培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
115.941576491577511578051578561576461577410.06
216.041564051561801562920.11
单位质量响应值RSD%判断
9895.929743.891.10数据可信
长期24月-供试品溶液-2023110721批-培哚普利-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152353-5235333.25631.3914.3133.2631.3914.32
249387-4938731.37231.37
343175-4317527.42627.43
461580-6158039.11739.12
547781-4778130.35230.35
642225-4222526.82226.82
10min1165377-165377105.05297.538.34105.1997.658.34
2155406-15540698.71898.84
3147499-14749993.69593.81
4167559-167559106.438106.59
5132544-13254484.19684.32
6152784-15278497.05397.16
15min1159814-159814101.518102.052.26102.07102.572.28
2159127-159127101.082101.60
3156776-15677699.588100.07
4166540-166540105.791106.37
5158285-158285100.547101.01
6163401-163401103.797104.29
20min1166529-166529105.784102.212.61106.74103.132.59
2158634-158634100.769101.69
3156537-15653799.437100.32
4160034-160034101.658102.66
5165690-165690105.251106.11
6157996-157996100.363101.27
30min1158953-158953100.971101.082.12102.35102.412.08
2157250-15725099.890101.22
3155970-15597099.076100.36
4159676-159676101.431102.84
5165435-165435105.089106.37
6157448-157448100.015101.33
45min1158541-158541100.710100.801.99102.50102.541.97
2157446-157446100.014101.74
3155009-15500998.466100.14
4159288-159288101.184103.00
5157420-15742099.998101.70
6164390-164390104.425106.14
60min1157923-157923100.317100.351.33102.51102.491.28
2157083-15708399.783101.91
3161789-161789102.773104.84
4157883-157883100.292102.51
5157704-157704100.178102.28
6155441-15544198.740100.87
极限1157356-15735699.957100.181.56102.55102.721.50
2156333-15633399.307101.83
3162443-162443103.188105.67
4157300-15730099.921102.54
5157444-157444100.013102.52
6155397-15539798.712101.24
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.693068883069353070983066753067453068680.06
212.623041343040073040700.03
单位质量响应值RSD%判断
24181.8824094.290.26数据可信
长期24月-供试品溶液-2023110721批-吲达帕胺-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140012-4001213.02211.9117.6913.0211.9117.68
235621-3562111.59311.59
329102-291029.4729.47
447601-4760115.49215.49
534443-3444311.21011.21
632750-3275010.65910.66
10min1143256-14325646.62442.6512.7046.6842.7012.71
2130971-13097142.62642.67
3120019-12001939.06239.10
4157948-15794851.40651.47
5117139-11713938.12438.17
6117001-11700138.07938.12
15min1200800-20080065.35362.295.8565.5962.515.87
2195598-19559863.66063.88
3190170-19017061.89362.09
4204804-20480466.65666.92
5180224-18022458.65658.85
6176811-17681157.54557.74
20min1233054-23305475.85073.732.7876.3574.202.80
2229652-22965274.74375.21
3220785-22078571.85772.30
4231243-23124375.26175.79
5217100-21710070.65871.09
6227429-22742974.01974.44
30min1267089-26708986.92785.341.6287.7386.111.63
2264059-26405985.94186.71
3261249-26124985.02785.76
4261111-26111184.98285.82
5254902-25490282.96183.68
6264912-26491286.21986.94
45min1291846-29184694.98591.544.7696.1492.644.73
2289862-28986294.33995.45
3288877-28887794.01895.09
4281178-28117891.51392.69
5255816-25581683.25884.30
6279904-27990491.09892.16
60min1302074-30207498.31496.802.1299.8498.272.09
2300361-30036197.75699.25
3300201-30020197.70499.15
4288708-28870893.96395.50
5290161-29016194.43695.82
6302997-30299798.614100.04
极限1310880-310880101.18098.903.88103.10100.753.80
2310784-310784101.148103.03
3309790-309790100.825102.66
4281687-28168791.67893.60
5299278-29927897.40499.16
6310783-310783101.148102.97
