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%
113.902425832425152425522424442422802424750.05
213.802440152441842441000.05
单位质量响应值RSD%判断
17444.2417688.410.99数据可信
供试品溶液-2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%
5min129475-2947510.87810.563.9110.8810.563.92
228380-2838010.47410.47
328535-2853510.53110.53
427421-2742110.12010.12
530311-3031111.18611.19
627552-2755210.16810.17
10min168697-6869725.35324.842.6525.3724.862.65
265607-6560724.21224.23
367887-6788725.05425.07
466605-6660524.58024.60
569781-6978125.75325.77
665282-6528224.09224.11
15min198245-9824536.25736.113.0336.3236.173.03
295791-9579135.35235.41
398501-9850136.35236.41
496964-9696435.78435.84
5103059-10305938.03438.10
694511-9451134.87934.94
20min1123764-12376445.67544.731.9045.8044.851.90
2119586-11958644.13344.25
3120909-12090944.62144.74
4121118-12111844.69844.82
5123792-12379245.68545.81
6117996-11799643.54643.66
30min1160965-16096559.40458.241.5459.6058.431.54
2155397-15539757.34957.54
3158222-15822258.39258.59
4155489-15548957.38357.57
5160274-16027459.14959.35
6156439-15643957.73457.92
45min1199205-19920573.51672.001.9573.8172.291.95
2193693-19369371.48271.77
3195355-19535572.09572.39
4191902-19190270.82171.11
5199848-19984873.75474.05
6190565-19056570.32870.61
60min1222621-22262182.15881.031.4982.5881.441.50
2218749-21874980.72981.13
3219899-21989981.15381.57
4214840-21484079.28679.69
5223671-22367182.54582.97
6217552-21755280.28780.69
90min1247965-24796591.51190.060.9492.0790.600.94
2243801-24380189.97490.51
3243372-24337289.81690.36
4243031-24303189.69090.23
5244805-24480590.34590.91
6241144-24114488.99489.53
120min1258212-25821295.29393.672.3296.0094.362.31
2253796-25379693.66394.35
3247250-24725091.24791.94
4253211-25321193.44794.13
5262443-26244396.85497.56
6247927-24792791.49792.18
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1261506-26150696.50895.021.1397.3895.871.14
2256573-25657394.68895.53
3254282-25428293.84294.69
4258353-25835395.34596.19
5259692-25969295.83996.71
6254448-25444893.90494.74
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%
115.999436303943647594390019434789942889594350930.05
216.009510704952560795181560.12
单位质量响应值RSD%判断
590062.10594884.750.58数据可信
供试品溶液-2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%
5min13004369-300436928.26828.002.3128.2728.002.31
22967585-296758527.92127.92
33011357-301135728.33328.33
42879334-287933427.09127.09
53071040-307104028.89528.89
62920548-292054827.47927.48
10min14982837-498283746.88346.431.7346.9346.471.72
24904091-490409146.14246.19
34978360-497836046.84046.89
44861471-486147145.74145.79
55052190-505219047.53547.58
64826536-482653645.41245.46
15min16138033-613803357.75257.511.4957.8857.641.49
26043680-604368056.86456.99
36124519-612451957.62457.75
46040217-604021756.83156.95
56275820-627582059.04859.18
66051855-605185556.94157.06
20min16933190-693319065.23364.771.2765.4564.981.27
26849330-684933064.44464.66
36907089-690708964.98765.21
46830076-683007664.26364.48
57014956-701495666.00266.23
66766845-676684563.66863.88
30min18001950-800195075.28974.551.1575.6274.881.15
27907742-790774274.40274.73
37929564-792956474.60874.94
47855525-785552573.91174.23
58045983-804598375.70376.04
67802032-780203273.40873.73
45min18936299-893629984.08083.301.0984.5483.751.09
28845101-884510183.22283.67
38853073-885307383.29783.75
48784768-878476882.65483.10
58981430-898143084.50584.97
68718587-871858782.03182.48
60min19479335-947933589.18988.341.0289.7988.931.02
29379134-937913488.24688.83
39390821-939082188.35688.95
49323369-932336987.72288.31
59508666-950866689.46590.07
69253242-925324287.06287.64
90min19942352-994235293.54692.640.9394.2993.380.93
29864170-986417092.81093.55
39813934-981393492.33793.08
49806911-980691192.27193.00
59945243-994524393.57394.32
69705894-970589491.32192.05
120min110103937-1010393795.06694.641.8595.9795.531.84
210039706-1003970694.46295.35
39968535-996853593.79294.69
49978500-997850093.88694.77
510399216-1039921697.84498.75
69860702-986070292.77793.66
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110129425-1012942595.30694.851.0896.3695.901.08
210106776-1010677695.09396.14
310035670-1003567094.42495.47
410038017-1003801794.44695.49
510248945-1024894596.43097.50
69926726-992672693.39994.43
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%
