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%
128.272752392756552780052786852749182765000.63
228.322791112790302790700.03
单位质量响应值RSD%判断
9780.699854.170.53数据可信
长期3月-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%
5min139575-395756.5294.1045.816.534.1045.79
225210-252104.1594.16
35880-58800.9700.97
419792-197923.2653.27
527718-277184.5734.57
630973-309735.1105.11
10min1119780-11978019.76114.1026.0019.7714.1026.01
295880-9588015.81815.82
363102-6310210.41010.41
496547-9654715.92815.93
569022-6902211.38711.39
668466-6846611.29511.30
15min1180682-18068229.80824.4313.3829.8524.4613.39
2155733-15573325.69225.73
3124015-12401520.45920.48
4151028-15102824.91624.95
5144328-14432823.81023.84
6132689-13268921.89021.92
20min1224367-22436737.01531.968.7837.1132.038.81
2198824-19882432.80132.88
3174764-17476428.83228.88
4192276-19227631.72131.79
5184987-18498730.51830.58
6187192-18719230.88230.95
30min1250987-25098741.40637.686.1641.5637.806.17
2238092-23809239.27939.41
3223918-22391836.94137.04
4223180-22318036.81936.95
5210782-21078234.77434.89
6223368-22336836.85036.97
45min1268522-26852244.29941.125.1744.5241.305.18
2260173-26017342.92243.12
3247830-24783040.88641.05
4242880-24288040.06940.26
5233436-23343638.51138.69
6242554-24255440.01540.19
60min1277050-27705045.70643.334.3046.0043.594.32
2275252-27525245.40945.68
3261825-26182543.19443.43
4254403-25440341.97042.22
5249078-24907841.09141.33
6258388-25838842.62742.87
极限1301673-30167349.76848.452.1450.1448.782.18
2300724-30072449.61249.96
3291695-29169548.12248.42
4291854-29185448.14848.47
5285399-28539947.08347.39
6290877-29087747.98748.30
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%
128.274893954902574923184834294797594870321.08
228.324783784783404783590.01
单位质量响应值RSD%判断
17227.8716891.211.40数据可信
长期3月-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%
5min150322-503224.5142.6451.904.512.6451.92
229299-292992.6282.63
34702-47020.4220.42
422318-223182.0022.00
533160-331602.9752.97
636880-368803.3083.31
10min1153220-15322013.7449.5728.0113.759.5728.02
2118858-11885810.66210.67
376685-766856.8796.88
4122424-12242410.98210.99
584926-849267.6187.62
683746-837467.5127.52
15min1238825-23882521.42417.2214.6821.4517.2414.70
2201062-20106218.03618.06
3157855-15785514.16014.17
4197117-19711717.68217.70
5186491-18649116.72916.75
6170284-17028415.27515.29
20min1304332-30433227.30023.0910.0427.3723.1410.07
2262658-26265823.56223.61
3228038-22803820.45620.49
4255699-25569922.93722.99
5244527-24452721.93521.98
6248838-24883822.32222.37
30min1350501-35050131.44128.027.3031.5528.107.32
2326121-32612129.25429.35
3304363-30436327.30327.37
4305055-30505527.36527.45
5285248-28524825.58825.67
6302553-30255327.14027.22
45min1388663-38866334.86531.616.7135.0331.756.72
2368835-36883533.08633.23
3352610-35261031.63131.75
4343756-34375630.83630.97
5321638-32163828.85228.98
6338836-33883630.39530.52
60min1410513-41051336.82534.215.8937.0534.405.91
2403587-40358736.20336.40
3384584-38458434.49934.67
4365903-36590332.82333.01
5352649-35264931.63431.81
6371158-37115833.29433.47
极限1481884-48188443.22741.363.2043.5141.603.23
2475733-47573342.67542.93
3456501-45650140.95041.18
4453248-45324840.65840.90
5442963-44296339.73639.96
6455987-45598740.90441.14
