替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.835113851570519585160851361515270.60
213.945193152100520160.23
单位质量响应值RSD%判断
3725.743731.420.11数据可信
供试品溶液-24120401批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141273-4127379.69978.702.2079.7078.702.19
241715-4171580.55380.55
341658-4165880.44380.44
439977-3997777.19777.20
540189-4018977.60677.61
639725-3972576.71076.71
10min146274-4627489.35786.363.8589.8086.793.83
244356-4435685.65386.10
346352-4635289.50789.95
445786-4578688.41488.84
542118-4211881.33181.76
643435-4343583.87484.30
15min145960-4596088.75087.562.9289.6988.472.91
246770-4677090.31491.24
346419-4641989.63790.58
445408-4540887.68488.60
543575-4357584.14585.03
643921-4392184.81385.70
20min150557-5055797.62790.554.8699.0691.964.83
247281-4728191.30192.73
348090-4809092.86394.31
445922-4592288.67790.08
544088-4408885.13586.49
645427-4542787.72189.08
30min146134-4613489.08689.093.3591.0691.003.33
247323-4732391.38293.31
347453-4745391.63393.59
447424-4742491.57793.48
544252-4425285.45287.28
644244-4424485.43787.29
45min145820-4582088.48089.853.5790.9592.253.53
249433-4943395.45797.90
347447-4744791.62294.09
446189-4618989.19291.60
545053-4505386.99989.30
645229-4522987.33989.66
60min146459-4645989.71488.804.5292.6791.704.46
248132-4813292.94495.91
347764-4776492.23495.21
445787-4578788.41691.32
542357-4235781.79384.57
645423-4542387.71390.52
极限144367-4436785.67489.493.7889.1392.883.71
247767-4776792.24095.73
348996-4899694.61398.10
445860-4586088.55791.95
544902-4490286.70789.94
646167-4616789.15092.45
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.201726051747971740701745561742291740510.50
2 11.211726751727421727080.03
单位质量响应值RSD%判断
15540.2715406.600.62数据可信
供试品溶液-24120401批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160301-6030135.07435.6611.2035.0735.6611.20
263255-6325536.79236.79
364949-6494937.77837.78
450454-5045429.34729.35
570783-7078341.17141.17
658157-5815733.82733.83
10min1103056-10305659.94361.497.0960.1461.697.09
2102597-10259759.67659.88
3114679-11467966.70366.91
496185-9618555.94656.11
5114907-11490766.83667.06
6102913-10291359.86060.05
15min1125398-12539872.93878.388.1673.4778.928.16
2137289-13728979.85580.39
3145062-14506284.37684.96
4123715-12371571.95972.43
5149784-14978487.12287.72
6127299-12729974.04474.56
20min1152644-15264488.78689.805.8489.7290.775.86
2154502-15450289.86790.85
3166479-16647996.83397.88
4145274-14527484.49985.37
5162989-16298994.80395.89
6144405-14440583.99484.93
30min1151627-15162788.19492.993.4489.6294.463.48
2161518-16151893.94795.43
3165783-16578396.42898.02
4158907-15890792.42993.77
5165340-16534096.17097.78
6156058-15605890.77292.17
45min1154162-15416289.66994.042.7491.5996.032.73
2166885-16688597.06999.07
3163040-16304094.83396.96
4159242-15924292.62494.48
5162884-16288494.74296.89
6163818-16381895.28597.19
60min1159359-15935992.69293.801.5395.1196.321.49
2164249-16424995.53698.08
3162847-16284794.72097.37
4160351-16035193.26995.64
5157875-15787591.82894.50
6162918-16291894.76297.19
极限1147159-14715985.59592.093.7588.5295.123.71
2158707-15870792.31295.38
3163127-16312794.88398.06
4157070-15707091.36094.25
5161533-16153393.95697.14
6162337-16233794.42497.38
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.835153851514516035221151983517700.61
213.945121252010516111.10
单位质量响应值RSD%判断
3743.313702.370.78数据可信
供试品溶液-24120402批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139672-3967276.72875.985.6776.7375.985.67
237936-3793673.37173.37
335580-3558068.81468.81
440300-4030077.94377.94
540275-4027577.89577.89
641939-4193981.11381.11
10min143570-4357084.26787.912.5984.6988.332.59
245468-4546887.93888.35
345085-4508587.19787.58
447010-4701090.92091.35
545258-4525887.53287.96
646330-4633089.60590.06
15min146182-4618289.31991.623.9790.2192.533.95
248135-4813593.09693.99
345833-4583388.64489.51
446298-4629889.54390.48
546952-4695290.80891.73
650834-5083498.31699.26
20min146513-4651389.95992.122.1991.3593.542.20
248145-4814593.11694.53
346854-4685490.61991.98
448440-4844093.68695.12
546797-4679790.50891.93
649035-4903594.83796.33
30min145574-4557488.14391.552.3290.0393.482.31
247524-4752491.91593.85
347032-4703290.96392.83
448833-4883394.44696.40
547032-4703290.96392.89
648014-4801492.86294.88
45min139099-3909975.62088.707.8678.0091.147.70
246396-4639689.73392.17
345096-4509687.21989.59
448496-4849693.79496.28
547093-4709391.08193.51
649001-4900194.77197.31
60min146013-4601388.99292.532.6291.7995.462.63
247502-4750291.87294.81
347868-4786892.58095.43
448616-4861694.02797.03
547346-4734691.57094.51
649716-4971696.15499.22
极限145521-4552188.04191.242.4491.3494.682.43
246856-4685690.62394.07
347942-4794292.72396.09
448192-4819293.20796.73
546238-4623889.42792.87
648294-4829493.40497.00
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.201732681731181734231732821741731734530.25
