缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.402585912586212584162582992581052584060.09
214.352573052574212573630.04
单位质量响应值RSD%判断
17944.8617934.700.05数据可信
供试品溶液-25080701批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146209-14620952.83253.612.4652.8353.612.46
2153784-15378455.57055.57
3151107-15110754.60254.60
4148543-14854353.67653.68
5143643-14364351.90551.91
6146801-14680153.04653.05
10min1169033-16903361.08062.592.3961.1762.682.39
2176089-17608963.62963.72
3174933-17493363.21263.30
4173013-17301362.51862.61
5167786-16778660.62960.72
6178453-17845364.48464.57
15min1180716-18071665.30166.762.5465.4966.952.54
2189653-18965368.53168.73
3186027-18602767.22167.42
4184825-18482566.78666.98
5177901-17790164.28464.47
6189313-18931368.40868.60
20min1187409-18740967.72069.522.7268.0269.822.72
2197706-19770671.44171.75
3194623-19462370.32770.64
4193216-19321669.81870.12
5184676-18467666.73267.03
6196691-19669171.07471.38
30min1194002-19400270.10272.792.7670.5173.212.76
2206395-20639574.58175.01
3203695-20369573.60574.03
4201912-20191272.96173.38
5195465-19546570.63171.04
6207227-20722774.88175.31
45min1206464-20646474.60576.432.4875.1376.972.48
2215255-21525577.78278.34
3213877-21387777.28477.83
4211888-21188876.56577.11
5204059-20405973.73674.26
6217555-21755578.61379.17
60min1213007-21300776.97078.432.0577.6279.102.05
2218487-21848778.95079.64
3220297-22029779.60480.28
4217752-21775278.68479.35
5210568-21056876.08876.73
6222228-22222880.30280.99
90min1219704-21970479.39080.892.2980.1781.692.29
2225824-22582481.60182.42
3225331-22533181.42382.23
4224299-22429981.05081.85
5216679-21667978.29779.07
6231303-23130383.58184.40
120min1224852-22485281.25082.202.0882.1683.132.09
2229776-22977683.02983.98
3229831-22983183.04983.99
4227215-22721582.10483.04
5219803-21980379.42580.33
6233401-23340184.33985.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1227441-22744182.18583.371.9383.2384.441.94
2233313-23331384.30785.40
3231697-23169783.72384.81
4231249-23124983.56184.64
5223982-22398280.93681.97
6236584-23658485.48986.59
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.879186105919337191896059183222917560591855820.08
215.899365854937248493691690.06
单位质量响应值RSD%判断
578801.64589626.751.32数据可信
供试品溶液-25080701批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1499343-4993434.7654.893.904.764.893.93
2546824-5468245.2185.22
3500845-5008454.7794.78
4527337-5273375.0325.03
5498688-4986884.7594.76
6502466-5024664.7954.79
10min1993155-9931559.4779.713.009.499.723.00
21071722-107172210.22710.24
3998451-9984519.5289.54
41036607-10366079.8929.90
51002087-10020879.5629.57
61005484-10054849.5959.60
15min11376995-137699513.14013.512.6513.1613.532.67
21483125-148312514.15314.18
31405567-140556713.41313.44
41430768-143076813.65313.68
51393711-139371113.29913.32
61402900-140290013.38713.41
20min11687797-168779716.10616.592.5116.1516.642.52
21809769-180976917.27017.32
31725866-172586616.46916.52
41761705-176170516.81116.86
51704780-170478016.26816.31
61740734-174073416.61116.66
30min12176512-217651220.76921.332.1820.8421.402.17
22314531-231453122.08622.16
32220989-222098921.19421.27
42262433-226243321.58921.66
52200975-220097521.00321.08
62235941-223594121.33621.41
45min12696546-269654625.73226.411.9125.8426.521.90
22849132-284913227.18827.30
32755869-275586926.29826.41
42798286-279828626.70326.81
52734898-273489826.09826.21
62773044-277304426.46226.57
