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100309-202205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%
112.112414182414372412972415262414592414270.04
212.242403692403062403380.02
单位质量响应值RSD%判断
19936.1719635.461.08数据可信
中间条件36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%
5min184295-8429530.58432.8915.8530.5832.8915.84
277467-7746728.10728.11
373963-7396326.83626.84
4110286-11028640.01540.01
5101724-10172436.90836.91
696142-9614234.88334.88
10min1226494-22649482.17883.9813.2882.2384.0413.28
2214245-21424577.73477.78
3190804-19080469.22969.27
4266586-26658696.72496.79
5269099-26909997.63697.70
6221565-22156580.39080.45
15min1279228-279228101.311100.121.11101.50100.321.11
2278165-278165100.926101.10
3271740-27174098.59498.75
4278257-278257100.959101.19
5273370-27337099.18699.41
6274909-27490999.74499.94
20min1282310-282310102.430101.191.04102.79101.551.03
2281240-281240102.041102.39
3278554-278554101.067101.39
4279262-279262101.324101.72
5274083-27408399.44599.83
6277886-277886100.824101.18
30min1282050-282050102.335101.180.99102.86101.710.97
2281054-281054101.974102.49
3279288-279288101.333101.83
4279088-279088101.260101.83
5274382-27438299.553100.11
6277277-277277100.603101.13
45min1281709-281709102.211101.130.91102.91101.830.90
2280583-280583101.803102.49
3279130-279130101.276101.94
4278854-278854101.176101.91
5274455-27445599.580100.30
6277617-277617100.727101.42
60min1281576-281576102.163100.981.01103.03101.841.00
2280445-280445101.753102.61
3278618-278618101.090101.92
4278566-278566101.071101.97
5273565-27356599.257100.14
6277082-277082100.533101.39
极限1280976-280976101.946100.761.07102.98101.801.05
2279932-279932101.567102.59
3278408-278408101.014102.01
4278101-278101100.902101.97
5272681-27268198.93699.99
6276198-276198100.212101.24
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%
115.551521351520271519041520671519651520200.06
215.721519121520691519900.08
单位质量响应值RSD%判断
9776.219668.580.79数据可信
中间条件36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%
5min118013-1801310.40111.2512.3910.4011.2612.38
217293-172939.9859.99
316742-167429.6679.67
422269-2226912.85912.86
521637-2163712.49412.49
620986-2098612.11812.12
10min169568-6956840.17042.6813.2040.1942.7013.20
268163-6816339.35939.38
361402-6140235.45535.47
485197-8519749.19549.22
585721-8572149.49749.52
673397-7339742.38142.40
15min1113338-11333865.44466.525.4565.5366.615.45
2112766-11276665.11465.20
3106670-10667061.59461.67
4122484-12248470.72570.83
5122769-12276970.89070.99
6113215-11321565.37365.46
20min1136388-13638878.75379.312.1878.9579.512.19
2136220-13622078.65678.85
3132952-13295276.76976.95
4140785-14078581.29281.51
5140686-14068681.23581.46
6137075-13707579.15079.35
30min1156320-15632090.26389.990.6790.5990.320.68
2155675-15567589.89090.21
3154123-15412388.99489.30
4157308-15730890.83391.19
5155834-15583489.98290.34
6155806-15580689.96690.30
45min1164177-16417794.79994.370.4195.2794.860.40
2163664-16366494.50394.97
3163195-16319594.23294.69
4163732-16373294.54295.05
5162237-16223793.67994.19
6163627-16362794.48294.96
60min1166039-16603995.87595.380.6396.5196.020.62
2165945-16594595.82096.45
3165015-16501595.28395.89
4165564-16556495.60096.27
5163229-16322994.25294.91
6165349-16534995.47696.12
极限1166483-16648396.13195.280.7696.9296.080.74
2165839-16583995.75996.55
3164866-16486695.19795.97
4165213-16521395.39896.22
5162833-16283394.02394.84
6164809-16480995.16495.96