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
115.941563901563261571151564731562821565170.22
216.041558181558921558550.04
单位质量响应值RSD%判断
9819.139716.650.75数据可信
长期24月-供试品溶液-2023110821批-培哚普利-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146572-4657229.74032.208.4829.7432.208.47
251142-5114232.65932.66
354026-5402634.50034.50
452461-5246133.50133.50
554439-5443934.76434.76
643892-4389228.02928.03
10min1138537-13853788.46894.325.8388.5994.455.82
2146250-14625093.39493.52
3156940-156940100.220100.36
4144044-14404491.98592.12
5140947-14094790.00790.15
6159518-159518101.867101.98
15min1156451-15645199.908101.901.30100.38102.401.30
2158157-158157100.997101.50
3159818-159818102.058102.60
4162107-162107103.520104.02
5159534-159534101.877102.38
6161310-161310103.011103.53
20min1154862-15486298.893101.933.0499.77102.843.02
2156875-156875100.179101.09
3157840-157840100.795101.74
4168769-168769107.774108.69
5159206-159206101.667102.57
6160119-160119102.250103.18
30min1154176-15417698.455101.553.1799.72102.873.15
2155355-15535599.208100.52
3157893-157893100.829102.18
4168407-168407107.543108.89
5158696-158696101.342102.65
6159576-159576101.904103.24
45min1153723-15372398.166101.813.4999.83103.543.46
2154582-15458298.714100.42
3156947-156947100.225101.98
4166975-166975106.628108.41
5165371-165371105.604107.32
6158952-158952101.505103.25
60min1153711-15371198.158101.533.74100.21103.663.70
2153653-15365398.121100.22
3156017-15601799.631101.79
4167626-167626107.044109.25
5164939-164939105.328107.47
6157975-157975100.881103.04
极限1153235-15323597.854100.893.63100.30103.433.59
2153261-15326197.871100.36
3154662-15466298.766101.32
4167161-167161106.747109.38
5162713-162713103.907106.47
6156890-156890100.188102.75
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.693067903067973070103067533070693068840.05
212.623039183036083037630.08
单位质量响应值RSD%判断
24183.1424069.970.34数据可信
长期24月-供试品溶液-2023110821批-吲达帕胺-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135227-3522711.47112.257.9911.4712.267.98
238589-3858912.56512.57
340666-4066613.24213.24
437148-3714812.09612.10
540846-4084613.30013.30
633308-3330810.84610.85
10min1116674-11667437.99141.645.0338.0441.695.03
2123782-12378240.30640.36
3132870-13287043.26543.32
4129756-12975642.25142.30
5132133-13213343.02543.08
6132117-13211743.02043.06
15min1186991-18699160.88860.952.8161.0961.162.81
2185553-18555360.41960.63
3188831-18883161.48761.71
4177886-17788657.92358.14
5192747-19274762.76262.99
6191080-19108062.21962.43
20min1218339-21833971.09571.861.5471.5472.321.54
2216535-21653570.50870.96
3218384-21838471.11071.58
4222336-22233672.39772.85
5223343-22334372.72573.20
6225119-22511973.30373.77
30min1254096-25409682.73883.601.7083.4684.341.69
2252568-25256882.24182.98
3253503-25350382.54583.30
4259497-25949784.49785.24
5256769-25676983.60984.38
6263973-26397385.95486.71
45min1280490-28049091.33391.121.7492.3992.201.73
2275164-27516489.59890.66
3276330-27633089.97891.06
4278383-27838390.64791.72
5279755-27975591.09392.19
6288829-28882994.04895.15
60min1292047-29204795.09694.991.8496.5296.441.82
2286713-28671393.35994.78
3285997-28599793.12694.57
4294224-29422495.80597.24
5290844-29084494.70496.17
6300535-30053597.86099.34
极限1301298-30129898.10897.911.7799.9199.741.75
2297253-29725396.79198.59
3294355-29435595.84797.67
4302294-30229498.432100.25
5299105-29910597.39499.24
6309806-309806100.878102.75
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
