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%
128.275752295729885748515696965793565744240.62
228.325734855727565731200.09
单位质量响应值RSD%判断
20319.2120237.290.29数据可信
长期3月-供试品溶液-2024032421批-缬沙坦钠-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%
5min1229774-22977418.35217.5715.7218.3517.5715.73
2222375-22237517.76117.76
3151552-15155212.10412.10
4229764-22976418.35118.35
5241771-24177119.31019.31
6244884-24488419.55919.56
10min1424276-42427633.88732.268.1933.9232.298.19
2373406-37340629.82429.85
3375307-37530729.97530.00
4381989-38198930.50930.54
5456344-45634436.44836.48
6411995-41199532.90632.94
15min1516269-51626941.23440.634.7441.3240.714.73
2470226-47022637.55737.64
3515792-51579241.19641.27
4502184-50218440.10940.19
5503785-50378540.23740.33
6543932-54393243.44343.53
20min1564309-56430945.07145.354.8145.2345.504.79
2523590-52359041.81941.96
3605452-60545248.35748.50
4570753-57075345.58645.73
5559057-55905744.65144.81
6583450-58345046.60046.76
30min1594266-59426647.46448.994.9947.6949.214.98
2569799-56979945.50945.72
3652950-65295052.15152.37
4603837-60383748.22848.45
5618852-61885249.42749.66
6640247-64024751.13651.37
45min1628367-62836750.18751.112.4250.5051.422.42
2615228-61522849.13849.43
3647150-64715051.68751.99
4644042-64404251.43951.74
5646927-64692751.67051.99
6658039-65803952.55752.88
60min1647004-64700451.67651.721.0852.0752.121.10
2637684-63768450.93151.30
3651012-65101251.99652.39
4641357-64135751.22551.62
5652700-65270052.13152.53
6655784-65578452.37752.79
极限1652169-65216952.08851.940.8052.5752.420.81
2647390-64739051.70652.16
3651334-65133452.02252.50
4641502-64150251.23651.71
5653655-65365552.20752.70
6655929-65592952.38852.89
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%
128.2799640399467810012389899839994689963540.45
228.329962389905199933780.41
单位质量响应值RSD%判断
35244.2235076.910.34数据可信
长期3月-供试品溶液-2024032421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%
5min1393736-39373617.13516.4116.3817.1416.4116.37
2380973-38097316.58016.58
3254745-25474511.08611.09
4395435-39543517.20917.21
5414943-41494318.05818.06
6422173-42217318.37318.37
10min1731753-73175331.84630.228.0531.8730.258.05
2641134-64113427.90227.93
3645694-64569428.10028.12
4658184-65818428.64428.67
5780779-78077933.97934.01
6709321-70932130.86930.90
15min1892636-89263638.84738.204.9638.9338.284.96
2809500-80950035.22935.30
3888992-88899238.68938.75
4865705-86570537.67537.75
5867114-86711437.73637.82
6942414-94241441.01341.10
20min1967596-96759642.10942.615.0042.2642.754.98
2900616-90061639.19439.33
31046201-104620145.53045.66
4986696-98669642.94143.08
5964658-96465841.98142.13
61008854-100885443.90544.06
30min11025609-102560944.63446.135.1444.8546.355.13
2983901-98390142.81943.02
31129635-112963549.16149.37
41042005-104200545.34845.56
51068087-106808746.48346.70
61111310-111131048.36448.59
45min11087667-108766747.33548.152.5047.6348.442.51
21061643-106164346.20246.47
31119972-111997248.74149.03
41113510-111351048.45948.75
51115787-111578748.55948.86
61140182-114018249.62049.92
60min11120546-112054648.76648.751.1349.1449.121.15
21100875-110087547.91048.26
31127454-112745449.06649.44
41111806-111180648.38548.75
51123821-112382148.90849.29
61137143-113714349.48849.87
极限11128129-112812949.09649.030.7849.5549.480.79
21123847-112384748.90949.34
31127807-112780749.08249.53
41111032-111103248.35248.80
51132959-113295949.30649.77
61135997-113599749.43849.91
