替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.817290807288337285747295537292107290500.06
210.757295787268237282000.27
单位质量响应值RSD%判断
67442.1867739.530.32数据可信
供试品溶液-2026031621批-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%
5min159673-596737.9466.3516.607.956.3416.63
247240-472406.2906.29
336665-366654.8824.88
441846-418465.5725.57
550502-505026.7256.72
649985-499856.6566.66
10min1114870-11487015.29514.128.0915.3414.168.10
2107877-10787714.36414.40
390807-9080712.09112.12
4102200-10220013.60813.64
5111572-11157214.85614.89
6109095-10909514.52714.56
15min1150118-15011819.98918.997.3520.1219.117.36
2150850-15085020.08620.20
3126768-12676816.88016.97
4134439-13443917.90118.01
5140855-14085518.75618.88
6152770-15277020.34220.46
20min1163029-16302921.70821.794.2321.9522.024.24
2172890-17289023.02123.25
3157468-15746820.96821.16
4156372-15637220.82221.03
5161124-16112421.45421.68
6171115-17111522.78523.02
30min1176463-17646323.49724.364.4423.8624.704.42
2183680-18368024.45824.81
3178242-17824223.73424.04
4174102-17410223.18323.50
5192321-19232125.60825.95
6192888-19288825.68426.04
45min1188699-18869925.12625.063.8825.6225.543.88
2192146-19214625.58526.08
3186357-18635724.81425.25
4174594-17459423.24823.70
5192766-19276625.66826.15
6194610-19461025.91326.41
60min1191183-19118325.45725.402.0526.0926.012.05
2193079-19307925.70926.34
3193612-19361225.78026.35
4183131-18313124.38524.96
5192780-19278025.67026.30
6190522-19052225.36926.01
极限1192699-19269925.65925.601.7826.4326.361.63
2193181-19318125.72326.50
3196798-19679826.20526.92
4194344-19434425.87826.59
5188112-18811225.04825.82
6188397-18839725.08625.87
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.817352997338877338887332737326807338050.14
210.757301177300227300700.01
单位质量响应值RSD%判断
67882.0567913.490.04数据可信
供试品溶液-2026031621批-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%
5min135074-350744.6495.7916.924.655.7916.88
252468-524686.9556.95
339357-393575.2175.22
442960-429605.6945.69
552822-528227.0027.00
639353-393535.2165.22
10min189364-8936411.84513.2912.7911.8713.3212.80
2123342-12334216.34916.39
393214-9321412.35612.38
490614-9061412.01112.04
599599-9959913.20213.24
6105418-10541813.97314.00
15min1133943-13394317.75418.378.4017.8518.488.38
2150125-15012519.89920.03
3139476-13947618.48818.59
4121073-12107316.04816.15
5134472-13447217.82517.94
6152645-15264520.23320.34
20min1160248-16024821.24121.795.0421.4322.005.06
2171980-17198022.79623.04
3161748-16174821.44021.64
4157107-15710720.82521.01
5157854-15785420.92421.14
6177258-17725823.49623.71
30min1176618-17661823.41124.073.2023.7224.403.21
2179554-17955423.80024.17
3181232-18123224.02324.34
4176464-17646423.39123.69
5183711-18371124.35124.68
6192006-19200625.45125.80
45min1188692-18869225.01225.041.2325.4525.501.27
2188308-18830824.96125.46
3185699-18569924.61525.07
4187674-18767424.87725.31
5190600-19060025.26425.73
6192356-19235625.49725.99
60min1190067-19006725.19425.181.4125.7725.781.40
2190725-19072525.28125.92
3192773-19277325.55226.14
4189174-18917425.07525.65
5185117-18511724.53825.14
6191755-19175525.41826.05
极限1190364-19036425.23325.691.6025.9526.431.55
2197170-19717026.13526.91
3195845-19584525.96026.69
4196279-19627926.01726.73
5193127-19312725.59926.34
6190100-19010025.19825.97
