厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000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%
112.609266792481926029272492575926100.10
212.679249192495924930.01
单位质量响应值RSD%判断
7350.007300.160.49数据可信
供试品溶液-GA5217批-氢氯噻嗪-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min120269-2026922.07025.497.7022.0725.497.69
222754-2275424.77624.78
323763-2376325.87525.87
423940-2394026.06826.07
525662-2566227.94327.94
624073-2407326.21226.21
10min174910-7491081.56882.170.8281.6882.300.82
276095-7609582.85882.98
375337-7533782.03382.16
476372-7637283.16083.29
575065-7506581.73681.88
675021-7502181.68881.82
15min182641-8264189.98691.631.2690.5092.171.27
283738-8373891.18091.72
384024-8402491.49292.03
485456-8545693.05193.60
585278-8527892.85793.41
683775-8377591.22091.76
20min184897-8489792.44292.880.8493.4193.880.84
285961-8596193.60194.59
384421-8442191.92492.92
486332-8633294.00595.02
585156-8515692.72493.74
685022-8502292.57893.57
30min187686-8768695.47994.510.6796.9195.970.65
286614-8661494.31295.77
386067-8606793.71695.17
486791-8679194.50595.99
587180-8718094.92896.40
686421-8642194.10295.56
45min189351-8935197.29295.121.4799.2097.061.43
285902-8590293.53795.47
386761-8676194.47296.40
486526-8652694.21696.17
588361-8836196.21498.16
687261-8726195.01696.95
60min188086-8808695.91594.792.1198.3197.202.06
283730-8373091.17193.57
388879-8887996.77899.18
487425-8742595.19597.62
587862-8786295.67198.10
686338-8633894.01196.42
极限188210-8821096.05095.421.7198.9298.301.67
286259-8625993.92596.78
388117-8811795.94898.83
490138-9013898.149101.05
586427-8642794.10897.02
686657-8665794.35997.23
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
114.682485612486222489412492312491122488930.12
214.772501402501512501460.01
单位质量响应值RSD%判断
16954.5616936.090.08数据可信
供试品溶液-GA5217批-厄贝沙坦-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min155462-5546221.82025.448.4521.8225.448.45
262220-6222024.47924.48
365394-6539425.72725.73
466372-6637226.11226.11
571747-7174728.22728.23
666846-6684626.29926.30
10min1210707-21070782.89783.001.0383.0183.131.03
2212744-21274483.69883.82
3209215-20921582.31082.44
4214399-21439984.34984.48
5209820-20982082.54882.69
6208946-20894682.20482.34
15min1235278-23527892.56493.821.2793.0994.361.27
2237379-23737993.39093.93
3237266-23726693.34693.89
4242908-24290895.56596.12
5241434-24143494.98695.54
6236504-23650493.04693.59
20min1241394-24139494.97095.211.1795.9696.221.16
2242840-24284095.53996.55
3238388-23838893.78794.79
4246870-24687097.12498.15
5241796-24179695.12896.16
6240728-24072894.70895.72
30min1246771-24677197.08595.960.8198.5597.450.80
2243466-24346695.78597.27
3241789-24178995.12596.60
4245870-24587096.73198.25
5242626-24262695.45496.96
6242924-24292495.57297.05
45min1250561-25056198.57696.131.56100.5298.101.53
2239860-23986094.36696.33
3242025-24202595.21897.17
4243036-24303695.61697.62
5246835-24683597.11099.09
6243750-24375095.89797.86
60min1245958-24595896.76595.542.1399.2097.982.08
2233362-23336291.81094.25
3247380-24738097.32599.75
4244628-24462896.24298.72
5245070-24507096.41698.88
6240632-24063294.67097.11
极限1244356-24435696.13595.951.7099.0698.881.67
2239517-23951794.23197.13
3245645-24564596.64299.56
4250995-25099598.747101.71
5241839-24183995.14598.09
6240964-24096494.80197.71
