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(%)99.70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%
111.784527594523864521694517984517544521730.10
211.784503914504314504110.01
单位质量响应值RSD%判断
38384.8038235.230.28数据可信
中间条件6月-供试品溶液-2024082821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%
5min1280196-28019652.50256.449.4752.5056.449.47
2268554-26855450.32150.32
3315860-31586059.18559.18
4348373-34837365.27765.28
5303654-30365456.89856.90
6290712-29071254.47354.47
10min1429218-42921880.42682.813.6480.5182.903.64
2426770-42677079.96780.05
3450581-45058184.42984.53
4459055-45905586.01686.13
5459218-45921886.04786.14
6426767-42676779.96680.06
15min1485574-48557490.98691.732.0991.2191.962.09
2493750-49375092.51892.73
3495084-49508492.76893.01
4492559-49255992.29492.55
5499532-49953293.60193.84
6470864-47086488.22988.45
20min1503455-50345594.33694.071.4194.7194.451.41
2503220-50322094.29294.66
3507596-50759695.11295.51
4500646-50064693.81094.22
5508277-50827795.24095.63
6488874-48887491.60491.98
30min1512550-51255096.04096.030.8796.5796.570.87
2513026-51302696.12996.66
3517938-51793897.05097.60
4508395-50839595.26295.82
5516423-51642396.76697.32
6506541-50654194.91495.44
45min1517767-51776797.01897.150.9097.7197.850.90
2519062-51906297.26097.95
3522448-52244897.89598.61
4512551-51255196.04096.76
5524639-52463998.30599.02
6514301-51430196.36897.05
60min1516445-51644596.77097.230.9797.6298.100.96
2519531-51953197.34898.20
3522789-52278997.95998.84
4512556-51255696.04196.92
5526241-52624198.60699.48
6515920-51592096.67297.51
极限1514484-51448496.40397.190.9797.4298.220.97
2520383-52038397.50898.52
3521926-52192697.79798.84
4511054-51105495.76096.80
5524714-52471498.31999.36
6519694-51969497.37998.38
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642969082975182974922977892977372974890.12
215.602970352974362972360.10
单位质量响应值RSD%判断
19021.0419053.590.13数据可信
中间条件6月-供试品溶液-2024082821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
10min12564-25640.7560.8512.110.760.8612.11
22798-27980.8250.83
33410-34101.0061.01
43083-30830.9090.91
52472-24720.7290.73
63005-30050.8860.89
15min14589-45891.3531.467.431.351.467.43
25014-50141.4791.48
35598-55981.6511.65
44815-48151.4201.42
54640-46401.3681.37
65000-50001.4741.48
20min15680-56801.6751.798.351.681.808.33
25957-59571.7571.76
36965-69652.0542.06
45885-58851.7351.74
55601-56011.6521.66
66322-63221.8641.87
30min17114-71142.0982.156.972.102.166.95
27158-71582.1112.12
38024-80242.3662.37
47634-76342.2512.26
56523-65231.9241.93
67328-73282.1612.17
45min17168-71682.1142.249.762.122.259.64
27893-78932.3282.34
36593-65931.9441.96
48516-85162.5112.52
57151-71512.1092.12
68247-82472.4322.44
60min18223-82232.4252.4812.392.442.4912.28
26428-64281.8951.91
39054-90542.6702.68
49173-91732.7052.72
58505-85052.5082.52
69083-90832.6782.69
极限17867-78672.3202.578.942.342.598.86
29083-90832.6782.70
39918-99182.9252.94
48013-80132.3632.38
58388-83882.4732.49
69080-90802.6782.70
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(%)99.70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%
111.784501764498044497184497384494614497790.06
211.784489094489014489050.01
单位质量响应值RSD%判断
38181.5838107.390.14数据可信
中间条件6月-供试品溶液-2024082821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%
5min1383489-38348972.16961.538.6572.1761.538.65
2322266-32226660.64760.65
3313918-31391859.07659.08
4305721-30572157.53457.53
5317736-31773659.79559.79
6318622-31862259.96159.96
10min1493820-49382092.93286.444.0293.0586.544.03
2463260-46326087.18187.28
3442988-44298883.36683.46
4458379-45837986.26286.36
5447388-44738884.19484.29
6449978-44997884.68184.78
15min1510079-51007995.99292.112.2696.2792.362.26
2491620-49162092.51892.76
3487540-48754091.75091.99
4483248-48324890.94291.18
5485817-48581791.42691.67
6478440-47844090.03890.28
20min1513077-51307796.55693.541.9896.9993.941.99
2497089-49708993.54793.95
3501392-50139294.35794.75
4486638-48663891.58091.97
5496897-49689793.51193.90
6487203-48720391.68792.08
30min1517546-51754697.39794.892.0097.9995.452.00
2503048-50304894.66995.23
3509899-50989995.95896.51
4489884-48988492.19192.74
5508828-50882895.75696.30
6496118-49611893.36493.91
45min1521421-52142198.12695.442.5798.8896.152.57
2502623-50262394.58995.30