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100309-202205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%
112.112388482388022387852387912387412387930.02
212.242399442401212400320.06
单位质量响应值RSD%判断
19718.6619610.460.39数据可信
中间条件36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%
5min190966-9096633.20739.4219.3633.2139.4219.35
2104162-10416238.02438.02
388990-8899032.48532.49
4102954-10295437.58337.58
5114863-11486341.93041.93
6146009-14600953.30053.30
10min1245787-24578789.72390.565.9789.7890.635.97
2234643-23464385.65585.72
3227103-22710382.90382.96
4261923-26192395.61495.68
5262223-26222395.72395.79
6256791-25679193.74093.83
15min1279735-279735102.116100.711.59102.32100.931.58
2278012-278012101.487101.69
3276323-276323100.870101.06
4279705-279705102.105102.33
5272973-27297399.64799.88
6268581-26858198.04498.29
20min1281866-281866102.894101.641.25103.27102.031.24
2280757-280757102.489102.86
3278812-278812101.779102.14
4280933-280933102.553102.95
5273944-273944100.002100.40
6274348-274348100.149100.56
30min1282117-282117102.985101.871.07103.53102.421.06
2280344-280344102.338102.88
3279056-279056101.868102.40
4280731-280731102.480103.04
5273610-27361099.880100.44
6278477-278477101.657102.23
45min1281389-281389102.720101.791.03103.44102.521.02
2280392-280392102.356103.07
3278448-278448101.646102.35
4280521-280521102.403103.14
5273474-27347499.830100.56
6278816-278816101.780102.53
60min1281938-281938102.920101.771.09103.81102.661.08
2279870-279870102.165103.05
3277756-277756101.394102.26
4280785-280785102.499103.40
5273351-27335199.785100.68
6279030-279030101.859102.77
极限1280323-280323102.331101.311.20103.39102.381.19
2279620-279620102.074103.13
3276399-276399100.898101.94
4279305-279305101.959103.03
5271364-27136499.060100.12
6278203-278203101.557102.64
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%
115.551510961510571512851509331511371511020.09
215.721523371523141523260.02
单位质量响应值RSD%判断
9717.179689.950.20数据可信
中间条件36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%
5min119260-1926011.14213.4719.4111.1413.4719.42
223079-2307913.35213.35
319314-1931411.17411.17
421172-2117212.24912.25
525922-2592214.99715.00
630939-3093917.89917.90
10min175464-7546443.65846.469.1943.6846.489.20
277110-7711044.61044.63
370088-7008840.54840.57
482651-8265147.81647.84
587276-8727650.49150.52
689258-8925851.63851.67
15min1117279-11727967.84968.762.9967.9468.863.00
2117612-11761268.04268.14
3113100-11310065.43165.52
4121015-12101570.01070.11
5122685-12268570.97671.09
6121430-12143070.25070.37
20min1140236-14023681.13080.661.4681.3380.881.46
2139620-13962080.77480.98
3135536-13553678.41178.61
4141417-14141781.81382.03
5140314-14031481.17581.40
6139429-13942980.66380.90
30min1156396-15639690.47990.570.8090.8290.920.80
2157770-15777091.27491.62
3155668-15566890.05890.38
4158369-15836991.62191.97
5155247-15524789.81490.18
6155827-15582790.15090.52
45min1163869-16386994.80295.231.4195.2995.731.41
2166909-16690996.56197.06
3163106-16310694.36194.84
4167792-16779297.07297.58
5161680-16168093.53694.05
6164304-16430495.05495.57
60min1166662-16666296.41895.921.1897.0796.581.17
2168332-16833297.38498.04
3164735-16473595.30395.94
4167157-16715796.70597.37
5162967-16296794.28194.95
6164944-16494495.42496.10
极限1164796-16479695.33995.601.2696.1596.421.25
2168108-16810897.25598.07
3164619-16461995.23696.03
4166889-16688996.55097.38
5162086-16208693.77194.60
6165024-16502495.47196.31