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%
128.275794845795015792905786775781495790200.11
228.325764225780325772270.20
单位质量响应值RSD%判断
20481.7820382.310.35数据可信
长期3月-供试品溶液-2024032421批-缬沙坦钠-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%
5min1188506-18850614.94314.4110.4714.9414.4110.48
2180929-18092914.34214.34
3175458-17545813.90813.91
4167162-16716213.25113.25
5215812-21581217.10717.11
6162974-16297412.91912.92
10min1360948-36094828.61228.165.8628.6428.195.87
2332048-33204826.32126.34
3370195-37019529.34529.37
4337159-33715926.72626.75
5386048-38604830.60130.63
6345408-34540827.38027.40
15min1505711-50571140.08738.924.6740.1638.994.67
2446822-44682235.41935.49
3504566-50456639.99640.07
4487177-48717738.61838.68
5506504-50650440.15040.23
6495045-49504539.24139.31
20min1574680-57468045.55445.433.8545.6945.573.85
2530390-53039042.04342.17
3577767-57776745.79845.94
4593156-59315647.01847.15
5585734-58573446.43046.58
6576956-57695645.73445.87
30min1640889-64088950.80249.813.1851.0250.023.18
2592727-59272746.98447.18
3628865-62886549.84950.06
4651385-65138551.63451.84
5632115-63211550.10750.33
6623913-62391349.45649.67
45min1648229-64822951.38450.901.4851.6851.191.49
2623780-62378049.44649.72
3641977-64197750.88851.19
4648012-64801251.36751.66
5642159-64215950.90351.21
6648450-64845051.40151.69
60min1645196-64519651.14351.101.2251.5351.481.23
2629037-62903749.86350.22
3648878-64887851.43551.82
4648211-64821151.38251.76
5646087-64608751.21451.61
6650210-65021051.54151.92
极限1640685-64068550.78651.470.9251.2651.940.90
2652221-65222151.70052.14
3657934-65793452.15352.62
4645259-64525951.14851.62
5649075-64907551.45151.93
6650830-65083051.59052.05
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%
128.271006072100624410065101003437100313710050800.17
228.32999478100194710007120.18
单位质量响应值RSD%判断
35552.8835335.880.44数据可信
长期3月-供试品溶液-2024032421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%
5min1321561-32156113.88213.3910.9113.8813.3910.90
2309067-30906713.34313.34
3299302-29930212.92112.92
4284253-28425312.27212.27
5370453-37045315.99315.99
6276026-27602611.91611.92
10min1621119-62111926.81426.365.8926.8426.385.88
2569940-56994024.60524.63
3637678-63767827.52927.55
4578756-57875624.98625.01
5662146-66214628.58628.61
6593654-59365425.62925.65
15min1874722-87472237.76336.604.8137.8336.664.80
2769373-76937333.21533.28
3870476-87047637.58037.65
4839412-83941236.23836.30
5874788-87478837.76637.84
6857488-85748837.01937.08
20min1992365-99236542.84242.724.0042.9742.854.00
2912472-91247239.39339.51
3999933-99993343.16843.30
41024636-102463644.23544.36
51010980-101098043.64543.78
6996983-99698343.04143.17
30min11107667-110766747.81946.893.1448.0247.083.13
21025019-102501944.25144.44
31085858-108585846.87847.08
41125444-112544448.58748.78
51090861-109086147.09447.30
61081524-108152446.69146.89
45min11121638-112163848.42347.891.7048.7048.161.71
21073982-107398246.36546.62
31103296-110329647.63147.91
41122871-112287148.47648.75
51112313-111231348.02048.31
61121084-112108448.39948.67
60min11118357-111835748.28148.071.2948.6448.421.30
21084603-108460346.82447.16
31119515-111951548.33148.69
41121083-112108348.39948.76
51115280-111528048.14848.52
61121670-112167048.42448.78
极限11110963-111096347.96248.580.8748.4049.020.86
21131079-113107948.83049.24
31139514-113951449.19449.63
41119162-111916248.31648.75
51125592-112559248.59349.04
61125730-112573048.59949.03
