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%
128.605860675856645859375857275846825856150.10
228.645841345843405842370.03
单位质量响应值RSD%判断
20476.0520399.340.27数据可信
加速3月-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%
5min135939-359392.8482.27103.782.852.28103.70
28936-89360.7080.71
385777-857776.7976.80
415232-152321.2071.21
57584-75840.6010.60
618624-186241.4761.48
10min1188052-18805214.90212.5932.6014.9112.6032.65
2119795-1197959.4939.49
3237314-23731418.80618.82
4101237-1012378.0238.02
5126109-1261099.9949.99
6180963-18096314.34114.34
15min1295671-29567123.43123.5613.8523.4623.5813.87
2241950-24195019.17419.19
3364083-36408328.85228.89
4277020-27702021.95321.97
5287142-28714222.75522.77
6318061-31806125.20525.23
20min1366181-36618129.01831.957.3129.0932.027.33
2384650-38465030.48230.53
3451830-45183035.80635.90
4398044-39804431.54331.60
5400363-40036331.72731.78
6418193-41819333.14033.21
30min1424578-42457833.64638.547.3833.7638.667.37
2511047-51104740.49840.60
3527180-52718041.77741.93
4497645-49764539.43639.54
5485788-48578838.49738.61
6471791-47179137.38837.51
45min1466289-46628936.95241.546.5137.1241.736.50
2552613-55261343.79243.96
3559362-55936244.32744.55
4536029-53602942.47842.65
5523526-52352641.48741.66
6507695-50769540.23340.42
60min1485993-48599338.51343.266.3138.7543.506.30
2573205-57320545.42445.66
3579906-57990645.95546.25
4558165-55816544.23244.47
5548341-54834143.45443.70
6529388-52938841.95242.20
极限1579949-57994945.95947.882.3446.2648.202.35
2617402-61740248.92749.24
3617475-61747548.93249.30
4609292-60929248.28448.60
5601119-60111947.63647.95
6599973-59997347.54547.87
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601016338101619210165621016133101547710161400.04
228.641013580101397310137760.03
单位质量响应值RSD%判断
35529.3735397.210.27数据可信
加速3月-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%
5min145915-459151.9811.72100.931.981.72100.80
212752-127520.5500.55
3118082-1180825.0955.09
418259-182590.7880.79
514867-148670.6410.64
629329-293291.2651.27
10min1243555-24355510.5098.9434.7510.518.9434.78
2154084-1540846.6486.65
3318426-31842613.73913.75
4126765-1267655.4705.47
5162418-1624187.0087.01
6237320-23732010.24010.24
15min1394089-39408917.00417.3014.8417.0217.3214.87
2323688-32368813.96613.98
3499072-49907221.53421.57
4372530-37253016.07416.08
5384387-38438716.58616.60
6431795-43179518.63118.65
20min1499631-49963121.55824.198.3921.6124.248.40
2532824-53282422.99023.03
3637413-63741327.50327.57
4554246-55424623.91523.95
5554793-55479323.93823.98
6585071-58507125.24525.29
30min1597385-59738525.77630.318.5425.8630.408.53
2742013-74201332.01632.09
3770519-77051933.24633.36
4722461-72246131.17331.25
5697688-69768830.10430.18
6684962-68496229.55529.65
45min1681579-68157929.40933.897.7029.5434.037.68
2834930-83493036.02636.15
3847658-84765836.57536.74
4808297-80829734.87635.01
5779801-77980133.64733.78
6760784-76078432.82632.97
60min1727912-72791231.40836.257.5231.5836.447.52
2887194-88719438.28138.47
3902681-90268138.94939.18
4865598-86559837.34937.54
5841000-84100036.28736.47
6816019-81601935.21035.41
极限1920311-92031139.71042.083.3039.9442.343.32
2999238-99923843.11543.37
31008480-100848043.51443.81
4990411-99041142.73442.98
5960199-96019941.43141.68
6973386-97338642.00042.25
