培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661513621508371515761518041526011516360.43
215.661511661507771509720.19
单位质量响应值RSD%判断
9683.019640.610.32数据可信
长期12月-供试品溶液-2023110822批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155580-5558035.88235.9217.7235.8835.9217.72
246905-4690530.28130.28
355983-5598336.14236.14
448693-4869331.43631.44
574349-7434947.99948.00
652303-5230333.76633.77
10min1140620-14062090.78293.7812.2490.8993.8912.23
2112846-11284672.85272.94
3153937-15393799.38099.49
4163242-163242105.387105.48
5155660-155660100.492100.64
6145305-14530593.80793.91
15min1156344-156344100.933100.455.57101.31100.845.58
2138782-13878289.59689.91
3160428-160428103.570103.98
4163330-163330105.444105.85
5156226-156226100.857101.30
6158453-158453102.295102.68
20min1156108-156108100.781101.392.54101.46102.082.57
2150987-15098797.47598.05
3159223-159223102.792103.51
4162999-162999105.230105.96
5155944-155944100.675101.42
6157086-157086101.412102.10
30min1155720-155720100.531101.542.14101.52102.532.17
2152795-15279598.64299.51
3159859-159859103.203104.23
4162193-162193104.710105.75
5155523-155523100.403101.45
6157572-157572101.726102.72
45min1155578-155578100.439101.141.80101.73102.441.83
2153042-15304298.80299.97
3158922-158922102.598103.93
4160858-160858103.848105.20
5155024-155024100.081101.43
6156559-156559101.072102.37
60min1153882-15388299.344100.822.14100.93102.422.16
2152444-15244498.41699.88
3159013-159013102.657104.30
4161286-161286104.124105.79
5154749-15474999.904101.56
6155606-155606100.457102.06
极限1153418-15341899.044100.202.20100.93102.102.23
2150396-15039697.09498.85
3157453-157453101.649103.60
4160300-160300103.487105.47
5154255-15425599.585101.54
6155401-155401100.325102.23
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222832602823512838382846522854502839100.43
212.152864952880932872940.40
单位质量响应值RSD%判断
23233.2223645.601.25数据可信
长期12月-供试品溶液-2023110822批-吲达帕胺-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142616-4261614.28413.6616.0014.2813.6616.00
235175-3517511.79011.79
339950-3995013.39113.39
438640-3864012.95212.95
552778-5277817.69117.69
635429-3542911.87511.88
10min1126618-12661842.44142.6812.0442.4842.7212.04
2107867-10786736.15636.19
3125926-12592642.20942.25
4143390-14339048.06348.10
5146252-14625249.02249.07
6113999-11399938.21138.25
15min1187231-18723162.75862.257.8562.9362.427.86
2160419-16041953.77153.91
3183835-18383561.61961.79
4203426-20342668.18668.37
5195587-19558765.55865.76
6183818-18381861.61461.76
20min1217721-21772172.97772.605.7073.3472.965.71
2197281-19728166.12666.43
3210705-21070570.62670.98
4234602-23460278.63679.02
5221700-22170074.31174.71
6217521-21752172.91073.25
30min1250710-25071084.03583.924.9684.6184.494.97
2235063-23506378.79079.29
3242916-24291681.42381.99
4272217-27221791.24491.87
5249937-24993783.77684.40
6251273-25127384.22484.78
45min1273553-27355391.69291.524.3992.5292.354.40
2260173-26017387.20787.95
3264059-26405988.50989.32
4294402-29440298.68099.58
5270509-27050990.67191.54
6275626-27562692.38793.19
60min1281510-28151094.35994.824.7995.4695.924.79
2267833-26783389.77490.78
3274556-27455692.02893.10
4307136-307136102.948104.14
5279296-27929693.61794.76
6286996-28699696.19897.28
极限1288866-28886696.82497.534.5698.2198.914.57
2276729-27672992.75694.03
3281788-28178894.45295.80
4314311-314311105.353106.86
5287531-28753196.37797.80
