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100309-202205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%
112.014558874559854560184561114558934559790.03
212.064548594546694547640.03
单位质量响应值RSD%判断
37966.6137708.460.49数据可信
中间条件6月-供试品溶液-2024082321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%
5min1279724-27972453.06961.4510.0953.0761.4510.09
2323398-32339861.35561.35
3302485-30248557.38757.39
4322267-32226761.14061.14
5339823-33982364.47164.47
6375585-37558571.25571.26
10min1431091-43109181.78685.913.7781.8786.013.77
2451822-45182285.71985.82
3440091-44009183.49383.59
4456820-45682086.66786.77
5456325-45632586.57386.68
6480878-48087891.23191.35
15min1489896-48989692.94294.171.4593.1794.411.46
2490549-49054993.06693.31
3500998-50099895.04995.28
4495653-49565394.03594.28
5492518-49251893.44093.69
6508451-50845196.46396.73
20min1501322-50132295.11096.611.4695.4997.021.46
2500348-50034894.92595.33
3516687-51668798.02598.42
4509880-50988096.73497.14
5509319-50931996.62797.03
6517911-51791198.25798.69
30min1506432-50643296.08098.151.5196.6298.711.52
2509230-50923096.61097.17
3524620-52462099.530100.09
4520997-52099798.84399.41
5518221-51822198.31698.88
6524552-52455299.517100.11
45min1508870-50887096.54299.121.6797.2499.851.68
2515665-51566597.83198.55
3531662-531662100.866101.59
4525974-52597499.787100.52
5522969-52296999.21799.95
6529634-529634100.481101.24
60min1509300-50930096.62499.471.7397.48100.361.73
2518797-51879798.42599.31
3534015-534015101.313102.20
4528018-528018100.175101.07
5524632-52463299.532100.43
6531013-531013100.743101.67
极限1518878-51887898.441100.191.4499.46101.251.44
2523187-52318799.258100.30
3534120-534120101.332102.39
4528871-528871100.337101.40
5524224-52422499.455100.52
6539285-539285102.312103.41
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%
116.521531801531761531851532341533391532230.05
216.491529091529851529470.04
单位质量响应值RSD%判断
9275.009275.140.01数据可信
中间条件6月-供试品溶液-2024082321批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11247-12470.7550.5577.870.750.5577.89
21326-13260.8030.80
31457-14570.8820.88
41412-14120.8550.85
5-0.0000.00
6-0.0000.00
15min12757-27571.6691.8212.901.671.8212.81
22425-24251.4681.47
33031-30311.8351.84
43504-35042.1212.12
52987-29871.8081.81
63327-33272.0142.01
20min14195-41952.5392.705.152.542.705.18
24810-48102.9112.92
34591-45912.7792.78
44494-44942.7202.72
54233-42332.5622.57
64437-44372.6862.69
30min15159-51593.1223.375.593.133.375.55
25494-54943.3253.33
35381-53813.2573.27
46085-60853.6833.69
55612-56123.3973.40
65638-56383.4123.42
45min15757-57573.4843.567.703.503.577.71
25481-54813.3173.33
36349-63493.8433.86
46522-65223.9473.96
55455-54553.3023.31
65692-56923.4453.46
60min17004-70044.2394.356.384.264.376.30
27580-75804.5884.61
37230-72304.3764.40
46438-64383.8973.92
57099-70994.2974.32
67724-77244.6754.69
极限17007-70074.2414.366.694.274.396.65
27221-72214.3714.40
36602-66023.9964.02
47836-78364.7434.77
57714-77144.6694.69
66886-68864.1684.19
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%
112.014542044541984538434540994543244541340.04
212.064530884531334531100.01
单位质量响应值RSD%判断
37812.9937571.310.46数据可信
中间条件6月-供试品溶液-2024082321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%
5min1291183-29118355.45660.0913.9255.4660.1013.92
2349935-34993566.64566.65
3269031-26903151.23751.24
4323612-32361261.63261.63
5278556-27855653.05153.05
6380876-38087672.53872.54
10min1436842-43684283.19785.684.9983.2985.785.00
2466256-46625688.79988.91
3432488-43248882.36782.45
4467999-46799989.13089.23
5421082-42108280.19580.28
6474759-47475990.41890.54
15min1490478-49047893.41294.751.9693.6494.991.97
2504187-50418796.02296.28
3495129-49512994.29794.52
4511095-51109597.33897.59
5484019-48401992.18192.40
6500002-50000295.22595.50
20min1501188-50118895.45196.671.5395.8497.071.54
2511152-51115297.34997.77
3506896-50689696.53896.92
4520113-52011399.05699.47
5498244-49824494.89195.27
6507879-50787996.72697.16
30min1510995-51099597.31998.331.3097.8698.891.31
