培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.762250722510225102253522538225200.07
210.832297222952229620.07
单位质量响应值RSD%判断
2092.942120.220.92数据可信
供试品溶液-2022081701批-培哚普利-pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118310-1831074.16278.275.1974.1678.275.19
219727-1972779.90179.90
319824-1982480.29480.29
419061-1906177.20377.20
520822-2082284.33684.34
618200-1820073.71673.72
10min119212-1921277.81582.244.4577.9482.374.45
220779-2077984.16284.30
320559-2055983.27183.40
420623-2062383.53083.66
521441-2144186.84386.98
619211-1921177.81177.93
15min120261-2026182.06484.113.6982.3284.383.69
221070-2107085.34185.61
320969-2096984.93285.20
420783-2078384.17884.45
521883-2188388.63488.92
619631-1963179.51279.76
20min119875-1987580.50083.872.9880.8984.272.98
221183-2118385.79886.21
320936-2093684.79885.21
420835-2083584.38984.80
521378-2137886.58887.02
620029-2002981.12481.51
30min121701-2170187.89687.142.0988.4287.692.10
221699-2169987.88888.45
321429-2142986.79587.35
421490-2149087.04287.59
522055-2205589.33089.91
620715-2071583.90384.42
45min121002-2100285.06589.143.8785.7489.833.86
223310-2331094.41395.12
321882-2188288.62989.33
421873-2187388.59389.29
522649-2264991.73692.46
621327-2132786.38287.04
极限122308-2230890.35592.031.3191.1792.871.29
222776-2277692.25093.11
322751-2275192.14993.00
422594-2259491.51392.35
522680-2268091.86292.74
623215-2321594.02994.83
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981673621673941672571673261674601673600.05
213.981670231669881670060.02
单位质量响应值RSD%判断
11971.3911946.070.15数据可信
供试品溶液-2022081701批-氨氯地平-pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167420-6742036.54739.129.2036.5539.129.19
277243-7724341.87141.87
374783-7478340.53840.54
468435-6843537.09737.10
581249-8124944.04344.04
663894-6389434.63534.64
10min197388-9738852.79246.6249.3852.8546.6849.32
2107917-10791758.49958.57
3105738-10573857.31857.39
41017-10170.5510.61
5113845-11384561.71261.79
690066-9006648.82248.88
15min1111121-11112160.23661.567.9660.3861.707.98
2117998-11799863.96464.13
3116723-11672363.27363.44
4111771-11177160.58860.65
5125369-12536967.95968.14
698387-9838753.33353.47
20min1112995-11299561.25263.857.6861.5064.107.69
2124266-12426667.36167.64
3121055-12105565.62165.89
4117024-11702463.43663.60
5128436-12843669.62269.91
6102970-10297055.81756.05
30min1131955-13195571.52956.7749.5471.8857.1349.19
2132341-13234171.73972.12
3128430-12843069.61970.00
4125291-12529167.91768.19
5137-1370.0740.48
6110260-11026059.76960.09
45min1127264-12726468.98772.027.0269.4672.466.99
2140276-14027676.04076.55
3134178-13417872.73473.23
4130995-13099571.00971.39
5145278-14527878.75179.16
6119118-11911864.57164.99
极限1158947-15894786.16187.510.8586.7588.080.85
2163035-16303588.37789.01
3161118-16111887.33887.95
4161824-16182487.72188.22
5161941-16194187.78488.32
6161775-16177587.69488.22
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.762284722777227322271522752227650.23
210.832286222825228440.12
单位质量响应值RSD%判断
2115.712109.330.22数据可信
供试品溶液-2022081701批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120033-2003380.90981.184.5480.9181.184.54
218878-1887876.24476.24
320531-2053182.92082.92
420576-2057683.10283.10
521331-2133186.15286.15
619245-1924577.72777.73
10min121032-2103284.94485.483.3685.0885.623.36
220625-2062583.30083.43
321669-2166987.51787.65
421867-2186788.31688.45
521713-2171387.69487.84
620088-2008881.13181.26
15min121204-2120485.63986.123.3385.9286.403.33
220893-2089384.38384.65
321550-2155087.03687.32
422122-2212289.34689.63
521949-2194988.64888.94
620216-2021681.64881.91
20min121678-2167887.55386.992.9187.9787.412.91
221326-2132686.13186.54
321862-2186288.29688.73
422081-2208189.18189.62
521911-2191188.49488.93
620375-2037582.29082.69
30min121864-2186488.30487.842.4288.8788.402.42
221884-2188488.38588.94
321946-2194688.63589.21
