坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
111.574419234413604417094410794413154414770.08
211.604406134410054408090.07
单位质量响应值RSD%判断
38157.0438000.780.30数据可信
供试品溶液-506993批-氢氯噻嗪-pH6.5(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194674-19467436.69938.6111.7536.7038.6111.75
2206842-20684238.99338.99
3179472-17947233.83333.83
4246700-24670046.50746.51
5187291-18729135.30735.31
6213779-21377940.30040.30
10min1358636-35863667.60873.327.2167.6773.387.21
2428894-42889480.85380.92
3370068-37006869.76369.82
4391686-39168673.83973.92
5369426-36942669.64269.70
6414788-41478878.19478.26
15min1432712-43271281.57386.107.3381.7586.297.33
2500607-50060794.37294.57
3423133-42313379.76779.94
4440356-44035683.01483.21
5446834-44683484.23584.41
6496784-49678493.65193.85
20min1473562-47356289.27391.295.9689.5891.625.96
2519565-51956597.94698.30
3446508-44650884.17384.48
4468948-46894888.40488.74
5479412-47941290.37690.69
6517690-51769097.59297.95
30min1504884-50488495.17894.973.8895.6495.453.89
2522906-52290698.57599.10
3471662-47166288.91589.36
4498929-49892994.05594.54
5499014-49901494.07194.54
6525310-52531099.02999.54
45min1512986-51298696.70596.812.2497.3297.452.26
2522658-52265898.52999.21
3494109-49410993.14793.74
4519197-51919797.87698.52
5507436-50743695.65996.28
6524805-52480598.93399.61
60min1515424-51542497.16597.291.5397.9498.091.56
2521556-52155698.32199.17
3504004-50400495.01295.76
4520995-52099598.21599.02
5509876-50987696.11996.90
6524526-52452698.88199.73
极限1524643-52464398.90399.080.5299.84100.050.51
2525230-52523099.014100.03
3529295-52929599.780100.69
4521144-52114498.24399.21
5527171-52717199.379100.32
6526136-52613699.184100.20
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903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1000
标示量(mg)16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%
115.783014593008583006523006603009983009250.12
215.823007853004563006200.08
单位质量响应值RSD%判断
19070.0319002.530.26数据可信
供试品溶液-506993批-坎地沙坦酯-pH6.5(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146406-4640613.68514.0812.3513.6914.0812.33
247002-4700213.86113.86
342005-4200512.38712.39
458807-5880717.34217.34
543804-4380412.91812.92
648402-4840214.27414.27
10min1123005-12300536.27439.046.2936.3039.066.29
2141285-14128541.66541.69
3127463-12746337.58937.61
4139713-13971341.20141.23
5124328-12432836.66436.69
6138427-13842740.82240.85
15min1184271-18427154.34158.136.5254.4258.226.52
2214577-21457763.27863.37
3186737-18673755.06855.15
4195683-19568357.70757.80
5190289-19028956.11656.20
6211202-21120262.28362.37
20min1230435-23043567.95571.606.2868.1371.786.28
2263520-26352077.71277.91
3227108-22710866.97467.15
4237508-23750870.04170.23
5238495-23849570.33270.51
6259714-25971476.58976.78
30min1288340-28834085.03186.675.0485.3286.985.04
2312135-31213592.04892.38
3273323-27332380.60380.89
4287660-28766084.83085.14
5291775-29177586.04486.34
6310119-31011991.45491.78
45min1324895-32489595.81196.133.3196.2496.583.32
2337436-33743699.50999.99
3308063-30806390.84791.27
4324671-32467195.74596.20
5323885-32388595.51395.95
6336964-33696499.37099.85
60min1336444-33644499.21799.252.1099.8199.862.12
2343590-343590101.324101.97
3324519-32451995.70096.27
4338370-33837099.785100.40
5333372-33337298.31198.91
6342955-342955101.137101.78
极限1344791-344791101.678101.610.48102.43102.390.50
2346880-346880102.294103.11
3343292-343292101.236101.97
4342344-342344100.957101.73
5344427-344427101.571102.33
6345680-345680101.940102.75