2518548-51854898.75899.34
3517033-51703398.46999.01
4527828-527828100.525101.10
5509023-50902396.94397.48
6514290-51429097.94798.54
45min1523241-52324199.65199.911.00100.36100.641.00
2525425-525425100.067100.81
3525759-525759100.131100.84
4533807-533807101.664102.41
5519360-51936098.91299.61
6520011-52001199.03699.79
60min1526546-526546100.281100.150.94101.15101.040.93
2525012-52501299.989100.90
3527582-527582100.478101.35
4534032-534032101.706102.62
5522086-52208699.431100.29
6519931-51993199.02199.94
极限1526749-526749100.31999.990.94101.36101.060.93
2523827-52382799.763100.84
3526597-526597100.290101.33
4532696-532696101.452102.54
5522234-52223499.460100.49
6518164-51816498.68499.77
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%
116.521529741531531531001531321530441530810.05
216.491527271530061528660.13
单位质量响应值RSD%判断
9266.409270.220.03数据可信
中间条件6月-供试品溶液-2024082321批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12235-22351.3541.2012.651.351.2012.73
22224-22241.3471.35
31686-16861.0211.02
41872-18721.1341.13
52156-21561.3061.31
61733-17331.0501.05
15min13541-35412.1452.097.942.152.097.93
23729-37292.2592.26
33083-30831.8671.87
43598-35982.1792.18
53118-31181.8891.89
63592-35922.1762.18
20min13891-38912.3572.627.212.362.637.22
24446-44462.6932.70
34662-46622.8242.83
44595-45952.7832.79
54347-43472.6332.64
64015-40152.4322.44
30min15761-57613.4893.602.913.503.612.86
26000-60003.6343.64
36117-61173.7053.71
46018-60183.6453.66
55707-57073.4573.47
66089-60893.6883.70
45min15457-54573.3054.029.443.324.049.39
26895-68954.1764.19
37142-71424.3264.34
46464-64643.9153.93
57062-70624.2774.29
66829-68294.1364.15
60min16936-69364.2014.276.954.224.296.97
26308-63083.8213.84
36966-69664.2194.24
47520-75204.5554.58
56902-69024.1804.20
67673-76734.6474.67
极限17443-74434.5084.615.434.544.645.34
27847-78474.7534.78
36911-69114.1864.22
48126-81264.9224.95
57727-77274.6804.71
67628-76284.6204.65
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100309-202205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%
112.014529364526984528074526984527234527720.03
212.064523364523424523390.01
单位质量响应值RSD%判断
37699.5837507.380.37数据可信
中间条件6月-供试品溶液-2024082521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%
5min1308472-30847258.88757.496.3858.8957.496.38
2302040-30204057.65957.66
3304102-30410258.05358.05
4288617-28861755.09755.10
5273327-27332752.17852.18
6330259-33025963.04663.05
10min1461347-46134788.07086.323.4388.1786.413.44
2463166-46316688.41888.51
3445607-44560785.06685.16
4449463-44946385.80285.89
5425660-42566081.25881.34
6467736-46773689.29089.40
15min1506065-50606596.60795.180.9696.8595.420.97
2500574-50057495.55995.80
3496987-49698794.87495.11
4496059-49605994.69794.93
5491953-49195393.91394.14
6499769-49976995.40595.66
20min1516283-51628398.55897.420.7598.9697.820.74
2507221-50722196.82897.23
3510911-51091197.53297.93
4512829-51282997.89898.29
5508428-50842897.05897.44
6506266-50626696.64597.06
30min1521304-52130499.51698.740.64100.0999.300.64
2513663-51366398.05798.62
3519461-51946199.16499.72
4518633-51863399.00699.56
5517258-51725898.74499.28
6512973-51297397.92698.50
45min1522957-52295799.83299.480.54100.57100.200.53
2517227-51722798.73899.47
3525023-525023100.226100.95
4520215-52021599.308100.03
5521941-52194199.638100.34
6519177-51917799.11099.85
60min1522338-52233899.71499.470.53100.62100.360.52
2516616-51661698.62199.51
3524339-524339100.096100.99
4520136-52013699.293100.18
5522909-52290999.823100.69
6520041-52004199.275100.18
极限1521338-52133899.52399.540.81100.59100.600.79
2515683-51568398.44399.50
3523293-52329399.896100.95
4526264-526264100.463101.51
5524819-524819100.187101.22
6517316-51731698.75599.82
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%
116.521532551533651532391532751531751532620.05
216.491533981534431534200.03
单位质量响应值RSD%判断
9277.369303.820.21数据可信
中间条件6月-供试品溶液-2024082521批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11986-19861.2001.2310.531.201.2210.53
