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%
116.411607461605421606211606801604801606140.07
216.471597151597681597420.03
单位质量响应值RSD%判断
9787.579698.970.65数据可信
加速6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%
5min170428-7042845.08851.9010.3445.0951.9010.34
276790-7679049.16149.16
386343-8634355.27755.28
474009-7400947.38047.38
590507-9050757.94257.94
688313-8831356.53856.54
10min1153992-15399298.58599.090.7898.7799.300.78
2157090-157090100.569100.77
3153714-15371498.40898.63
4154544-15454498.93999.13
5154697-15469799.03799.27
6154633-15463398.99699.22
15min1161249-161249103.231101.561.69103.81102.161.66
2161062-161062103.112103.71
3157789-157789101.016101.63
4160549-160549102.783103.37
5155453-15545399.521100.15
6155710-15571099.685100.31
20min1160122-160122102.510101.071.90103.50102.081.87
2160803-160803102.946103.96
3155430-15543099.506100.52
4160585-160585102.806103.80
5153986-15398698.58299.61
6156281-156281100.051101.07
30min1159179-159179101.906100.601.47103.30102.021.44
2159915-159915102.377103.80
3155694-15569499.675101.09
4158329-158329101.362102.77
5155427-15542799.504100.92
6154302-15430298.784100.21
45min1156403-156403100.12999.881.33101.93101.701.32
2159529-159529102.130103.96
3154821-15482199.116100.93
4156363-156363100.103101.92
5155679-15567999.666101.48
6153304-15330498.14599.96
60min1156985-156985100.50299.561.66102.71101.781.64
2159379-159379102.034104.28
3154008-15400898.596100.81
4156132-15613299.956102.17
5154602-15460298.976101.19
6151954-15195497.28199.49
极限1154629-15462998.99399.081.62101.60101.701.60
2158861-158861101.703104.35
3154021-15402198.604101.21
4155772-15577299.725102.34
5154096-15409698.652101.26
6151233-15123396.81999.42
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%
112.302959312960542957132957762956732958290.06
212.352949072948932949000.01
单位质量响应值RSD%判断
24051.1423878.540.51数据可信
加速6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%
5min146285-4628515.17316.445.7315.1716.445.74
247794-4779415.66815.67
349643-4964316.27416.27
451051-5105116.73516.74
554228-5422817.77717.78
651887-5188717.00917.01
10min1147431-14743148.33147.463.1548.3947.533.14
2148397-14839748.64748.71
3136819-13681944.85244.92
4146389-14638947.98948.06
5147824-14782448.45948.53
6141879-14187946.51046.58
15min1199003-19900365.23762.713.9965.4962.973.98
2196804-19680464.51664.77
3179359-17935958.79759.04
4196539-19653964.42964.69
5190272-19027262.37562.64
6185875-18587560.93361.19
20min1226972-22697274.40571.344.3774.9271.854.35
2224858-22485873.71274.23
3204325-20432566.98167.46
4225395-22539573.88874.41
5214701-21470170.38370.90
6209571-20957168.70169.20
30min1257476-25747684.40580.794.5085.2281.584.49
2255357-25535783.71184.52
3232499-23249976.21776.96
4255941-25594183.90284.71
5240792-24079278.93679.73
6236682-23668277.58978.36
45min1279263-27926391.54787.324.5192.7088.444.50
2275361-27536190.26891.41
3251173-25117382.33983.39
4276195-27619590.54291.69
5260348-26034885.34786.46
6255907-25590783.89184.97
60min1288849-28884994.69090.494.7696.2191.954.75
2287613-28761394.28595.79
3260937-26093785.54086.92
4287140-28714094.13095.64
5267379-26737987.65289.10
6264274-26427486.63488.05
极限1296906-29690697.33193.035.1199.2394.865.09
2297758-29775897.61099.49
3267232-26723287.60389.33
4295639-29563996.91698.80
5275608-27560890.34992.15
6269631-26963188.39090.15
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%
