沙库巴曲缬沙坦片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.31对照品水分(%)0对照品稀释倍数500
标示量(mg)50供试品稀释倍数0.9276438系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.032868042878432878192872482874512874330.16
228.082882512883542883020.03
单位质量响应值RSD%判断
10254.4810267.170.09数据可信
供试品溶液-23122601批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11392-13920.2080.6489.510.210.6489.67
26424-64240.9580.96
3634-6340.0950.09
49083-90831.3541.35
57641-76411.1391.14
6612-6120.0910.09
10min12694-26940.4020.3129.920.400.3129.30
22492-24920.3720.37
31660-16600.2480.25
42762-27620.4120.41
51535-15350.2290.23
61394-13940.2080.21
15min17863-78631.1720.4774.191.170.4773.76
22729-27290.4070.41
32155-21550.3210.32
42685-26850.4000.40
51793-17930.2670.27
61727-17270.2580.26
20min133799-337995.0401.87122.755.041.87122.64
22996-29960.4470.45
32564-25640.3820.38
42897-28970.4320.44
530861-308614.6024.60
62031-20310.3030.30
30min153909-539098.0395.1743.788.055.1843.81
227035-270354.0314.03
39508-95081.4181.42
437334-373345.5675.57
543585-435856.4996.51
636734-367345.4785.48
45min159555-595558.8806.8342.008.916.8542.01
235545-355455.3005.31
314058-140582.0962.10
466577-665779.9289.94
556252-562528.3888.41
642929-429296.4016.41
60min164387-643879.6017.5539.919.647.5839.90
239504-395045.8915.91
318028-180282.6882.70
474037-7403711.04011.07
560903-609039.0819.12
647003-470037.0097.03
极限1122104-12210418.20717.487.8018.2617.527.87
2108954-10895416.24716.28
3106828-10682815.92915.94
4126795-12679518.90718.96
5127004-12700418.93818.99
6111739-11173916.66216.69
沙库巴曲缬沙坦片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.034908814913414927074914484916374916030.14
228.034921214934594927900.20
单位质量响应值RSD%判断
17538.4617580.810.18数据可信
供试品溶液-23122601批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12517-25171.2901.8183.831.291.8183.90
27200-72003.6903.69
31115-11150.5710.57
47380-73803.7833.78
51882-18820.9650.96
61092-10920.5600.56
10min14812-48122.4661.7138.532.471.7138.45
24303-43032.2052.21
33227-32271.6541.65
43885-38851.9912.00
51315-13150.6740.68
62472-24721.2671.27
15min116155-161558.2803.0086.978.293.0186.84
24799-47992.4602.47
34049-40492.0752.08
44297-42972.2022.21
52728-27281.3981.40
63150-31501.6151.62
20min167700-6770034.69912.66126.9834.7212.67126.90
25077-50772.6022.62
34355-43552.2322.24
44899-48992.5112.52
562542-6254232.05532.06
63606-36061.8481.85
30min1105368-10536854.00535.4543.4854.0835.4843.50
254914-5491428.14628.16
317927-179279.1889.20
475757-7575738.82838.85
586822-8682244.50044.56
674157-7415738.00838.02
45min1113799-11379958.32745.3741.9358.4945.4641.92
270390-7039036.07836.14
325775-2577513.21113.24
4128638-12863865.93266.01
5107506-10750655.10155.23
685029-8502943.58143.65
60min1120390-12039061.70549.0040.7861.9749.1640.78
276656-7665639.28939.41
330908-3090815.84215.89
4141079-14107972.30972.50
5114107-11410758.48458.71
690453-9045346.36146.51
极限1224965-224965115.304110.807.95115.67111.048.02
2200724-200724102.879103.07
3194988-19498899.939100.01
4233672-233672119.766120.08
5234550-234550120.216120.54
6208123-208123106.671106.89
沙库巴曲缬沙坦片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.31对照品水分(%)0对照品稀释倍数500
标示量(mg)50供试品稀释倍数0.9276438系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.032896902893262894132893432886992892940.13
228.082900382901952901160.04
单位质量响应值RSD%判断
10320.8710331.770.08数据可信
