氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)6.25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%
112.132346062353832353202344002353672350150.21
212.152352592350592351590.07
单位质量响应值RSD%判断
19374.6919354.650.08数据可信
中间条件24月-供试品溶液-2023020821批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122157-12215745.28345.412.6545.2845.412.65
2123075-12307545.62345.62
3119662-11966244.35844.36
4126578-12657846.92246.92
5125351-12535146.46746.47
6118121-11812143.78743.79
10min1239882-23988288.92391.291.6289.0091.361.62
2252181-25218193.48293.56
3245076-24507690.84990.92
4245936-24593691.16791.25
5247256-24725691.65791.73
6247215-24721591.64291.71
15min1264020-26402097.87199.111.1298.0999.341.12
2264476-26447698.04098.27
3267197-26719799.04999.27
4267165-26716599.03799.27
5271818-271818100.762100.99
6269527-26952799.913100.14
20min1263749-26374997.77199.341.3098.1699.731.30
2265076-26507698.26398.66
3267723-26772399.24499.63
4267416-26741699.13099.53
5272927-272927101.173101.57
6270990-270990100.455100.85
30min1263412-26341297.64699.091.2298.2099.651.22
2264447-26444798.02998.59
3267173-26717399.04099.60
4267098-26709899.01299.57
5272368-272368100.966101.53
6269300-26930099.828100.39
45min1263580-26358097.70899.081.1898.4299.801.17
2264644-26464498.10298.82
3267199-26719999.05099.77
4266847-26684798.91999.64
5272217-272217100.910101.64
6269235-26923599.804100.53
60min1263197-26319797.56698.931.1798.4499.821.17
2264375-26437598.00398.89
3266528-26652898.80199.69
4266150-26615098.66199.55
5271497-271497100.643101.55
6269456-26945699.886100.78
极限1262354-26235497.25498.741.2498.2999.791.24
2264085-26408597.89598.94
3266057-26605798.62699.68
4265465-26546598.40799.46
5271489-271489100.640101.71
6268706-26870699.608100.67
氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)8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%
115.821494951493641493081492241493721493530.07
215.881494501495951495220.07
单位质量响应值RSD%判断
9440.779415.740.19数据可信
中间条件24月-供试品溶液-2023020821批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134105-3410520.30720.511.9120.3120.521.92
234555-3455520.57520.57
333826-3382620.14120.14
434663-3466320.63920.64
535615-3561521.20621.21
633959-3395920.22020.22
10min187520-8752052.11153.051.5452.1453.081.54
291262-9126254.33954.37
388218-8821852.52752.56
489245-8924553.13853.17
589994-8999453.58453.62
688352-8835252.60652.64
15min1119040-11904070.87971.950.9671.0072.080.96
2121108-12110872.11072.23
3120443-12044371.71471.84
4121210-12121072.17172.29
5122596-12259672.99673.12
6120686-12068671.85971.98
20min1134247-13424779.93380.961.1080.1781.201.11
2135280-13528080.54880.79
3135559-13555980.71480.95
4136153-13615381.06881.31
5138709-13870982.59082.84
6135860-13586080.89481.13
30min1147574-14757487.86889.061.1188.2489.441.11
2148535-14853588.44188.82
3149596-14959689.07289.45
4149789-14978989.18789.57
5152492-15249290.79791.18
6149458-14945888.99089.37
45min1154939-15493992.25493.741.1992.7794.261.19
2156107-15610792.94993.48
3157348-15734893.68894.21
4157482-15748293.76894.29
5160343-16034395.47196.01
6158364-15836494.29394.82
60min1157316-15731693.66995.111.3194.3495.791.31
2157807-15780793.96194.64
3160095-16009595.32496.00
4159538-15953894.99295.68
5163126-16312697.12897.82
6160507-16050795.56996.25
极限1157948-15794894.04595.401.3094.8796.241.30
2158795-15879594.55095.39
3160224-16022495.40096.24
4159340-15934094.87495.72
5163741-16374197.49498.35
6161274-16127496.02696.87
氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)6.25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%
112.132353012351862352702350662352362352120.04
212.152351432353912352670.08
单位质量响应值RSD%判断
19390.9319363.540.10数据可信
中间条件24月-供试品溶液-2023020921批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123910-12391045.90346.714.5845.9046.714.58
2130221-13022148.24148.24
3132596-13259649.12149.12
4116232-11623243.05943.06
5125308-12530846.42146.42
6128231-12823147.50447.50
10min1249952-24995292.59694.701.8392.6794.781.83
2249963-24996392.60092.68
3259726-25972696.21796.30
4260695-26069596.57696.65
5256622-25662295.06795.14
6256829-25682995.14495.22
15min1268670-26867099.53099.580.5599.7699.810.55
2266537-26653798.74098.97
3269457-26945799.822100.06
4270388-270388100.167100.40
5270013-270013100.028100.26
6267714-26771499.17699.41
20min1269027-26902799.66399.640.61100.06100.040.60
2266636-26663698.77799.18
3269431-26943199.812100.22
4270660-270660100.267100.67
5270532-270532100.220100.62
6267514-26751499.10299.51
30min1268935-26893599.62899.510.57100.19100.080.57
2266121-26612198.58699.15
3268913-26891399.620100.20
4270409-270409100.175100.74
5269674-26967499.902100.47
6267663-26766399.15799.73
45min1268365-26836599.41799.250.65100.1599.980.65
2265774-26577498.45799.19
3268212-26821299.361100.10
4269857-26985799.970100.70
5269343-26934399.780100.52
6265863-26586398.49099.22
60min1267583-26758399.12899.300.42100.02100.200.42
2268930-26893099.627100.52
3267866-26786699.232100.14
4269008-26900899.655100.56
5268820-26882099.586100.49
6266134-26613498.59199.49
极限1267362-26736299.04698.750.53100.1199.820.53
2264803-26480398.09899.16
3266900-26690098.87599.95
4268130-26813099.330100.40
5267334-26733499.035100.10
6264886-26488698.12899.19
氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)8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%
115.821490991492531492591493141492551492360.06
215.881487631489051488340.07
单位质量响应值RSD%判断
9433.389372.420.46数据可信
中间条件24月-供试品溶液-2023020921批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132173-3217319.20819.665.8119.2119.665.80
234703-3470320.71920.72
334810-3481020.78320.78
429824-2982417.80617.81
532202-3220219.22619.23
633828-3382820.19620.20
10min188351-8835152.74853.841.5552.7853.881.55
289337-8933753.33753.37
392453-9245355.19755.23
490867-9086754.25054.28
589971-8997153.71553.75
690132-9013253.81153.85
15min1118912-11891270.99471.810.8971.1171.930.89
2119180-11918071.15471.28
3121136-12113672.32272.45
4121345-12134572.44772.57
5121065-12106572.27972.40
6120019-12001971.65571.78
20min1133947-13394779.97080.560.6980.2180.800.69
2134291-13429180.17680.42
3135108-13510880.66380.91
4135686-13568681.00981.25
5136300-13630081.37581.62
6134288-13428880.17480.42
30min1147813-14781388.24988.820.7888.6289.190.78
2147665-14766588.16088.54
3148776-14877688.82489.21
4149785-14978589.42689.80
5150501-15050189.85490.23
6148046-14804688.38888.76
45min1155376-15537692.76493.140.6093.2893.670.60
2155487-15548792.83093.35
3156562-15656293.47294.00
4156714-15671493.56394.09
5157168-15716893.83494.36
6154768-15476892.40192.92
60min1157057-15705793.76894.410.8094.4495.090.80
2157255-15725593.88694.56
3158473-15847394.61395.30
4158934-15893494.88895.57
5160098-16009895.58396.27
6156990-15699093.72894.41
极限1157562-15756294.06994.590.5894.9095.430.58
2157986-15798694.32295.16
3159197-15919795.04595.89
4158726-15872694.76495.60
5159683-15968395.33596.18
6157438-15743893.99594.83
氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)6.25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%
112.132357412356862356782358082357392357300.03
212.152356702357962357330.04
单位质量响应值RSD%判断
19433.6419401.890.12数据可信
中间条件24月-供试品溶液-2023021021批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130356-13035648.19047.462.0948.1947.462.09
2127990-12799047.31647.32
3131916-13191648.76748.77
4129286-12928647.79547.79
5125815-12581546.51246.51
6124941-12494146.18846.19
10min1250959-25095992.77593.331.9192.8693.411.90
2250806-25080692.71992.80
3256908-25690894.97495.06
4248257-24825791.77691.86
5248083-24808391.71291.79
6259779-25977996.03696.11
15min1269374-26937499.58399.950.9199.82100.180.91
2269948-26994899.795100.03
3268576-26857699.28899.53
4268488-26848899.25599.49
5270764-270764100.097100.33
6275015-275015101.668101.91
20min1269853-26985399.760100.040.79100.16100.440.78
2270611-270611100.040100.44
3268769-26876999.35999.76
4269223-26922399.52799.93
5270483-27048399.993100.39
6274659-274659101.537101.94
30min1269088-26908899.477100.021.00100.04100.581.00
2270775-270775100.101100.67
3268616-26861699.30399.87
4268985-26898599.439100.00
5270041-27004199.829100.39
6275776-275776101.950102.53
45min1269794-26979499.738100.230.92100.47100.970.92
2271195-271195100.256100.99
3269152-26915299.501100.24
4269908-26990899.780100.51
5270753-270753100.093100.82
6276000-276000102.032102.78
60min1269175-26917599.509100.030.81100.41100.930.80
2270984-270984100.178101.08
3269620-26962099.674100.58
4268555-26855599.280100.18
5270515-270515100.005100.90
6274616-274616101.521102.44
极限1270970-270970100.17399.900.81101.24100.970.81
2270412-27041299.967101.03
3268628-26862899.307100.38
4267774-26777498.991100.05
5269642-26964299.682100.75
6274008-274008101.296102.38
氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)8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%
115.821491641492141492731492661493091492450.04
215.881490001487271488640.13
单位质量响应值RSD%判断
9433.949374.310.45数据可信
中间条件24月-供试品溶液-2023021021批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134043-3404320.32220.152.4020.3220.152.39
233080-3308019.74719.75
335152-3515220.98420.98
433941-3394120.26120.26
533095-3309519.75619.76
633197-3319719.81719.82
10min188165-8816552.63053.421.8952.6653.451.89
289373-8937353.35153.38
392382-9238255.14855.18
488661-8866152.92652.96
587897-8789752.47052.50
690426-9042653.98054.01
15min1120814-12081472.12072.380.7472.2472.500.74
2122119-12211972.89973.02
3122342-12234273.03273.16
4120128-12012871.71171.83
5120559-12055971.96872.09
6121558-12155872.56472.69
20min1137364-13736482.00082.130.3782.2482.380.37
2138386-13838682.61082.85
3137823-13782382.27482.52
4137756-13775682.23482.48
5136960-13696081.75882.00
6137232-13723281.92182.16
30min1151420-15142090.39090.820.6090.7791.200.60
2153211-15321191.46091.84
3150997-15099790.13890.52
4152575-15257591.08091.46
5151611-15161190.50490.88
6152974-15297491.31891.70
45min1159571-15957195.25695.700.8795.7996.230.87
2162137-16213796.78897.32
3158546-15854694.64495.18
4160943-16094396.07596.61
5159260-15926095.07095.60
6161412-16141296.35596.89
60min1161085-16108596.16096.850.4796.8597.540.46
2162438-16243896.96897.66
3161796-16179696.58497.28
4162901-16290197.24497.93
5162112-16211296.77397.46
6163118-16311897.37498.07
极限1162353-16235396.91797.341.2997.7698.191.29
2165963-16596399.07299.93
3161285-16128596.27997.13
4161238-16123896.25197.10
5162102-16210296.76797.61
6165462-16546298.77399.63
氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)6.25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%
112.132359412359592357162359962358782358980.05
212.152360112361642360880.05
单位质量响应值RSD%判断
19447.4919431.110.06数据可信
中间条件24月-供试品溶液-GL031批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1139537-13953751.52748.4110.9151.5348.4110.91
2150260-15026055.48755.49
3127485-12748547.07747.08
4136587-13658750.43850.44
5109096-10909640.28640.29
6123624-12362445.65145.65
10min1255769-25576994.44893.894.0494.5393.974.05
2259682-25968295.89395.99
3264926-26492697.83097.91
4251204-25120492.76392.85
5235451-23545186.94687.01
6258556-25855695.47895.55
15min1268298-26829899.07599.591.2999.3299.831.30
2274656-274656101.423101.68
3271679-271679100.324100.57
4270115-27011599.74699.98
5264353-26435397.61897.83
6269022-26902299.34299.58
20min1268120-26812099.00999.611.4099.42100.011.41
2275633-275633101.784102.21
3271591-271591100.291100.70
4269816-26981699.636100.04
5264358-26435897.62097.99
6268933-26893399.31099.71
30min1267706-26770698.85799.471.2499.43100.041.25
2274240-274240101.269101.86
3271552-271552100.277100.85
4269659-26965999.578100.15
5264506-26450697.67598.21
6268538-26853899.16499.73
45min1267399-26739998.74399.221.3299.4899.951.33
2273906-273906101.146101.91
3271057-271057100.094100.84
4268739-26873999.23899.97
5263544-26354497.32098.02
6267448-26744898.76199.49
60min1266931-26693198.57099.221.2799.47100.121.28
2273840-273840101.122102.05
3270697-27069799.961100.87
4268772-26877299.250100.15
5263793-26379397.41298.27
6268086-26808698.99799.89
极限1266715-26671598.49198.941.3399.56100.011.34
2273102-273102100.849101.95
3270321-27032199.822100.90
4267752-26775298.87399.94
5262552-26255296.95397.98
6267214-26721498.67599.74
氢氯噻嗪坎地沙坦酯片项目信息
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2000
标示量(mg)8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%
115.821492301488861491361492251492341491420.10
215.881486931486621486780.02
单位质量响应值RSD%判断
9427.439362.590.49数据可信
中间条件24月-供试品溶液-GL031批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129631-2963117.70517.209.9017.7117.209.90
231638-3163818.90518.90
328000-2800016.73116.73
431582-3158218.87118.87
524071-2407114.38314.38
627762-2776216.58916.59
10min188265-8826552.74153.664.0852.7753.694.08
294003-9400356.17056.20
391823-9182354.86754.90
489364-8936453.39853.43
583574-8357449.93849.96
691760-9176054.82954.86
15min1124784-12478474.56274.712.4074.6874.822.40
2128823-12882376.97677.10
3127000-12700075.88776.01
4124742-12474274.53774.66
5119908-11990871.64971.76
6124890-12489074.62674.74
20min1141474-14147484.53584.682.0284.7884.922.02
2145865-14586587.15987.41
3143153-14315385.53885.78
4141018-14101884.26384.51
5137151-13715181.95282.18
6141604-14160484.61384.86
30min1155697-15569793.03492.881.5493.4293.271.54
2158967-15896794.98895.39
3156767-15676793.67394.06
4155344-15534492.82393.21
5152031-15203190.84391.21
6153848-15384891.92992.31
45min1161811-16181196.68796.441.4997.2296.971.50
2165354-16535498.80499.36
3162234-16223496.94097.48
4160498-16049895.90396.44
5158196-15819694.52795.04
6160246-16024695.75296.29
60min1161758-16175896.65696.821.4297.3597.521.43
2165576-16557698.93799.66
3163122-16312297.47198.18
4162050-16205096.83097.53
5158651-15865194.79995.47
6161008-16100896.20796.90
极限1161449-16144996.47196.401.7497.3397.261.75
2165786-16578699.06299.95
3162197-16219796.91897.79
4160744-16074496.05096.91
5157104-15710493.87594.70
6160719-16071996.03596.89
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