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%
115.661568331566721572251567501567511568460.14
215.661568941572981570960.19
单位质量响应值RSD%判断
10015.7110031.670.12数据可信
长期12月-供试品溶液-2023110821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%
5min154003-5400333.60535.5713.6833.6035.5713.69
257451-5745135.75035.75
372201-7220144.92944.93
453784-5378433.46933.47
555867-5586734.76534.76
649663-4966330.90430.90
10min1158759-15875998.79294.646.6298.8994.756.61
2132750-13275082.60782.71
3151633-15163394.35894.49
4152117-15211794.65994.76
5159294-15929499.12599.23
6157990-15799098.31398.41
15min1159209-15920999.072100.090.6499.47100.480.63
2161895-161895100.743101.10
3161475-161475100.482100.90
4160823-160823100.076100.46
5160115-16011599.636100.04
6161543-161543100.524100.91
20min1157164-15716497.79999.591.3198.49100.281.29
2163074-163074101.477102.13
3160119-16011999.638100.36
4159427-15942799.20899.89
5158853-15885398.85099.55
6161627-161627100.577101.27
30min1158339-15833998.53199.711.1499.52100.701.11
2163549-163549101.773102.73
3160239-16023999.713100.73
4160170-16017099.670100.65
5158856-15885698.85299.85
6160210-16021099.695100.69
45min1157031-15703197.71799.161.2699.00100.451.23
2162925-162925101.384102.65
3159912-15991299.509100.83
4159008-15900898.947100.23
5158319-15831998.51899.81
6158904-15890498.882100.17
60min1156758-15675897.54798.241.7599.1299.821.73
2160970-160970100.168101.74
3159488-15948899.246100.86
4153091-15309195.26596.84
5157797-15779798.19399.78
6159134-15913499.025100.61
极限1155658-15565896.86298.501.1798.73100.381.16
2160906-160906100.128102.00
3159811-15981199.447101.36
4158125-15812598.397100.26
5157755-15775598.167100.05
6157493-15749398.00499.89
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%
112.222826912823972823822824152823072824380.06
212.152832842836182834510.09
单位质量响应值RSD%判断
23112.7723329.300.66数据可信
长期12月-供试品溶液-2023110821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%
5min138391-3839112.98813.1422.9612.9913.1422.97
238615-3861513.06413.06
353932-5393218.24618.25
431700-3170010.72510.72
542034-4203414.22114.22
628433-284339.6199.62
10min1134214-13421445.40744.2411.0545.4544.2811.07
2112948-11294838.21338.25
3150453-15045350.90150.96
4119420-11942040.40240.43
5143277-14327748.47448.52
6124312-12431242.05742.09
15min1189460-18946064.09864.814.4264.2764.984.44
2182829-18282961.85562.01
3203519-20351968.85569.06
4183717-18371762.15562.31
5199909-19990967.63367.82
6189888-18988864.24364.40
20min1217711-21771173.65675.383.3774.0275.743.39
2216745-21674573.32973.67
3234834-23483479.44979.86
4216765-21676573.33673.68
5228829-22882977.41877.81
6221878-22187875.06675.41
30min1248188-24818883.96786.252.6084.5686.842.62
2251702-25170285.15685.72
3265848-26584889.94290.59
4249953-24995384.56485.12
5259283-25928387.72188.34
6254636-25463686.14986.72
45min1268143-26814390.71893.302.5191.5694.152.52
2273190-27319092.42693.24
3286829-28682997.04097.96
4270211-27021191.41892.23
5280229-28022994.80795.69
6276053-27605393.39594.23
60min1277562-27756293.90596.522.3495.0297.652.36
2282385-28238595.53796.63
3296185-296185100.206101.42
4280804-28080495.00296.09
5289248-28924897.85999.03
6285492-28549296.58897.70
极限1285531-28553196.60198.952.3798.00100.372.39
2290693-29069398.34899.73
3304842-304842103.135104.65
4287161-28716197.15398.53
5295065-29506599.827101.29
6291531-29153198.631100.03