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000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%
112.609250092519925799247892391924930.08
212.679242892162922950.21
单位质量响应值RSD%判断
7340.717284.530.55数据可信
供试品溶液-GA5217批-氢氯噻嗪-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114575-1457515.89722.4217.7215.9022.4217.71
225692-2569228.02328.02
322128-2212824.13624.14
421112-2111223.02823.03
519432-1943221.19521.20
620366-2036622.21422.21
10min170378-7037876.76479.712.2476.8479.822.26
273301-7330179.95280.09
374102-7410280.82580.95
472762-7276279.36479.48
575254-7525482.08282.19
672693-7269379.28979.40
15min182811-8281190.32590.521.4190.7991.031.42
285206-8520692.93793.48
382601-8260190.09690.62
483054-8305490.59091.10
582495-8249589.98090.50
681769-8176989.18889.70
20min183111-8311190.65292.301.8491.5793.271.84
286478-8647894.32495.33
383470-8347091.04392.02
486678-8667894.54395.51
583973-8397391.59292.56
684050-8405091.67692.63
30min186835-8683594.71494.601.3096.0896.021.30
287862-8786295.83497.31
386226-8622694.05095.48
488199-8819996.20297.64
585868-8586893.65995.08
685366-8536693.11294.52
45min186517-8651794.36795.220.9796.2197.120.97
287950-8795095.93097.89
386211-8621194.03395.93
488165-8816596.16498.08
586976-8697694.86896.76
687976-8797695.95897.84
60min188121-8812196.11695.230.7498.4397.600.72
287548-8754895.49197.93
387350-8735095.27697.65
487406-8740695.33797.74
586160-8616093.97896.34
687251-8725195.16897.52
极限185443-8544393.19594.450.9695.9997.300.96
287465-8746595.40198.31
386133-8613393.94896.80
486690-8669094.55697.43
586264-8626494.09196.93
687588-8758895.53598.37
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
114.682505172504702504022506072498942503780.12
214.772502072500552501310.05
单位质量响应值RSD%判断
17055.7216935.070.51数据可信
供试品溶液-GA5217批-厄贝沙坦-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min138842-3884215.23622.1618.7115.2422.1618.71
271141-7114127.90627.91
361231-6123124.01924.02
458050-5805022.77122.77
553882-5388221.13621.14
655759-5575921.87221.87
10min1196094-19609476.92180.102.4377.0080.212.43
2203866-20386679.97080.11
3207285-20728581.31181.43
4203348-20334879.76779.88
5210975-21097582.75982.86
6203624-20362479.87579.98
15min1234028-23402891.80292.121.1892.2692.631.19
2239538-23953893.96394.50
3234297-23429791.90792.43
4235455-23545592.36192.87
5234725-23472592.07592.59
6230979-23097990.60691.11
20min1235079-23507992.21493.871.6893.1394.841.68
2243138-24313895.37596.38
3236699-23669992.84993.84
4245276-24527696.21497.19
5238453-23845393.53794.52
6237170-23717093.03494.00
30min1244249-24424995.81195.581.2897.1997.021.28
2245919-24591996.46697.95
3243542-24354295.53496.98
4247848-24784897.22398.68
5241062-24106294.56196.01
6239321-23932193.87895.30
45min1241763-24176394.83695.760.8096.7097.680.80
2245428-24542896.27498.24
3242370-24237095.07497.00
4246354-24635496.63798.58
5243121-24312195.36997.29
6245638-24563896.35698.25
60min1245241-24524196.20095.430.6798.5397.830.63
2242477-24247795.11697.57
3244965-24496596.09298.50
4243089-24308995.35697.78
5240952-24095294.51896.91
6242933-24293395.29597.67
极限1236711-23671192.85494.330.9095.6797.210.90
2242136-24213694.98297.91
3241023-24102394.54697.43
4240527-24052794.35197.25
5239657-23965794.01096.88
6242799-24279995.24298.10
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