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%
128.605844555837345839365837175842625840210.06
228.645845385840235842800.07
单位质量响应值RSD%判断
20420.3120400.840.07数据可信
加速3月-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%
5min176855-768556.0993.9282.596.103.9282.53
210191-101910.8090.81
370375-703755.5845.58
4107158-1071588.5038.50
510689-106890.8480.85
621506-215061.7071.71
10min1212004-21200416.82313.4328.6616.8313.4428.69
2130180-13018010.33010.33
3180053-18005314.28714.30
4238123-23812318.89518.91
5132920-13292010.54710.55
6122099-1220999.6899.69
15min1342450-34245027.17423.5614.4827.2123.5814.50
2266509-26650921.14821.17
3307459-30745924.39724.43
4349947-34994727.76927.81
5267210-26721021.20321.22
6247614-24761419.64819.67
20min1410124-41012432.54430.4310.1532.6330.5010.17
2337995-33799526.82026.87
3406651-40665132.26832.34
4422907-42290733.55833.65
5391064-39106431.03131.09
6332161-33216126.35726.41
30min1476276-47627637.79336.409.1237.9336.529.13
2403160-40316031.99132.09
3482670-48267038.30038.43
4475389-47538937.72337.87
5504794-50479440.05640.16
6410019-41001932.53532.63
45min1519617-51961741.23239.658.0441.4339.848.04
2439266-43926634.85635.01
3523241-52324141.52041.71
4506083-50608340.15840.37
5546160-54616043.33843.51
6464082-46408236.82536.98
60min1542504-54250443.04841.497.4643.3241.737.47
2463865-46386536.80837.02
3547601-54760143.45343.71
4527461-52746141.85542.13
5566883-56688344.98345.23
6488724-48872438.78138.99
极限1605983-60598348.08547.252.5148.4347.562.57
2581757-58175746.16346.43
3599459-59945947.56847.90
4607933-60793348.24048.59
5605360-60536048.03648.36
6572090-57209045.39645.67
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%
128.601014570101413610138221014185101404310141510.03
228.641013566101268210131240.07
单位质量响应值RSD%判断
35459.8335374.440.18数据可信
加速3月-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%
5min189408-894083.8632.7080.013.862.7080.05
215327-153270.6620.66
381724-817243.5313.53
4141425-1414256.1106.11
522562-225620.9750.97
625121-251211.0851.09
10min1274099-27409911.8429.4929.8311.859.4929.86
2168539-1685397.2827.28
3231666-23166610.00910.01
4315499-31549913.63113.64
5175400-1754007.5787.58
6152077-1520776.5706.57
15min1463960-46396020.04517.3015.3820.0717.3215.42
2357790-35779015.45815.47
3413933-41393317.88417.91
4477181-47718120.61620.65
5364021-36402115.72715.74
6324996-32499614.04114.05
20min1571577-57157724.69422.9711.4024.7523.0211.43
2463233-46323320.01420.05
3563582-56358224.34924.40
4593917-59391725.66025.73
5548681-54868123.70523.75
6448696-44869619.38619.42
30min1682947-68294729.50628.4710.5029.6128.5610.51
2569440-56944024.60224.67
3697779-69777930.14730.24
4689511-68951129.79029.90
5737410-73741031.85931.94
6576808-57680824.92024.99
45min1770685-77068533.29732.179.4833.4532.309.47
2641050-64105027.69627.81
3786495-78649533.98034.12
4758591-75859132.77432.93
5830255-83025535.87036.00
6680025-68002529.38029.49
60min1828049-82804935.77534.608.7735.9834.788.78
2697697-69769730.14330.30
3846071-84607136.55436.75
4812300-81230035.09535.31
5884035-88403538.19438.39
6736243-73624331.80931.97
极限1972614-97261442.02141.343.2542.2941.583.29
2926096-92609640.01140.22
3968024-96802441.82342.08
4978661-97866142.28242.55
5985513-98551342.57842.83
6909850-90985039.30939.52