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)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%
115.661579831581971580451581181570651578820.30
215.661571911587801579860.72
单位质量响应值RSD%判断
10081.8610088.510.05数据可信
长期12月-供试品溶液-2023110821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%
5min159504-5950436.80233.248.1436.8033.238.14
254781-5478133.88133.88
350191-5019131.04231.04
458036-5803635.89435.89
549059-4905930.34230.34
650855-5085531.45331.45
10min1157582-15758297.46292.203.9597.5792.303.95
2154051-15405195.27895.38
3142771-14277188.30188.39
4150091-15009192.82992.94
5144146-14414689.15289.24
6145823-14582390.18990.28
15min1157717-15771797.54598.071.4097.9598.451.41
2162281-162281100.368100.76
3158333-15833397.92698.28
4159922-15992298.90999.29
5156869-15686997.02197.38
6156279-15627996.65697.02
20min1158464-15846498.00798.431.2398.7099.101.23
2161820-161820100.083100.77
3159458-15945898.62299.27
4160911-16091199.520100.20
5157140-15714097.18897.84
6157097-15709797.16297.82
30min1158124-15812497.79798.601.5098.7999.571.50
2162949-162949100.781101.77
3161032-16103299.595100.54
4160306-16030699.146100.13
5157019-15701997.11398.05
6157142-15714297.18998.14
45min1158269-15826997.88698.131.0299.1799.391.02
2160997-16099799.574100.86
3158851-15885198.24699.49
4159636-15963698.732100.01
5157948-15794897.68898.92
6156237-15623796.63097.87
60min1157595-15759597.47098.001.1999.0599.561.19
2161266-16126699.740101.33
3158264-15826497.88399.42
4159896-15989698.893100.47
5157769-15776997.57799.10
6155914-15591496.43097.96
极限1156267-15626796.64897.531.7498.5299.391.74
2161231-16123199.718101.61
3159327-15932798.541100.38
4159672-15967298.754100.63
5155217-15521795.99997.82
6154476-15447695.54197.36
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%
112.222844982850782846832840192835142843580.22
212.152852452861962857200.24
单位质量响应值RSD%判断
23269.8923516.050.75数据可信
长期12月-供试品溶液-2023110821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%
5min138551-3855112.94710.6215.9912.9510.6215.99
229112-291129.7779.78
325909-259098.7018.70
436210-3621012.16112.16
532671-3267110.97210.97
627303-273039.1699.17
10min1137021-13702146.01738.5611.9246.0638.5911.93
2100900-10090033.88633.92
3111126-11112637.32037.35
4122804-12280441.24241.28
5115303-11530338.72338.76
6101703-10170334.15634.18
15min1189015-18901563.47859.204.7963.6659.344.81
2172625-17262557.97458.10
3167712-16771256.32456.46
4183231-18323161.53661.70
5176389-17638959.23859.39
6168631-16863156.63256.76
20min1217817-21781773.15169.993.2173.5270.313.22
2206897-20689769.48469.79
3199351-19935166.94967.26
4214167-21416771.92572.27
5207693-20769369.75170.08
6204424-20442468.65368.95
30min1249215-24921583.69681.732.0084.2882.272.02
2242150-24215081.32381.84
3237591-23759179.79280.30
4249374-24937483.74984.31
5241351-24135181.05581.59
6240520-24052080.77581.28
45min1270003-27000390.67789.571.1991.5190.351.21
2266776-26677689.59390.35
3263508-26350888.49689.24
4271010-27101091.01591.83
5264439-26443988.80889.59
6264490-26449088.82589.57
60min1281490-28149094.53593.201.2495.6494.251.26
2277792-27779293.29394.32
3274477-27447792.17993.19
4281756-28175694.62495.71
5274153-27415392.07193.12
6275400-27540092.48993.50
极限1289655-28965597.27795.931.3998.6797.261.40
2286131-28613196.09397.40
3281708-28170894.60895.90
4290914-29091497.70099.07
5281903-28190394.67396.00