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100309-202205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%
112.112409302410672408492407102406442408400.08
212.242419192419572419380.02
单位质量响应值RSD%判断
19887.7019766.180.44数据可信
中间条件36月-供试品溶液-GJ031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%
5min185413-8541330.92431.968.4630.9231.968.47
282290-8229029.79429.79
385007-8500730.77730.78
486509-8650931.32131.32
5103103-10310337.32937.33
687287-8728731.60331.60
10min1210869-21086976.34676.124.2176.4076.174.22
2210060-21006076.05476.10
3196016-19601670.96971.02
4209518-20951875.85775.91
5223929-22392981.07581.14
6211067-21106776.41876.47
15min1280061-280061101.398100.671.60101.58100.851.60
2280637-280637101.606101.78
3269262-26926297.48897.66
4279755-279755101.287101.47
5280767-280767101.653101.85
6277751-277751100.562100.74
20min1282624-282624102.326102.320.76102.67102.670.76
2285418-285418103.337103.68
3279809-279809101.307101.64
4284771-284771103.103103.45
5281561-281561101.941102.31
6281533-281533101.931102.28
30min1282473-282473102.271102.400.57102.79102.920.57
2284780-284780103.106103.62
3280930-280930101.712102.21
4284795-284795103.112103.63
5281863-281863102.050102.59
6282186-282186102.167102.68
45min1283176-283176102.526102.350.63103.21103.040.63
2284398-284398102.968103.66
3280474-280474101.547102.22
4284842-284842103.129103.82
5282108-282108102.139102.85
6281127-281127101.784102.47
60min1283122-283122102.506102.620.35103.37103.480.34
2284652-284652103.060103.92
3283724-283724102.724103.56
4284292-284292102.930103.79
5282746-282746102.370103.25
6282094-282094102.134102.99
极限1282137-282137102.149101.990.59103.18103.020.59
2283506-283506102.645103.68
3279158-279158101.071102.08
4283369-283369102.596103.63
5281148-281148101.791102.84
6280859-280859101.687102.71
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%
115.551524991526691527081526391527461526520.07
215.721527271529741528500.12
单位质量响应值RSD%判断
9816.859723.280.68数据可信
中间条件36月-供试品溶液-GJ031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%
5min120228-2022811.62312.007.2411.6211.997.24
219465-1946511.18511.18
320314-2031411.67211.67
420699-2069911.89411.89
523815-2381513.68413.68
620737-2073711.91511.92
10min167045-6704538.52438.914.1538.5438.944.15
267937-6793739.03739.06
363759-6375936.63636.66
467197-6719738.61138.63
572508-7250841.66341.69
667883-6788339.00639.03
15min1110141-11014163.28763.222.5263.3763.312.52
2111981-11198164.34464.43
3105556-10555660.65260.73
4111018-11101863.79163.88
5113217-11321765.05465.15
6108233-10823362.19162.28
20min1132826-13282676.32275.991.5376.5176.181.53
2134966-13496677.55177.74
3129225-12922574.25374.43
4133350-13335076.62376.81
5132406-13240676.08076.28
6130746-13074675.12775.32
30min1150143-15014386.27286.771.0086.5987.091.00
2153097-15309787.97088.29
3149594-14959485.95786.26
4152651-15265187.71388.03
5150751-15075186.62286.95
6149863-14986386.11186.42
45min1160144-16014492.01992.450.8692.4892.910.86
2162620-16262093.44193.91
3159985-15998591.92792.38
4162687-16268793.48093.94
5160175-16017592.03792.51
6159757-15975791.79692.25
60min1163408-16340893.89494.390.7394.5195.000.72
2166221-16622195.51196.13
3163982-16398294.22494.83
4165109-16510994.87295.49
5163801-16380194.12094.75
6163066-16306693.69894.31
极限1164129-16412994.30994.240.8595.0895.010.85
2165947-16594795.35396.13
3162329-16232993.27494.03
4165151-16515194.89695.67
5163817-16381794.12994.91
6162703-16270393.48994.26
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100309-202205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%
