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%
116.411635481652051651471651481651951648490.45
216.471647271647651647460.02
单位质量响应值RSD%判断
10045.6410002.790.31数据可信
加速6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%
5min199276-9927661.77453.3642.7161.7753.3542.71
2153127-15312795.28395.28
360154-6015437.43137.43
479966-7996649.75949.76
555193-5519334.34434.34
666761-6676141.54241.54
10min1155680-15568096.87197.741.2997.1297.951.26
2155824-15582496.96197.34
3155509-15550996.76596.91
4158928-15892898.89299.09
5156259-15625997.23297.37
6160268-16026899.72699.89
15min1155355-15535596.66997.731.3497.3098.341.29
2155459-15545996.73497.50
3156235-15623597.21797.75
4157816-15781698.20098.79
5156600-15660097.44497.97
6160931-160931100.139100.70
20min1154876-15487696.37197.381.3297.3998.381.27
2154491-15449196.13197.29
3155770-15577096.92797.85
4157770-15777098.17299.16
5156124-15612497.14898.06
6159995-15999599.556100.52
30min1154474-15447496.12197.261.3197.5398.641.26
2154353-15435396.04697.59
3155742-15574296.91098.22
4157443-15744397.96899.35
5156051-15605197.10298.41
6159757-15975799.408100.77
45min1153717-15371795.65096.951.1997.4498.721.15
2154719-15471996.27398.20
3155160-15516096.54898.25
4156773-15677397.55199.32
5155462-15546296.73698.43
6158976-15897698.922100.68
60min1153503-15350395.51796.501.2797.6998.661.23
2153231-15323195.34797.66
3154232-15423295.97098.06
4156416-15641697.32999.49
5154711-15471196.26898.35
6158371-15837198.546100.70
极限1152884-15288495.13196.181.3397.6998.731.28
2152546-15254694.92197.61
3153769-15376995.68298.15
4155708-15570896.88999.44
5154442-15444296.10198.57
6158047-15804798.344100.90
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%
112.303046543044143045903047063049703046670.07
212.353049343046823048080.06
单位质量响应值RSD%判断
24769.6724680.810.26数据可信
加速6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%
5min158112-5811218.46416.9526.7818.4616.9526.77
279885-7988525.38225.38
341887-4188713.30913.31
450945-5094516.18716.19
546160-4616014.66714.67
643106-4310613.69613.70
10min1148975-14897547.33447.535.7247.4147.605.74
2164764-16476452.35152.45
3138913-13891344.13744.19
4151004-15100447.97948.04
5148409-14840947.15447.21
6145466-14546646.21946.27
15min1192981-19298161.31662.162.4361.5862.422.45
2202375-20237564.30164.61
3188446-18844659.87660.11
4195220-19522062.02862.28
5198453-19845363.05563.30
6196355-19635562.38862.63
20min1218424-21842469.40170.612.0069.9171.122.02
2228365-22836572.55973.13
3217690-21769069.16769.64
4219069-21906969.60570.11
5224051-22405171.18871.69
6225794-22579471.74272.23
30min1246872-24687278.43979.942.1779.2380.732.18
2256525-25652581.50682.36
3243292-24329277.30278.05
4251652-25165279.95880.74
5255307-25530781.11981.90
6255996-25599681.33882.11
45min1268897-26889785.43787.221.4786.5488.331.48
2278285-27828588.42089.60
3271189-27118986.16687.22
4273400-27340086.86887.97
5276353-27635387.80688.92
6278939-27893988.62889.73
60min1278830-27883088.59390.491.4490.0491.941.44
2287885-28788591.47193.01
3281360-28136089.39790.80
4284665-28466590.44791.90
5286316-28631690.97292.43
6289663-28966392.03593.49
极限1287642-28764291.39393.622.1693.1995.442.14
2295862-29586294.00595.91
3289625-28962592.02393.78
4291799-29179992.71494.53
5305023-30502396.91698.74
6297906-29790694.65596.48
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%