6283591-28359195.24096.53
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%
115.661584271589841574851563941576131577810.63
215.661588811602061595440.59
单位质量响应值RSD%判断
10075.4210187.990.79数据可信
长期12月-供试品溶液-2023110821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%
5min149529-4952930.49331.917.5830.4931.917.58
251600-5160031.76831.77
355757-5575734.32734.33
446699-4669928.75128.75
550323-5032330.98230.98
657100-5710035.15435.15
10min1157218-15721896.79396.192.0996.8896.292.09
2156919-15691996.60996.70
3158391-15839197.51597.62
4154868-15486895.34695.43
5150444-15044492.62292.72
6159623-15962398.27498.38
15min1163946-163946100.93598.382.49101.3298.772.48
2158090-15809097.33097.71
3156247-15624796.19596.59
4155324-15532495.62796.00
5164871-164871101.505101.88
6160337-16033798.71399.11
20min1162921-162921100.30498.052.36100.9998.732.34
2158008-15800897.27997.96
3156716-15671696.48497.17
4154367-15436795.03895.70
5164229-164229101.109101.78
6159284-15928498.06598.76
30min1162037-16203799.76097.662.29100.7598.642.28
2156417-15641796.30097.27
3156229-15622996.18497.16
4154303-15430394.99895.94
5163576-163576100.707101.69
6159219-15921998.02599.02
45min1162190-16219099.85497.492.33101.1498.762.31
2155834-15583495.94197.20
3157650-15765097.05998.32
4153783-15378394.67895.91
5163273-163273100.521101.80
6157356-15735696.87898.16
60min1161415-16141599.37796.962.56100.9698.522.55
2155842-15584295.94697.49
3154515-15451595.12996.68
4152508-15250893.89395.41
5162899-162899100.291101.87
6157794-15779497.14898.72
极限1161097-16109799.18196.512.63101.0698.362.61
2154686-15468695.23497.07
3153551-15355194.53596.37
4152232-15223293.72395.52
5162302-16230299.923101.81
6156723-15672396.48898.35
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%
112.222853812862962857452843152842062851890.32
212.152853052874982864020.55
单位质量响应值RSD%判断
23337.8923572.180.71数据可信
长期12月-供试品溶液-2023110821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%
5min124810-248108.31010.4314.848.3110.4414.84
229618-296189.9209.92
336709-3670912.29612.30
428442-284429.5279.53
531072-3107210.40710.41
636248-3624812.14112.14
10min1105978-10597835.49740.889.8035.5240.919.81
2116108-11610838.89038.92
3132186-13218644.27544.31
4120382-12038240.32240.35
5118168-11816839.58039.61
6139399-13939946.69146.73
15min1173121-17312157.98659.623.3658.1259.773.37
2172504-17250457.78057.93
3177356-17735659.40559.57
4175223-17522358.69058.84
5181547-18154760.80960.96
6188151-18815163.02163.20
20min1208451-20845169.82069.932.4470.1370.272.45
2203754-20375468.24768.57
3205878-20587868.95869.31
4204858-20485868.61768.94
5213268-21326871.43371.77
6216546-21654672.53172.90
30min1245396-24539682.19580.962.1082.7181.502.09
2235470-23547078.87079.39
3238056-23805679.73680.29
4238051-23805179.73480.27
5247046-24704682.74783.29
6246194-24619482.46283.05
45min1270868-27086890.72688.942.0891.4989.732.08
2258358-25835886.53687.30
3262740-26274088.00488.80
4261113-26111387.45988.23
5271391-27139190.90291.70
6268753-26875390.01890.85
60min1285504-28550495.62992.552.5796.6693.602.55
2269701-26970190.33691.36
3268667-26866789.98991.05
4272076-27207691.13192.16
5282281-28228194.54995.62
6279626-27962693.66094.76
极限1296165-29616599.20095.492.75100.5296.822.73
2278485-27848593.27894.57
3276063-27606392.46793.79
4280938-28093894.09995.41
5290904-29090497.43798.79
6288014-28801496.46997.85