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272842352842352841092837122839092840400.08
228.322842712843022842860.01
单位质量响应值RSD%判断
10047.4010038.350.07数据可信
长期3月-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%
5min113553-135532.1863.6161.672.193.6161.68
243275-432756.9796.98
34608-46080.7430.74
420447-204473.2973.30
532941-329415.3125.31
619542-195423.1523.15
10min166805-6680510.77412.1141.8010.7812.1241.80
2121725-12172519.63019.64
366037-6603710.65010.65
479977-7997712.89812.90
589579-8957914.44614.46
626453-264534.2664.27
15min1151609-15160924.45022.2327.7624.4722.2627.75
2170550-17055027.50427.55
3148535-14853523.95423.97
4157040-15704025.32625.35
5136066-13606621.94321.98
663205-6320510.19310.21
20min1204166-20416632.92630.0514.1032.9930.1214.11
2194502-19450231.36731.46
3194147-19414731.31031.37
4215382-21538234.73434.80
5164556-16455626.53826.61
6145283-14528323.43023.46
30min1247281-24728139.87936.719.7640.0036.829.75
2214614-21461434.61134.75
3240570-24057038.79638.91
4251515-25151540.56140.69
5195217-19521731.48231.60
6216568-21656834.92634.99
45min1269763-26976343.50440.617.6543.6940.797.63
2232445-23244537.48637.69
3260663-26066342.03742.21
4272341-27234143.92044.11
5226301-22630136.49536.66
6249462-24946240.23040.36
60min1282959-28295945.63242.916.8845.8943.156.86
2243839-24383939.32439.59
3275261-27526144.39144.64
4284482-28448245.87846.15
5244380-24438039.41139.64
6265499-26549942.81743.01
极限1302453-30245348.77647.902.5949.1148.212.61
2294261-29426147.45547.78
3295285-29528547.62047.94
4308104-30810449.68850.03
5285542-28554246.04946.34
6296513-29651347.81848.08
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.274925524926784921404919444920834922790.07
228.324924534924864924700.01
单位质量响应值RSD%判断
17413.4817389.480.10数据可信
长期3月-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%
5min117313-173131.5222.5860.131.522.5860.17
256766-567664.9924.99
37739-77390.6810.68
427463-274632.4152.41
542297-422973.7193.72
624550-245502.1592.16
10min184274-842747.4108.5144.107.418.5144.08
2161401-16140114.19214.20
385024-850247.4767.48
4102665-1026659.0289.03
5115628-11562810.16810.17
631636-316362.7822.79
15min1202188-20218817.77916.1928.7117.7916.2028.70
2233136-23313620.50020.53
3200633-20063317.64217.66
4208107-20810718.29918.32
5177935-17793515.64615.67
682425-824257.2487.26
20min1279180-27918024.54922.4914.6724.5922.5314.68
2273098-27309824.01424.08
3269252-26925223.67623.72
4293961-29396125.84925.90
5220902-22090219.42519.47
6198072-19807217.41717.44
30min1354555-35455531.17728.6411.0131.2628.7210.99
2311426-31142627.38527.49
3348319-34831930.62930.71
4362722-36272231.89531.99
5269433-26943323.69223.77
6307480-30748027.03827.09
45min1405024-40502435.61532.979.2635.7533.109.24
2348804-34880430.67130.82
3394328-39432834.67434.81
4409595-40959536.01736.16
5321733-32173328.29128.41
6370322-37032232.56432.66
60min1438264-43826438.53835.858.4938.7336.048.47
2375619-37561933.02933.23
3430128-43012837.82238.01
4439641-43964138.65938.86
5357716-35771631.45531.62
6405147-40514735.62635.77
极限1485988-48598842.73441.703.7043.0041.953.72
2470918-47091841.40941.67
3473850-47385041.66741.92
4495414-49541443.56343.83
5443642-44364239.01139.23
6475755-47575541.83542.04