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%
128.605834445837865837175838955838965837480.04
228.645847895845025846460.04
单位质量响应值RSD%判断
20410.7720413.620.01数据可信
加速3月-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%
5min190953-909537.2176.1742.997.226.1743.03
2112753-1127538.9468.95
395148-951487.5497.55
465706-657065.2135.21
584746-847466.7246.72
617035-170351.3521.35
10min1233526-23352618.52917.1923.1818.5417.2023.19
2250873-25087319.90519.92
3227269-22726918.03318.05
4212112-21211216.83016.84
5256533-25653320.35520.37
6119594-1195949.4899.49
15min1327783-32778326.00825.8412.0626.0525.8712.08
2339936-33993626.97227.02
3324372-32437225.73725.78
4317034-31703425.15525.19
5383089-38308930.39630.44
6261460-26146020.74520.76
20min1375489-37548929.79332.398.7629.8832.478.76
2392046-39204631.10731.20
3440401-44040134.94435.03
4389423-38942330.89930.98
5464842-46484236.88336.98
6386817-38681730.69230.74
30min1420554-42055433.36937.018.0733.5037.148.06
2440569-44056934.95735.10
3514042-51404240.78740.93
4458190-45819036.35536.49
5509513-50951340.42740.58
6455851-45585136.16936.27
45min1461987-46198736.65640.077.0336.8540.277.03
2478742-47874237.98638.19
3552572-55257243.84444.06
4498917-49891739.58639.78
5542041-54204143.00843.23
6495668-49566839.32939.49
60min1489218-48921838.81742.396.5739.0742.656.57
2506036-50603640.15140.42
3579444-57944445.97646.26
4537737-53773742.66742.92
5568606-56860645.11645.41
6524379-52437941.60741.84
极限1584156-58415646.35047.401.8546.6747.741.87
2604954-60495448.00048.33
3611934-61193448.55448.92
4585835-58583546.48346.81
5602334-60233447.79248.16
6595217-59521747.22747.53
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%
128.601014204101450010144161015075101445810145310.04
228.641016703101582010162620.07
单位质量响应值RSD%判断
35473.1135484.010.03数据可信
加速3月-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%
5min1117163-1171635.0534.3643.775.054.3643.82
2154439-1544396.6616.66
3121191-1211915.2275.23
486136-861363.7153.71
5104874-1048744.5234.52
623248-232481.0031.00
10min1307121-30712113.24612.2224.5013.2512.2324.49
2338920-33892014.61714.63
3294111-29411112.68512.69
4275971-27597111.90211.91
5334190-33419014.41314.42
6150327-1503276.4836.49
15min1445825-44582519.22818.8513.0819.2618.8813.10
2466057-46605720.10120.14
3431006-43100618.58918.62
4422213-42221318.21018.24
5514975-51497522.21022.24
6341792-34179214.74114.75
20min1522999-52299922.55724.218.8922.6224.278.89
2548440-54844023.65423.72
3603586-60358626.03226.09
4530333-53033322.87322.93
5641662-64166227.67427.74
6521277-52127722.48222.52
30min1607194-60719426.18828.738.0626.2928.838.05
2637117-63711727.47827.59
3733292-73329231.62631.73
4647672-64767227.93428.03
5732816-73281631.60631.72
6638250-63825027.52727.60
45min1693924-69392429.92832.467.3130.0732.617.30
2718381-71838130.98331.14
3829732-82973235.78635.94
4738982-73898231.87232.01
5811577-81157735.00335.17
6723171-72317131.19031.31
60min1760708-76070832.80935.587.0333.0035.787.02
2780230-78023033.65133.86
3904915-90491539.02839.24
4825561-82556135.60635.80
5883292-88329238.09638.32
6795586-79558634.31334.49
极限1944259-94425940.72541.582.4340.9741.842.46
2976699-97669942.12442.39
3997259-99725943.01143.29
4938648-93864840.48340.74
5978236-97823642.19142.48
6948858-94885840.92441.15