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%
115.661563461575641585861574821571271574210.52
215.661585301594091589700.40
单位质量响应值RSD%判断
10052.4310151.340.70数据可信
长期12月-供试品溶液-2023110821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%
5min145017-4501727.79728.4810.8527.8028.4810.86
242221-4222126.07026.07
355429-5542934.22634.23
444104-4410427.23327.23
542212-4221226.06526.06
647737-4773729.47629.48
10min1136406-13640684.22788.063.5984.3188.143.59
2145934-14593490.11090.19
3143915-14391588.86488.97
4139354-13935486.04786.13
5139667-13966786.24186.32
6150390-15039092.86292.95
15min1158855-15885598.08996.211.7098.4296.561.69
2154581-15458195.45095.80
3156452-15645296.60596.97
4151586-15158693.60093.94
5158184-15818497.67498.01
6155196-15519695.82996.20
20min1157719-15771997.38796.081.8598.0296.721.84
2153441-15344194.74695.38
3157029-15702996.96197.62
4151310-15131093.43094.05
5158972-15897298.16198.79
6155149-15514995.80096.45
30min1158517-15851797.88095.831.9198.8096.761.90
2153023-15302394.48895.41
3156212-15621296.45797.41
4150768-15076893.09594.00
5157875-15787597.48498.41
6154831-15483195.60496.55
45min1156921-15692196.89595.721.8798.1196.941.87
2152833-15283394.37095.57
3156652-15665296.72997.97
4150689-15068993.04794.23
5158478-15847897.85699.07
6154584-15458495.45296.68
60min1156399-15639996.57295.571.8098.0897.071.80
2152665-15266594.26795.75
3157055-15705596.97798.51
4150629-15062993.00994.47
5157753-15775397.40898.92
6154108-15410895.15896.67
极限1156042-15604296.35295.251.9698.1597.031.95
2152402-15240294.10495.87
3155186-15518695.82397.64
4149680-14968092.42394.16
5158382-15838297.79799.60
6153817-15381794.97896.78
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%
112.222838412844662856652849142846732847120.24
212.152837462852832845140.39
单位质量响应值RSD%判断
23298.8523416.790.36数据可信
长期12月-供试品溶液-2023110821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%
5min124896-248968.3739.8612.458.379.8612.46
227541-275419.2639.26
335298-3529811.87211.87
430700-3070010.32510.33
527055-270559.1009.10
630335-3033510.20310.20
10min193013-9301331.28436.458.7131.3136.488.71
2108660-10866036.54636.57
3118658-11865839.90939.94
4114506-11450638.51238.54
5102027-10202734.31534.34
6113405-11340538.14238.17
15min1163369-16336954.94758.022.7355.0758.162.74
2175320-17532058.96659.10
3173104-17310458.22158.38
4174342-17434258.63758.78
5172473-17247358.00958.14
6176415-17641559.33559.48
20min1198133-19813366.63969.432.1066.9269.752.11
2206931-20693169.59869.91
3207875-20787569.91670.25
4206924-20692469.59669.92
5210892-21089270.93071.23
6207909-20790969.92770.25
30min1232702-23270278.26681.082.1178.7581.612.12
2241227-24122781.13381.66
3241802-24180281.32681.87
4239759-23975980.63981.17
5248474-24847483.57084.09
6242506-24250681.56382.10
45min1257014-25701486.44389.412.2187.1690.182.20
2265297-26529789.22990.00
3266714-26671489.70590.49
4264827-26482789.07189.84
5275395-27539592.62593.39
6265841-26584189.41290.19
60min1267814-26781490.07593.322.3791.0594.352.36
2275481-27548192.65493.69
3280941-28094194.49095.54
4275464-27546492.64893.69
5287534-28753496.70897.75
6277548-27754893.34994.39
极限1277157-27715793.21895.962.2794.4797.272.27
2282810-28281095.11996.43
3289014-28901497.20598.54
4283238-28323895.26396.58
5296080-29608099.582100.92
6283579-28357995.37896.70
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