116.411600091600731600001599051596701599310.10
216.471602041602171602100.01
单位质量响应值RSD%判断
9745.959727.380.14数据可信
长期6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%
5min159761-5976138.28451.2932.6638.2851.2932.66
2132052-13205284.59584.60
367871-6787143.48043.48
476894-7689449.26049.26
569636-6963644.61044.61
674177-7417747.51947.52
10min1142901-14290191.54596.563.7591.7096.773.77
2153841-15384198.55498.89
3159600-159600102.243102.42
4149551-14955195.80596.00
5150693-15069396.53796.72
6147824-14782494.69994.89
15min1157486-157486100.889101.171.48101.41101.771.44
2155301-15530199.489100.22
3160368-160368102.735103.32
4155830-15583099.828100.41
5161038-161038103.164103.73
6157570-157570100.943101.51
20min1159900-159900102.435101.961.18103.36102.961.11
2155658-15565899.718100.85
3160568-160568102.863103.86
4159017-159017101.870102.85
5160762-160762102.987103.96
6159043-159043101.886102.86
30min1160131-160131102.583101.761.47103.92103.161.40
2154305-15430598.851100.38
3160550-160550102.852104.26
4158603-158603101.604102.99
5160154-160154102.598103.99
6159328-159328102.069103.45
45min1163927-163927105.015101.821.86106.76103.631.77
2154888-15488899.224101.15
3158634-158634101.624103.44
4157657-157657100.998102.79
5159361-159361102.090103.89
6159184-159184101.977103.76
60min1166609-166609106.733102.222.62108.90104.442.53
2153888-15388898.584100.91
3159439-159439102.140104.36
4157521-157521100.911103.11
5160658-160658102.921105.13
6159246-159246102.016104.21
极限1159307-159307102.055100.611.53104.65103.241.46
2152844-15284497.915100.63
3157946-157946101.183103.82
4157271-157271100.751103.35
5159027-159027101.876104.50
6155918-15591899.884102.49
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%
112.302937182936602933122932052930932933980.10
212.352940002940822940410.02
单位质量响应值RSD%判断
23853.5023808.990.14数据可信
长期6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%
5min142614-4261414.04817.0125.5414.0517.0125.53
277180-7718025.44325.44
342219-4221913.91813.92
450101-5010116.51616.52
545105-4510514.86914.87
652335-5233517.25217.25
10min1132434-13243443.65747.197.7243.7147.267.74
2164553-16455354.24554.35
3138572-13857245.68045.74
4142173-14217346.86846.93
5141445-14144546.62846.69
6139733-13973346.06346.13
15min1182053-18205360.01463.023.5960.2463.283.62
2202627-20262766.79667.12
3193287-19328763.71763.96
4188056-18805661.99362.25
5192072-19207263.31763.56
6188926-18892662.28062.53
20min1211193-21119369.62072.372.6970.0972.882.71
2225159-22515974.22474.81
3223442-22344273.65874.15
4214384-21438470.67271.17
5224911-22491174.14274.64
6218072-21807271.88872.39
30min1242794-24279480.03782.352.4380.7983.152.42
2250828-25082882.68683.57
3255321-25532184.16784.95
4243026-24302680.11480.90
5257350-25735084.83685.63
6249625-24962582.28983.08
45min1263757-26375786.94889.272.1988.0290.402.19
2270208-27020889.07490.29
3276674-27667491.20692.33
4264640-26464087.23988.34
5278078-27807891.66992.80
6271421-27142189.47490.59
60min1273144-27314490.04292.842.5791.4694.332.55
2280274-28027492.39393.96
3288951-28895195.25396.74
4274371-27437190.44791.90
5290524-29052495.77297.27
6282607-28260793.16294.64
极限1283352-28335293.40795.791.9895.1897.651.97
2288178-28817894.99896.94
3295481-29548197.40699.28
4287302-28730294.71096.52
5299039-29903998.579100.46
6290154-29015495.65097.50
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%