116.411646491648891647601647451648401647770.06
216.471646201642791644500.15
单位质量响应值RSD%判断
10041.269984.820.40数据可信
长期6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%
5min160718-6071837.82434.4016.3137.8234.4016.32
244839-4483927.93227.93
365512-6551240.81040.81
462300-6230038.80938.81
553147-5314733.10833.11
644859-4485927.94527.94
10min1162411-162411101.17398.742.54101.3298.872.56
2154550-15455096.27696.39
3161355-161355100.515100.68
4162566-162566101.269101.42
5155917-15591797.12797.26
6154200-15420096.05896.17
15min1166344-166344103.623102.121.34104.18102.651.33
2167021-167021104.045104.54
3162333-162333101.124101.69
4163338-163338101.750102.31
5162622-162622101.304101.83
6161907-161907100.859101.35
20min1166748-166748103.874102.431.28104.84103.371.27
2167400-167400104.281105.19
3162771-162771101.397102.37
4163449-163449101.819102.79
5163640-163640101.938102.86
6162533-162533101.249102.15
30min1166396-166396103.655102.051.37105.04103.401.36
2166919-166919103.981105.31
3162333-162333101.124102.50
4162643-162643101.317102.69
5162923-162923101.492102.83
6161705-161705100.733102.04
45min1166400-166400103.658101.961.47105.46103.721.46
2167010-167010104.038105.78
3161910-161910100.861102.64
4162786-162786101.406103.19
5162516-162516101.238102.98
6161454-161454100.577102.28
60min1166425-166425103.673102.291.31105.89104.451.31
2166980-166980104.019106.18
3162115-162115100.988103.17
4164523-164523102.488104.67
5163127-163127101.619103.76
6162012-162012100.924103.03
极限1166462-166462103.696101.811.52106.33104.381.50
2166728-166728103.862106.44
3161954-161954100.888103.48
4162288-162288101.096103.69
5161777-161777100.778103.33
6161369-161369100.524103.04
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%
112.303048883046563044753045343043153045740.08
212.353035083030223032650.12
单位质量响应值RSD%判断
24762.1124555.870.60数据可信
长期6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%
5min142098-4209813.41211.9420.2413.4111.9420.24
226967-269678.5918.59
342291-4229113.47413.47
446406-4640614.78514.78
536832-3683211.73411.73
630239-302399.6349.63
10min1138682-13868244.18341.0412.3644.2441.0912.37
2104870-10487033.41133.45
3139606-13960644.47744.53
4145885-14588546.47846.54
5128729-12872941.01241.06
6115104-11510436.67136.71
15min1191587-19158761.03859.494.4461.2759.704.47
2177368-17736856.50856.68
3191518-19151861.01661.25
4197634-19763462.96463.21
5184716-18471658.84959.06
6177483-17748356.54556.73
20min1221717-22171770.63769.662.6971.1170.102.72
2215428-21542868.63369.03
3221221-22122170.47970.95
4226812-22681272.26072.76
5216657-21665769.02569.47
6209973-20997366.89667.31
30min1253606-25360680.79780.271.7981.5581.001.81
2254049-25404980.93881.61
3252584-25258480.47181.23
4257342-25734281.98782.77
5250000-25000079.64880.37
6244152-24415277.78578.46
45min1277174-27717488.30588.161.6489.3989.211.64
2282877-28287790.12291.11
3276772-27677288.17789.26
4279791-27979189.13990.25
5273817-27381787.23688.28
6269865-26986585.97786.97
60min1289327-28932792.17792.221.6593.6193.621.63
2297683-29768394.83996.19
3289043-28904392.08793.52
4290640-29064092.59594.07
5286518-28651891.28292.67
6283518-28351890.32691.66
极限1298538-29853895.11295.061.9996.9196.831.96
2309112-30911298.480100.21
3298883-29888395.22197.02
4297863-29786394.89796.74
5293650-29365093.55495.31
6292231-29223193.10294.80