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%
128.272843862845572845212845932844482845010.03
228.322850282850092850180.01
单位质量响应值RSD%判断
10063.7110064.190.01数据可信
长期3月-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%
5min138861-388616.2543.8054.246.253.8054.27
26604-66041.0631.06
316568-165682.6662.67
422400-224003.6053.60
538503-385036.1966.20
618661-186613.0033.00
10min199417-9941715.99912.6946.9716.0112.7046.95
29099-90991.4641.47
394439-9443915.19815.20
470813-7081311.39611.40
5113720-11372018.30118.31
685766-8576613.80213.81
15min1148652-14865223.92321.5042.0423.9621.5342.04
222568-225683.6323.64
3159088-15908825.60225.63
4146239-14623923.53423.56
5181663-18166329.23529.28
6143420-14342023.08123.11
20min1194294-19429431.26829.4927.8931.3429.5527.92
284347-8434713.57413.58
3204595-20459532.92633.00
4205772-20577233.11533.18
5229902-22990236.99837.09
6180521-18052129.05129.12
30min1222225-22222535.76337.0613.7535.8937.1713.80
2176866-17686628.46328.50
3240167-24016738.65038.78
4254300-25430040.92541.04
5266786-26678642.93443.09
6221319-22131935.61735.73
45min1264324-26432442.53843.125.5042.7343.305.55
2253652-25365240.82040.90
3274550-27455044.18444.38
4276354-27635444.47444.66
5288768-28876846.47246.69
6250116-25011640.25140.43
60min1279099-27909944.91645.883.8345.1846.123.88
2277615-27761544.67744.83
3290727-29072746.78747.05
4289461-28946146.58346.84
5301672-30167248.54848.85
6271788-27178843.73943.98
极限1301876-30187648.58148.662.5148.9248.982.55
2298092-29809247.97248.20
3308582-30858249.66050.00
4301430-30143048.50948.85
5312815-31281550.34250.72
6291443-29144346.90247.22
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%
128.274928774930714929074930634927744929380.03
228.324931754930684931220.02
单位质量响应值RSD%判断
17436.7917412.500.10数据可信
长期3月-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%
5min148649-486494.2722.6651.614.272.6651.57
29681-96810.8500.85
320805-208051.8271.83
429375-293752.5802.58
548502-485024.2594.26
624458-244582.1482.15
10min1127826-12782611.2258.7847.7811.238.7847.78
210095-100950.8870.89
3118553-11855310.41110.41
490068-900687.9097.91
5145212-14521212.75212.76
6108154-1081549.4989.50
15min1201126-20112617.66215.5242.9317.6915.5442.93
226945-269452.3662.37
3210925-21092518.52318.54
4193772-19377217.01617.03
5241594-24159421.21621.24
6186158-18615816.34816.37
20min1274166-27416624.07622.0729.0924.1322.1229.12
2110484-1104849.7029.71
3285345-28534525.05825.11
4281409-28140924.71224.76
5315938-31593827.74427.81
6240502-24050221.12021.17
30min1335294-33529429.44429.3815.1929.5429.4615.24
2247581-24758121.74221.76
3359569-35956931.57631.67
4368550-36855032.36532.45
5388059-38805934.07834.19
6308301-30830127.07427.16
45min1415786-41578636.51335.937.1836.6636.067.23
2383345-38334533.66433.72
3430669-43066937.82037.97
4420203-42020336.90137.04
5440638-44063838.69538.86
6364123-36412331.97632.10
60min1450078-45007839.52439.495.4339.7339.685.46
2437632-43763238.43138.55
3470112-47011241.28341.49
4454876-45487639.94540.15
5476634-47663441.85642.09
6408983-40898335.91536.10
极限1498128-49812843.74443.303.9544.0143.563.98
2487050-48705042.77142.95
3511917-51191744.95545.23
4490871-49087143.10643.38
5511356-51135644.90545.21
6459339-45933940.33740.58
