坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007707977089769507698576963770130.09
215.987697077008769890.04
单位质量响应值RSD%判断
4813.314817.830.07数据可信
供试品溶液-12468328批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110099-1009911.77311.617.8811.7711.617.86
29630-963011.22611.23
310947-1094712.76112.76
410743-1074312.52412.52
59434-943410.99811.00
68918-891810.39610.40
10min126873-2687331.32732.012.9631.3532.032.96
227214-2721431.72531.74
328655-2865533.40533.43
428061-2806132.71232.73
527508-2750832.06732.09
626419-2641930.79830.82
15min143110-4311050.25551.912.8650.3351.982.85
243779-4377951.03551.11
345532-4553253.07953.16
444626-4462652.02352.10
546461-4646154.16254.23
643676-4367650.91550.98
20min156001-5600165.28367.992.9665.4468.152.95
258004-5800467.61867.77
358356-5835668.02868.19
457795-5779567.37467.54
561333-6133371.49971.66
658436-5843668.12268.28
30min171487-7148783.33687.043.2083.6087.313.20
274552-7455286.90987.18
373553-7355385.74486.02
474081-7408186.36086.63
578631-7863191.66491.95
675673-7567388.21688.48
45min178743-7874391.79594.872.4192.2095.282.40
281734-8173495.28195.70
379987-7998793.24593.67
480676-8067694.04894.47
583743-8374397.62398.06
683380-8338097.20097.61
60min179660-7966092.86495.161.7993.4295.731.79
282862-8286296.59697.17
380160-8016093.44694.02
481368-8136894.85595.43
582849-8284996.58197.18
682859-8285996.59397.17
极限180097-8009793.37394.861.2794.0895.601.27
282538-8253896.21996.95
380109-8010993.38794.12
482045-8204595.64496.38
581684-8168495.22395.98
681786-8178695.34296.08
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007720577487772757735577307773260.14
215.987725177273772620.03
单位质量响应值RSD%判断
4832.884834.920.03数据可信
供试品溶液-12468328批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18952-895210.39611.239.0310.4011.239.02
29339-933910.84610.85
39581-958111.12711.13
48990-899010.44010.44
511307-1130713.13113.13
69857-985711.44711.45
10min128318-2831832.88732.013.5332.9032.033.53
227995-2799532.51132.53
326331-2633130.57930.60
426322-2632230.56930.59
528410-2841032.99333.02
628003-2800332.52132.54
15min147973-4797355.71252.484.5155.7852.554.50
246361-4636153.84053.91
342655-4265549.53749.61
443524-4352450.54650.61
544221-4422151.35551.43
646403-4640353.88953.96
20min164017-6401774.34569.325.0274.5169.485.02
261252-6125271.13471.30
355559-5555964.52264.67
458264-5826467.66467.82
558036-5803667.39967.56
661030-6103070.87671.04
30min179778-7977892.64988.613.4592.9488.883.46
277790-7779090.34090.62
373142-7314284.94285.20
474821-7482186.89287.16
574120-7412086.07886.35
678140-7814090.74691.03
45min184903-8490398.60096.071.5599.0496.491.56
282808-8280896.16796.60
381504-8150494.65395.05
481867-8186795.07595.48
581846-8184695.05095.47
683407-8340796.86397.30
60min183421-8342196.87995.490.9297.4996.080.93
281816-8181695.01595.61
381298-8129894.41494.97
481876-8187695.08595.65
582227-8222795.49396.07
682731-8273196.07896.67
极限181867-8186795.07594.430.7395.8495.170.74
280871-8087193.91894.67
380878-8087893.92694.64
480652-8065293.66494.39
582074-8207495.31596.05
681520-8152094.67295.43
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007711777296772617697976877771060.24
215.987767577405775400.25
单位质量响应值RSD%判断
4819.124852.320.49数据可信
供试品溶液-12468328批-pH4.5(内含1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18365-83659.71110.105.349.7110.105.35
28834-883410.25510.26
39303-930310.80010.80
49136-913610.60610.61
58414-84149.7689.77
68143-81439.4539.45
10min122785-2278526.45128.084.8026.4728.104.79
223920-2392027.76927.79
324965-2496528.98229.00
424923-2492328.93328.95
525588-2558829.70529.72
622930-2293026.62026.64
15min138787-3878745.02847.805.0945.0947.875.08
239901-3990146.32146.38
340758-4075847.31647.38
442856-4285649.75249.82
544463-4446351.61751.68
640309-4030946.79546.86
20min152930-5293061.44765.526.4761.5865.666.47
254488-5448863.25563.40
356299-5629965.35865.50
458960-5896068.44768.60
562411-6241172.45372.61
653550-5355062.16762.30
30min174597-7459786.60090.304.2786.8490.554.27
274680-7468086.69686.94
379900-7990092.75693.01
480373-8037393.30593.57
581939-8193995.12395.40