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
111.574398224399944401094403764401754400950.05
211.604392934390804391860.04
单位质量响应值RSD%判断
38037.6037860.860.33数据可信
供试品溶液-506993批-氢氯噻嗪-pH6.5(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1241276-24127645.64039.2211.1145.6439.2211.11
2184797-18479734.95634.96
3200861-20086137.99537.99
4180716-18071634.18434.18
5219416-21941641.50541.50
6217099-21709941.06641.07
10min1414225-41422578.35471.337.6478.4371.407.64
2345177-34517765.29365.35
3390737-39073773.91173.97
4341456-34145664.58964.65
5377023-37702371.31771.39
6394004-39400474.52974.60
15min1456377-45637786.32882.665.5886.5382.845.58
2415212-41521278.54178.71
3449677-44967785.06085.25
4407752-40775277.13077.29
5424972-42497280.38780.58
6467852-46785288.49888.69
20min1474723-47472389.79888.194.1090.1588.514.11
2450307-45030785.18085.48
3477547-47754790.33290.66
4446571-44657184.47384.77
5453259-45325985.73886.06
6494828-49482893.60193.94
30min1493408-49340893.33393.241.7693.8393.711.78
2484461-48446191.64092.08
3498242-49824294.24794.73
4486790-48679092.08192.51
5487406-48740692.19792.66
6507270-50727095.95596.45
45min1504523-50452395.43595.670.7796.0996.290.77
2507425-50742595.98496.58
3506840-50684095.87396.51
4505727-50572795.66396.25
5499165-49916594.42295.04
6510808-51080896.62497.28
60min1506433-50643395.79696.270.6096.6197.050.59
2513227-51322797.08297.83
3508671-50867196.22097.02
4509638-50963896.40397.15
5504752-50475295.47896.25
6510803-51080396.62397.44
极限1526038-52603899.50598.910.95100.4899.860.93
2527137-52713799.713100.63
3525926-52592699.484100.44
4523144-52314498.95799.86
5521404-52140498.62899.56
6513773-51377397.18598.16
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903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1000
标示量(mg)16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%
115.783000582998443001993005143005523002330.11
215.822998083017803007940.47
单位质量响应值RSD%判断
19026.1719013.530.05数据可信
供试品溶液-506993批-坎地沙坦酯-pH6.5(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158856-5885617.37115.1311.3217.3715.1311.31
245301-4530113.37113.37
348514-4851414.31914.32
445021-4502113.28813.29
554019-5401915.94415.94
655848-5584816.48416.48
10min1145913-14591343.06738.788.1143.1038.808.11
2120772-12077235.64635.67
3132638-13263839.14839.17
4117456-11745634.66734.69
5133564-13356439.42239.45
6137927-13792740.70940.74
15min1206742-20674261.02056.666.6361.1256.756.63
2180072-18007253.14953.23
3195574-19557457.72457.81
4175427-17542751.77851.86
5189529-18952955.94056.03
6204435-20443560.33960.43
20min1247446-24744673.03469.765.2273.2469.955.22
2225837-22583766.65666.83
3241329-24132971.22971.41
4220357-22035765.03965.21
5231828-23182868.42568.61
6251354-25135474.18874.38
30min1294251-29425186.84984.913.1887.1785.213.19
2279437-27943782.47682.76
3290712-29071285.80486.11
4277453-27745381.89182.17
5283375-28337583.63983.94
6300854-30085488.79889.12
45min1323802-32380295.57195.431.2096.0495.871.21
2321007-32100794.74695.16
3323443-32344395.46595.91
4321863-32186394.99995.41
5319329-31932994.25194.69
6330456-33045697.53598.00
60min1334175-33417598.63298.530.7599.2699.130.75
2335664-33566499.07299.65
3331832-33183297.94198.55
4333860-33386098.54099.11
5330278-33027897.48298.08
6337114-33711499.500100.13
极限1348535-348535102.871101.881.07103.66102.641.05
2348483-348483102.856103.60
3341799-341799100.883101.65
4346985-346985102.413103.15
5345481-345481101.969102.73
6339690-339690100.260101.06
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