6296568-29656899.406100.78
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661523211528961528781527771527851527310.16
215.661523691524021523860.02
单位质量响应值RSD%判断
9752.949730.910.16数据可信
长期12月-供试品溶液-2023110822批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150984-5098432.64435.1610.0732.6435.1610.07
247920-4792030.68230.68
354602-5460234.96034.96
463917-6391740.92440.92
554458-5445834.86834.87
657563-5756336.85636.86
10min1139706-13970689.45095.634.2989.5595.744.29
2151099-15109996.74596.84
3150784-15078496.54396.65
4158102-158102101.229101.35
5144553-14455392.55492.66
6151945-15194597.28797.40
15min1158190-158190101.285100.161.68101.65100.551.67
2153963-15396398.57998.96
3159900-159900102.380102.77
4157784-157784101.025101.45
5155610-15561099.633100.02
6153157-15315798.06398.47
20min1158383-158383101.409100.491.75102.08101.181.75
2153871-15387198.52099.20
3160816-160816102.966103.67
4158226-158226101.308102.04
5156442-156442100.166100.85
6153925-15392598.55499.25
30min1157861-157861101.074100.181.54102.05101.181.54
2153633-15363398.36799.34
3159568-159568102.167103.18
4157745-157745101.000102.03
5156325-156325100.091101.07
6153695-15369598.40799.40
45min1157119-157119100.59999.801.96101.88101.101.94
2153461-15346198.25799.53
3160627-160627102.845104.16
4157068-157068100.567101.90
5154817-15481799.125100.41
6152169-15216997.43098.72
60min1157240-157240100.67799.631.48102.26101.221.48
2153107-15310798.03199.59
3158600-158600101.548103.17
4156823-156823100.410102.05
5154817-15481799.125100.70
6153052-15305297.99599.58
极限1156940-156940100.48599.381.61102.37101.271.60
2152688-15268897.76299.62
3158774-158774101.659103.59
4155873-15587399.802101.74
5154634-15463499.008100.88
6152372-15237297.56099.43
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222857932869952869822878062867732868700.26
212.152857852852212855030.14
单位质量响应值RSD%判断
23475.4523498.190.07数据可信
长期12月-供试品溶液-2023110822批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129991-2999110.03212.2116.0210.0312.2116.05
231160-3116010.42310.42
335651-3565111.92511.92
445280-4528015.14615.15
535750-3575011.95811.96
641155-4115513.76613.77
10min1105827-10582735.39840.0410.6035.4340.0810.60
2111954-11195437.44737.48
3118769-11876939.72739.76
4141696-14169647.39547.44
5114236-11423638.21038.25
6125808-12580842.08142.12
15min1170493-17049357.02759.114.5857.1659.264.61
2170038-17003856.87557.02
3177433-17743359.34959.50
4190589-19058963.74963.94
5170870-17087057.15457.30
6180837-18083760.48760.65
20min1202216-20221667.63869.413.1467.9569.743.16
2203627-20362768.11068.42
3209317-20931770.01470.35
4218710-21871073.15573.53
5201590-20159067.42967.75
6209597-20959770.10770.46
30min1237721-23772179.51480.342.0180.0280.882.04
2236323-23632379.04779.57
3242273-24227381.03781.58
4248148-24814883.00283.60
5235120-23512078.64479.17
6241542-24154280.79281.35
45min1261763-26176387.55688.071.8988.3088.851.90
2263363-26336388.09188.85
3266051-26605188.99089.78
4271099-27109990.67991.53
5256457-25645785.78186.54
6261020-26102087.30788.11
60min1274204-27420491.71791.881.4192.7392.931.42
2276730-27673092.56293.58
3276993-27699392.65093.70
4279397-27939793.45494.57
5268669-26866989.86690.88
6272183-27218391.04192.10
极限1281070-28107094.01494.051.3095.3095.371.31
2282685-28268594.55495.85
3283602-28360294.86196.19
4285410-28541095.46696.87
5275196-27519692.04993.34