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%
128.275726675736595745405752485750695742370.19
228.325737515735675736590.03
单位质量响应值RSD%判断
20312.5920256.320.20数据可信
长期3月-供试品溶液-2024032521批-缬沙坦钠-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%
5min1181193-18119314.46714.0114.8614.4714.0114.87
2159607-15960712.74412.74
3147784-14778411.80011.80
4153055-15305512.22112.22
5209145-20914516.69916.70
6202097-20209716.13616.14
10min1347188-34718827.72128.256.6327.7528.276.64
2332130-33213026.51926.54
3336090-33609026.83526.85
4342506-34250627.34727.37
5373471-37347129.82029.85
6391253-39125331.23931.27
15min1467483-46748337.32638.743.3637.4038.813.35
2506289-50628940.42440.49
3467180-46718037.30237.37
4488101-48810138.97239.04
5481909-48190938.47838.56
6500167-50016739.93640.01
20min1528113-52811342.16743.905.2642.3044.045.25
2588462-58846246.98547.12
3521823-52182341.66541.79
4552004-55200444.07544.21
5528040-52804042.16142.30
6580566-58056646.35546.50
30min1585745-58574546.76947.865.1146.9748.065.11
2643474-64347451.37851.59
3570785-57078545.57445.77
4579261-57926146.25146.46
5584226-58422646.64746.86
6632639-63263950.51350.74
45min1627285-62728550.08549.982.4150.3750.272.42
2643407-64340751.37351.67
3608105-60810548.55448.83
4612789-61278948.92849.21
5620865-62086549.57349.86
6643623-64362351.39051.70
60min1651655-65165552.03150.971.8452.4051.341.84
2637499-63749950.90151.28
3621847-62184749.65150.00
4627426-62742650.09750.46
5647569-64756951.70552.08
6643848-64384851.40851.80
极限1655544-65554452.34251.511.2652.7951.971.26
2642492-64249251.29951.77
3631262-63126250.40350.84
4647102-64710251.66852.11
5649266-64926651.84052.30
6645329-64532951.52652.00
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%
128.279947709944399960069966519966139956960.11
228.329957789947089952430.08
单位质量响应值RSD%判断
35220.9435142.760.16数据可信
长期3月-供试品溶液-2024032521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%
5min1311578-31157813.55113.0515.3513.5513.0515.35
2271920-27192011.82711.83
3250755-25075510.90610.91
4260383-26038311.32511.32
5360058-36005815.66015.66
6345533-34553315.02815.03
10min1595905-59590525.91826.436.8025.9426.466.80
2570099-57009924.79524.82
3575670-57567025.03825.06
4588463-58846325.59425.61
5642885-64288527.96127.99
6673483-67348329.29229.32
15min1806306-80630635.06936.423.4335.1336.483.44
2876144-87614438.10638.17
3805527-80552735.03535.09
4841793-84179336.61236.67
5832682-83268236.21636.29
6861808-86180837.48337.56
20min1909440-90944039.55441.275.4039.6841.395.38
21016703-101670344.22044.34
3899641-89964139.12839.25
4953440-95344041.46841.59
5910118-91011839.58439.72
61003423-100342343.64243.78
30min11009712-100971243.91544.975.3244.1145.175.32
21113162-111316248.41548.61
3980849-98084942.66042.84
4998998-99899843.44943.64
51008055-100805543.84344.04
61093484-109348447.55947.77
45min11084892-108489247.18547.072.4347.4547.342.44
21112252-111225248.37548.65
31049828-104982845.66045.91
41059931-105993146.10046.36
51074331-107433146.72647.00
61112573-111257348.38948.68
60min11125825-112582548.96647.981.9649.3148.331.96
21101815-110181547.92148.28
31073221-107322146.67847.01
41081669-108166947.04547.39
51120722-112072248.74449.09
61115342-111534248.51048.88
极限11135535-113553549.38848.611.2749.8149.041.27
21111346-111134648.33648.78
31093777-109377747.57247.98
41122329-112232948.81349.23
51125085-112508548.93349.36
61117901-111790148.62149.07