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%
128.272851452851252849122848942848642849880.05
228.322848992848782848880.01
单位质量响应值RSD%判断
10080.9310059.600.15数据可信
长期3月-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%
5min122372-223723.5982.5339.273.602.5339.24
28494-84941.3661.37
318123-181232.9152.91
413445-134452.1622.16
522509-225093.6203.62
69576-95761.5401.54
10min170525-7052511.3439.4539.7811.359.4539.78
238950-389506.2646.27
325232-252324.0584.06
458984-589849.4869.49
589980-8998014.47114.48
668778-6877811.06211.06
15min1154478-15447824.84522.6619.1824.8722.6819.18
2136210-13621021.90721.92
388208-8820814.18614.20
4153223-15322324.64324.66
5159904-15990425.71725.75
6153202-15320224.63924.66
20min1217256-21725634.94132.308.6735.0132.368.69
2198989-19898932.00332.05
3167709-16770926.97327.01
4205232-20523233.00733.07
5204544-20454432.89732.97
6211345-21134533.99134.05
30min1258944-25894441.64639.802.9041.7739.912.90
2243999-24399939.24239.34
3250586-25058640.30240.38
4238371-23837138.33738.45
5249555-24955540.13640.26
6243504-24350439.16339.28
45min1281009-28100945.19543.453.5445.3943.633.51
2267725-26772543.05843.23
3280966-28096645.18845.34
4257422-25742241.40141.58
5270812-27081243.55543.75
6262960-26296042.29242.48
60min1291764-29176446.92445.543.8447.1945.793.80
2279302-27930244.92045.16
3298949-29894948.08048.30
4268689-26868943.21343.46
5283405-28340545.58045.85
6276778-27677844.51444.77
极限1312667-31266750.28649.351.4350.6349.681.42
2307153-30715349.39949.71
3310207-31020749.89150.19
4300999-30099948.41048.73
5307326-30732649.42749.77
6302906-30290648.71649.05
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%
128.274934904934124933434933214932104933550.03
228.324936394934884935640.03
单位质量响应值RSD%判断
17451.5417428.110.10数据可信
长期3月-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%
5min126659-266592.3391.7437.172.341.7437.22
210712-107120.9400.94
320917-209171.8351.84
419740-197401.7321.73
528785-287852.5262.53
612081-120811.0601.06
10min189944-899447.8926.5141.967.906.5241.95
246729-467294.1004.10
329224-292242.5642.57
478455-784556.8846.89
5115009-11500910.09110.10
686058-860587.5517.55
15min1207523-20752318.20816.4519.7018.2316.4619.70
2179960-17996015.79015.80
3115694-11569410.15110.16
4207017-20701718.16418.18
5211339-21133918.54318.56
6203394-20339417.84617.86
20min1303081-30308126.59224.359.4126.6424.399.43
2274275-27427524.06524.10
3228276-22827620.02920.05
4289218-28921825.37625.42
5279220-27922024.49924.55
6290810-29081025.51625.56
30min1388352-38835234.07431.793.8034.1731.873.79
2360749-36074931.65231.73
3365047-36504732.02932.09
4352991-35299130.97131.06
5355456-35545631.18831.28
6351313-35131330.82430.91
45min1444601-44460139.00936.525.0439.1636.665.01
2416091-41609136.50836.64
3438365-43836538.46238.57
4397618-39761834.88735.03
5405066-40506635.54035.69
6395475-39547534.69934.84
60min1472854-47285441.48839.365.5841.7039.565.54
2443596-44359638.92139.11
3485739-48573942.61942.79
4427176-42717637.48037.68
5436859-43685938.33038.53
6425508-42550837.33437.53
极限1519079-51907945.54443.992.6945.8344.252.68
2500024-50002443.87244.13
3515173-51517345.20145.45
4492287-49228743.19343.45
5497741-49774143.67243.94
6483910-48391042.45842.72