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.817302737246767261297276137259767269330.30
210.757252007260067256030.08
单位质量响应值RSD%判断
67246.3567497.950.27数据可信
供试品溶液-2026031821批-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%
5min195406-9540612.74512.525.8712.7412.525.88
2103511-10351113.82813.83
394667-9466712.64612.65
489743-8974311.98811.99
589997-8999712.02212.02
689032-8903211.89411.89
10min1135028-13502818.03816.989.7918.1117.059.77
2143648-14364819.18919.27
3123685-12368516.52316.59
4132176-13217617.65717.72
5108722-10872214.52414.59
6119291-11929115.93616.00
15min1165437-16543722.10020.837.0622.2721.007.03
2158747-15874721.20721.39
3158366-15836621.15621.32
4159607-15960721.32121.49
5134131-13413117.91818.07
6159430-15943021.29821.45
20min1186057-18605724.85523.556.5125.1523.836.49
2181100-18110024.19324.49
3175390-17539023.43023.71
4176504-17650423.57923.86
5154524-15452420.64220.89
6184308-18430824.62124.89
30min1195449-19544926.10925.322.7226.5425.732.75
2195876-19587626.16626.60
3183917-18391724.56924.98
4189701-18970125.34225.76
5185047-18504724.72025.08
6187237-18723725.01225.42
45min1192528-19252825.71925.780.4826.3026.340.56
2194603-19460325.99626.58
3193203-19320325.80926.36
4193237-19323725.81426.37
5191939-19193925.64126.14
6192524-19252425.71926.27
60min1185010-18501024.71525.742.1225.4326.442.00
2194261-19426125.95126.68
3193126-19312625.79926.49
4192434-19243425.70726.40
5196918-19691826.30626.95
6194462-19446225.97826.67
极限1188250-18825025.14826.302.1626.0027.132.06
2197885-19788526.43527.30
3199038-19903826.58927.42
4198552-19855226.52427.37
5199339-19933926.62927.42
6197976-19797626.44727.28
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.817296557294367293937289667287467292390.06
210.757222747220587221660.03
单位质量响应值RSD%判断
67459.6767178.230.30数据可信
供试品溶液-2026031821批-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%
5min188003-8800311.76512.289.5311.7712.289.54
2103136-10313613.78913.79
387186-8718611.65611.66
482229-8222910.99310.99
588144-8814411.78411.78
6102439-10243913.69513.70
10min1117194-11719415.66816.3410.3215.7316.4110.32
2139013-13901318.58518.66
3112987-11298715.10615.17
4118089-11808915.78815.85
5109268-10926814.60814.67
6136967-13696718.31118.39
15min1153834-15383420.56620.777.6420.7220.937.65
2167528-16752822.39722.58
3148478-14847819.85020.00
4156448-15644820.91621.06
5137276-13727618.35318.50
6168698-16869822.55422.73
20min1177729-17772923.76122.776.1324.0323.046.12
2167395-16739522.37922.68
3168145-16814522.48022.74
4172809-17280923.10323.37
5152769-15276920.42420.67
6183019-18301924.46824.77
30min1201936-20193626.99725.703.4627.4026.103.47
2192490-19249025.73426.16
3188959-18895925.26225.65
4193179-19317925.82726.22
5181910-18191024.32024.68
6195011-19501126.07226.51
45min1189093-18909325.28025.661.1325.8326.201.15
2192554-19255425.74326.31
3189736-18973625.36625.89
4194646-19464626.02326.56
5191894-19189425.65526.15
6193602-19360225.88326.47
60min1191134-19113425.55325.740.9426.2426.430.91
2190993-19099325.53426.25
3191035-19103525.54026.21
4192801-19280125.77626.46
5194917-19491726.05926.70
6194532-19453226.00726.74
极限1192160-19216025.69025.761.1326.5226.581.16
2191000-19100025.53526.39
3190964-19096425.53026.34
4191926-19192625.65926.48
5193083-19308325.81426.60
6196774-19677426.30727.18