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%
128.605876115870925873945868295852665868380.16
228.645905505908725907110.04
单位质量响应值RSD%判断
20518.8120625.380.37数据可信
加速3月-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%
5min190085-900857.0924.7764.537.094.7764.55
281371-813716.4066.41
394268-942687.4227.42
48784-87840.6920.69
576164-761645.9966.00
612838-128381.0111.01
10min1232764-23276418.32515.7329.8018.3415.7429.81
2233302-23330218.36818.38
3242698-24269819.10719.12
4125624-1256249.8909.89
5243433-24343319.16519.18
6120733-1207339.5059.51
15min1367685-36768528.94726.1815.6128.9926.2115.64
2358391-35839128.21628.26
3382233-38223330.09330.14
4257499-25749920.27320.29
5352032-35203227.71527.76
6277112-27711221.81721.83
20min1428085-42808533.70331.729.7933.7931.799.83
2443781-44378134.93835.03
3429509-42950933.81533.91
4352131-35213127.72327.77
5407138-40713832.05332.14
6356398-35639828.05928.11
30min1474377-47437737.34736.115.1137.4936.245.14
2483949-48394938.10138.25
3476973-47697337.55137.70
4451718-45171835.56335.66
5438932-43893234.55634.70
6425767-42576733.52033.62
45min1509941-50994140.14738.974.3540.3639.164.38
2519660-51966040.91241.12
3506827-50682739.90240.12
4493029-49302938.81538.97
5478183-47818337.64737.85
6462472-46247236.41036.57
60min1546227-54622743.00441.862.6143.2842.112.62
2548011-54801143.14443.42
3531492-53149241.84442.12
4524152-52415241.26641.49
5511353-51135340.25840.52
6528737-52873741.62741.84
极限1607598-60759847.83547.041.3548.1847.361.38
2604287-60428747.57547.92
3594961-59496146.84047.19
4585074-58507446.06246.35
5593980-59398046.76347.09
6599092-59909247.16647.45
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601019910101944810191391018530101595110185960.16
228.641022818102325310230360.04
单位质量响应值RSD%判断
35615.2435720.530.21数据可信
加速3月-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%
5min1111676-1116764.7913.3163.814.793.3263.77
2105388-1053884.5214.52
3121284-1212845.2035.20
411964-119640.5130.51
596156-961564.1254.13
617136-171360.7350.74
10min1302672-30267212.98511.1830.4612.9911.1830.48
2304719-30471913.07313.08
3319497-31949713.70713.72
4160523-1605236.8876.89
5319093-31909313.68913.70
6156441-1564416.7116.71
15min1494941-49494121.23319.2016.5821.2619.2316.61
2484776-48477620.79720.83
3519819-51981922.30022.33
4337448-33744814.47714.49
5476803-47680320.45520.48
6371986-37198615.95815.97
20min1591989-59198925.39723.8511.0025.4623.9111.03
2616013-61601326.42726.49
3600250-60025025.75125.82
4469809-46980920.15520.19
5567242-56724224.33524.40
6490599-49059921.04721.09
30min1682123-68212329.26328.135.8829.3728.225.92
2697399-69739929.91930.03
3689387-68938729.57529.69
4630766-63076627.06027.13
5627480-62748026.91927.02
6606506-60650626.01926.09
45min1765252-76525232.83031.585.1932.9931.725.22
2779430-77943033.43833.60
3763559-76355932.75732.92
4716743-71674330.74930.86
5705728-70572830.27630.43
6686090-68609029.43429.55
60min1846761-84676136.32635.083.5536.5435.283.58
2851075-85107536.51136.73
3829017-82901735.56535.78
4788357-78835733.82133.99
5783711-78371133.62233.82
6807423-80742334.63934.81
极限1982086-98208642.13241.222.0842.4041.482.11
2978529-97852941.97942.25
3965811-96581141.43441.71
4927823-92782339.80440.03
5950401-95040140.77341.03
6960814-96081441.21941.44
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%