675192-7519287.29187.53
45min183823-8382397.31198.541.2497.6998.951.25
283792-8379297.27597.67
386190-86190100.058100.47
485518-8551899.27899.70
585708-8570899.49999.93
684283-8428397.84598.23
60min184738-8473898.37398.930.9698.9299.490.96
284169-8416997.71298.26
386420-86420100.325100.90
484754-8475498.39198.98
585522-8552299.28399.88
685687-8568799.475100.02
极限184626-8462698.24398.881.0098.9599.611.00
284201-8420197.74998.46
386495-86495100.413101.16
484634-8463498.25299.00
585432-8543299.17999.94
685670-8567099.455100.17
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007666276882766937668476711767260.12
215.987687676733768040.14
单位质量响应值RSD%判断
4795.384806.260.17数据可信
供试品溶液-12468328批-pH4.5(内含1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18254-82549.65210.408.019.6510.408.01
29099-909910.64010.64
310221-1022111.95211.95
48668-866810.13610.14
58742-874210.22210.22
68393-83939.8149.81
10min124526-2452628.67929.187.7028.7029.207.69
226732-2673231.25931.28
326504-2650430.99231.01
426507-2650730.99631.01
522339-2233926.12226.14
623105-2310527.01727.03
15min142475-4247549.66749.408.6149.7349.468.61
245980-4598053.76653.84
343511-4351150.87950.95
445661-4566153.39353.46
537063-3706343.33943.40
638783-3878345.35045.41
20min159583-5958369.67267.688.8669.8267.828.85
262583-6258373.18073.34
359191-5919169.21469.37
462646-6264673.25473.41
550281-5028158.79558.93
652974-5297461.94462.08
30min179692-7969293.18791.635.4593.4591.895.46
281822-8182295.67795.96
380389-8038994.00294.27
482151-8215196.06296.34
571901-7190184.07684.31
674217-7421786.78487.02
45min184869-8486999.24099.190.9799.6699.600.99
285594-85594100.088100.53
385333-8533399.783100.21
485254-8525499.690100.13
583326-8332697.43697.81
684556-8455698.87499.26
60min184931-8493199.31399.820.5599.90100.400.53
285765-85765100.288100.90
385384-8538499.842100.44
484745-8474599.09599.70
585418-8541899.882100.42
685939-85939100.491101.04
极限184925-8492599.30699.640.91100.05100.380.90
285147-8514799.565100.34
385667-85667100.173100.93
484945-8494599.329100.10
584158-8415898.40999.11
686427-86427101.062101.78
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007438974276752827489675240748170.63
215.987523075531753800.29
单位质量响应值RSD%判断
4676.064717.150.62数据可信
供试品溶液-12468328批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13018-30183.6073.5311.093.613.5311.05
23434-34344.1054.10
32879-28793.4413.44
42946-29463.5213.52
53049-30493.6443.64
62418-24182.8902.89
10min110397-1039712.42811.908.4312.4311.918.43
210420-1042012.45512.46
310035-1003511.99512.00
410225-1022512.22212.23
510395-1039512.42512.43
68272-82729.8889.89
15min119745-1974523.60122.637.4523.6322.667.46
219726-1972623.57923.61
319122-1912222.85722.88
419401-1940123.19023.22
519520-1952023.33223.36
616095-1609519.23819.26
20min128800-2880034.42533.766.3934.4933.826.40
229400-2940035.14235.21
328945-2894534.59834.66
428901-2890134.54534.61
528835-2883534.46734.53
624588-2458829.39029.44
30min141324-4132449.39548.843.4249.5248.963.43
242023-4202350.23050.36
341689-4168949.83149.95
441153-4115349.19049.31
540857-4085748.83648.96
638136-3813645.58445.69
45min152600-5260062.87362.441.7763.0862.641.78
252958-5295863.30163.51
352616-5261662.89263.10
452679-5267962.96763.17
552128-5212862.30962.51
650440-5044060.29160.47
60min159590-5959071.22870.751.3171.5471.051.32
260009-6000971.72972.04
359408-5940871.01071.32
459375-5937570.97171.28
558975-5897570.49370.80
657774-5777469.05769.34
极限162943-6294375.23674.890.7675.6775.310.78
263134-6313475.46475.90
362615-6261574.84475.27
462976-6297675.27575.70
562378-6237874.56174.99
661856-6185673.93774.33
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007513575284746377438374707748290.50
215.987580075186754930.58
单位质量响应值RSD%判断
4676.814724.220.72数据可信
供试品溶液-12468328批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11727-17272.0632.309.012.062.308.98
22101-21012.5092.51
31849-18492.2082.21
42028-20282.4222.42
52094-20942.5012.50
61738-17382.0762.08
10min17511-75118.9709.095.398.979.095.41
27331-73318.7568.76
37607-76079.0859.09
48310-83109.9259.93
57773-77739.2839.29
67125-71258.5098.51