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%
116.411638071645891643951645871647051644170.22
216.471645921644411645160.07
单位质量响应值RSD%判断
10019.329988.830.22数据可信
加速6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%
5min146136-4613628.76645.1457.6828.7745.1457.68
2156179-15617997.37797.38
364092-6409239.96139.96
455185-5518534.40834.41
548292-4829230.11030.11
664496-6449640.21340.21
10min1155514-15551496.96396.561.3997.0896.741.48
2158809-15880999.01799.41
3153569-15356995.75095.91
4154040-15404096.04496.18
5152716-15271695.21895.34
6154583-15458396.38296.54
15min1161950-161950100.97597.901.90101.4898.461.91
2158631-15863198.90699.69
3153531-15353195.72696.27
4156600-15660097.64098.16
5156556-15655697.61298.11
6154822-15482296.53197.08
20min1161807-161807100.88697.711.98101.7998.661.98
2157923-15792398.46599.65
3152883-15288395.32296.25
4157138-15713897.97598.89
5156043-15604397.29298.18
6154455-15445596.30297.23
30min1162005-162005101.01097.891.99102.3299.242.00
2158774-15877498.995100.57
3153375-15337595.62996.94
4156914-15691497.83599.14
5156668-15666897.68298.96
6154306-15430696.20997.53
45min1161645-161645100.78597.671.96102.5099.411.96
2158062-15806298.551100.52
3152901-15290195.33397.02
4156508-15650897.58299.28
5156578-15657897.62699.30
6154220-15422096.15697.86
60min1160807-160807100.26397.371.81102.3899.501.82
2157553-15755398.234100.60
3152768-15276895.25097.32
4155954-15595497.23799.32
5155896-15589697.20199.26
6154001-15400196.01998.11
极限1160471-160471100.05396.941.93102.5799.461.94
2156997-15699797.887100.65
3152032-15203294.79297.24
4154951-15495196.61299.09
5155273-15527396.81299.26
6153137-15313795.48197.95
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%
112.303041093041843039723040773041093040900.03
212.353036573034213035390.06
单位质量响应值RSD%判断
24722.7624578.060.42数据可信
加速6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%
5min130319-303199.66314.4147.109.6614.4147.11
287211-8721127.79427.79
343231-4323113.77813.78
438136-3813612.15412.15
530420-304209.6959.69
642044-4204413.39913.40
10min1119295-11929538.01942.7313.9738.0642.7914.01
2167563-16756353.40253.51
3137201-13720143.72643.78
4126523-12652340.32340.37
5115878-11587836.93036.97
6138023-13802343.98844.04
15min1177553-17755356.58658.816.5956.7859.046.65
2207413-20741366.10266.43
3184757-18475758.88259.11
4178352-17835256.84157.05
5173326-17332655.23955.43
6185830-18583059.22459.45
20min1210085-21008566.95468.154.3267.3768.624.38
2231793-23179373.87274.46
3212024-21202467.57268.04
4209189-20918966.66867.11
5205818-20581865.59466.00
6214126-21412668.24268.71
30min1244844-24484478.03278.252.9778.7278.993.04
2259889-25988982.82683.71
3240888-24088876.77177.51
4241374-24137476.92677.63
5241028-24102876.81577.49
6245212-24521278.14978.89
45min1272094-27209486.71686.172.1787.7187.222.22
2280459-28045989.38290.60
3264851-26485184.40885.45
4264792-26479284.38985.40
5268609-26860985.60586.58
6271447-27144786.51087.56
60min1283694-28369490.41389.722.3491.7691.122.37
2291279-29127992.83094.40
3276398-27639888.08889.47
4272325-27232586.79088.14
5281664-28166489.76691.09
6283812-28381290.45191.85
极限1292959-29295993.36692.802.0395.0794.552.06
2298951-29895195.27597.22
3284607-28460790.70492.44
4283653-28365390.40092.10
5294172-29417293.75295.43
6292695-29269593.28295.04