113.902437442439402440142441502440462439790.07
213.802457972458452458210.02
单位质量响应值RSD%判断
17552.4517813.121.05数据可信
供试品溶液-2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%
5min127943-2794310.24410.953.8410.2410.953.86
231358-3135811.49611.50
329379-2937910.77110.77
430072-3007211.02511.03
530441-3044111.16011.16
630018-3001811.00511.01
10min166069-6606924.22225.272.8324.2425.282.82
269584-6958425.51125.53
368829-6882925.23425.25
467596-6759624.78224.80
569698-6969825.55325.57
671753-7175326.30626.32
15min1100209-10020936.73937.532.6436.8037.602.64
2102002-10200237.39637.46
3101254-10125437.12237.18
499622-9962236.52336.58
5104601-10460138.34938.41
6106584-10658439.07639.14
20min1126767-12676746.47547.461.9546.5947.581.96
2130479-13047947.83647.96
3129101-12910147.33147.45
4126486-12648646.37246.49
5130904-13090447.99248.12
6132995-13299548.75948.89
30min1163078-16307859.78861.953.7359.9862.163.73
2169319-16931962.07662.28
3166448-16644861.02361.22
4164288-16428860.23160.43
5170276-17027662.42762.63
6180512-18051266.17966.39
45min1205312-20531275.27274.791.9275.5775.101.92
2205296-20529675.26675.57
3202763-20276374.33774.64
4196805-19680572.15372.45
5205867-20586775.47575.78
6208020-20802076.26476.58
60min1226740-22674083.12783.060.9583.5583.490.95
2228021-22802183.59784.03
3224066-22406682.14782.57
4224405-22440582.27182.69
5226440-22644083.01783.45
6229690-22969084.20984.65
90min1250507-25050791.84190.631.1092.4091.201.10
2249015-24901591.29491.87
3245117-24511789.86590.43
4244374-24437489.59290.15
5244861-24486189.77190.34
6249324-24932491.40791.99
120min1257649-25764994.45993.691.0595.1794.411.04
2258157-25815794.64695.37
3251632-25163292.25392.97
4254298-25429893.23193.94
5253859-25385993.07093.79
6257651-25765194.46095.20
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1262176-26217696.11994.871.5596.9995.741.53
2262805-26280596.35097.23
3253723-25372393.02093.89
4259189-25918995.02495.88
5254031-25403193.13394.01
6260620-26062095.54996.44
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%
115.999507763952396895232129533252953306195242510.11
216.009588984960535395971680.13
单位质量响应值RSD%判断
595637.96599823.000.50数据可信
供试品溶液-2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%
5min13040063-304006328.35229.162.3428.3529.162.34
23166419-316641929.53029.53
33086722-308672228.78728.79
43248325-324832530.29430.29
53127617-312761729.16829.17
63092058-309205828.83728.84
10min15023665-502366546.85147.571.4146.9047.621.41
25154279-515427948.06948.12
35076402-507640247.34347.39
45016445-501644546.78346.83
55148047-514804748.01148.06
65185037-518503748.35648.40
15min16298749-629874958.74259.241.2258.8759.361.22
26402232-640223259.70759.84
36306187-630618758.81258.94
46256311-625631158.34658.47
56384542-638454259.54259.67
66462546-646254660.27060.40
20min17143830-714383066.62367.061.0366.8567.291.03
27249829-724982967.61267.84
37134781-713478166.53966.76
47103764-710376466.25066.48
57227038-722703867.39967.63
67287887-728788767.96768.20
30min18230647-823064776.75977.542.5777.0977.882.57
28303098-830309877.43577.78
38172028-817202876.21276.55
48174938-817493876.24076.58
58265711-826571177.08677.43
68737341-873734181.48581.83
45min19139606-913960685.23684.830.8185.7085.300.81
29140591-914059185.24585.72
39000504-900050483.93984.40
49015442-901544284.07884.54
59102263-910226384.88885.36
69180331-918033185.61686.09
60min19598596-959859689.51789.130.7890.1289.740.78
29604244-960424489.56990.18
39446010-944601088.09488.70
49498837-949883788.58689.19
59547307-954730789.03889.65
69646532-964653289.96490.58
90min110009214-1000921493.34692.440.8494.1093.190.84
29973784-997378493.01693.78
39810762-981076291.49592.24
49849791-984979191.85992.61
59854509-985450991.90392.66
69971506-997150692.99493.77
120min110115672-1011567294.33993.630.8095.2594.540.80
210118779-1011877994.36895.28
39924709-992470992.55893.46
49985595-998559593.12694.03
510000963-1000096393.26994.18
610089133-1008913394.09195.02
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110184270-1018427094.97994.370.6796.0495.440.67
210201984-1020198495.14496.22
310029108-1002910893.53294.59
410094470-1009447094.14195.20
510067495-1006749593.89094.96
610134789-1013478994.51795.60
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