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%
115.941526271527101528851527291528771527660.08
216.041525851525051525450.04
单位质量响应值RSD%判断
9583.819510.290.55数据可信
长期24月-供试品溶液-2023110721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%
5min160132-6013239.28734.0214.0139.2934.0214.01
251039-5103933.34633.35
340853-4085326.69126.69
452947-5294734.59334.59
559554-5955438.91038.91
647932-4793231.31731.32
10min1136525-13652589.19987.687.5789.3687.827.57
2131772-13177286.09486.23
3128663-12866384.06284.17
4147339-14733996.26496.40
5142100-14210092.84193.00
6118775-11877577.60277.73
15min1157296-157296102.770101.293.19103.28101.783.20
2155215-155215101.410101.89
3154542-154542100.970101.41
4161607-161607105.586106.11
5155057-155057101.307101.83
6146487-14648795.70896.14
20min1156794-156794102.442102.333.19103.37103.223.21
2156114-156114101.998102.88
3155152-155152101.369102.22
4165194-165194107.930108.88
5156799-156799102.445103.38
6149640-14964097.76898.59
30min1155977-155977101.908102.503.34103.24103.813.35
2155469-155469101.576102.87
3155432-155432101.552102.80
4166049-166049108.489109.87
5158299-158299103.425104.77
6150118-15011898.08099.29
45min1154739-154739101.099102.292.98102.84104.003.00
2154383-154383100.867102.56
3154349-154349100.844102.50
4164710-164710107.614109.43
5159299-159299104.078105.83
6151895-15189599.241100.84
60min1154596-154596101.006101.403.27103.15103.523.28
2153906-153906100.555102.66
3152692-15269299.762101.82
4164984-164984107.793110.03
5154811-154811101.146103.32
6150247-15024798.164100.16
极限1154242-154242100.774101.023.11103.33103.553.12
2153749-153749100.452102.96
3153386-153386100.215102.68
4163457-163457106.795109.47
5154150-154150100.714103.29
6148746-14874697.18499.58
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%
112.692908222910682912452914962919942913250.16
212.622919422916352917880.08
单位质量响应值RSD%判断
22957.0523121.080.51数据可信
长期24月-供试品溶液-2023110721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%
5min146959-4695916.01312.6720.5816.0112.6720.57
237657-3765712.84112.84
326653-266539.0889.09
431867-3186710.86610.87
544518-4451815.18015.18
635296-3529612.03612.04
10min1139603-13960347.60340.6113.6647.6740.6613.68
2116099-11609939.58939.64
396448-9644832.88832.92
4115882-11588239.51539.56
5136212-13621246.44746.51
6110310-11031037.61537.66
15min1198484-19848467.68161.906.4067.9462.116.43
2183327-18332762.51362.72
3172129-17212958.69458.86
4174941-17494159.65359.85
5191263-19126365.21965.47
6168977-16897757.62057.82
20min1230624-23062478.64173.654.6679.1774.114.69
2219025-21902574.68575.15
3212120-21212072.33172.73
4208499-20849971.09671.54
5222607-22260775.90776.41
6203072-20307269.24669.67
30min1263608-26360889.88885.713.7890.7386.463.81
2256805-25680587.56888.33
3251022-25102285.59686.29
4241385-24138582.31083.03
5256130-25613087.33888.15
6239142-23914281.54582.25
45min1284699-28469997.08093.592.7798.2894.692.79
2280311-28031195.58396.69
3276096-27609694.14695.18
4265415-26541590.50491.56
5273907-27390793.40094.56
6266425-26642590.84891.88
60min1295580-295580100.79097.092.59102.3898.562.62
2290568-29056899.081100.57
3284890-28489097.14598.56
4277449-27744994.60796.02
5283213-28321396.57398.11
6276708-27670894.35595.75
极限1304919-304919103.97499.982.92105.97101.852.93
2299399-299399102.092103.98
3296538-296538101.117102.92
4283471-28347196.66198.46
5290436-29043699.036100.96