6279105-27910593.35794.69
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661530151531871536621530301530751531940.18
215.661533351544041538700.50
单位质量响应值RSD%判断
9782.509825.670.32数据可信
长期12月-供试品溶液-2023110822批-培哚普利-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136336-3633623.11831.4313.8623.1231.4313.86
254735-5473534.82334.82
352743-5274333.55633.56
451566-5156632.80732.81
547627-4762730.30130.30
653405-5340533.97733.98
10min1139714-13971488.88896.024.0988.9696.124.10
2157152-15715299.983100.09
3150046-15004695.46295.56
4155641-15564199.02299.12
5152481-15248197.01197.10
6150505-15050595.75495.86
15min1152766-15276697.19299.121.2997.5399.501.30
2157824-157824100.410100.81
3154130-15413098.06098.45
4155646-15564699.02599.42
5157423-157423100.155100.54
6156967-15696799.865100.25
20min1152144-15214496.79798.691.0897.4299.361.10
2155566-15556698.97499.68
3154456-15445698.26898.95
4155324-15532498.82099.51
5156763-15676399.735100.42
6156433-15643399.525100.21
30min1152440-15244096.98598.961.2097.9099.941.22
2157605-157605100.271101.27
3154611-15461198.36699.34
4155505-15550598.93599.92
5157030-15703099.905100.89
6156102-15610299.315100.30
45min1151741-15174196.54098.541.1997.7599.821.20
2156883-15688399.812101.12
3154089-15408998.03499.31
4154846-15484698.51699.80
5156243-15624399.405100.69
6155532-15553298.952100.24
60min1140936-14093689.66697.023.7991.1698.583.77
2156624-15662499.647101.25
3153415-15341597.60599.17
4154396-15439698.22999.81
5155632-15563299.016100.60
6153924-15392497.92999.51
极限1150190-15019095.55397.741.3297.3299.601.34
2155903-15590399.188101.09
3152978-15297897.32799.19
4153093-15309397.40099.28
5154830-15483098.506100.38
6154763-15476398.463100.34
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222865722872672868442866302867142868050.10
212.152858822882822870820.60
单位质量响应值RSD%判断
23470.1323628.150.48数据可信
长期12月-供试品溶液-2023110822批-吲达帕胺-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120539-205396.85210.9919.756.8510.9919.77
236949-3694912.32612.33
334828-3482811.61911.62
437848-3784812.62612.63
531231-3123110.41910.42
636289-3628912.10612.11
10min187622-8762229.23139.3114.3329.2539.3414.34
2131142-13114243.75043.79
3119204-11920439.76739.80
4132751-13275144.28644.32
5110737-11073736.94236.97
6125584-12558441.89541.93
15min1159665-15966553.26558.355.4053.3758.505.43
2183835-18383561.32861.50
3171823-17182357.32157.48
4180921-18092160.35660.53
5170235-17023556.79156.93
6183017-18301761.05561.22
20min1194794-19479464.98468.673.4065.2569.003.43
2211629-21162970.60070.95
3202792-20279267.65267.98
4209218-20921869.79670.15
5202985-20298567.71768.03
6213619-21361971.26471.61
30min1234572-23457278.25480.222.4678.7280.752.48
2247772-24777282.65883.22
3234691-23469178.29478.82
4240518-24051880.23880.80
5237933-23793379.37579.89
6247249-24724982.48383.04
45min1263867-26386788.02788.481.9288.7289.261.93
2273298-27329891.17391.99
3259990-25999086.73487.50
4262138-26213887.45088.25
5262571-26257187.59588.35
6269520-26952089.91390.72
60min1258355-25835586.18891.193.2887.1592.233.28
2284820-28482095.01796.10
3271789-27178990.67091.69
4271306-27130690.50991.57
5274577-27457791.60092.62
6279277-27927793.16894.24
极限1288707-28870796.31495.132.2297.5396.442.19
2293495-29349597.91199.28
3280550-28055093.59394.89
4276634-27663492.28693.62
5282424-28242494.21895.51
6289076-28907696.43797.79
