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zjs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2000
标示量(mg)4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%
115.943267333263153266853270763260953265810.12
216.043247213243883245540.08
单位质量响应值RSD%判断
20488.1420234.040.89数据可信
供试品溶液-2023111121批-培哚普利-pH2.0(内含0.19g/L的EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193808-9380828.73925.557.7628.7425.557.76
284238-8423825.80725.81
377269-7726923.67223.67
486919-8691926.62826.63
576563-7656323.45623.46
681570-8157024.98924.99
10min1317246-31724697.19087.058.5997.3187.158.59
2303634-30363493.02093.12
3295593-29559390.55790.65
4261713-26171380.17780.28
5264056-26405680.89580.99
6262641-26264180.46280.56
15min1333079-333079102.041102.190.75102.54102.640.73
2332579-332579101.888102.36
3333400-333400102.139102.60
4330470-330470101.241101.67
5337978-337978103.542103.96
6333977-333977102.316102.74
20min1335007-335007102.631102.300.40103.54103.160.40
2333649-333649102.215103.10
3332009-332009101.713102.58
4332938-332938101.998102.83
5335529-335529102.791103.62
6334344-334344102.428103.26
30min1334843-334843102.581102.400.54103.90103.670.52
2333052-333052102.032103.32
3331368-331368101.517102.79
4334767-334767102.558103.80
5335126-335126102.668103.91
6336428-336428103.067104.31
45min1330753-330753101.328101.870.44103.06103.540.41
2331262-331262101.484103.18
3331623-331623101.595103.27
4333715-333715102.236103.89
5333964-333964102.312103.97
6333724-333724102.238103.89
60min1331594-331594101.586101.480.42103.72103.560.39
2328771-328771100.721102.83
3331081-331081101.429103.51
4332865-332865101.975104.03
5331192-331192101.463103.53
6331910-331910101.683103.74
极限1329662-329662100.994101.520.44103.54104.020.40
2329825-329825101.044103.55
3331386-331386101.522104.01
4333304-333304102.110104.58
5331856-331856101.666104.13
6332315-332315101.807104.28
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100257-202106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5000
标示量(mg)1.25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%
112.696005836004786008806003296001676004870.05
212.626002456002586002520.01
单位质量响应值RSD%判断
47319.7047563.550.37数据可信
供试品溶液-2023111121批-吲达帕胺-pH2.0(内含0.19g/L的EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163420-6342010.5027.5123.1610.507.5123.14
251376-513768.5088.51
343349-433497.1787.18
441225-412256.8276.83
534952-349525.7885.79
637683-376836.2406.24
10min1273617-27361745.30932.9222.5745.3532.9622.57
2229280-22928037.96738.00
3195905-19590532.44132.47
4169802-16980228.11828.15
5160437-16043726.56726.59
6163897-16389727.14027.17
15min1401985-40198566.56659.706.8166.7959.866.86
2376116-37611662.28362.47
3359268-35926859.49359.65
4344064-34406456.97557.11
5340021-34002156.30556.43
6341617-34161756.57056.70
20min1467776-46777677.46172.943.5777.9573.343.62
2450438-45043874.59075.02
3436345-43634572.25672.65
4431133-43113371.39371.76
5428952-42895271.03271.39
6428175-42817570.90371.26
30min1535740-53574088.71586.071.7389.5186.761.78
2523311-52331186.65787.39
3511028-51102884.62385.31
4518115-51811585.79786.45
5512582-51258284.88185.52
6517917-51791785.76486.41
45min1580278-58027896.09194.321.2097.2495.351.23
2569992-56999294.38795.47
3559301-55930192.61793.64
4571868-57186894.69895.69
5567159-56715993.91894.90
6568741-56874194.18095.17
60min1601044-60104499.52997.491.73101.0798.901.72
2573717-57371795.00496.46
3579748-57974896.00397.40
4595476-59547698.60799.98
5590809-59080997.83499.19
6591575-59157597.96199.32
极限1609531-609531100.935101.080.80102.87102.880.78
2609699-609699100.963102.80
3604262-604262100.062101.84
4618373-618373102.399104.17