115.941567991566201566031567551568761567310.08
216.041562491564081563280.08
单位质量响应值RSD%判断
9832.569746.130.63数据可信
长期24月-供试品溶液-2023110822批-培哚普利-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143703-4370327.84730.0911.0627.8530.0911.06
247425-4742530.21830.22
357057-5705736.35636.36
444135-4413528.12228.12
543091-4309127.45727.46
647899-4789930.52130.52
10min1145400-14540092.64796.804.2292.7696.924.22
2148767-14876794.79294.91
3156125-15612599.48099.63
4156768-15676899.890100.00
5144787-14478792.25692.37
6159672-159672101.741101.86
15min1156657-15665799.819100.141.10100.30100.651.11
2157357-157357100.265100.77
3157786-157786100.539101.08
4155674-15567499.19399.71
5155398-15539899.01799.50
6160120-160120102.026102.56
20min1157049-157049100.069100.000.98100.95100.910.99
2155841-15584199.299100.20
3157366-157366100.271101.22
4155601-15560199.147100.06
5156082-15608299.453100.33
6159718-159718101.770102.71
30min1154172-15417298.23699.351.4899.52100.661.49
2154971-15497198.745100.04
3156889-15688999.967101.31
4154840-15484098.66299.97
5154435-15443598.40499.68
6160191-160191102.071103.42
45min1157023-157023100.05399.701.37101.73101.411.37
2157055-157055100.073101.77
3155216-15521698.901100.65
4154748-15474898.603100.30
5154562-15456298.485100.15
6160226-160226102.094103.85
60min1155106-15510698.831100.392.06100.91102.492.04
2155054-15505498.798100.89
3157768-157768100.527102.67
4162997-162997103.859105.95
5154906-15490698.704100.76
6159451-159451101.600103.76
极限1153907-15390798.06799.592.20100.54102.102.17
2154138-15413898.214100.70
3155470-15547099.063101.61
4161767-161767103.075105.59
5153274-15327497.664100.12
6159238-159238101.464104.03
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.693069913067403066973069523069553068670.05
212.623019303015033017160.11
单位质量响应值RSD%判断
24181.8023907.770.81数据可信
长期24月-供试品溶液-2023110822批-吲达帕胺-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131619-3161910.33110.9813.1210.3310.9813.11
233892-3389211.07411.07
341144-4114413.44313.44
434647-3464711.32011.32
527790-277909.0809.08
632471-3247110.60910.61
10min1122949-12294940.17242.089.5840.2142.129.59
2130795-13079542.73542.78
3145474-14547447.53147.59
4137897-13789745.05645.10
5110061-11006135.96136.00
6125497-12549741.00441.05
15min1188028-18802861.43561.884.3161.6462.104.33
2191329-19132962.51462.73
3197382-19738264.49164.74
4195927-19592764.01664.24
5174564-17456457.03657.22
6189139-18913961.79862.00
20min1224770-22477073.44072.663.3773.8973.123.39
2223923-22392373.16373.63
3226739-22673974.08374.59
4228700-22870074.72475.21
5207763-20776367.88368.29
6222372-22237272.65773.11
30min1262842-26284285.88084.612.6086.6285.362.61
2259996-25999684.95085.71
3257693-25769384.19785.00
4263945-26394586.24087.02
5246079-24607980.40281.08
6263182-26318285.99186.73
45min1291827-29182795.35093.342.3596.4394.432.35
2287477-28747793.92995.03
3282087-28208792.16893.30
4289654-28965494.64095.77
5273797-27379789.45990.46
6289258-28925894.51195.60
60min1303500-30350099.16497.232.05100.6398.692.05
2297160-29716097.09298.57
3292515-29251595.57597.08
4300793-30079398.27999.78
5288431-28843194.24095.60
6303115-30311599.038100.50
极限1315472-315472103.076100.232.38104.94102.082.37
2308579-308579100.823102.69
3301135-30113598.391100.28
4309979-309979101.281103.18
5295280-29528096.47898.21
6310175-310175101.345103.21
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