266858-26685822.26522.28
20min1333842-33384227.85329.7413.0327.9329.8113.03
2335954-33595428.02928.09
3284187-28418723.71023.76
4393011-39301132.79032.87
5405124-40512433.80033.88
6386885-38688532.27932.33
30min1415265-41526534.64735.6811.6434.7735.8011.64
2404608-40460833.75733.86
3347985-34798529.03329.12
4441608-44160836.84436.98
5477102-47710239.80639.94
6479680-47968040.02140.13
45min1460605-46060538.42939.1610.4938.6139.3410.50
2444979-44497937.12637.29
3391778-39177832.68732.82
4478255-47825539.90240.10
5511870-51187042.70742.91
6528808-52880844.12044.30
60min1491940-49194041.04441.439.5941.2941.679.60
2474873-47487339.62039.84
3419915-41991535.03535.22
4503295-50329541.99142.25
5533367-53336744.50044.78
6556273-55627346.41146.66
90min1522933-52293343.63044.268.7043.9444.578.71
2509800-50980042.53442.82
3456979-45697938.12738.38
4538318-53831844.91345.25
5565288-56528847.16347.51
6589409-58940949.17649.50
120min1540719-54071945.11345.838.2145.5046.218.23
2528798-52879844.11944.48
3477110-47711039.80640.12
4560254-56025446.74347.15
5582879-58287948.63149.06
6605945-60594550.55550.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1554267-55426746.24447.357.7246.7147.817.74
2545590-54559045.52045.95
3501942-50194241.87842.26
4578160-57816048.23748.72
5597736-59773649.87150.38
6627608-62760852.36352.86
极限1595617-59561749.69450.363.8350.2350.903.89
2585754-58575448.87149.38
3574121-57412147.90048.35
4609614-60961450.86251.43
5619999-61999951.72852.32
6636867-63686753.13553.72
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%
128.061004366100203010047491003880100344710036940.11
228.02999578100133310004560.13
单位质量响应值RSD%判断
35769.5735705.070.13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%
5min1112449-1124495.1901.96103.095.191.96103.22
28972-89720.4140.41
36173-61730.2850.28
469477-694773.2073.21
553310-533102.4612.46
64736-47360.2190.22
10min1253852-25385211.7179.8925.8111.739.9025.83
2184211-1842118.5038.50
3145108-1451086.6986.70
4260767-26076712.03612.04
5274767-27476712.68212.69
6167196-1671967.7177.72
15min1356175-35617516.44016.9817.8316.4717.0017.83
2332470-33247015.34615.36
3280445-28044512.94412.96
4430768-43076819.88319.91
5458288-45828821.15321.18
6349584-34958416.13616.15
20min1443168-44316820.45522.0614.9920.5122.1014.99
2443131-44313120.45320.49
3368697-36869717.01817.05
4528971-52897124.41624.47
5558611-55861125.78425.84
6524601-52460124.21424.25
30min1571702-57170226.38827.3613.5126.4827.4413.52
2555447-55544725.63825.71
3464937-46493721.46021.52
4615178-61517828.39528.49
5675684-67568431.18731.29
6673391-67339131.08131.16
45min1665418-66541830.71331.2212.4530.8531.3512.46
2637000-63700029.40229.52
3541130-54113024.97725.07
4688957-68895731.80031.95
5751286-75128634.67734.83
6774833-77483335.76435.90
60min1736580-73658033.99834.1111.6234.1834.2911.62
2702745-70274532.43632.60
3598110-59811027.60727.75
4746730-74673034.46734.67
5805115-80511537.16137.37
6845014-84501439.00339.19
90min1817876-81787637.75038.0110.5537.9938.2510.56
2790944-79094436.50736.73
3680476-68047631.40931.59
4833489-83348938.47138.73
5882956-88295640.75441.03
6935335-93533543.17243.43
120min1865307-86530739.94040.4210.0540.2440.7310.06
2838956-83895638.72339.00
3731823-73182333.77934.02
4893854-89385441.25741.58
5938336-93833643.31043.65
6986601-98660145.53845.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1895610-89561041.33842.369.4441.7142.739.45
2878098-87809840.53040.88
3785438-78543836.25336.55
4934061-93406143.11343.50
5976574-97657445.07545.49
61036880-103688047.85948.26
极限1973206-97320644.92045.515.7045.3645.955.75
2950576-95057643.87544.29
3905223-90522341.78242.14
4996905-99690546.01446.48
51025927-102592747.35347.84
61064004-106400449.11149.60
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%
128.065862155868375862785861755861205863250.05
228.025870025872215871120.03
单位质量响应值RSD%判断
20895.4020953.320.20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%
5min16958-69580.5811.62106.100.581.62105.95
260061-600615.0125.01
37735-77350.6450.65
47070-70700.5900.59
513747-137471.1471.15
621198-211981.7691.77