5607533-607533100.604102.35
6612980-612980101.506103.26
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zjs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2000
标示量(mg)4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%
115.943269523271763281503272573274633274000.14
216.043264453269213266830.11
单位质量响应值RSD%判断
20539.5220366.770.60数据可信
供试品溶液-2023111121批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178255-7825523.86525.6110.0523.8725.6110.04
284235-8423525.68925.69
376565-7656523.35023.35
490153-9015327.49427.49
577162-7716223.53223.53
697510-9751029.73829.74
10min1297732-29773290.80091.096.2290.9091.196.22
2303928-30392892.68992.79
3314132-31413295.80195.89
4295561-29556190.13790.25
5264811-26481180.76080.85
6315962-31596296.35996.48
15min1327874-32787499.992100.622.79100.45101.082.79
2326207-32620799.48499.96
3336995-336995102.774103.25
4316663-31666396.57397.04
5328577-328577100.206100.62
6343222-343222104.673105.18
20min1328924-328924100.312101.542.15101.17102.412.16
2330890-330890100.912101.78
3336878-336878102.738103.63
4327187-32718799.782100.64
5328186-328186100.087100.91
6345696-345696105.427106.35
30min1328863-328863100.294101.431.93101.55102.701.95
2331452-331452101.083102.36
3336640-336640102.665103.96
4327530-32753099.887101.14
5327360-32736099.835101.05
6343610-343610104.791106.14
45min1327844-32784499.983101.272.10101.64102.952.11
2331336-331336101.048102.73
3334758-334758102.091103.80
4328149-328149100.076101.73
5325638-32563899.310100.93
6344683-344683105.118106.88
60min1326724-32672499.641100.852.08101.70102.932.09
2329335-329335100.438102.52
3333190-333190101.613103.73
4325663-32566399.318101.37
5325792-32579299.357101.37
6343391-343391104.724106.91
极限1327096-32709699.755100.541.71102.21103.021.74
2328645-328645100.227102.71
3332131-332131101.290103.81
4327897-32789799.999102.45
5322823-32282398.452100.86
6339409-339409103.510106.11
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100257-202106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5000
标示量(mg)1.25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%
112.696021566034536021906015276022396023130.12
212.626012786030836021800.22
单位质量响应值RSD%判断
47463.5947716.320.38数据可信
供试品溶液-2023111121批-吲达帕胺
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147613-476137.8608.0925.077.868.0825.04
249016-490168.0918.09
337832-378326.2456.25
458416-584169.6439.64
534167-341675.6405.64
666843-6684311.03411.03
10min1244187-24418740.31036.0417.8640.3436.0717.87
2217717-21771735.94035.97
3205262-20526233.88433.91
4233048-23304838.47138.51
5149210-14921024.63124.65
6260351-26035142.97843.02
15min1386757-38675763.84559.218.5364.0459.398.53
2345829-34582957.08957.26
3368065-36806560.75960.92
4322561-32256153.24853.44
5330851-33085154.61654.74
6398053-39805365.71065.93
20min1458901-45890175.75473.394.5476.2073.804.58
2437403-43740372.20672.61
3446592-44659273.72374.13
4432609-43260971.41471.82
5417512-41751268.92269.26
6474522-47452278.33378.81
30min1531164-53116487.68385.823.8488.4386.523.87
2512433-51243384.59185.28
3528916-52891687.31288.01
4502579-50257982.96583.66
5495415-49541581.78282.40
6548591-54859190.56091.35
45min1572559-57255994.51794.023.0095.6295.073.03
2563060-56306092.94993.98
3579572-57957295.67596.72
4553474-55347491.36692.39
5552047-55204791.13192.07
6596639-59663998.49299.65
60min1593029-59302997.89697.592.7599.3899.022.79
2585063-58506396.58197.98
3601300-60130099.261100.69
4573808-57380894.72396.11
5576870-57687095.22996.54
6617057-617057101.863103.41
极限1610112-610112100.716100.182.67102.59101.992.71
2602170-60217099.405101.19
3615986-615986101.686103.51
4590523-59052397.48299.25