60min13097070-309707029.55430.251.8329.7030.401.83
23262599-326259931.13331.29
33155278-315527830.10930.26
43193159-319315930.47130.63
53127461-312746129.84430.00
63184926-318492630.39230.55
90min13632067-363206734.65935.411.5534.8635.611.55
23791681-379168136.18236.39
33696070-369607035.27035.47
43736246-373624635.65335.86
53666352-366635234.98635.19
63740581-374058135.69435.90
120min14030468-403046838.46139.041.0838.7239.301.09
24160862-416086239.70539.98
34094830-409483039.07539.34
44088686-408868639.01639.28
54062013-406201338.76239.02
64109583-410958339.21639.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14269113-426911340.73841.251.0241.0641.581.03
24385786-438578641.85142.19
34310207-431020741.13041.46
44340127-434012741.41641.75
54282559-428255940.86641.19
64350286-435028641.51341.84
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.402575912573862577802578022579412577000.09
214.352609202613462611330.12
单位质量响应值RSD%判断
17895.8318197.421.19数据可信
供试品溶液-25080702批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1168736-16873660.61659.852.6060.6259.852.60
2174564-17456462.70962.71
3164186-16418658.98158.98
4164356-16435659.04259.04
5163796-16379658.84158.84
6164037-16403758.92858.93
10min1179381-17938164.44067.423.2664.5467.523.26
2196951-19695170.75270.86
3190008-19000868.25768.36
4188199-18819967.60767.71
5182701-18270165.63265.73
6188768-18876867.81267.91
15min1201852-20185272.51272.052.2572.7272.262.25
2207995-20799574.71974.94
3202656-20265672.80173.01
4196402-19640270.55470.77
5197645-19764571.00171.21
6196776-19677670.68970.90
20min1201029-20102972.21674.212.5172.5574.542.50
2214859-21485977.18577.53
3209902-20990275.40475.74
4203814-20381473.21773.55
5202679-20267972.80973.13
6207184-20718474.42874.76
30min1214121-21412176.92077.191.9677.3777.651.96
2221749-22174979.66080.14
3217590-21759078.16678.62
4210295-21029575.54576.00
5211420-21142075.94976.40
6214132-21413276.92477.38
45min1212463-21246376.32478.632.2976.9079.212.29
2227179-22717981.61082.22
3220129-22012979.07879.67
4216048-21604877.61278.19
5217043-21704377.96978.54
6220395-22039579.17379.75
60min1225268-22526880.92480.931.8181.6381.641.81
2231242-23124283.07083.81
3227450-22745081.70882.43
4221800-22180079.67880.38
5219844-21984478.97579.68
6226047-22604781.20481.92
90min1222109-22210979.78981.742.1580.6382.592.14
2234282-23428284.16285.04
3232257-23225783.43584.29
4225034-22503480.84081.68
5223673-22367380.35181.19
6227936-22793681.88282.73
120min1230658-23065882.86082.851.7083.8383.831.70
2235741-23574184.68685.71
3233669-23366983.94284.94
4227197-22719781.61782.59
5225262-22526280.92281.89
6231205-23120583.05784.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1230525-23052582.81283.371.8583.9284.501.85
2237943-23794385.47786.64
3236619-23661985.00286.14
4227663-22766381.78482.89
5228290-22829082.01083.11
6231490-23149083.15984.28
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.879165848917287191787919182085918590491771000.09
215.899300216931758593089000.14
单位质量响应值RSD%判断
578267.17585833.860.92数据可信
供试品溶液-25080702批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1588078-5880785.6325.593.745.635.593.76
2607455-6074555.8185.82
3553368-5533685.3005.30
4607448-6074485.8185.82
5581382-5813825.5685.57
6566266-5662665.4235.42
10min11099240-109924010.52810.482.1110.5410.502.15
21120895-112089510.73510.75
31063527-106352710.18610.19
41116725-111672510.69510.71