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.817327137422007311367356417388317361040.62
210.757384667284867334760.97
单位质量响应值RSD%判断
68094.7368230.330.15数据可信
供试品溶液-2026031721批-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%
5min146342-463426.1197.2213.996.127.2214.01
266813-668138.8228.82
353039-530397.0037.00
453186-531867.0237.02
560335-603357.9667.97
648430-484306.3956.39
10min199581-9958113.14815.0310.0213.1815.0710.04
2128973-12897317.02917.08
3109456-10945614.45214.49
4105191-10519113.88913.93
5124917-12491716.49416.54
6115020-11502015.18715.22
15min1123564-12356416.31519.819.0816.4219.939.06
2149777-14977719.77619.92
3154319-15431920.37620.50
4152671-15267120.15820.27
5158311-15831120.90321.04
6161549-16154921.33121.45
20min1163926-16392621.64423.385.1521.8423.625.15
2176064-17606423.24723.50
3181836-18183624.00924.24
4177303-17730323.41123.64
5172303-17230322.75023.00
6191082-19108225.23025.47
30min1179250-17925023.66824.833.0523.9925.193.07
2183874-18387424.27824.66
3191998-19199825.35125.72
4188825-18882524.93225.29
5189041-18904124.96025.34
6195247-19524725.78026.16
45min1194747-19474725.71425.601.3626.1626.101.35
2191491-19149125.28425.80
3192677-19267725.44125.95
4191862-19186225.33325.83
5194006-19400625.61626.13
6198650-19865026.22926.75
60min1192435-19243525.40925.431.6126.0026.081.59
2189364-18936425.00325.66
3189841-18984125.06625.71
4193084-19308425.49426.13
5193004-19300425.48426.14
6198020-19802026.14626.81
极限1199215-19921526.30425.970.9827.0426.760.88
2197103-19710326.02526.82
3195625-19562525.83026.62
4197029-19702926.01526.79
5197613-19761326.09226.89
6193586-19358625.56126.37
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.817266367230747234757329697299677272240.59
210.757320297340047330160.20
单位质量响应值RSD%判断
67273.2768187.530.96数据可信
供试品溶液-2026031721批-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%
5min163791-637918.4776.3523.028.486.3523.03
238231-382315.0805.08
353542-535427.1157.11
434156-341564.5394.54
544132-441325.8655.86
652723-527237.0067.01
10min1121481-12148116.14313.7116.4016.1913.7416.41
295970-9597012.75312.78
3120707-12070716.04016.08
480524-8052410.70010.73
589989-8998911.95811.99
6110160-11016014.63914.68
15min1145430-14543019.32618.0110.1219.4618.1210.16
2131599-13159917.48817.59
3151469-15146920.12820.26
4118606-11860615.76115.85
5121257-12125716.11316.21
6144595-14459519.21519.33
20min1170786-17078622.69521.448.6122.9421.668.65
2162928-16292821.65121.85
3178046-17804623.66023.90
4147351-14735119.58119.75
5142208-14220818.89719.09
6166912-16691222.18022.41
30min1178816-17881623.76223.704.6324.1324.034.64
2186288-18628824.75525.07
3179064-17906423.79524.17
4174596-17459623.20123.48
5164527-16452721.86322.16
6186790-18679024.82225.17
45min1194790-19479025.88525.401.6126.3925.861.62
2191082-19108225.39225.85
3187046-18704624.85625.36
4187934-18793424.97425.38
5193139-19313925.66526.08
6192771-19277125.61726.10
60min1183712-18371224.41325.201.9225.0625.811.86
2193165-19316525.66926.26
3193811-19381125.75526.40
4189090-18909025.12725.68
5189334-18933425.16025.72
6188770-18877025.08525.72
极限1195716-19571626.00825.701.3826.7926.451.36
2190595-19059525.32726.07
3191835-19183525.49226.28
4196655-19665526.13326.82
5190791-19079125.35326.05
6194966-19496625.90826.68
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