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%
128.275762205802395776675763175778025776490.29
228.325757315752185754740.07
单位质量响应值RSD%判断
20433.2920320.410.40数据可信
长期3月-供试品溶液-2024032521批-缬沙坦钠-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%
5min1188855-18885515.01113.308.9215.0113.308.92
2182491-18249114.50514.50
3163501-16350112.99613.00
4162154-16215412.88812.89
5154561-15456112.28512.28
6152641-15264112.13212.13
10min1358578-35857828.50129.349.7128.5329.369.70
2423462-42346233.65833.68
3396340-39634031.50231.52
4322664-32266425.64625.67
5348133-34813327.67127.69
6365316-36531629.03629.06
15min1494552-49455239.30839.4910.9139.3839.5610.91
2596674-59667447.42547.51
3476182-47618237.84837.92
4435754-43575434.63534.70
5474533-47453337.71737.78
6503478-50347840.01840.09
20min1567960-56796045.14344.028.4545.2844.168.45
2636452-63645250.58750.75
3521908-52190841.48341.62
4505082-50508240.14540.27
5532014-53201442.28642.42
6559453-55945344.46744.60
30min1628655-62865549.96748.245.8850.1848.455.88
2660748-66074852.51852.76
3577356-57735645.89046.10
4566298-56629845.01145.20
5589424-58942446.84947.05
6619244-61924449.21949.43
45min1651487-65148751.78250.443.3052.0850.733.32
2657293-65729352.24452.57
3619934-61993449.27449.56
4603299-60329947.95248.22
5628335-62833549.94250.22
6646968-64696851.42351.71
60min1650686-65068651.71851.381.5452.1051.751.56
2655855-65585552.12952.55
3641925-64192551.02251.39
4628835-62883549.98250.33
5653796-65379651.96652.33
6647214-64721451.44251.82
极限1655454-65545452.09751.930.5952.5752.390.62
2658255-65825552.32052.83
3654593-65459352.02952.48
4652721-65272151.88052.31
5652147-65214751.83552.28
6646883-64688351.41651.88
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%
128.2799987810025271000635999452100140510007790.13
228.3210002709988349995520.11
单位质量响应值RSD%判断
35400.7435294.920.22数据可信
长期3月-供试品溶液-2024032521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%
5min1323286-32328613.99512.339.3513.9912.339.33
2311677-31167713.49213.49
3278830-27883012.07012.07
4275324-27532411.91811.92
5261871-26187111.33611.34
6258497-25849711.19011.19
10min1616935-61693526.70627.469.9526.7327.489.93
2730031-73003131.60231.62
3680817-68081729.47229.49
4551168-55116823.85923.88
5598274-59827425.89925.92
6628156-62815627.19227.21
15min1852684-85268436.91237.1011.0736.9837.1611.06
21031301-103130144.64444.72
3821721-82172135.57135.64
4749376-74937632.44032.50
5817494-81749435.38835.45
6868967-86896737.61737.68
20min1980465-98046542.44341.368.5942.5741.488.59
21099864-109986447.61247.76
3900575-90057538.98539.11
4868444-86844437.59437.71
5917108-91710839.70139.82
6965578-96557841.79941.93
30min11084076-108407646.92845.376.0147.1345.576.02
21144692-114469249.55249.78
31000280-100028043.30143.49
4974895-97489542.20242.38
51015438-101543843.95744.14
61069195-106919546.28446.48
45min11125445-112544548.71947.513.4049.0047.783.42
21139682-113968249.33649.65
31071723-107172346.39446.66
41042209-104220945.11645.36
51085338-108533846.98347.24
61120118-112011848.48948.76
60min11126008-112600848.74448.401.6849.1048.761.71
21137250-113725049.23049.62
31109899-110989948.04648.39
41084715-108471546.95647.28
51129768-112976848.90649.25
61121498-112149848.54848.90
极限11133882-113388249.08449.040.5649.5349.470.57
21140411-114041149.36749.84
31138186-113818649.27149.69
41132259-113225949.01449.41
51128533-112853348.85349.27
61123410-112341048.63149.07