51095662-109566210.49410.50
61072438-107243810.27110.28
15min11478312-147831214.15914.121.3514.1914.151.35
21499817-149981714.36514.39
31447073-144707313.85913.89
41486959-148695914.24114.27
51480281-148028114.17714.20
61454993-145499313.93513.96
20min11790036-179003617.14417.061.0817.1917.111.07
21803483-180348317.27317.32
31760449-176044916.86116.91
41796529-179652917.20617.26
51779718-177971817.04517.10
61756791-175679116.82616.88
30min12250174-225017421.55121.530.8121.6321.610.81
22257057-225705721.61721.70
32236014-223601421.41621.49
42272260-227226021.76321.84
52253325-225332521.58121.66
62219933-221993321.26121.34
45min12759758-275975826.43226.420.7926.5526.530.79
22771784-277178426.54726.66
32738782-273878226.23126.34
42783350-278335026.65826.77
52769201-276920126.52226.64
62725881-272588126.10726.22
60min13136137-313613730.03629.990.5630.2030.150.57
23138202-313820230.05630.22
33114035-311403529.82529.98
43159190-315919030.25730.42
53125463-312546329.93430.09
63113269-311326929.81729.97
90min13519109-351910933.70434.791.6933.9135.001.69
23669495-366949535.14535.36
33630216-363021634.76934.97
43690796-369079635.34935.56
53664421-366442135.09635.30
63621481-362148134.68534.89
120min14022525-402252538.52638.500.9238.7938.760.91
24000846-400084638.31838.59
33985016-398501638.16738.43
44050454-405045438.79339.06
54074850-407485039.02739.29
63985316-398531638.17038.43
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14196825-419682540.19540.500.6340.5240.830.64
24243794-424379440.64540.98
34231653-423165340.52940.86
44268373-426837340.88141.22
54229923-422992340.51240.84
64202476-420247640.24940.58
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.402587772586772591362590942591502589670.09
214.352613912597082605500.46
单位质量响应值RSD%判断
17983.8218156.790.68数据可信
供试品溶液-25080701批-氨氯地平-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%
5min141717-4171714.96613.256.7014.9713.256.73
236073-3607312.94112.94
335022-3502212.56412.56
437291-3729113.37813.38
535270-3527012.65312.65
636273-3627313.01313.01
10min182764-8276429.69127.883.4329.7227.903.44
277809-7780927.91427.94
375734-7573427.16927.19
478002-7800227.98328.01
575988-7598827.26027.28
676001-7600127.26527.29
15min1112840-11284040.48138.682.9640.5638.742.96
2108671-10867138.98539.05
3105260-10526037.76237.83
4109298-10929839.21039.28
5103920-10392037.28137.35
6106864-10686438.33738.40
20min1135704-13570448.68347.602.2648.8347.742.27
2133625-13362547.93848.07
3128227-12822746.00146.13
4135512-13551248.61448.75
5133025-13302547.72247.85
6130052-13005246.65646.79
30min1171308-17130861.45660.441.4461.6860.651.44
2169509-16950960.81161.02
3165939-16593959.53059.74
4170760-17076061.26061.47
5165672-16567259.43459.64
6167647-16764760.14360.35
45min1205251-20525173.63372.371.3473.9672.681.34
2203625-20362573.05073.36
3199433-19943371.54671.85
4202428-20242872.62072.94
5201680-20168072.35272.66
6197927-19792771.00671.31
60min1217721-21772178.10778.210.5878.5578.640.58
2217741-21774178.11478.55
3217088-21708877.88078.30
4220252-22025279.01579.45
5216749-21674977.75878.19
6218545-21854578.40278.83
90min1233379-23337983.72483.570.9984.3084.130.99
2231573-23157383.07683.64
3230135-23013582.56083.11
4235659-23565984.54285.11
5231431-23143183.02583.58
6235511-23551184.48985.05
120min1236126-23612684.70984.561.3485.4385.261.33
2232910-23291083.55684.26
3233303-23330383.69784.39