6284520-28452097.01998.79
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%
115.941529871531901528501530141529681530020.09
216.041528021528431528220.02
单位质量响应值RSD%判断
9598.629527.560.53数据可信
长期24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%
5min147110-4711030.72830.525.8630.7330.525.85
247355-4735530.88830.89
349002-4900231.96231.96
448466-4846631.61231.61
547441-4744130.94430.94
641405-4140527.00727.01
10min1145432-14543294.85991.887.3594.9892.007.34
2145452-14545294.87295.00
3148046-14804696.56496.69
4147130-14713095.96696.09
5138136-13813690.10090.22
6121005-12100578.92679.03
15min1148979-14897997.17397.693.0097.6798.183.01
2152289-15228999.33199.83
3156478-156478102.064102.58
4150783-15078398.34998.86
5146335-14633595.44895.93
6143801-14380193.79594.22
20min1148865-14886597.09898.221.9397.9999.101.93
2151481-15148198.80499.70
3155722-155722101.571102.49
4150571-15057198.21199.11
5147350-14735096.11096.98
6149498-14949897.51198.31
30min1148270-14827096.71098.843.1897.99100.123.17
2151280-15128098.67399.97
3160918-160918104.960106.29
4150112-15011297.91299.21
5147672-14767296.32097.57
6150973-15097398.47399.66
45min1148262-14826296.70598.032.0298.3799.702.02
2150426-15042698.11699.81
3155777-155777101.607103.36
4149696-14969697.64099.33
5146955-14695595.85297.49
6150629-15062998.24999.83
60min1147896-14789696.46697.881.6798.5299.941.68
2150447-15044798.130100.21
3154461-154461100.748102.90
4149450-14945097.48099.56
5147531-14753196.22898.25
6150620-15062098.243100.22
极限1147280-14728096.06497.451.7098.5099.901.70
2150473-15047398.147100.62
3153761-153761100.292102.85
4148195-14819596.66199.13
5147014-14701495.89198.29
6149716-14971697.653100.02
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%
112.692917532917392918632914412916522916900.06
212.622915832914812915320.03
单位质量响应值RSD%判断
22985.8223100.790.36数据可信
长期24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%
5min133640-3364011.46911.0814.0711.4711.0814.05
232330-3233011.02211.02
329061-290619.9089.91
436656-3665612.49712.50
537674-3767412.84412.84
625627-256278.7378.74
10min1117964-11796440.21739.8011.7240.2639.8411.72
2113090-11309038.55538.60
3106515-10651536.31436.35
4133409-13340945.48345.53
5131006-13100644.66344.71
698439-9843933.56033.60
15min1184373-18437362.85761.116.9463.0661.326.94
2182152-18215262.10062.30
3180128-18012861.41061.60
4191438-19143865.26665.50
5182283-18228362.14562.37
6155190-15519052.90853.08
20min1215479-21547973.46272.194.7773.9272.644.79
2215356-21535673.42073.87
3214953-21495373.28373.71
4221386-22138675.47675.97
5211006-21100671.93772.42
6192293-19229365.55865.94
30min1248318-24831884.65883.523.6085.4184.253.63
2248853-24885384.84085.58
3249541-24954185.07585.80
4252112-25211285.95186.75
5242950-24295082.82883.59
6228057-22805777.75078.39
45min1270023-27002392.05890.972.6893.1592.042.71
2270131-27013192.09593.17
3271761-27176192.65093.71
4271316-27131692.49993.64
5264468-26446890.16491.26
6253262-25326286.34387.30
60min1278903-27890395.08594.272.1996.5495.702.23
2279007-27900795.12196.57
3280349-28034995.57897.01
4279878-27987895.41896.93
5276435-27643594.24495.70
6264494-26449490.17391.47
极限1285980-28598097.49896.771.6899.3498.581.72
2286283-28628397.60199.43
3286093-28609397.53699.35
4284844-28484497.11199.00
5285698-28569897.40299.24
6274220-27422093.48995.15
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%