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661533991542101541921539931537821539150.22
215.661537541537511537520.01
单位质量响应值RSD%判断
9828.549818.140.08数据可信
长期12月-供试品溶液-2023110822批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196418-9641861.22235.7737.7961.2235.7737.79
251351-5135132.60632.61
340847-4084725.93725.94
462921-6292139.95339.95
541153-4115326.13126.13
645333-4533328.78528.78
10min1145853-14585392.61292.394.6592.8092.504.65
2152524-15252496.84896.95
3145736-14573692.53892.62
4152485-15248596.82396.94
5134823-13482385.60885.69
6141554-14155489.88289.97
15min1151360-15136096.10997.011.8396.5797.401.82
2155737-15573798.88899.28
3153347-15334797.37097.73
4152461-15246196.80897.22
5155490-15549098.73199.07
6148261-14826194.14194.50
20min1150818-15081895.76597.042.3896.5197.722.35
2156155-15615599.15399.84
3152823-15282397.03897.69
4151693-15169396.32097.02
5157708-157708100.139100.77
6147775-14777593.83294.47
30min1150958-15095895.85396.661.9396.8997.621.91
2152605-15260596.89997.88
3153167-15316797.25698.19
4151953-15195396.48597.47
5156821-15682199.576100.51
6147855-14785593.88394.80
45min1150544-15054495.59196.652.0896.9297.912.06
2155061-15506198.45999.73
3152613-15261396.90498.13
4151483-15148396.18797.47
5156152-15615299.151100.38
6147421-14742193.60894.81
60min1149906-14990695.18595.892.2796.8097.442.25
2154521-15452198.11699.68
3148629-14862994.37595.90
4150799-15079995.75297.32
5155535-15553598.760100.29
6146691-14669193.14494.63
极限1149008-14900894.61595.752.1196.5197.592.08
2153345-15334597.36999.23
3151122-15112295.95897.76
4150130-15013095.32897.18
5155069-15506998.464100.29
6146139-14613992.79494.56
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222865082883852893762894412890192885460.43
212.152873772876612875190.07
单位质量响应值RSD%判断
23612.6023664.120.16数据可信
长期12月-供试品溶液-2023110822批-吲达帕胺-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160373-6037320.06413.6631.7420.0613.6631.73
238605-3860512.83012.83
329744-297449.8859.89
453946-5394617.92817.93
529314-293149.7429.74
634716-3471611.53811.54
10min1150544-15054450.03242.3817.4950.0942.4217.49
2127938-12793842.51942.56
3110660-11066036.77736.81
4155743-15574351.76051.81
598553-9855332.75332.78
6121671-12167140.43640.47
15min1196988-19698865.46760.827.6065.6860.997.64
2184985-18498561.47861.64
3170960-17096056.81756.96
4200984-20098466.79567.00
5166596-16659655.36755.49
6177584-17758459.01959.17
20min1222935-22293574.09170.784.9374.5071.134.97
2215678-21567871.67972.03
3202633-20263367.34367.65
4226955-22695575.42775.84
5202872-20287267.42367.72
6206794-20679468.72669.06
30min1253318-25331884.18881.593.3384.8282.153.37
2245338-24533881.53682.10
3238361-23836179.21779.73
4257321-25732185.51886.15
5240616-24061679.96780.46
6237965-23796579.08679.62
45min1275322-27532291.50189.572.8292.3890.382.86
2273832-27383291.00691.82
3264192-26419287.80288.55
4278839-27883992.67093.56
5265670-26567088.29389.03
6259230-25923086.15386.93
60min1284814-28481494.65692.683.0395.8193.763.06
2284535-28453594.56395.65
3269070-26907089.42390.44
4288477-28847795.87397.04
5277299-27729992.15893.16
6268980-26898089.39390.43
极限1291932-29193297.02195.562.3098.4696.922.33
2290720-29072096.61897.99
3285298-28529894.81696.10
4295162-29516298.09599.55
5285586-28558694.91296.19
6276548-27654891.90893.21
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