4241544-24154486.65387.36
5235979-23597984.65785.35
6234431-23443184.10184.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1248210-24821089.04488.641.1389.9089.491.12
2242845-24284587.12087.96
3245061-24506187.91588.75
4249149-24914989.38190.24
5246907-24690788.57789.41
6250391-25039189.82790.67
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.879242101925153992667629271147926881592600730.14
215.899310641926094192857910.38
单位质量响应值RSD%判断
583495.46584379.550.11数据可信
供试品溶液-25080701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%
5min13129220-312922029.87227.654.2329.8727.654.23
22887196-288719627.56227.56
32814805-281480526.87126.87
42916612-291661227.84327.84
52823390-282339026.95326.95
62806603-280660326.79226.79
10min14790477-479047745.73143.892.5945.7843.932.59
24646238-464623844.35444.40
34482258-448225842.78842.83
44641086-464108644.30544.35
54535815-453581543.30043.34
64488812-448881242.85142.90
15min15991453-599145357.19654.213.1057.3254.333.10
25723886-572388654.64154.76
35542380-554238052.90953.02
45710635-571063554.51554.64
55588967-558896753.35353.47
65516071-551607152.65752.77
20min16537903-653790362.41261.011.8262.6361.221.83
26468391-646839161.74861.96
36287389-628738960.02160.22
46469757-646975761.76261.97
56331821-633182160.44560.65
66251694-625169459.68059.88
30min17488995-748899571.49170.461.3471.8270.771.34
27455562-745556271.17271.49
37287236-728723669.56569.87
47463088-746308871.24471.56
57314821-731482169.82970.14
67275576-727557669.45469.76
45min18300121-830012179.23578.471.2179.6878.901.22
28299944-829994479.23379.67
38120745-812074577.52277.94
48328488-832848879.50579.94
58154657-815465777.84678.27
68117273-811727377.48977.91
60min18730558-873055883.34482.831.4483.9283.401.44
28724142-872414283.28283.85
38579212-857921281.89982.45
48881236-888123684.78285.35
58568734-856873481.79982.35
68579265-857926581.89982.45
90min19028963-902896386.19285.790.7886.9186.490.78
29028841-902884186.19186.89
38931863-893186385.26585.95
49071583-907158386.59987.31
58885159-888515984.81985.51
68976207-897620785.68986.37
120min19103967-910396786.90886.741.1287.7787.581.12
29001758-900175885.93286.78
39049133-904913386.38587.21
49272564-927256488.51889.37
58997832-899783285.89586.73
69092870-909287086.80287.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限19351634-935163489.27288.740.8190.2889.730.81
29242634-924263488.23289.22
39253678-925367888.33789.31
49400702-940070289.74190.74
59205215-920521587.87588.85
69323575-932357589.00589.98
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.402553182554352563982562032558132558330.19
214.352568172577742572960.27
单位质量响应值RSD%判断
17766.1817930.030.65数据可信
供试品溶液-25080702批-氨氯地平-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%
5min168282-6828224.80125.594.1624.8025.594.17
268452-6845224.86324.86
376067-7606727.62827.63
470613-7061325.64725.65
570459-7045925.59225.59
668837-6883725.00225.00
10min1124675-12467545.28344.892.7845.3244.932.78
2122177-12217744.37644.42
3129290-12929046.96047.01
4120422-12042243.73943.78
5120186-12018643.65343.70
6124731-12473145.30445.35
15min1155978-15597856.65356.632.2956.7756.742.30
2151453-15145355.01055.12
3161427-16142758.63258.76
4152768-15276855.48755.60
5156030-15603056.67256.79
6157794-15779457.31357.43
20min1177598-17759864.50663.342.2364.7263.552.23
2172054-17205462.49262.70
3179923-17992365.35065.57
4170837-17083762.05062.26
5170470-17047061.91762.13