115.941525411528581528531528911529221528130.11
216.041524491525761525120.06
单位质量响应值RSD%判断
9586.769508.230.59数据可信
长期24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%
5min143390-4339028.34840.4052.0128.3540.4052.01
243119-4311928.17128.17
343214-4321428.23328.23
449554-4955432.37532.37
567000-6700043.77343.77
6124733-12473381.49181.49
10min1130238-13023885.08893.587.1085.2093.747.15
2133336-13333687.11287.22
3140048-14004891.49791.61
4149894-14989497.92998.06
5151130-15113098.73798.91
6154751-154751101.102101.43
15min1154620-154620101.017100.682.16101.47101.222.16
2151048-15104898.68399.14
3150664-15066498.43298.91
4157312-157312102.776103.30
5158616-158616103.628104.20
6152365-15236599.544100.27
20min1155088-155088101.323100.652.34102.18101.592.36
2150954-15095498.62299.48
3148895-14889597.27798.15
4157177-157177102.687103.62
5158239-158239103.381104.37
6153991-153991100.606101.73
30min1153915-153915100.556100.121.79101.82101.461.80
2151235-15123598.805100.06
3149352-14935297.57598.84
4156092-156092101.979103.32
5156294-156294102.111103.51
6152597-15259799.695101.23
45min1153828-153828100.499100.031.84102.16101.771.87
2150690-15069098.449100.09
3149136-14913697.43499.09
4155111-155111101.338103.09
5156760-156760102.415104.22
6153092-153092100.019101.95
60min1152542-15254299.65999.292.22101.73101.432.23
2149281-14928197.52999.57
3147435-14743596.32398.36
4155257-155257101.433103.59
5156105-156105101.987104.20
6151216-15121698.793101.12
极限1151906-15190699.24498.972.10101.71101.512.12
2148581-14858197.07199.50
3147388-14738896.29298.72
4153781-153781100.469103.03
5155901-155901101.854104.48
6151399-15139998.913101.64
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%
112.692910562913392914312911222911132912120.06
212.622909552909222909380.01
单位质量响应值RSD%判断
22948.1523053.720.33数据可信
长期24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%
5min131544-3154410.77414.6240.7210.7714.6240.71
232607-3260711.13711.14
334070-3407011.63711.64
435707-3570712.19612.20
546215-4621515.78515.78
676719-7671926.20426.20
10min1102644-10264435.05843.6819.9835.1043.7420.01
2109363-10936337.35337.40
3120379-12037941.11641.16
4121392-12139241.46241.51
5140754-14075448.07548.14
6172830-17283059.03159.14
15min1176064-17606460.13564.466.6960.3264.696.76
2178945-17894561.11961.31
3183628-18362862.71962.93
4187247-18724763.95564.17
5196490-19649067.11267.37
6209970-20997071.71672.06
20min1213824-21382473.03275.033.7673.4675.523.83
2213585-21358572.95173.39
3213838-21383873.03773.50
4218328-21832874.57175.04
5224344-22434476.62577.15
6234179-23417979.98580.61
30min1250988-25098885.72686.131.3286.4486.921.40
2248304-24830484.80985.54
3249945-24994585.36986.12
4251988-25198886.06786.84
5254160-25416086.80987.64
6257636-25763687.99688.94
45min1276257-27625794.35694.040.5295.4295.180.58
2274042-27404293.60094.67
3274481-27448193.75094.85
4273794-27379493.51594.63
5276269-27626994.36195.54
6277182-27718294.67295.97
60min1284895-28489597.30797.230.4698.7498.740.45
2283930-28393096.97798.42
3283759-28375996.91998.39
4285214-28521497.41698.90
5286909-28690997.99599.55
6283351-28335196.77998.46
极限1293545-293545100.26199.710.64102.09101.610.59
2290661-29066199.276101.11
3291593-29159399.594101.45
4292210-29221099.805101.68
5294257-294257100.504102.45
6289260-28926098.798100.86
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