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272842072843332844932844022844152843700.04
228.322858512858872858690.01
单位质量响应值RSD%判断
10059.0710094.240.25数据可信
长期3月-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%
5min150129-501298.0573.12104.468.063.12104.47
227527-275274.4244.42
3-0.0000.00
4-0.0000.00
57274-72741.1691.17
631720-317205.0985.10
10min1135957-13595721.85212.4659.3621.8712.4659.39
299756-9975616.03416.04
338251-382516.1486.15
420177-201773.2433.24
556160-561609.0279.03
6114797-11479718.45118.46
15min1197594-19759431.75923.2529.4731.8123.2829.51
2162493-16249326.11726.15
3131388-13138821.11821.13
494077-9407715.12115.13
5101186-10118616.26316.28
6181300-18130029.14029.18
20min1222677-22267735.79131.1312.8535.8931.1912.91
2203785-20378532.75432.83
3183490-18349029.49229.54
4170406-17040627.38927.42
5163515-16351526.28226.33
6218115-21811535.05735.15
30min1242691-24269139.00737.245.9539.1737.366.02
2241474-24147438.81238.94
3234162-23416237.63637.73
4209696-20969633.70433.78
5220145-22014535.38435.47
6242178-24217838.92539.07
45min1259156-25915641.65440.755.1841.8840.935.22
2263804-26380442.40142.60
3262700-26270042.22342.38
4230784-23078437.09437.23
5244684-24468439.32839.47
6260100-26010041.80542.02
60min1269773-26977343.36042.944.1043.6643.194.14
2273446-27344643.95144.22
3279865-27986544.98245.21
4250902-25090240.32740.52
5257022-25702241.31141.52
6271933-27193343.70743.99
极限1297598-29759847.83247.481.9948.2047.792.04
2298439-29843947.96848.31
3299147-29914748.08148.38
4283773-28377345.61045.87
5295080-29508047.42847.71
6298273-29827347.94148.29
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%
128.274924334926274927224926324928974926620.04
228.324945544945714945620.01
单位质量响应值RSD%判断
17427.0317463.350.15数据可信
长期3月-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%
5min159419-594195.2121.99106.415.211.99106.47
233056-330562.8992.90
3-0.0000.00
4-0.0000.00
57237-72370.6350.63
636369-363693.1903.19
10min1176080-17608015.4448.5162.3715.458.5262.36
2124940-12494010.95910.96
345924-459244.0284.03
422087-220871.9371.94
568707-687076.0266.03
6144464-14446412.67112.68
15min1267483-26748323.46216.6531.6323.5016.6631.69
2211773-21177318.57518.60
3172079-17207915.09415.10
4118447-11844710.38910.39
5129536-12953611.36211.37
6239404-23940420.99921.03
20min1310661-31066127.24923.0514.4227.3223.1014.47
2274133-27413324.04524.10
3247355-24735521.69621.73
4226303-22630319.85019.87
5219415-21941519.24519.28
6298872-29887226.21526.28
30min1350910-35091030.77928.726.9930.9028.807.05
2338198-33819829.66429.76
3329754-32975428.92428.99
4291225-29122525.54425.60
5309403-30940327.13927.20
6344947-34494730.25630.36
45min1390747-39074734.27332.816.4234.4432.946.45
2388742-38874234.09834.24
3389225-38922534.14034.26
4331548-33154829.08129.18
5359115-35911531.49931.61
6385089-38508933.77733.93
60min1418824-41882436.73635.685.6436.9635.875.67
2413896-41389636.30436.50
3432022-43202237.89438.07
4370314-37031432.48132.63
5388058-38805834.03834.20
6417650-41765036.63336.85
极限1476906-47690641.83141.123.5142.1241.363.56
2475273-47527341.68841.95
3479930-47993042.09642.33
4436602-43660238.29638.49
5466564-46656440.92441.14
6477593-47759341.89142.16
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%