5590042-59004297.40399.09
6632285-632285104.376106.33
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zjs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2000
标示量(mg)4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%
115.943009213021183025633031923033313024250.33
216.043021923048773035340.63
单位质量响应值RSD%判断
18972.7118923.570.19数据可信
供试品溶液-2023090811批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178680-7868025.90124.543.6025.9024.543.59
274442-7444224.50524.51
374748-7474824.60624.61
470320-7032023.14923.15
575182-7518224.74924.75
673878-7387824.32024.32
10min1263933-26393386.88485.674.8686.9985.774.86
2250148-25014882.34682.44
3269180-26918088.61188.71
4240030-24003079.01579.11
5264885-26488587.19787.30
6273380-27338089.99490.09
15min1284769-28476993.74398.272.9794.1998.712.94
2296213-29621397.51097.94
3299759-29975998.67799.13
4311522-311522102.549102.96
5302892-30289299.709100.16
6295979-29597997.43397.89
20min1283209-28320993.22998.182.6194.0699.012.59
2301233-30123399.16299.98
3298822-29882298.36999.22
4305492-305492100.564101.38
5302111-30211199.451100.30
6298577-29857798.28899.14
30min1282298-28229892.92998.373.1394.1399.603.10
2305276-305276100.493101.71
3297733-29773398.01099.25
4309541-309541101.897103.12
5300736-30073698.999100.24
6297436-29743697.91399.15
45min1281774-28177492.75798.243.3394.3399.863.30
2304402-304402100.206101.82
3297476-29747697.92699.56
4309586-309586101.912103.54
5303937-303937100.053101.69
6293449-29344996.60098.23
60min1284549-28454993.67097.862.6595.6199.882.63
2300747-30074799.002101.02
3295784-29578497.36999.39
4308651-308651101.604103.64
5298472-29847298.254100.29
6295509-29550997.27899.30
极限1280059-28005992.19297.633.1594.51100.033.12
2300209-30020998.825101.24
3295259-29525997.19699.61
4307563-307563101.246103.69
5301477-30147799.243101.68
6294816-29481697.05099.46
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100257-202106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5000
标示量(mg)1.25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%
112.695558845574075567965579965585855573340.19
212.625440495447715444100.10
单位质量响应值RSD%判断
43919.1543138.671.27数据可信
供试品溶液-2023090811批-吲达帕胺
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150567-505679.1277.8411.079.137.8411.08
243280-432807.8127.81
343511-435117.8537.85
435517-355176.4116.41
542933-429337.7497.75
644667-446678.0628.06
10min1205476-20547637.08733.5510.9637.1233.5810.96
2175200-17520031.62231.65
3193233-19323334.87734.91
4151555-15155527.35527.38
5204409-20440936.89436.93
6185297-18529733.44533.48
15min1335301-33530160.51959.613.9860.7059.774.00
2320863-32086357.91358.07
3338423-33842361.08361.25
4309368-30936855.83955.97
5345897-34589762.43262.61
6331630-33163059.85760.02
20min1397400-39740071.72872.203.5972.1572.603.60
2394414-39441471.18971.58
3410898-41089874.16474.58
4375428-37542867.76268.12
5414794-41479474.86775.30
6407003-40700373.46173.87
30min1464808-46480883.89485.172.0384.6185.862.04
2468841-46884184.62285.30
3479342-47934286.51887.23
4458402-45840282.73883.37
5483792-48379287.32188.05
6475956-47595685.90686.61
45min1509577-50957791.97593.891.8293.0294.921.83
2516983-51698393.31194.32
3527498-52749895.20996.27
4510122-51012292.07393.03
5532332-53233296.08297.16
6524679-52467994.70195.74
60min1530271-53027195.71097.701.4697.1399.111.47
2539979-53997997.46298.85
3545877-54587798.52799.97
4534684-53468496.50697.84
5551489-55148999.540101.00
6545558-54555898.46999.89
极限1548138-54813898.935101.241.12100.73103.041.11
2563308-563308101.673103.45
3563451-563451101.699103.53
4563328-563328101.676103.39
5564062-564062101.809103.67
6563194-563194101.652103.47