422200-2220089.66190.24
521890-2189088.40988.99
620707-2070783.63184.17
45min121776-2177687.94988.561.9388.6689.281.94
222063-2206389.10889.81
322416-2241690.53491.26
421964-2196488.70889.44
522164-2216489.51690.25
621182-2118285.55086.23
极限122734-2273491.81890.781.3592.6891.641.34
222550-2255091.07591.92
322254-2225489.87990.75
422059-2205989.09289.97
522873-2287392.37993.26
622391-2239190.43391.25
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981671111673601670221670261670161671070.09
213.981675621677081676350.07
单位质量响应值RSD%判断
11953.2911991.060.23数据可信
供试品溶液-2022081701批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176040-7604041.17341.225.9441.1741.225.94
274014-7401440.07640.08
376054-7605441.18141.18
476320-7632041.32541.32
584051-8405145.51145.51
670239-7023938.03238.03
10min1108310-10831058.64658.765.7558.7158.835.75
2107859-10785958.40258.47
3109848-10984859.47959.55
4113415-11341561.41061.48
5114618-11461862.06262.14
697067-9706752.55852.62
15min1118646-11864664.24364.176.2564.4164.346.24
2119068-11906864.47164.64
3119040-11904064.45664.62
4124216-12421667.25967.43
5125444-12544467.92468.10
6104642-10464256.66056.81
20min1125171-12517167.77667.076.1968.0567.346.19
2125252-12525267.82068.09
3125228-12522867.80768.08
4129964-12996470.37170.65
5128780-12878069.73070.02
6108798-10879858.91059.16
30min1132027-13202771.48870.145.1871.8770.525.19
2130939-13093970.89971.28
3129851-12985170.31070.70
4134643-13464372.90573.31
5133417-13341772.24172.65
6116291-11629162.96863.31
45min1137939-13793974.68973.574.2675.1974.074.27
2137709-13770974.56575.07
3138552-13855275.02175.53
4136652-13665273.99274.51
5140068-14006875.84276.37
6124296-12429667.30267.75
极限1163088-16308888.30772.4148.4588.9473.0448.04
21627-16270.8811.51
3156971-15697184.99485.62
4156004-15600484.47185.12
5163196-16319688.36589.02
6161542-16154287.47088.03
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.762294422969229902296722995229730.09
210.832297422981229780.03
单位质量响应值RSD%判断
2135.042121.700.45数据可信
供试品溶液-2022081801批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118412-1841273.80978.487.7773.8178.487.77
218975-1897576.06676.07
319438-1943877.92277.92
417921-1792171.84171.84
520750-2075083.18183.18
621962-2196288.04088.04
10min119791-1979179.33783.586.6079.4683.706.60
220834-2083483.51883.64
320664-2066482.83782.97
419518-1951878.24378.36
520880-2088083.70383.84
623403-2340393.81793.96
15min120197-2019780.96585.865.8881.2286.135.88
221310-2131085.42685.69
321140-2114084.74585.01
420050-2005080.37580.63
523067-2306792.47092.75
622741-2274191.16391.47
20min119863-1986379.62686.736.7480.0287.146.74
221602-2160286.59787.01
321322-2132285.47485.88
420367-2036781.64682.03
523186-2318692.94793.38
623469-2346994.08194.54
30min120897-2089783.77186.344.6684.2986.904.67
220894-2089483.75984.31
321676-2167686.89487.45
420369-2036981.65482.17
522426-2242689.90090.49
622963-2296392.05392.66
45min121856-2185687.61588.332.9488.2889.042.96
222221-2222189.07889.77
321916-2191687.85688.55
420918-2091883.85584.51
522668-2266890.87091.61
622634-2263490.73491.50
极限122395-2239589.77690.850.8490.5891.700.83
222873-2287391.69292.53
322606-2260690.62291.46
422876-2287691.70492.50
522548-2254890.38991.28
622681-2268190.92291.84
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981671651673321672601671351671681672120.05
213.981673781672691673240.05
单位质量响应值RSD%判断
11960.8011968.810.05数据可信
供试品溶液-2022081801批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152365-5236528.37131.3514.6028.3731.3414.60
247138-4713825.53925.54
357336-5733631.06531.06
455326-5532629.97629.98
564356-6435634.86834.87
670601-7060138.25238.25
10min183503-8350345.24251.5515.8545.2951.6015.85
281541-8154144.17944.22
389620-8962048.55648.61
489768-8976848.63648.69
5106076-10607657.47257.53
6120393-12039365.22965.29
