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100309-202205对照品来源中检所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%
113.825193351956517645199851868519040.18
213.905183751810518240.04
单位质量响应值RSD%判断
3755.723728.350.52数据可信
供试品溶液-24122501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%
5min147853-4785391.79894.623.8291.8094.623.82
252267-52267100.266100.27
350670-5067097.20297.20
449468-4946894.89794.90
547258-4725890.65790.66
648438-4843892.92192.92
10min153196-53196102.048101.121.59102.56101.651.59
253816-53816103.238103.79
352855-52855101.394101.93
452797-52797101.283101.81
552249-52249100.231100.74
651368-5136898.54199.06
15min155496-55496106.460100.992.87107.54102.082.84
251834-5183499.435100.57
353050-53050101.768102.87
452390-52390100.502101.59
551517-5151798.82799.89
651595-5159598.977100.04
20min154535-54535104.617102.671.87106.29104.321.87
254477-54477104.506106.19
354238-54238104.047105.72
452910-52910101.499103.15
552409-52409100.538102.15
652556-52556100.820102.43
30min154220-54220104.013101.841.65106.26104.061.64
252844-52844101.373103.64
353826-53826103.257105.50
453264-53264102.179104.39
552567-52567100.841103.01
651818-5181899.405101.58
45min152406-52406100.533100.921.60103.36103.711.59
252601-52601100.907103.73
354134-54134103.848106.67
452788-52788101.265104.05
551784-5178499.339102.07
651946-5194699.650102.38
60min154056-54056103.698103.561.48107.08106.911.46
255124-55124105.747109.13
353522-53522102.674106.07
454697-54697104.928108.27
553045-53045101.758105.04
653475-53475102.583105.86
极限154775-54775105.077103.822.49109.04107.742.41
254380-54380104.319108.29
355066-55066105.635109.60
451531-5153198.854102.78
555077-55077105.657109.50
653875-53875103.351107.20
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100629-202204对照品来源中检所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%
111.011706271705301705211703941703091704760.08
211.091708241707051707640.05
单位质量响应值RSD%判断
15483.7415398.020.40数据可信
供试品溶液-24122501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%
5min152377-5237730.52932.705.8530.5332.705.85
254647-5464731.85231.85
356123-5612332.71332.71
462126-6212636.21236.21
556424-5642432.88832.89
654941-5494132.02432.02
10min1105307-10530761.38162.715.4861.5562.895.48
299216-9921657.83058.01
3112263-11226365.43565.62
4115674-11567467.42367.62
5104413-10441360.86061.04
6108675-10867563.34463.52
15min1143694-14369483.75580.456.5884.2780.986.56
2124664-12466472.66373.16
3145219-14521984.64485.19
4146026-14602685.11585.69
5128926-12892675.14775.67
6139622-13962281.38281.91
20min1156762-15676291.37290.244.7292.3591.224.71
2148858-14885886.76587.67
3160411-16041193.49994.51
4162737-16273794.85595.90
5143461-14346183.62084.56
6156737-15673791.35892.34
30min1161526-16152694.14993.402.5595.6394.882.57
2158271-15827192.25293.64
3162737-16273794.85596.39
4166174-16617496.85898.43
5154633-15463390.13191.53
6158121-15812192.16493.65
45min1160178-16017893.36393.652.1595.3795.652.18
2159692-15969293.08094.98
3165194-16519496.28798.35
4164447-16444795.85297.97
5156959-15695991.48793.39
6157574-15757491.84693.85
60min1164583-16458395.93195.892.3998.4698.412.37
2168302-16830298.099100.51
3163266-16326695.16397.76
4169642-16964298.880101.53
5159100-15910092.73595.15
6162199-16219994.54197.05
极限1163931-16393195.55194.552.2698.6197.602.14
2164119-16411995.66198.62
3165753-16575396.61399.74
4156214-15621491.05394.25
5163994-16399495.58898.51
6159229-15922992.81095.85