6175378-17537863.69963.91
30min1202496-20249673.54971.941.7073.8772.261.70
2193866-19386670.41470.73
3201663-20166373.24673.58
4195934-19593471.16671.48
5197381-19738171.69172.00
6197018-19701871.55971.88
45min1215972-21597278.44477.302.1878.8877.742.17
2209831-20983176.21376.64
3219423-21942379.69780.15
4208826-20882675.84876.28
5214955-21495578.07478.51
6207952-20795275.53175.97
60min1224194-22419481.43079.402.3782.0079.962.36
2211040-21104076.65277.21
3224499-22449981.54182.13
4215588-21558878.30478.86
5218550-21855079.38079.94
6217736-21773679.08479.65
90min1225873-22587382.04080.981.5882.7581.681.58
2222010-22201080.63781.32
3222070-22207080.65881.38
4216828-21682878.75579.44
5224667-22466781.60282.30
6226313-22631382.20082.90
120min1231666-23166684.14481.842.2684.9982.682.25
2221013-22101380.27581.09
3230054-23005483.55884.41
4218581-21858179.39180.21
5224246-22424681.44982.28
6226455-22645582.25183.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1244013-24401388.62887.731.6289.6188.701.61
2241752-24175287.80788.76
3242537-24253788.09289.09
4234986-23498685.35086.30
5239655-23965587.04688.01
6246279-24627989.45190.42
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.879166893918434592085749207425919402791922530.19
215.899231043923122992311360.01
单位质量响应值RSD%判断
579221.99580939.960.21数据可信
供试品溶液-25080702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%
5min12823517-282351727.13327.132.1627.1327.132.17
22730015-273001526.23526.23
32911659-291165927.98027.98
42861436-286143627.49727.50
52809065-280906526.99426.99
62804395-280439526.94926.95
10min14455158-445515842.81342.041.8142.8642.091.81
24223627-422362740.58840.63
34394945-439494542.23442.28
44408762-440876242.36742.41
54376787-437678742.05942.10
64390745-439074542.19442.24
15min15517019-551701953.01751.781.9053.1351.901.90
25209790-520979050.06450.18
35394340-539434051.83851.95
45425638-542563852.13952.26
55359690-535969051.50551.62
65426538-542653852.14752.26
20min16289024-628902460.43558.851.9860.6459.061.97
25921354-592135456.90257.10
36125983-612598358.86959.07
46167019-616701959.26359.47
56084987-608498758.47558.68
66158291-615829159.17959.38
30min17326096-732609670.40168.791.7270.7169.091.72
26953163-695316366.81867.11
37142167-714216768.63468.94
47194390-719439069.13669.44
57124880-712488068.46868.77
67209233-720923369.27869.58
45min18237053-823705379.15577.611.5479.5878.021.54
27864960-786496075.58075.98
38096853-809685377.80878.22
48080983-808098377.65678.07
58038556-803855677.24877.66
68140519-814051978.22878.64
60min18744048-874404884.02782.601.4484.5883.141.45
28379331-837933180.52381.05
38650649-865064983.13083.68
48577536-857753682.42782.97
58566808-856680882.32482.87
68655396-865539683.17683.72
90min19164432-916443288.06787.041.3288.7687.721.32
28863242-886324285.17385.83
39171002-917100288.13088.81
49012249-901224986.60587.29
59011061-901106186.59387.27
69125717-912571787.69588.38
120min19330179-933017989.66088.601.3990.5089.421.39
29033787-903378786.81287.61
39348532-934853289.83690.67
49113548-911354887.57888.41
59194819-919481988.35989.18
69297243-929724389.34390.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限19588678-958867892.14491.570.9993.1492.541.00
29430691-943069190.62691.57
39595910-959591092.21493.19
49450465-945046590.81691.79
59454760-945476090.85791.83
69651204-965120492.74593.73
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