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%
115.941630871632041633991630431635961632660.15
216.041638371645721642040.32
单位质量响应值RSD%判断
10242.5310237.160.04数据可信
长期24月-供试品溶液-2023110721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%
5min162135-6213537.84929.3917.0937.8529.3817.09
254576-5457633.24433.24
343982-4398226.79126.79
443836-4383626.70226.70
541403-4140325.22025.22
643515-4351526.50726.51
10min1166366-166366101.34099.352.37101.4999.462.38
2165177-165177100.616100.75
3167915-167915102.284102.39
4158776-15877696.71796.82
5160543-16054397.79397.89
6159785-15978597.33197.44
15min1168986-168986102.936101.041.90103.49101.561.91
2167738-167738102.176102.71
3167661-167661102.129102.65
4163780-16378099.765100.26
5160562-16056297.80598.30
6166505-166505101.425101.92
20min1168401-168401102.580100.662.06103.55101.572.06
2163731-16373199.735100.68
3169174-169174103.051103.98
4164414-164414100.151101.04
5159883-15988397.39198.27
6165846-165846101.023101.92
30min1166771-166771101.587100.241.91102.97101.561.92
2165925-165925101.072102.41
3167201-167201101.849103.19
4162649-16264999.076100.37
5159041-15904196.87898.15
6165737-165737100.957102.26
45min1166224-166224101.254100.231.46103.04101.961.48
2166182-166182101.228102.98
3166941-166941101.690103.43
4162051-16205198.712100.40
5161191-16119198.18899.85
6164695-164695100.322102.03
60min1165810-165810101.00299.842.03103.19101.962.03
2165964-165964101.095103.25
3166943-166943101.692103.84
4162924-16292499.244101.33
5157839-15783996.14698.20
6163895-16389599.835101.95
极限1167352-167352101.941100.082.14104.54102.602.14
2165547-165547100.841103.40
3166277-166277101.286103.84
4162152-16215298.773101.25
5158141-15814196.33098.77
6166319-166319101.312103.82
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%
112.693073663070893070533075603074683073070.08
212.623070333088183079260.41
单位质量响应值RSD%判断
24216.4724399.840.54数据可信
长期24月-供试品溶液-2023110721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%
5min146760-4676015.11211.5918.1615.1111.5918.15
241034-4103413.26213.26
332524-3252410.51110.51
431562-3156210.20010.20
531059-3105910.03810.04
632184-3218410.40110.40
10min1144106-14410646.57342.756.3746.6342.806.38
2139522-13952245.09245.14
3132032-13203242.67142.71
4120584-12058438.97139.01
5128529-12852941.53941.58
6128925-12892541.66741.71
15min1201457-20145765.10962.522.8265.3662.742.83
2196637-19663763.55163.78
3195662-19566263.23663.45
4186856-18685660.39060.59
5189177-18917761.14061.35
6190808-19080861.66761.88
20min1229034-22903474.02173.251.5474.5373.721.55
2228083-22808373.71474.20
3231404-23140474.78775.25
4222612-22261271.94672.38
5223055-22305572.08972.54
6225778-22577872.96973.42
30min1261371-26137184.47284.591.2085.2885.351.21
2262745-26274584.91685.70
3267558-26755886.47287.24
4259386-25938683.83184.56
5259428-25942883.84484.58
6259958-25995884.01584.76
45min1282985-28298591.45792.631.2992.6093.731.28
2286866-28686692.71293.83
3293568-29356894.87895.99
4284932-28493292.08793.15
5286563-28656392.61493.69
6284727-28472792.02093.10
60min1293277-29327794.78496.361.5096.2997.831.49
2299988-29998896.95398.45
3306001-30600198.896100.39
4296977-29697795.97997.41
5297386-29738696.11297.56
6295220-29522095.41296.86
极限1305867-30586798.85399.591.17100.74101.441.16
2307604-30760499.414101.29
3315135-315135101.848103.73
4306228-30622898.969100.78
5305590-30559098.763100.59