10min1118111-1181119.85510.8337.259.8610.8337.27
2206265-20626517.21117.22
386844-868447.2467.25
480213-802136.6936.69
5121198-12119810.11310.11
6166188-16618813.86713.87
15min1251908-25190821.01921.3813.0321.0421.4013.06
2300567-30056725.08025.12
3243152-24315220.28920.30
4207662-20766217.32817.34
5246907-24690720.60220.62
6287370-28737023.97824.00
20min1355178-35517829.63629.236.8829.6929.286.90
2355430-35543029.65729.74
3363703-36370330.34830.39
4306949-30694925.61225.65
5342937-34293728.61528.67
6377501-37750131.49931.57
30min1471885-47188539.37537.887.7739.4837.987.76
2410035-41003534.21434.34
3467882-46788239.04139.14
4416597-41659734.76134.84
5454857-45485737.95438.05
6502661-50266141.94342.06
45min1521629-52162943.52541.736.9943.6941.906.97
2449496-44949637.50637.69
3518341-51834143.25143.41
4467450-46745039.00439.15
5502737-50273741.94942.11
6540978-54097845.14045.33
60min1547779-54777945.70743.806.5545.9544.046.53
2473932-47393239.54539.79
3543744-54374445.37145.61
4493912-49391241.21241.42
5527138-52713843.98544.22
6563000-56300046.97747.24
90min1574837-57483747.96546.206.2448.2846.516.23
2504417-50441742.08942.40
3575330-57533048.00648.32
4521252-52125243.49443.77
5552787-55278746.12546.43
6593226-59322649.49949.84
120min1590675-59067549.28647.965.9949.6848.345.98
2525270-52527043.82944.21
3592292-59229249.42149.81
4544760-54476045.45545.80
5575949-57594948.05848.44
6619484-61948451.69052.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1606658-60665850.62049.565.9451.1050.025.93
2546147-54614745.57146.03
3610093-61009350.90751.38
4560379-56037946.75947.18
5597662-59766249.86950.33
6642476-64247653.60954.12
极限1626952-62695252.31352.054.1152.8852.604.12
2594174-59417449.57850.11
3629701-62970152.54353.10
4600066-60006650.07050.57
5625533-62553352.19552.74
6666028-66602855.57456.17
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%
128.061000823100193910011891001583100074610012560.06
228.021001749100269610022220.07
单位质量响应值RSD%判断
35682.6835768.090.17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%
5min14926-49260.2270.94125.990.230.95125.79
271615-716153.3073.31
36451-64510.2980.30
46032-60320.2790.28
512808-128080.5910.59
620928-209280.9660.97
10min1152214-1522147.0287.4940.487.037.4940.49
2266222-26622212.29212.30
3104335-1043354.8174.82
493285-932854.3074.31
5146877-1468776.7826.78
6210060-2100609.6999.70
15min1332667-33266715.36015.4214.1315.3715.4314.16
2397039-39703918.33218.36
3314882-31488214.53914.55
4265370-26537012.25312.26
5317260-31726014.64914.66
6376286-37628617.37417.39
20min1488630-48863022.56121.737.5922.6021.777.60
2478406-47840622.08922.15
3487046-48704622.48822.52
4406846-40684618.78518.81
5454954-45495421.00621.04
6508042-50804223.45723.50
30min1678123-67812331.31029.248.4831.3929.328.47
2567749-56774926.21426.31
3650998-65099830.05830.13
4576145-57614526.60226.66
5626986-62698628.94929.02
6700362-70036232.33732.42
45min1781437-78143736.08133.568.1136.2133.698.09
2644260-64426029.74729.88
3753030-75303034.76934.89
4671375-67137530.99931.10
5723090-72309033.38733.51
6788231-78823136.39436.53
60min1841178-84117838.83936.287.5139.0336.467.50
2700746-70074632.35532.54
3814971-81497137.62937.81
4731477-73147733.77433.93
5783086-78308636.15736.33
6843204-84320438.93339.13
90min1910868-91086842.05739.697.0242.3139.937.01
2778799-77879935.95936.20
3895537-89553741.34941.59
4800999-80099936.98437.20
5847523-84752339.13239.37
6924119-92411942.66942.93
120min1950046-95004643.86642.226.4744.1942.536.47
2834403-83440338.52638.83
3944504-94450443.61043.92
4863670-86367039.87740.15
5900648-90064841.58541.89
6992842-99284245.84246.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1988697-98869745.65044.596.6746.0544.976.67
2879596-87959640.61340.98
3997520-99752046.05846.44
4902970-90297041.69242.03
5971533-97153344.85845.23
61054010-105401048.66649.08
极限11033101-103310147.70047.274.9048.1747.724.91
2963716-96371644.49744.93
31039905-103990548.01548.47
4976687-97668745.09645.50
51026239-102623947.38447.83
61103600-110360050.95651.45
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