15min194524-9452451.21359.4818.1451.3459.6218.13
292798-9279850.27850.39
3100097-10009754.23254.37
4100940-10094054.68954.82
5134623-13462372.93973.09
6135700-13570073.52273.69
20min197692-9769252.92963.4319.6453.1463.6719.63
299711-9971154.02354.22
3105576-10557657.20157.42
4106687-10668757.80358.03
5144562-14456278.32378.60
6148229-14822980.31080.61
30min1108682-10868258.88466.2217.1859.1866.5617.17
2108560-10856058.81859.11
3105681-10568157.25857.58
4112271-11227160.82861.15
5145814-14581479.00279.41
6152275-15227582.50282.93
45min1123527-12352766.92771.2312.2167.3271.6912.24
2118616-11861664.26664.65
3122091-12209166.14966.56
4120510-12051065.29265.71
5150888-15088881.75182.29
6153230-15323083.02083.59
极限1157779-15777985.48486.740.9085.9987.320.94
2159807-15980786.58387.08
3159654-15965486.50087.02
4161994-16199487.76888.30
5160292-16029286.84687.52
6161094-16109487.28087.99
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.762298422955229552297223032229800.14
210.832302823085230560.18
单位质量响应值RSD%判断
2135.692128.900.23数据可信
供试品溶液-2022081801批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119343-1934377.39879.235.9877.4079.235.98
219371-1937177.51077.51
318641-1864174.58974.59
419093-1909376.39776.40
520489-2048981.98381.98
621871-2187187.51387.51
10min120956-2095683.85285.965.4583.9886.095.45
220503-2050382.03982.17
321242-2124284.99685.12
420502-2050282.03582.16
522181-2218188.75488.89
623508-2350894.06394.21
15min121487-2148785.97787.203.4986.2587.483.50
221454-2145485.84586.11
321482-2148285.95786.22
420987-2098783.97684.24
522244-2224489.00689.29
623108-2310892.46392.77
20min121367-2136785.49687.013.9685.9187.433.96
220988-2098883.98084.39
322124-2212488.52688.93
421720-2172086.90987.31
521009-2100984.06484.50
623262-2326293.07993.54
30min121883-2188387.56188.692.5588.1289.262.56
221346-2134685.41285.96
322468-2246889.90290.46
421876-2187687.53388.08
522527-2252790.13890.71
622896-2289691.61592.23
45min122451-2245189.83490.341.3990.5391.051.41
222286-2228689.17489.87
322621-2262190.51491.22
422280-2228089.15089.84
522725-2272590.93091.65
623101-2310192.43593.20
极限122986-2298691.97592.641.1092.8293.501.08
223088-2308892.38393.22
323575-2357594.33195.19
423174-2317492.72793.57
523257-2325793.05993.93
622833-2283391.36292.28
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.9816727116716734216704716730213382655.84
213.981672971674491673730.07
单位质量响应值RSD%判断
9572.6811972.3215.76数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2022081801批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164463-6446339.27937.9913.0639.2837.9913.06
262551-6255138.11438.11
350726-5072630.90930.91
455104-5510433.57633.58
571804-7180443.75243.75
669404-6940442.29042.29
10min194349-9434957.48961.5814.0557.5561.6414.05
294194-9419457.39557.46
390927-9092755.40455.46
489193-8919354.34754.40
5114450-11445069.73769.81
6123246-12324675.09775.17
15min1107262-10726265.35769.4711.8965.5269.6411.89
2107281-10728165.36965.53
3104278-10427863.53963.68
4103359-10335962.97963.13
5126184-12618476.88777.08
6135696-13569682.68382.88
20min1112424-11242468.50372.6511.9668.7772.9311.96
2109684-10968466.83367.10
3112016-11201668.25468.50
4110631-11063167.41067.66
5124420-12442075.81276.13
6146175-14617589.06889.40
30min1118747-11874772.35578.1211.2172.7478.5211.21
2117340-11734071.49871.88
3121993-12199374.33374.70
4119923-11992373.07273.44
5138148-13814884.17784.62
6153051-15305193.25893.74
45min1131721-13172180.26183.557.7780.7784.087.80
2129902-12990279.15279.65
3131176-13117679.92980.42
4130173-13017379.31779.80
5143659-14365987.53588.12
6156091-15609195.11095.75
极限1160663-16066397.89699.671.2498.53100.341.25
2162137-16213798.79499.42
3165195-165195100.657101.28
4164157-164157100.025100.64
5166183-166183101.259101.99
6163122-16312299.394100.19
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