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zjs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2000
标示量(mg)4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%
115.943041253042783068123042333041143047120.39
216.043021193021763021480.02
单位质量响应值RSD%判断
19116.1918837.161.04数据可信
供试品溶液-2023090811批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170455-7045523.15926.1815.3923.1626.1815.38
277705-7770525.54225.54
387105-8710528.63228.63
467463-6746322.17622.18
5100455-10045533.02133.02
674638-7463824.53424.53
10min1249464-24946482.00285.984.4082.0986.094.41
2256431-25643184.29284.39
3264993-26499387.10687.22
4249947-24994782.16082.25
5277073-27707391.07791.21
6271546-27154689.26089.36
15min1297456-29745697.77795.133.3998.2095.583.37
2295681-29568197.19497.63
3299494-29949498.44798.91
4281307-28130792.46992.89
5287365-28736594.46094.96
6275092-27509290.42690.88
20min1297866-29786697.91296.003.7598.7296.833.73
2298268-29826898.04498.87
3305719-305719100.493101.35
4287900-28790094.63695.42
5287987-28798794.66495.54
6274601-27460190.26491.08
30min1295380-29538097.09595.633.9098.3096.843.88
2298507-29850798.12299.34
3306429-306429100.727101.99
4282162-28216292.75093.92
5287391-28739194.46995.72
6275630-27563090.60391.78
45min1292594-29259496.17995.664.1197.7797.264.09
2300555-30055598.796100.41
3306591-306591100.780102.44
4284860-28486093.63795.17
5288835-28883594.94396.57
6272690-27269089.63691.18
60min1294932-29493296.94795.874.3998.9297.844.36
2303029-30302999.609101.62
3308480-308480101.401103.47
4281520-28152092.53994.45
5286526-28652694.18496.19
6275393-27539390.52592.42
极限1294707-29470796.87395.764.2199.2498.134.18
2300550-30055098.794101.20
3308574-308574101.432103.90
4280602-28060292.23794.52
5287217-28721794.41196.80
6276343-27634390.83793.10
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100257-202106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5000
标示量(mg)1.25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%
112.695491275497385491115494675497935494470.06
212.625395215397175396190.03
单位质量响应值RSD%判断
43297.6442759.030.89数据可信
供试品溶液-2023090811批-吲达帕胺
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141206-412067.5249.1925.097.529.1825.10
246289-462898.4528.45
355612-5561210.15410.15
441971-419717.6637.66
573715-7371513.45913.46
643086-430867.8677.87
10min1181230-18123033.09038.7815.4733.1238.8215.48
2197243-19724336.01436.05
3214685-21468539.19839.24
4200106-20010636.53636.57
5275553-27555350.31250.37
6205523-20552337.52537.56
15min1328036-32803659.89461.494.6260.0661.684.65
2328836-32883660.04060.22
3331373-33137360.50460.70
4329374-32937460.13960.32
5368097-36809767.20967.46
6334839-33483961.13661.32
20min1401013-40101373.21973.352.2373.6273.782.27
2397635-39763572.60273.02
3394444-39444472.01972.46
4397897-39789772.65073.07
5419355-41935576.56877.09
6399949-39994973.02473.45
30min1473152-47315286.39085.241.3987.0985.971.40
2466426-46642685.16285.87
3455116-45511683.09783.82
4467163-46716385.29786.00
5472510-47251086.27387.10
6466645-46664585.20285.92
45min1521571-52157195.23193.401.4696.2794.481.44
2512627-51262793.59894.65
3498492-49849291.01792.08
4510772-51077293.25994.31
5512272-51227293.53394.71
6513583-51358393.77294.83
60min1538011-53801198.23296.820.9699.6598.270.91
2530860-53086096.92798.35
3526666-52666696.16197.59
4528983-52898396.58498.01
5523655-52365595.61197.16
6533477-53347797.40598.84
极限1559236-559236102.108100.171.17103.92102.001.12
2552691-552691100.913102.72
3546984-54698499.871101.68
4543569-54356999.247101.06
5541855-54185598.934100.87
6547456-54745699.957101.78
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