116.411630361619641619651619041618901621520.31
216.471609771608571609170.06
单位质量响应值RSD%判断
9881.299770.310.80数据可信
加速6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%
5min1106777-10677767.78583.8811.4867.7983.8811.48
2153721-15372197.58697.59
3136722-13672286.79586.80
4129958-12995882.50182.50
5130102-13010282.59282.59
6135517-13551786.03086.03
10min1154879-15487998.322100.231.3398.59100.571.36
2160526-160526101.906102.30
3158395-158395100.554100.90
4159504-159504101.258101.59
5156140-15614099.12299.45
6157881-157881100.227100.57
15min1154935-15493598.35799.891.1299.02100.621.15
2160145-160145101.665102.46
3157440-15744099.947100.70
4157958-157958100.276101.01
5156213-15621399.16899.90
6157364-15736499.899100.64
20min1152978-15297897.11599.381.3298.17100.521.35
2159338-159338101.152102.36
3156526-15652699.367100.52
4156716-15671699.488100.62
5156411-15641199.294100.42
6157303-15730399.860101.01
30min1151856-15185696.40398.501.4697.85100.031.49
2158828-158828100.829102.44
3155951-15595199.002100.55
4154664-15466498.18599.72
5154815-15481598.28199.80
6154815-15481598.28199.83
45min1150585-15058595.59697.971.4497.4399.891.46
2156688-15668899.470101.48
3155509-15550998.722100.66
4153093-15309397.18899.11
5154308-15430897.95999.87
6155751-15575198.875100.81
60min1150850-15085095.76497.861.1697.98100.181.19
2156058-15605899.070101.48
3154954-15495498.369100.71
4153733-15373397.59499.91
5154654-15465498.179100.48
6154702-15470298.209100.54
极限1150125-15012595.30497.351.2797.90100.061.30
2155825-15582598.922101.73
3153814-15381497.646100.38
4152493-15249396.80799.51
5153348-15334897.350100.05
6154467-15446798.060100.79
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)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%
112.302992182989322988272990662990782990240.06
212.352943402942392942900.03
单位质量响应值RSD%判断
24310.8923829.151.42数据可信
加速6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%
5min158792-5879219.19122.6614.5019.1922.6614.50
287708-8770828.62928.63
372673-7267323.72123.72
464264-6426420.97720.98
568249-6824922.27722.28
664879-6487921.17721.18
10min1148095-14809548.34049.803.3648.4249.903.38
2161834-16183452.82552.94
3154069-15406950.29050.39
4148751-14875148.55448.64
5149714-14971448.86948.96
6152985-15298549.93650.02
15min1191032-19103262.35562.741.8862.6363.031.90
2198848-19884864.90765.23
3192213-19221362.74163.04
4187912-18791261.33761.62
5191158-19115862.39762.68
6192064-19206462.69262.98
20min1215980-21598070.49970.581.5771.0271.121.58
2221037-22103772.15072.73
3214815-21481570.11970.67
4211258-21125868.95869.48
5215496-21549670.34170.88
6218849-21884971.43571.97
30min1244627-24462779.85079.591.1580.6580.421.16
2246406-24640680.43081.30
3241592-24159278.85979.69
4239766-23976678.26379.06
5243606-24360679.51680.33
6247058-24705880.64381.46
45min1265857-26585786.77986.081.4887.9087.231.48
2265260-26526086.58587.78
3260160-26016084.92086.06
4257980-25798084.20885.32
5264671-26467186.39287.53
6268451-26845187.62688.77
60min1277654-27765490.63089.501.4092.1090.991.38
2273527-27352789.28390.83
3269863-26986388.08789.57
4269779-26977988.06089.51
5275751-27575190.00991.49
6278644-27864490.95392.45
极限1283722-28372292.61191.651.3694.4493.501.35
2279247-27924791.15093.05
3276305-27630590.19092.02
4276839-27683990.36492.17
5283454-28345492.52394.36
6285153-28515393.07894.94