供试品溶液-23122601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%
5min139763-397635.8924.7356.565.894.7256.58
22818-28180.4180.42
344713-447136.6256.63
445148-451486.6896.69
543002-430026.3726.37
615894-158942.3552.35
10min1112420-11242016.65715.2616.7516.6715.2716.76
275087-7508711.12511.13
399365-9936514.72314.73
4121495-12149518.00218.01
5116198-11619817.21717.23
693503-9350313.85413.86
15min1173338-17333825.68323.7310.0225.7223.7610.03
2140110-14011020.76020.78
3147102-14710221.79621.83
4176082-17608226.09026.13
5173867-17386725.76125.80
6150254-15025422.26322.29
20min1209869-20986931.09628.877.4531.1828.947.45
2187371-18737127.76227.82
3171143-17114325.35825.43
4206149-20614930.54530.63
5203038-20303830.08430.17
6191366-19136628.35428.42
30min1240181-24018135.58733.507.4335.7233.627.43
2222387-22238732.95133.05
3195241-19524128.92829.04
4232998-23299834.52334.66
5240134-24013435.58035.71
6225596-22559633.42633.54
45min1257700-25770038.18336.076.8138.3736.256.82
2238376-23837635.32035.47
3213535-21353531.63931.80
4250625-25062537.13537.33
5257547-25754738.16038.35
6243012-24301236.00736.17
60min1270439-27043940.07037.747.2240.3337.987.23
2245116-24511636.31836.53
3223567-22356733.12533.34
4265545-26554539.34539.60
5270870-27087040.13440.39
6252904-25290437.47237.70
极限1289654-28965442.91742.142.5443.2442.442.57
2279215-27921541.37141.65
3272876-27287640.43140.70
4284288-28428842.12242.44
5291627-29162743.21043.53
6288899-28889942.80643.10
沙库巴曲缬沙坦片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.034933574933414933374925404922734929700.11
228.034948224946764947490.03
单位质量响应值RSD%判断
17587.2317650.700.26数据可信
供试品溶液-23122601批-缬沙坦-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%
5min1-0.0009.29155.000.009.29155.00
2-0.0000.00
353190-5319027.17027.17
455906-5590628.55828.56
5-0.0000.00
6-0.0000.00
10min1147694-14769475.44469.1817.0775.4469.2017.08
298785-9878550.46150.46
3129388-12938866.09366.14
4159983-15998381.72281.77
5154513-15451378.92878.93
6122249-12224962.44762.45
15min1231343-231343118.173109.4010.69118.30109.5310.69
2187899-18789995.98296.07
3194537-19453799.37299.53
4239023-239023122.097122.28
5233691-233691119.373119.50
6198470-198470101.381101.49
20min1288107-288107147.169136.658.26147.49136.968.26
2258416-258416132.003132.25
3231006-231006118.001118.32
4287211-287211146.712147.10
5280116-280116143.087143.42
6260200-260200132.914133.19
30min1343075-343075175.248164.638.21175.82165.178.20
2318468-318468162.678163.14
3273073-273073139.490140.01
4336652-336652171.967172.60
5342621-342621175.016175.58
6319799-319799163.358163.85
45min1380882-380882194.560182.917.62195.42183.727.62
2350147-350147178.860179.60
3308951-308951157.817158.57
4374794-374794191.450192.37
5378870-378870193.532194.39
6354797-354797181.236182.00
60min1413742-413742211.346196.428.67212.53197.548.67
2365366-365366186.634187.67
3330722-330722168.938169.95
4411145-411145210.019211.26
5410124-410124209.497210.68
6376068-376068192.101193.17
极限1454806-454806232.322226.192.92233.86227.642.95
2431792-431792220.566221.91
3422531-422531215.835217.13
4449133-449133229.424231.01
5453477-453477231.643233.18
6445112-445112227.370228.76
沙库巴曲缬沙坦片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.31对照品水分(%)0对照品稀释倍数500
标示量(mg)50供试品稀释倍数0.9276438系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.032894122892942891162885482884592889660.16
228.082889542894092891820.12