15min115069-1506917.99718.326.2918.0218.346.27
214258-1425817.02917.05
316121-1612119.25419.27
416815-1681520.08220.10
515201-1520118.15518.17
614567-1456717.39817.42
20min123506-2350628.07428.316.2128.1228.366.20
222032-2203226.31326.36
325255-2525530.16230.21
425652-2565230.63730.69
523383-2338327.92727.98
622408-2240826.76226.81
30min138342-3834245.79245.463.9645.8945.563.97
235446-3544642.33442.42
339546-3954647.23047.33
439472-3947247.14247.25
538008-3800845.39445.49
637577-3757744.87944.97
45min150626-5062660.46360.542.0260.6360.722.03
248786-4878658.26658.43
351860-5186061.93762.12
451086-5108661.01361.20
550923-5092360.81860.99
650871-5087160.75660.92
60min157283-5728368.41469.491.2868.6969.761.28
257289-5728968.42168.68
358857-5885770.29470.58
458559-5855969.93870.22
558214-5821469.52669.80
658908-5890870.35570.62
极限160789-6078972.60174.081.3872.9974.471.38
261264-6126473.16873.54
363083-6308375.34175.74
462409-6240974.53674.94
562540-6254074.69275.08
662080-6208074.14374.53
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007490575071749437503474984749870.09
215.987506774478747720.56
单位质量响应值RSD%判断
4686.694679.100.12数据可信
供试品溶液-12468328批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17636-76369.1547.6610.009.157.669.99
26127-61277.3457.34
35805-58056.9596.96
46143-61437.3647.36
56316-63167.5717.57
66303-63037.5567.56
10min123669-2366928.37424.517.9228.3924.527.93
219629-1962923.53123.54
319530-1953023.41223.42
419605-1960523.50223.51
519747-1974723.67223.68
620497-2049724.57124.58
15min139968-3996847.91343.135.6347.9843.185.64
234978-3497841.93141.98
334841-3484141.76741.82
434903-3490341.84141.89
534944-3494441.89041.94
636240-3624043.44443.50
20min156273-5627367.45961.744.8567.6061.864.85
249531-4953159.37759.50
351053-5105361.20161.32
450131-5013160.09660.22
550040-5004059.98760.11
651970-5197062.30162.43
30min172196-7219686.54785.381.6286.8085.611.62
270103-7010384.03884.26
372377-7237786.76486.99
471260-7126085.42585.65
569578-6957883.40983.63
671818-7181886.09486.32
45min180944-8094497.03495.771.2997.4396.141.29
278608-7860894.23494.59
381165-8116597.29997.67
480074-8007495.99196.35
579099-7909994.82295.18
679433-7943395.22395.60
60min181667-8166797.90197.480.5798.4698.010.58
280908-8090896.99197.51
381808-8180898.07098.60
481728-8172897.97498.50
580974-8097497.07097.59
680819-8081996.88497.42
极限181282-8128297.43997.390.7398.1698.080.72
281210-8121097.35398.03
380698-8069896.73997.43
482180-8218098.51699.20
581528-8152897.73498.41
680567-8056796.58297.28
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.007507474867749127505274683749180.22
215.987508975472752800.36
单位质量响应值RSD%判断
4682.384710.890.43数据可信
供试品溶液-12468328批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16794-67948.1216.5215.088.126.5215.09
25798-57986.9306.93
34568-45685.4605.46
44821-48215.7625.76
55742-57426.8636.86
65007-50075.9855.98
10min120481-2048124.48121.946.8824.4921.956.88
218869-1886922.55422.57
318089-1808921.62121.63
416660-1666019.91319.92
518024-1802421.54421.56
617995-1799521.50921.52
15min136647-3664743.80440.167.2743.8640.217.27
234175-3417540.84940.90
335118-3511841.97642.02
429730-2973035.53635.58
531941-3194138.17938.23
633992-3399240.63040.68
20min150832-5083260.75957.117.0760.8957.237.07
247631-4763156.93257.05
351115-5111561.09761.21
441921-4192150.10750.21
546577-4657755.67355.78
648614-4861458.10758.22
30min170805-7080584.63281.344.7684.8681.554.77
269260-6926082.78583.00
369829-6982983.46583.68
461748-6174873.80673.99
567927-6792781.19281.40
668728-6872882.14982.36
45min179613-7961395.16093.962.5395.5394.312.53
279772-7977295.35095.70
379895-7989595.49795.85
474674-7467489.25789.57
578936-7893694.35194.69
678773-7877394.15694.50
60min181283-8128397.15697.141.4797.6897.641.48
280941-8094196.74797.26
383261-8326199.520100.04
480204-8020495.86696.32
581897-8189797.89098.39
680046-8004695.67896.18
极限180977-8097796.79096.911.1597.4897.571.13
281178-8117897.03197.70
379913-7991395.51996.20
481902-8190297.89698.51
582296-8229698.36799.03
680198-8019895.85996.52
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