22093-20931.2651.26
32121-21211.2821.28
41977-19771.1951.19
51673-16731.0111.01
62318-23181.4011.40
15min14071-40712.4602.2712.072.462.2712.09
24013-40132.4252.43
33691-36912.2302.23
43484-34842.1052.11
53013-30131.8211.82
64235-42352.5592.56
20min15046-50463.0492.942.893.062.952.87
24958-49582.9963.00
34957-49572.9953.00
44720-47202.8522.86
54835-48352.9222.93
64700-47002.8402.85
30min16091-60913.6803.514.553.693.524.54
26056-60563.6593.67
35882-58823.5543.56
45879-58793.5523.56
55469-54693.3053.31
65520-55203.3353.35
45min16771-67714.0914.016.914.114.026.93
25935-59353.5863.60
37289-72894.4044.42
46501-65013.9283.94
56430-64303.8853.90
66865-68654.1484.17
60min17141-71414.3154.472.134.344.492.10
27449-74494.5014.52
37304-73044.4134.44
47574-75744.5774.60
57377-73774.4574.48
67519-75194.5434.57
极限17484-74844.5224.636.474.554.666.40
26860-68604.1454.18
37678-76784.6394.67
48188-81884.9484.98
58178-81784.9414.97
67573-75734.5764.61
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100309-202205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%
112.014519884520534520004516854517044518860.04
212.064508084505284506680.05
单位质量响应值RSD%判断
37625.8137368.820.49数据可信
中间条件6月-供试品溶液-2024082521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%
5min1375957-37595771.97361.9411.6771.9761.9411.67
2332092-33209263.57663.58
3348157-34815766.65166.65
4317390-31739060.76160.76
5299897-29989757.41257.41
6267874-26787451.28251.28
10min1480734-48073492.03288.432.8392.1588.532.84
2460584-46058488.17488.28
3469065-46906589.79889.91
4462810-46281088.60088.70
5456952-45695287.47987.57
6441419-44141984.50584.59
15min1499339-49933995.59394.981.1195.8795.231.10
2489075-48907593.62893.88
3494403-49440394.64894.91
4504888-50488896.65696.90
5493025-49302594.38594.63
6496040-49604094.96295.19
20min1503839-50383996.45596.341.0596.8996.751.04
2496894-49689495.12595.53
3501696-50169696.04596.46
4510785-51078597.78598.19
5498827-49882795.49595.89
6507483-50748397.15397.54
30min1504333-50433396.54997.171.2497.1497.741.23
2501449-50144995.99796.56
3506044-50604496.87797.46
4514909-51490998.57499.15
5502777-50277796.25296.81
6515949-51594998.77399.32
45min1503396-50339696.37097.501.5497.1298.231.52
2502812-50281296.25896.99
3505805-50580596.83197.57
4517112-51711298.99699.73
5505482-50548296.76997.49
6521224-52122499.783100.49
60min1502166-50216696.13597.331.7097.0598.221.68
2501820-50182096.06896.96
3504981-50498196.67497.57
4515167-51516798.62499.53
5503435-50343596.37897.26
6522792-522792100.083100.96
极限1509538-50953897.54698.720.6898.6299.770.66
2516620-51662098.90299.95
3517021-51702198.978100.04
4513809-51380998.36499.43
5519054-51905499.368100.41
6517906-51790699.148100.19
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%
116.521532221535401533071532111531321532820.11
216.491528781530331529560.08
单位质量响应值RSD%判断
9278.579275.680.03数据可信
中间条件6月-供试品溶液-2024082521批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13255-32551.9701.4222.221.971.4222.29
22174-21741.3161.32
32414-24141.4611.46
41693-16931.0241.02
52474-24741.4971.50
62101-21011.2711.27
15min14249-42492.5712.428.182.572.428.20
23933-39332.3802.38
34072-40722.4642.47
43770-37702.2812.28
54453-44532.6952.70
63546-35462.1462.15
20min15143-51433.1122.919.333.122.929.35
25337-53373.2303.24
34135-41352.5022.51
44762-47622.8822.89
54474-44742.7072.71
65023-50233.0403.05
30min16239-62393.7753.833.343.793.843.35
26201-62013.7523.76
36634-66344.0144.03
46362-63623.8503.86
56061-60613.6683.68
66512-65123.9413.95
45min17342-73424.4434.147.774.464.167.78
25994-59943.6273.64
37469-74694.5204.54
46892-68924.1704.19
56753-67534.0864.10
66644-66444.0204.04
60min17722-77224.6734.629.244.704.649.18
28033-80334.8614.88
38400-84005.0835.11
47924-79244.7954.82
57283-72834.4074.43
66402-64023.8743.90
极限18229-82294.9804.804.485.014.834.42
27763-77634.6984.73
37683-76834.6494.68
48269-82695.0045.04
57426-74264.4944.53
68219-82194.9735.00
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