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%
128.275758625721875746755739715737745740940.24
228.325747265746665746960.01
单位质量响应值RSD%判断
20307.5320292.940.06数据可信
长期3月-供试品溶液-2024032621批-缬沙坦钠-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%
5min1232488-23248818.54816.1217.9918.5516.1217.99
2243321-24332119.41319.41
3188247-18824715.01915.02
4206633-20663316.48616.49
5140784-14078411.23211.23
6200600-20060016.00416.00
10min1380310-38031030.34229.756.2330.3729.776.23
2384198-38419830.65230.68
3370319-37031929.54529.57
4382364-38236430.50630.53
5327749-32774926.14926.17
6392291-39229131.29831.32
15min1464215-46421537.03639.074.1737.1239.154.17
2495112-49511239.50139.58
3477633-47763338.10738.18
4485408-48540838.72738.81
5491045-49104539.17739.24
6524887-52488741.87741.96
20min1520058-52005841.49144.014.9441.6344.154.93
2556567-55656744.40444.55
3534512-53451242.64542.78
4534496-53449642.64342.79
5593471-59347147.34947.48
6570400-57040045.50845.66
30min1567141-56714145.24847.595.3145.4647.815.28
2596270-59627047.57247.80
3577099-57709946.04246.25
4581852-58185246.42246.64
5655995-65599552.33752.54
6600970-60097047.94748.17
45min1620594-62059449.51250.632.4849.8050.922.47
2635596-63559650.70951.01
3614164-61416448.99949.29
4639610-63961051.03051.32
5658652-65865252.54952.84
6638793-63879350.96451.27
60min1639088-63908850.98851.561.7951.3651.941.77
2643164-64316451.31351.70
3638025-63802550.90351.27
4656315-65631552.36252.74
5664670-66467053.02953.41
6636592-63659250.78951.18
极限1649869-64986951.84851.891.4652.3052.351.44
2643235-64323551.31951.79
3646967-64696751.61752.07
4659306-65930652.60153.06
5663869-66386952.96553.43
6639168-63916850.99451.47
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%
128.279981719950339943039960409959609959010.15
228.329989129980249984680.07
单位质量响应值RSD%判断
35228.1935256.640.06数据可信
长期3月-供试品溶液-2024032621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%
5min1401497-40149717.43215.0818.6417.4315.0818.64
2420934-42093418.27618.28
3322216-32221613.99013.99
4355653-35565315.44215.44
5238298-23829810.34610.35
6344959-34495914.97814.98
10min1654352-65435228.41127.856.3028.4427.886.30
2659914-65991428.65228.68
3637378-63737827.67427.70
4658664-65866428.59828.62
5562971-56297124.44324.46
6675549-67554929.33129.36
15min1800315-80031534.74836.664.2834.8236.734.27
2852116-85211636.99737.08
3821654-82165435.67535.74
4837169-83716936.34836.42
5848387-84838736.83536.89
6906939-90693939.37839.45
20min1896334-89633438.91741.325.1439.0541.455.12
2959584-95958441.66341.80
3919891-91989139.94040.07
4921151-92115139.99540.13
51027249-102724944.60144.72
6985717-98571742.79842.94
30min1977883-97788342.45844.675.3142.6644.875.28
21027299-102729944.60444.81
3995019-99501943.20243.40
41003480-100348043.56943.77
51131006-113100649.10649.30
61037641-103764145.05345.26
45min11070528-107052846.48047.582.5446.7547.862.53
21096583-109658347.61247.90
31060881-106088146.06246.33
41104260-110426047.94548.22
51138742-113874249.44249.72
61104235-110423547.94448.23
60min11107064-110706448.06748.551.7948.4148.911.78
21110251-111025148.20548.57
31103946-110394647.93148.28
41134366-113436649.25249.61
51151077-115107749.97850.34
61102300-110230047.86048.23
极限11125704-112570448.87648.901.4649.3049.341.44
21114680-111468048.39748.84
31119816-111981648.62049.04
41141133-114113349.54649.98
51149693-114969349.91850.36
61106576-110657648.04648.49