112.112380702378142376912375702373732377040.12
212.242402502403332402920.03
单位质量响应值RSD%判断
19628.7419631.700.02数据可信
中间条件36月-供试品溶液-GJ031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%
5min174950-7495027.40836.8722.4527.4136.8722.45
296085-9608535.13635.14
381801-8180129.91329.91
496096-9609635.14035.14
5126126-12612646.12246.12
6129884-12988447.49647.50
10min1204596-20459674.81784.0710.2474.8684.1310.26
2216991-21699179.35079.41
3210408-21040876.94276.99
4233689-23368985.45685.51
5249185-24918591.12291.20
6264509-26450996.72696.81
15min1274946-274946100.543101.971.09100.71102.171.11
2281918-281918103.092103.28
3275860-275860100.877101.05
4279801-279801102.318102.52
5278412-278412101.810102.04
6282188-282188103.191103.43
20min1278126-278126101.705102.631.05102.04103.001.06
2285038-285038104.233104.60
3279165-279165102.085102.43
4280392-280392102.534102.91
5277852-277852101.605102.00
6283412-283412103.638104.05
30min1278551-278551101.861102.590.90102.37103.130.89
2285296-285296104.327104.86
3279656-279656102.265102.78
4280729-280729102.657103.20
5278534-278534101.855102.42
6280505-280505102.575103.16
45min1278352-278352101.788102.710.92102.47103.420.92
2285330-285330104.340105.05
3280130-280130102.438103.13
4280816-280816102.689103.40
5278632-278632101.890102.63
6281901-281901103.086103.84
60min1276699-276699101.184102.571.02102.03103.451.02
2284796-284796104.145105.03
3279643-279643102.260103.12
4281565-281565102.963103.85
5278492-278492101.839102.75
6281699-281699103.012103.94
极限1276859-276859101.242102.430.95102.26103.480.96
2284396-284396103.998105.06
3278737-278737101.929102.96
4280611-280611102.614103.67
5278567-278567101.867102.94
6281396-281396102.901104.00
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%
115.551506081504771502511504641501671503930.12
215.721518121517791517960.02
单位质量响应值RSD%判断
9671.589656.230.12数据可信
中间条件36月-供试品溶液-GJ031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%
5min117402-1740210.10914.0324.7110.1114.0324.71
223951-2395113.91313.91
319163-1916311.13211.13
421849-2184912.69212.69
530807-3080717.89617.90
631768-3176818.45418.45
10min163108-6310836.65942.9712.2736.6842.9912.27
271192-7119241.35541.38
366461-6646138.60738.63
474161-7416143.08043.10
582194-8219447.74647.78
686684-8668450.35550.39
15min1106840-10684062.06366.004.2762.1466.094.28
2112686-11268665.45965.55
3109859-10985963.81763.90
4114843-11484366.71266.81
5117543-11754368.28168.39
6119886-11988669.64269.76
20min1128858-12885874.85377.412.1775.0377.622.19
2134293-13429378.01178.21
3131016-13101676.10776.30
4134026-13402677.85678.06
5134284-13428478.00578.23
6137089-13708979.63579.87
30min1148559-14855986.29887.631.0986.6087.961.10
2153199-15319988.99389.32
3150168-15016887.23287.55
4151974-15197488.28288.62
5149957-14995787.11087.46
6151267-15126787.87188.23
45min1158560-15856092.10793.221.3692.5693.701.36
2163297-16329794.85995.34
3159683-15968392.76093.22
4162381-16238194.32794.81
5157771-15777191.64992.15
6161206-16120693.64494.15
60min1159957-15995792.91994.711.5193.5295.351.51
2165595-16559596.19496.83
3161945-16194594.07494.69
4165718-16571896.26596.90
5160901-16090193.46794.12
6164143-16414395.35196.02
极限1160734-16073493.37095.051.4394.1395.841.43
2166612-16661296.78597.58
3162485-16248594.38795.16
4165318-16531896.03396.83
5161615-16161593.88294.69
6164948-16494895.81896.64
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