单位质量响应值RSD%判断
10309.1710298.500.08数据可信
供试品溶液-23122601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%
5min178974-7897411.72714.3018.8011.7314.3018.79
293828-9382813.93313.93
379352-7935211.78311.78
498403-9840314.61214.61
5128448-12844819.07319.07
698746-9874614.66314.66
10min1175191-17519126.01429.2112.0326.0329.2412.02
2213132-21313231.64831.67
3169358-16935825.14825.17
4187916-18791627.90427.93
5231212-23121234.33334.36
6203586-20358630.23130.26
15min1240794-24079435.75639.4211.0235.8239.4911.02
2307860-30786045.71445.79
3230300-23030034.19734.26
4254263-25426337.75637.83
5286813-28681342.58942.68
6272678-27267840.49040.57
20min1279371-27937141.48445.037.5141.6145.177.52
2328014-32801448.70748.86
3272529-27252940.46840.59
4303488-30348845.06545.20
5314809-31480946.74646.91
6321408-32140847.72647.87
30min1304809-30480945.26147.644.1245.4547.854.14
2327214-32721448.58848.82
3303827-30382745.11645.30
4332440-33244049.36449.57
5332669-33266949.39849.64
6323962-32396248.10548.33
45min1318159-31815947.24448.562.8347.5148.862.85
2326823-32682348.53048.84
3317281-31728147.11347.37
4337929-33792950.17950.47
5338198-33819850.21950.54
6323927-32392748.10048.40
60min1323144-32314447.98448.912.3448.3349.282.35
2326420-32642048.47048.87
3324095-32409548.12548.46
4339609-33960950.42950.80
5338762-33876250.30350.71
6324214-32421448.14348.53
极限1325628-32562848.35349.082.2448.7849.542.24
2326330-32633048.45748.93
3328379-32837948.76149.18
4340312-34031250.53350.99
5339362-33936250.39250.88
6323311-32331148.00948.47
沙库巴曲缬沙坦片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.034937994942284936134932014928434935370.11
228.034941414944794943100.05
单位质量响应值RSD%判断
17607.4617635.030.12数据可信
供试品溶液-23122601批-缬沙坦-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%
5min1129687-12968766.23781.9419.3066.2481.9419.30
2155889-15588979.62079.62
3134885-13488568.89268.89
4160705-16070582.08082.08
5216588-216588110.622110.62
6164781-16478184.16184.16
10min1295197-295197150.771169.5312.30150.88169.6712.31
2360052-360052183.896184.03
3285084-285084145.606145.72
4315234-315234161.005161.14
5391616-391616200.017200.20
6344385-344385175.894176.03
15min1406545-406545207.642229.7511.37208.00230.1711.37
2524297-524297267.783268.22
3389649-389649199.012199.37
4428547-428547218.879219.28
5487256-487256248.865249.38
6462746-462746236.346236.78
20min1473412-473412241.794263.107.66242.50263.907.67
2558308-558308285.154286.04
3462760-462760236.353237.04
4513951-513951262.499263.27
5535271-535271273.388274.32
6547067-547067279.413280.24
30min1518056-518056264.596278.684.17265.71279.924.19
2557846-557846284.918286.28
3516047-516047263.570264.65
4563894-563894288.007289.21
5566275-566275289.223290.61
6551721-551721281.790283.08
45min1540747-540747276.185284.002.74277.74285.702.76
2557048-557048284.511286.35
3539623-539623275.611277.13
4572955-572955292.635294.32
5574579-574579293.465295.33
6551347-551347281.599283.36
60min1549989-549989280.905286.352.29282.92288.532.30
2556749-556749284.358286.67
3550941-550941281.392283.37
4576460-576460294.425296.60
5577327-577327294.868297.23
6552401-552401282.137284.37
极限1555592-555592283.767287.962.21286.25290.622.21
2556580-556580284.272287.06
3559878-559878285.956288.41
4579285-579285295.868298.53
5579708-579708296.084298.94
6551727-551727281.793284.50
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