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.275741695754705765705764455754045756120.17
228.325774855757825766340.21
单位质量响应值RSD%判断
20361.2320361.370.01数据可信
长期3月-供试品溶液-2024032621批-缬沙坦钠-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%
5min1188589-18858915.00116.2222.9215.0016.2222.90
2256344-25634420.39020.39
3234386-23438618.64418.64
4236950-23695018.84818.85
5132949-13294910.57510.58
6174320-17432013.86613.87
10min1375310-37531029.85331.267.6329.8831.287.66
2431627-43162734.33334.37
3405456-40545632.25132.28
4418198-41819833.26533.30
5354484-35448428.19728.21
6372617-37261729.63929.66
15min1537281-53728142.73741.425.0142.8141.495.01
2551539-55153943.87143.96
3483638-48363838.47038.55
4534995-53499542.55542.64
5496423-49642339.48739.55
6520228-52022841.38141.45
20min1581866-58186646.28346.434.9546.4346.574.93
2613510-61351048.80048.96
3530754-53075442.21842.37
4578781-57878146.03846.20
5601199-60119947.82147.95
6595802-59580247.39247.53
30min1626140-62614049.80550.283.9950.0350.513.98
2668921-66892153.20853.45
3593999-59399947.24847.47
4621297-62129749.42049.65
5645637-64563751.35651.57
6636987-63698750.66850.89
45min1650946-65094651.77852.161.2052.0852.471.21
2670872-67087253.36353.70
3655944-65594452.17652.47
4648686-64868651.59851.92
5654640-65464052.07252.37
6653558-65355851.98652.29
60min1644754-64475451.28652.141.6851.6852.541.68
2672300-67230053.47753.90
3660777-66077752.56052.95
4642318-64231851.09251.49
5656330-65633052.20652.59
6656442-65644252.21552.61
极限1646105-64610551.39352.171.1651.8752.661.16
2666842-66684253.04353.56
3662176-66217652.67253.14
4651691-65169151.83752.33
5656450-65645052.21652.69
6652279-65227951.88452.36
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.2799566799836299968210000469979999983510.18
228.32100164899854810000980.22
单位质量响应值RSD%判断
35314.8635314.190.01数据可信
长期3月-供试品溶液-2024032621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%
5min1322372-32237213.96815.1423.6213.9715.1423.63
2441032-44103219.11019.11
3405245-40524517.55917.56
4406997-40699717.63517.64
5224358-2243589.7219.72
6296171-29617112.83312.83
10min1644866-64486627.94229.337.7627.9729.367.77
2745491-74549132.30232.33
3697893-69789330.23930.27
4721322-72132231.25531.28
5610851-61085126.46826.48
6641181-64118127.78227.80
15min1928329-92832940.22438.915.0940.2938.995.09
2951070-95107041.20941.30
3833146-83314636.10036.18
4923924-92392440.03340.11
5855616-85561637.07337.13
6896612-89661238.85038.92
20min11005929-100592943.58643.655.0343.7243.795.01
21058809-105880945.87846.03
3913824-91382439.59639.74
4999330-99933043.30143.45
51038193-103819344.98445.11
61027869-102786944.53744.67
30min11083080-108308046.92947.304.0447.1447.514.03
21154423-115442350.02150.25
31023634-102363444.35444.56
41071991-107199146.44946.67
51116847-111684748.39348.59
61099164-109916447.62647.83
45min11125397-112539748.76349.131.2149.0549.421.22
21160651-116065150.29150.60
31133635-113363549.12049.40
41122988-112298848.65948.96
51131828-113182849.04249.32
61128578-112857848.90149.19
60min11116803-111680348.39149.161.6848.7649.541.68
21163632-116363250.42050.82
31145893-114589349.65150.01
41111841-111184148.17648.55
51135985-113598549.22249.58
61133728-113372849.12449.49
极限11118335-111833548.45749.191.1448.9149.651.14
21154347-115434750.01750.50
31145012-114501249.61350.06
41127920-112792048.87249.33
51136506-113650649.24449.69
61129976-112997648.96149.41
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