128.605866195859985860425855765856215859710.08
228.645846705851015848860.06
单位质量响应值RSD%判断
20488.5020422.000.23数据可信
加速3月-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%
5min1104821-1048218.3003.6087.558.303.6087.57
252698-526984.1734.17
317452-174521.3821.38
412401-124010.9820.98
57678-76780.6080.61
677389-773896.1286.13
10min1242278-24227819.18315.9418.9019.2015.9518.93
2196969-19696915.59615.60
3167417-16741713.25613.26
4175935-17593513.93013.93
5171014-17101413.54113.54
6254510-25451020.15220.16
15min1344853-34485327.30525.447.6727.3525.487.71
2329790-32979026.11226.15
3300926-30092623.82723.85
4306648-30664824.28024.30
5293083-29308323.20623.23
6352672-35267227.92427.97
20min1415596-41559632.90632.615.9033.0032.695.89
2437276-43727634.62334.70
3409486-40948632.42232.49
4430568-43056834.09134.16
5367965-36796529.13529.20
6410587-41058732.50932.60
30min1493815-49381539.09938.948.3739.2539.078.35
2536698-53669842.49542.63
3497431-49743139.38639.50
4532598-53259842.17042.29
5431198-43119834.14134.25
6459184-45918436.35736.50
45min1530891-53089142.03542.227.3542.2542.427.33
2575963-57596345.60445.81
3542084-54208442.92143.10
4574332-57433245.47445.67
5484351-48435138.35038.52
6492130-49213038.96639.17
60min1557391-55739144.13344.326.8244.4144.586.80
2601725-60172547.64347.92
3569063-56906345.05745.31
4598905-59890547.42047.69
5516694-51669440.91141.14
6514633-51463340.74841.02
极限1620590-62059049.13748.682.0949.4949.022.11
2619851-61985149.07949.44
3614855-61485548.68349.01
4633094-63309450.12750.47
5598589-59858947.39547.69
6601896-60189647.65747.99
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%
128.601016998101593010159451015464101541610159510.07
228.641015830101622110160260.03
单位质量响应值RSD%判断
35522.7635475.770.10数据可信
加速3月-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%
5min1137306-1373065.9182.5787.805.922.5687.84
267659-676592.9162.92
322514-225140.9700.97
417195-171950.7410.74
59589-95890.4130.41
6102847-1028474.4334.43
10min1321792-32179213.87111.4020.8113.8811.4020.82
2257132-25713211.08311.09
3212934-2129349.1789.18
4229864-2298649.9089.91
5221963-2219639.5689.57
6342777-34277714.77514.78
15min1469824-46982420.25118.729.2620.2818.749.29
2447646-44764619.29519.32
3398139-39813917.16117.18
4412456-41245617.77917.80
5389444-38944416.78716.80
6487637-48763721.01921.05
20min1577987-57798724.91424.606.6724.9824.656.67
2611288-61128826.34926.40
3556021-55602123.96724.01
4595774-59577425.68025.73
5502909-50290921.67721.72
6579845-57984524.99425.06
30min1715775-71577530.85330.569.0930.9630.669.07
2783539-78353933.77433.87
3707850-70785030.51130.60
4767592-76759233.08633.18
5607468-60746826.18426.27
6671539-67153928.94629.05
45min1808522-80852234.85134.678.2535.0134.828.24
2881689-88168938.00438.16
3808092-80809234.83234.97
4868935-86893537.45537.60
5711734-71173430.67930.80
6747327-74732732.21332.37
60min1878529-87852937.86837.687.8438.0937.897.83
2954661-95466141.15041.37
3880886-88088637.97038.16
4940022-94002240.51940.73
5785434-78543433.85534.03
6805778-80577834.73234.94
极限11009493-100949343.51343.062.9843.7943.332.99
21014798-101479843.74244.03
3999479-99947943.08243.34
41040196-104019644.83745.11
5960242-96024241.39041.62
6969929-96992941.80842.08
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%