6308392-30839299.669101.50
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%
115.941628431628301644331646151636151636670.52
216.041639941638951639440.05
单位质量响应值RSD%判断
10267.6910220.950.33数据可信
长期24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%
5min147911-4791129.17226.2413.9329.1726.2413.93
247832-4783229.12429.12
348855-4885529.74729.75
441683-4168325.38025.38
537204-3720422.65322.65
635069-3506921.35321.35
10min1160189-16018997.53590.705.4397.6590.805.43
2155824-15582494.87894.99
3151567-15156792.28692.40
4141124-14112485.92786.03
5141515-14151586.16586.26
6143541-14354187.39987.48
15min1167897-167897102.229100.741.59102.74101.221.59
2165961-165961101.050101.55
3164073-16407399.900100.39
4162876-16287699.17199.62
5162890-16289099.18099.62
6169054-169054102.933103.37
20min1168445-168445102.562100.282.35103.48101.142.34
2165975-165975101.058101.96
3159574-15957497.16198.05
4162969-16296999.228100.07
5161843-16184398.54399.37
6169324-169324103.098103.94
30min1168104-168104102.355100.411.78103.68101.681.78
2165651-165651100.861102.17
3163415-16341599.500100.78
4163627-16362799.629100.87
5160632-16063297.80599.03
6168038-168038102.315103.57
45min1164107-16410799.92199.791.63101.66101.461.63
2164986-164986100.456102.16
3163118-16311899.319100.99
4161484-16148498.32499.96
5161203-16120398.15399.77
6168454-168454102.568104.24
60min1166952-166952101.65399.671.71103.79101.741.72
2164009-16400999.861101.97
3162726-16272699.080101.15
4160779-16077997.89599.93
5160773-16077397.89199.90
6166909-166909101.627103.71
极限1165436-165436100.73099.441.53103.27101.911.54
2164016-16401699.866102.37
3162387-16238798.874101.34
4161035-16103598.051100.47
5160346-16034697.631100.03
6166679-166679101.487103.97
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%
112.693077083073433094253095103090763086120.33
212.623074523074513074520.01
单位质量响应值RSD%判断
24319.3124362.280.13数据可信
长期24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%
5min134525-3452511.1439.3416.3611.149.3416.36
233427-3342710.78910.79
329197-291979.4239.42
429540-295409.5349.53
523642-236427.6307.63
623274-232747.5127.51
10min1131246-13124642.36036.6513.8742.4036.6813.86
2127622-12762241.19041.23
3122745-12274539.61639.65
4106817-10681734.47534.51
594105-9410530.37230.40
698742-9874231.86931.90
15min1194856-19485662.89058.634.7663.1058.814.79
2188611-18861160.87461.08
3181791-18179158.67358.87
4177223-17722357.19957.37
5172185-17218555.57355.72
6175254-17525456.56356.72
20min1228986-22898673.90570.403.0574.3770.823.08
2222939-22293971.95472.41
3213705-21370568.97369.40
4217186-21718670.09770.50
5211162-21116268.15368.53
6214822-21482269.33469.72
30min1263988-26398885.20282.621.9785.9683.321.98
2256910-25691082.91883.66
3248611-24861180.23980.95
4257336-25733683.05583.74
5253606-25360681.85182.50
6255436-25543682.44283.10
45min1292407-29240794.37591.022.3095.4892.062.30
2281674-28167490.91091.98
3272534-27253487.96188.99
4281888-28188890.98092.00
5279456-27945690.19591.17
6284198-28419891.72592.72
60min1300322-30032296.92994.571.9998.4195.961.98
2289969-28996993.58895.02
3283939-28393991.64193.02
4293576-29357694.75296.13
5292386-29238694.36895.70
6297879-29787996.14197.50
极限1308666-30866699.62297.741.93101.4999.521.92
2301950-30195097.45599.26
3292493-29249394.40296.15
4302030-30203097.48099.24
5303932-30393298.09499.81
6307990-30799099.404101.15
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%