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%
116.411615191613121612811612091613261613290.08
216.471606371607961607160.07
单位质量响应值RSD%判断
9831.149758.110.53数据可信
长期6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%
5min198019-9801962.42284.5817.8062.4284.5817.80
2151635-15163596.56796.57
3153696-15369697.87997.88
4112049-11204971.35771.36
5151610-15161096.55196.55
6129907-12990782.73082.73
10min1156227-15622799.49199.331.5599.7499.661.52
2153878-15387897.99598.38
3157133-157133100.068100.46
4160053-160053101.928102.21
5154876-15487698.63199.02
6153634-15363497.84098.17
15min1156448-15644899.63299.281.73100.28100.011.70
2153936-15393698.03298.81
3157151-157151100.080100.87
4160435-160435102.171102.86
5153964-15396498.05098.83
6153415-15341597.70098.42
20min1155866-15586699.26199.111.58100.31100.251.55
2153847-15384797.97699.15
3156693-15669399.788100.98
4159831-159831101.786102.89
5154585-15458598.44699.62
6152990-15299097.43098.54
30min1155065-15506598.75198.561.63100.19100.091.60
2153158-15315897.53799.10
3155702-15570299.157100.75
4159152-159152101.354102.86
5153354-15335497.66299.23
6152133-15213396.88498.39
45min1155614-15561499.10198.561.56100.94100.491.52
2153341-15334197.65399.61
3155531-15553199.048101.04
4158759-158759101.104103.02
5153301-15330197.62899.59
6152043-15204396.82798.72
60min1153878-15387897.99598.091.46100.23100.411.44
2152592-15259297.17699.52
3155469-15546999.009101.39
4157705-157705100.433102.75
5153084-15308497.49099.84
6151445-15144596.44698.72
极限1153423-15342397.70697.751.45100.33100.461.43
2152550-15255097.15099.88
3153986-15398698.064100.84
4157543-157543100.329103.05
5152391-15239197.04899.79
6151073-15107396.20998.87
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%
112.302940142939242937922940022939102939280.04
212.352927262927352927300.01
单位质量响应值RSD%判断
23896.5923702.830.58数据可信
长期6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%
5min154235-5423517.90325.9520.1717.9025.9520.18
292221-9222130.44230.44
388541-8854129.22729.23
463947-6394721.10821.11
581742-8174226.98326.98
691030-9103030.04830.05
10min1145319-14531947.96952.935.6948.0453.035.72
2164617-16461754.33954.46
3165994-16599454.79454.91
4156157-15615751.54651.63
5158669-15866952.37652.48
6171286-17128656.54056.66
15min1187264-18726461.81565.944.2762.0866.264.29
2199914-19991465.99066.33
3204565-20456567.52667.86
4197740-19774065.27365.56
5196402-19640264.83165.15
6212713-21271370.21570.56
20min1210638-21063869.53072.722.3870.0473.302.41
2220823-22082372.89273.50
3225650-22565074.48675.09
4223583-22358373.80374.36
5219119-21911972.33072.91
6221909-22190973.25173.88
30min1239194-23919478.95682.353.0979.7583.223.10
2245357-24535780.99181.89
3252698-25269883.41484.32
4251850-25185083.13483.98
5246152-24615281.25382.12
6261582-26158286.34787.27
45min1261161-26116186.20888.852.1687.3190.052.17
2265379-26537987.60088.82
3272906-27290690.08591.32
4276224-27622491.18092.36
5266051-26605187.82289.01
6273224-27322490.18991.46
60min1269866-26986689.08191.722.1390.5393.272.14
2272760-27276090.03691.61
3282382-28238293.21294.81
4284938-28493894.05695.60
5276042-27604291.12092.66
6281148-28114892.80594.43
极限1275191-27519190.83993.942.4692.6495.862.46
2279034-27903492.10794.04
3287876-28787695.02697.00
4294379-29437997.17399.09
5282545-28254593.26695.17
6288439-28843995.21297.21
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