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100309-202205对照品来源中检所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%
113.825018150012502624993250113501000.27
213.905048250740506110.37
单位质量响应值RSD%判断
3625.183641.080.31数据可信
供试品溶液-24122502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%
5min147080-4708093.02286.069.3693.0286.069.36
235910-3591070.95270.95
342819-4281984.60384.60
443729-4372986.40186.40
545374-4537489.65189.65
646440-4644091.75791.76
10min152095-52095102.931100.623.52103.45101.103.50
252635-52635103.998104.39
349499-4949997.80198.27
450982-50982100.732101.21
548099-4809995.03595.53
652237-52237103.211103.72
15min151033-51033100.832100.993.84101.92102.033.79
254378-54378107.441108.41
349803-4980398.40299.42
450638-50638100.052101.09
548734-4873496.29097.32
652104-52104102.948104.03
20min154313-54313107.313103.482.90108.96105.082.88
253517-53517105.740107.31
350730-50730100.234101.79
450992-50992100.751102.35
551398-51398101.554103.11
653293-53293105.298106.95
30min154353-54353107.392104.902.46109.64107.082.45
254079-54079106.851109.01
351290-51290101.340103.46
453638-53638105.979108.13
551625-51625102.002104.13
653579-53579105.863108.10
45min152735-52735104.195102.201.55107.04104.961.57
251841-51841102.429105.18
351561-51561101.876104.56
451121-51121101.006103.75
550621-50621100.018102.71
652470-52470103.672106.50
60min153729-53729106.159102.923.57109.58106.243.51
253312-53312105.335108.65
351790-51790102.328105.57
451709-51709102.168105.47
548712-4871296.24699.49
653279-53279105.270108.67
极限155619-55619109.893105.423.67113.90109.313.61
255690-55690110.034113.94
351704-51704102.158105.97
452810-52810104.343108.22
551002-51002100.771104.55
653298-53298105.308109.30
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100629-202204对照品来源中检所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%
111.011708111718701717231714471711391713980.26
211.091724141722471723300.07
单位质量响应值RSD%判断
15567.4815539.220.13数据可信
供试品溶液-24122502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%
5min155559-5555932.14928.9120.6532.1528.9120.65
229135-2913516.85916.86
353488-5348830.95130.95
451526-5152629.81629.82
555554-5555432.14732.15
654528-5452831.55331.55
10min1112583-11258365.14762.166.0765.3362.326.07
2102015-10201559.03159.13
3100514-10051458.16358.33
4107252-10725262.06262.23
5104721-10472160.59760.78
6117478-11747867.97968.15
15min1141528-14152881.89679.284.0382.4479.794.03
2136471-13647178.96979.39
3128213-12821374.19174.69
4139187-13918780.54181.05
5133557-13355777.28377.80
6143128-14312882.82283.37
20min1160866-16086693.08690.113.1694.0891.063.18
2151351-15135187.58088.44
3148133-14813385.71886.62
4158653-15865391.80592.76
5158508-15850891.72192.67
6156848-15684890.76191.77
30min1164810-16481095.36895.742.6596.8897.192.65
2162492-16249294.02795.37
3159691-15969192.40693.79
4171886-17188699.462100.93
5165019-16501995.48996.94
6168840-16884097.70099.22
45min1161227-16122793.29593.721.8995.3495.701.92
2157689-15768991.24793.12
3161125-16112593.23695.13
4164274-16427495.05897.08
5160980-16098093.15295.14
6166523-16652396.35998.42
60min1164293-16429395.06993.953.2497.6396.453.20
2160570-16057092.91495.29
3161672-16167293.55295.97
4162793-16279394.20196.75
5154348-15434889.31491.82
6170494-17049498.657101.25
极限1168585-16858597.55294.582.63100.6497.602.59
2166235-16623596.19399.08
3159922-15992292.53995.47
4162852-16285294.23597.31
5157181-15718190.95393.95
6165883-16588395.98999.13
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