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%
116.411638051639431637141636981639501638220.08
216.471640071638461639260.07
单位质量响应值RSD%判断
9983.069953.010.22数据可信
加速6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%
5min1125223-12522378.35967.8029.5978.3667.8029.59
2145676-14567691.15791.16
384585-8458552.92952.93
4136984-13698485.71885.72
591582-9158257.30857.31
666013-6601341.30841.31
10min1154514-15451496.68798.261.4197.0098.531.38
2156284-15628497.79598.16
3154626-15462696.75796.97
4158606-15860699.24899.59
5158492-15849299.17799.41
6159663-15966399.909100.07
15min1153695-15369596.17598.131.2696.8898.801.22
2155978-15597897.60498.36
3156022-15602297.63198.23
4157829-15782998.76299.50
5158682-15868299.29699.92
6158754-15875499.34199.91
20min1153545-15354596.08197.941.3497.1799.001.30
2155473-15547397.28898.43
3155252-15525297.14998.14
4158045-15804598.897100.03
5157729-15772998.69999.72
6159091-15909199.551100.51
30min1152315-15231595.31197.621.5196.7899.071.48
2155436-15543697.26498.80
3154521-15452196.69298.07
4157607-15760798.623100.15
5157604-15760498.621100.04
6158539-15853999.206100.57
45min1153257-15325795.90197.601.3597.7599.441.33
2155327-15532797.19699.12
3153942-15394296.32998.09
4157596-15759698.616100.54
5157300-15730098.431100.24
6158389-15838999.112100.87
60min1152331-15233195.32197.211.4597.5699.441.42
2155094-15509497.05099.36
3153167-15316795.84597.99
4156909-15690998.186100.51
5156547-15654797.960100.17
6158045-15804598.897101.05
极限1151435-15143594.76196.781.4397.3899.401.39
2153685-15368596.16998.87
3153444-15344496.01898.55
4156019-15601997.629100.34
5155845-15584597.520100.12
6157553-15755398.589101.14
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%
112.303011523011253010223010923010013010780.03
212.353013513014273013890.02
单位质量响应值RSD%判断
24477.8924403.970.22数据可信
加速6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%
5min165246-6524620.97220.1321.4420.9720.1321.45
276720-7672024.66024.66
354206-5420617.42317.42
476024-7602424.43624.44
561991-6199119.92619.93
641534-4153413.35013.35
10min1162200-16220052.13651.988.2052.2252.068.20
2164310-16431052.81452.91
3149265-14926547.97848.05
4162892-16289252.35852.46
5184258-18425859.22659.31
6147353-14735347.36347.42
15min1200013-20001364.29065.102.6364.5865.392.65
2204862-20486265.84966.16
3204302-20430265.66965.93
4199829-19982964.23164.54
5210824-21082467.76568.08
6195423-19542362.81563.06
20min1228517-22851773.45272.131.8574.0072.681.85
2228697-22869773.51074.08
3217483-21748369.90570.43
4224890-22489072.28672.85
5223577-22357771.86472.45
6223268-22326871.76572.26
30min1254961-25496181.95280.961.7382.8081.801.72
2254979-25497981.95882.82
3243709-24370978.33579.14
4252378-25237881.12281.97
5250827-25082780.62381.50
6254460-25446081.79182.57
45min1276985-27698589.03187.322.1090.2088.482.07
2275184-27518488.45289.65
3263083-26308384.56285.68
4271064-27106487.12888.31
5266997-26699785.82187.02
6276657-27665788.92690.03
60min1286054-28605491.94690.292.4093.4791.802.37
2284558-28455891.46593.01
3271222-27122287.17988.63
4279291-27929189.77291.30
5275509-27550988.55790.10
6288734-28873492.80794.27
极限1291338-29133893.64492.502.6595.5494.372.61
2292247-29224793.93795.85
3276410-27641088.84690.65
4285116-28511691.64493.53
5283616-28361691.16293.06
6297930-29793095.76397.60
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