115.941632571635741631121628361632771632110.17
216.041634621645951640280.49
单位质量响应值RSD%判断
10239.0810226.180.09数据可信
长期24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%
5min140960-4096024.96832.3648.2824.9732.3648.28
241530-4153025.31525.32
342695-4269526.02626.03
4105283-10528364.17764.18
541969-4196925.58325.58
646119-4611928.11328.11
10min1162858-16285899.27396.095.6999.3796.225.67
2167424-167424102.057102.16
3163821-16382199.86099.96
4156669-15666995.50195.76
5143354-14335487.38487.49
6151703-15170392.47492.59
15min1166728-166728101.632101.000.97102.13101.520.94
2166561-166561101.531102.04
3167605-167605102.167102.67
4163543-16354399.691100.33
5164060-164060100.006100.46
6165680-165680100.993101.48
20min1166142-166142101.275100.960.94102.18101.880.87
2166630-166630101.573102.49
3165812-165812101.074101.99
4162558-16255899.090100.13
5166702-166702101.616102.47
6165918-165918101.139102.02
30min1163263-16326399.520100.471.14100.83101.791.09
2166614-166614101.563102.88
3166588-166588101.547102.86
4162013-16201398.758100.19
5165770-165770101.048102.31
6164674-164674100.380101.67
45min1164714-164714100.405100.081.46102.11101.801.41
2165075-165075100.625102.35
3166822-166822101.690103.41
4161467-16146798.425100.25
5165945-165945101.155102.82
6161030-16103098.15999.85
60min1166078-166078101.236100.681.38103.34102.801.33
2168295-168295102.588104.72
3165935-165935101.149103.28
4161558-16155898.481100.70
5165187-165187100.693102.76
6163903-16390399.910102.00
极限1165112-165112100.64799.800.93103.16102.330.87
2164561-164561100.311102.85
3162478-16247899.042101.58
4161250-16125098.293100.91
5164721-164721100.409102.88
6164242-164242100.117102.60
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%
112.693073643074493075103070203074353073560.07
212.623065833075793070810.23
单位质量响应值RSD%判断
24220.3324332.880.33数据可信
长期24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%
5min131552-3155210.21012.3837.1310.2112.3837.13
231776-3177610.28310.28
332364-3236410.47310.47
467093-6709321.71221.71
531442-3144210.17510.17
635306-3530611.42511.43
10min1122671-12267139.69741.3613.4439.7441.4113.46
2124130-12413040.16940.21
3125738-12573840.69040.73
4161486-16148652.25852.34
5112075-11207536.26836.31
6120809-12080939.09439.14
15min1186521-18652160.35961.525.7660.5661.745.81
2187513-18751360.68060.88
3191399-19139961.93862.14
4210316-21031668.05968.36
5177324-17732457.38357.57
6187643-18764360.72260.92
20min1220912-22091271.48872.353.4071.9372.813.44
2222469-22246971.99272.44
3224563-22456372.67073.12
4237594-23759476.88777.45
5214904-21490469.54469.96
6221036-22103671.52871.97
30min1255946-25594682.82684.282.0783.5585.032.12
2260096-26009684.16884.90
3264551-26455185.61086.35
4269102-26910287.08387.96
5255674-25567482.73783.43
6257276-25727683.25683.99
45min1282238-28223891.33491.744.2392.3992.824.21
2286724-28672492.78593.85
3293669-29366995.03396.12
4293717-29371795.04896.27
5283392-28339291.70792.73
6261213-26121384.53085.59
60min1293741-29374195.05696.942.1496.4898.392.16
2303529-30352998.22499.66
3308027-30802799.679101.14
4303792-30379298.30999.91
5295869-29586995.74597.14
6292329-29232994.59996.00
极限1302424-30242497.86699.772.2199.67101.612.21
2310196-310196100.381102.21
3319755-319755103.474105.34
4310038-310038100.330102.33
5306703-30670399.251101.02
6300757-30075797.32799.11
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