128.605853825853955850565850595854455852670.04
228.645918475915175916820.04
单位质量响应值RSD%判断
20463.8820659.290.68数据可信
加速3月-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%
5min135197-351972.7723.5881.612.773.5881.54
299164-991647.8117.81
328888-288882.2762.28
483893-838936.6086.61
513544-135441.0671.07
612008-120080.9460.95
10min1202514-20251415.95215.2321.1015.9615.2321.13
2258950-25895020.39720.41
3162042-16204212.76412.77
4217295-21729517.11617.13
5165692-16569213.05213.05
6153246-15324612.07112.07
15min1314847-31484724.80125.299.1524.8325.329.18
2366737-36673728.88828.93
3312769-31276924.63724.66
4345056-34505627.18027.22
5296711-29671123.37223.40
6290234-29023422.86222.88
20min1415601-41560132.73732.934.9932.8133.005.02
2445672-44567235.10635.20
3423180-42318033.33433.40
4432264-43226434.04934.13
5386023-38602330.40730.47
6405731-40573131.95932.02
30min1494833-49483338.97838.684.1639.1138.814.17
2492747-49274738.81438.97
3477484-47748437.61137.73
4521381-52138141.06941.21
5461071-46107136.31936.43
6498846-49884639.29439.41
45min1535024-53502442.14441.854.0242.3442.044.03
2538242-53824242.39742.62
3515518-51551840.60740.79
4556167-55616743.80944.02
5497501-49750139.18839.36
6545455-54545542.96643.14
60min1559910-55991044.10444.073.6644.3744.343.67
2568950-56895044.81645.11
3535509-53550942.18242.43
4582364-58236445.87346.16
5534443-53444342.09842.34
6576045-57604545.37545.63
极限1608157-60815747.90548.581.5748.2448.921.58
2631825-63182549.76950.13
3606370-60637047.76448.09
4617901-61790148.67249.03
5612977-61297748.28448.59
6623242-62324249.09349.42
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%
128.601015686101565610154251015373101568110155640.02
228.641024823102425610245400.04
单位质量响应值RSD%判断
35509.2335773.040.53数据可信
加速3月-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%
5min146670-466702.0042.5576.922.002.5576.94
2127464-1274645.4725.47
336868-368681.5831.58
4104896-1048964.5044.50
519521-195210.8380.84
620980-209800.9010.90
10min1267013-26701311.46410.8721.4411.4710.8821.45
2342274-34227414.69514.70
3210380-2103809.0329.03
4281255-28125512.07512.08
5216785-2167859.3079.31
6201590-2015908.6558.66
15min1427646-42764618.36018.649.3218.3818.669.34
2500324-50032421.48021.51
3424461-42446118.22318.24
4460888-46088819.78719.81
5399542-39954217.15417.17
6392243-39224316.84016.86
20min1579164-57916424.86524.975.5424.9225.025.56
2626415-62641526.89426.96
3593070-59307025.46225.51
4595374-59537425.56125.62
5531192-53119222.80622.85
6564145-56414524.22024.26
30min1722885-72288531.03630.564.3631.1330.664.37
2722038-72203830.99931.11
3696721-69672129.91230.00
4748660-74866032.14232.25
5658143-65814328.25628.34
6722546-72254631.02131.11
45min1814166-81416634.95534.454.3035.1034.604.31
2818514-81851435.14135.31
3782453-78245333.59333.73
4833156-83315635.77035.93
5741626-74162631.84031.97
6824900-82490035.41635.55
60min1875822-87582237.60237.444.2337.8137.644.24
2894648-89464838.41038.63
3833460-83346035.78335.98
4907260-90726038.95139.17
5820108-82010835.21035.39
6900847-90084738.67638.87
极限1993857-99385742.66943.191.7342.9443.461.75
21030507-103050744.24344.53
3985889-98588942.32742.58
41011769-101176943.43843.72
5994231-99423142.68542.93
61019562-101956243.77344.03
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