128.272841122839512841492842282841342841150.04
228.322899812900162899980.01
单位质量响应值RSD%判断
10050.0510240.041.33数据可信
长期3月-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%
5min111133-111331.7775.3584.031.785.3584.00
230561-305614.8794.88
315924-159242.5422.54
487441-8744113.96113.96
537219-372195.9425.94
618711-187112.9872.99
10min1111851-11185117.85817.2316.2617.8617.2416.28
2112230-11223017.91817.93
389287-8928714.25514.26
4125027-12502719.96219.98
5125060-12506019.96719.98
684027-8402713.41613.42
15min1180914-18091428.88428.557.1928.9228.597.22
2171640-17164027.40427.44
3164354-16435426.24026.27
4198049-19804931.62031.68
5188692-18869230.12630.17
6169212-16921227.01627.04
20min1234746-23474637.47935.605.0137.5635.695.02
2205769-20576932.85332.94
3219349-21934935.02135.09
4234550-23455037.44837.56
5226191-22619136.11336.21
6217401-21740134.71034.78
30min1259480-25948041.42839.844.8341.5739.984.84
2229788-22978836.68836.83
3245824-24582439.24839.38
4264420-26442042.21742.39
5249161-24916139.78139.93
6248395-24839539.65839.79
45min1276833-27683344.19942.634.6744.4142.844.67
2246136-24613639.29839.50
3263257-26325742.03142.23
4282029-28202945.02845.27
5265626-26562642.40942.63
6268179-26817942.81743.01
60min1288299-28829946.02944.504.6046.3244.784.60
2256625-25662540.97241.24
3274870-27487043.88544.15
4292378-29237846.68147.00
5275837-27583744.04044.33
6284259-28425945.38445.65
极限1305344-30534448.75148.121.7049.1148.471.70
2295206-29520647.13247.47
3306102-30610248.87249.21
4306072-30607248.86749.26
5296066-29606647.26947.63
6299412-29941247.80448.15
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.274924254920694925214925704923524923870.05
228.325025445025605025520.01
单位质量响应值RSD%判断
17417.3017745.481.32数据可信
长期3月-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%
5min113268-132681.1553.4680.731.153.4680.76
238315-383153.3353.33
317811-178111.5501.55
499986-999868.7038.70
546078-460784.0114.01
622831-228311.9871.99
10min1148764-14876412.94912.2117.3812.9512.2217.39
2144703-14470312.59512.60
3114144-1141449.9359.94
4161365-16136514.04514.06
5165697-16569714.42214.43
6107019-1070199.3159.32
15min1247917-24791721.57921.028.1421.6021.058.15
2229580-22958019.98320.01
3218127-21812718.98619.01
4268429-26842923.36423.40
5257971-25797122.45422.48
6227182-22718219.77419.79
20min1333005-33300528.98527.205.9229.0427.265.91
2285481-28548124.84824.91
3302211-30221126.30526.36
4330149-33014928.73628.81
5320323-32032327.88127.95
6303699-30369926.43426.49
30min1383773-38377333.40431.885.4733.5131.985.47
2333466-33346629.02529.13
3358620-35862031.21531.31
4389628-38962833.91434.04
5368434-36843432.06932.18
6363458-36345831.63631.73
45min1424973-42497336.99035.455.4237.1535.605.42
2370494-37049432.24832.40
3398988-39898834.72834.87
4433673-43367337.74737.93
5407011-40701135.42735.59
6408283-40828335.53735.69
60min1454565-45456539.56638.075.3539.7938.295.34
2396962-39696234.55234.76
3429117-42911737.35137.56
4462835-46283540.28540.53
5434730-43473037.83938.07
6446263-44626338.84339.05
极限1495630-49563043.14042.452.0643.4342.732.07
2474077-47407741.26441.52
3495358-49535843.11643.38
4498405-49840543.38243.69
5480164-48016441.79442.08
6482901-48290142.03242.30
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