2 11.211732851730201731520.11
单位质量响应值RSD%判断
15486.8815446.210.19数据可信
供试品溶液-24120402批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154560-5456031.74932.0010.3731.7532.0010.37
252271-5227130.41730.42
345118-4511826.25426.25
459390-5939034.55934.56
558952-5895234.30434.30
659707-5970734.74434.74
10min198542-9854257.34261.767.9857.5261.947.98
2106562-10656262.00962.18
393557-9355754.44154.59
4114166-11416666.43366.63
5109832-10983263.91164.10
6114112-11411266.40266.60
15min1128642-12864274.85781.328.9375.3581.848.92
2144198-14419883.90984.42
3121548-12154870.72971.18
4143015-14301583.22183.78
5145003-14500384.37884.92
6156040-15604090.80091.36
20min1145648-14564884.75391.567.1885.6692.547.19
2162040-16204094.29195.27
3140988-14098882.04182.88
4169095-16909598.39799.42
5161598-16159894.03495.05
6164756-16475695.87296.94
30min1153282-15328289.19595.664.2690.5897.144.29
2168110-16811097.82499.33
3158161-15816192.03493.33
4170688-17068899.324100.89
5168899-16889998.28399.82
6167231-16723197.31298.91
45min1134187-13418778.08493.628.5679.9695.638.49
2164239-16423995.57197.62
3158704-15870492.35094.16
4168436-16843698.013100.14
5169341-16934198.540100.62
6170379-17037999.144101.28
60min1162048-16204894.29697.251.9696.6199.792.06
2165824-16582496.49399.07
3165852-16585296.51098.83
4169551-16955198.662101.33
5168218-16821897.886100.52
6171288-17128899.673102.36
极限1156715-15671591.19394.912.9094.0397.982.90
2158195-15819592.05495.17
3164849-16484995.92698.78
4167582-16758297.516100.73
5167903-16790397.703100.88
6163358-16335895.05898.30
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.835252751590522185221851972521050.67
213.945215451785519700.51
单位质量响应值RSD%判断
3767.533728.120.75数据可信
供试品溶液-2批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143956-4395684.44785.051.0984.4585.051.09
245141-4514186.72386.72
344429-4442985.35585.36
443842-4384284.22884.23
543967-4396784.46884.47
644282-4428285.07385.07
10min150920-5092097.82697.642.1398.2998.112.12
252243-52243100.367100.85
349958-4995895.97896.45
449326-4932694.76395.23
550775-5077597.54798.02
651719-5171999.36199.83
15min153878-53878103.50999.722.01104.52100.731.99
251776-5177699.470100.51
351754-5175499.428100.44
450799-5079997.59398.59
551392-5139298.73399.74
651831-5183199.576100.60
20min150648-5064897.303100.181.7398.89101.751.69
252331-52331100.537102.13
353264-53264102.329103.89
452703-52703101.251102.79
552229-52229100.341101.90
651703-5170399.330100.91
30min154005-54005103.753102.961.54105.88105.091.52
254255-54255104.233106.38
354666-54666105.022107.15
452843-52843101.520103.62
553125-53125102.062104.18
652671-52671101.190103.32
45min150561-5056197.136101.202.7099.84103.892.64
254784-54784105.249107.98
352193-52193100.271102.98
452222-52222100.327102.99
553531-53531102.842105.53
652753-52753101.347104.04
60min149707-4970795.495100.492.7798.74103.752.70
253184-53184102.175105.49
353797-53797103.353106.62
452045-5204599.987103.21
552048-5204899.993103.25
653071-53071101.958105.21
极限153529-53529102.838100.651.77106.61104.471.70
252604-52604101.061104.94
350818-5081897.630101.47
451961-5196199.826103.60
552913-52913101.655105.47
652528-52528100.915104.74
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.201736651724301731621739671735901733630.35
2 11.211732401739821736110.31
单位质量响应值RSD%判断
15478.8415487.150.04数据可信
供试品溶液-2批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162721-6272136.45935.053.9636.4635.053.96
263296-6329636.79336.79
359649-5964934.67334.67
460458-6045835.14335.14
557085-5708533.18333.18
658605-5860534.06634.07
10min1122658-12265871.29965.077.1471.5065.267.13
2120557-12055770.07870.28
3102247-10224759.43459.63
4110232-11023264.07664.27
5106987-10698762.19062.37
6108988-10898863.35363.54
15min1161436-16143693.84082.928.3394.4483.488.31
2152328-15232888.54689.14
3129631-12963175.35275.88
4139922-13992281.33481.89
5136352-13635279.25979.79
6136237-13623779.19279.73
20min1156926-15692691.21890.264.3892.3491.284.39
2164693-16469395.73396.82
3145868-14586884.79185.73
4160390-16039093.23294.24
5152941-15294188.90289.87
6150875-15087587.70188.68
30min1170155-17015598.90896.712.37100.5398.232.42
2172300-172300100.155101.77
3162983-16298394.73996.15
4165595-16559596.25897.78
5163058-16305894.78396.25
6164142-16414295.41396.88
45min1151819-15181988.25095.154.2390.4397.214.13
2173264-173264100.715102.89
3162732-16273294.59396.53
4164339-16433995.52797.58
5164155-16415595.42097.41
6165843-16584396.40298.40
60min1142099-14209982.60093.305.6785.2795.885.48
2163927-16392795.28898.02
3163805-16380595.21797.68
4165007-16500795.91698.50
5162351-16235194.37296.89
6165828-16582896.39398.93
极限1164052-16405295.36194.011.7798.4997.111.78
2163083-16308394.79798.06
3156149-15614990.76793.76
4161596-16159693.93397.05
5162243-16224394.30997.35
6163250-16325094.89497.96
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