3516959-51695997.28697.99
4491500-49150092.49593.19
5516916-51691697.27897.99
6493442-49344292.86193.56
60min1520541-52054197.96195.492.7098.8896.362.69
2502173-50217394.50495.38
3518529-51852997.58298.45
4490862-49086292.37593.23
5519129-51912997.69598.56
6493176-49317692.81193.67
极限1522967-52296798.41798.160.2899.5099.190.30
2519964-51996497.85298.88
3521799-52179998.19799.23
4519671-51967197.79798.80
5522967-52296798.41799.45
6522096-52209698.25399.26
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642972182974932973022971762967532971880.10
215.602975002976312975660.04
单位质量响应值RSD%判断
19001.7919074.740.28数据可信
中间条件6月-供试品溶液-2024082821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
10min13093-30930.9120.836.570.910.836.39
22539-25390.7490.75
32739-27390.8080.81
42826-28260.8330.83
52731-27310.8050.81
62884-28840.8500.85
15min15214-52141.5371.408.771.541.408.75
24621-46211.3631.36
35264-52641.5521.55
44340-43401.2801.28
54296-42961.2671.27
64750-47501.4011.40
20min15611-56111.6551.736.551.661.746.44
25476-54761.6151.62
35935-59351.7501.75
45605-56051.6531.66
56156-61561.8151.82
66473-64731.9091.91
30min16888-68882.0312.037.662.042.037.60
26752-67521.9912.00
37507-75072.2142.22
46123-61231.8051.81
57417-74172.1872.19
66553-65531.9321.94
45min18101-81012.3892.269.582.402.279.54
28205-82052.4192.43
38502-85022.5072.52
47052-70522.0792.09
57394-73942.1802.19
66640-66401.9581.97
60min16971-69712.0562.4211.422.072.4311.28
28978-89782.6472.66
37500-75002.2122.23
49332-93322.7522.76
58723-87232.5722.59
67723-77232.2772.29
极限18948-89482.6382.547.722.662.567.76
27838-78382.3112.33
38987-89872.6502.67
47849-78492.3142.33
59486-94862.7972.82
68534-85342.5162.53
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(%)99.70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%
111.784489404488044488174488454491124489040.03
211.784470554474014472280.06
单位质量响应值RSD%判断
38107.3037965.030.27数据可信
中间条件6月-供试品溶液-2024083021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%
5min1257018-25701848.50648.877.8248.5148.877.82
2267912-26791250.56250.56
3282958-28295853.40253.40
4255490-25549048.21848.22
5267378-26737850.46150.46
6222848-22284842.05742.06
10min1412137-41213777.78179.092.6277.8679.172.63
2420060-42006079.27679.36
3433974-43397481.90281.99
4420584-42058479.37579.46
5425550-42555080.31280.40
6402152-40215275.89775.97
15min1482231-48223191.01089.821.2091.2290.041.20
2468949-46894988.50388.72
3479041-47904190.40890.63
4475622-47562289.76289.98
5480467-48046790.67790.89
6469360-46936088.58188.78
20min1497088-49708893.81493.291.2194.1893.661.21
2484096-48409691.36291.73
3493142-49314293.06993.45
4498412-49841294.06394.43
5500919-50091994.53794.91
6492165-49216592.88493.23
30min1505182-50518295.34195.551.1195.8696.071.11
2497452-49745293.88294.40
3503731-50373195.06795.60
4511627-51162796.55797.08
5512851-51285196.78897.32
6506951-50695195.67596.17
45min1507765-50776595.82996.871.2696.5197.551.25
2506049-50604995.50596.18
3509744-50974496.20296.89
4520466-52046698.22698.91
5520985-52098598.32499.01
6514644-51464497.12797.79
60min1506809-50680995.64897.011.3696.4997.851.36
2507518-50751895.78296.61
3509904-50990496.23297.08
4521776-52177698.47399.32
5522310-52231098.57499.43
6515784-51578497.34298.16
极限1505018-50501895.31096.771.3596.3197.771.34
2506583-50658395.60696.60
3508414-50841495.95196.96
4520286-52028698.19299.20
5519975-51997598.13399.15
6516093-51609397.40098.38
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642980402979682979502980802985292981130.08
215.602972772974412973590.04
单位质量响应值RSD%判断
19060.9319061.470.01数据可信
中间条件6月-供试品溶液-2024083021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
10min12814-28140.8290.777.000.830.777.03
22389-23890.7040.70
32862-28620.8430.84
42506-25060.7380.74
52542-25420.7490.75
62626-26260.7730.77
15min14560-45601.3431.315.011.341.315.12
24172-41721.2291.23
34516-45161.3301.33
44643-46431.3671.37
54181-41811.2311.23
64666-46661.3741.38
20min15504-55041.6211.696.141.621.696.11
25275-52751.5541.56
35742-57421.6911.69
45636-56361.6601.66
56281-62811.8501.85
65948-59481.7521.76
30min17071-70712.0822.095.022.092.104.94
26522-65221.9211.93
37123-71232.0982.10
46948-69482.0462.05
57454-74542.1952.20
67489-74892.2062.21
45min17483-74832.2042.288.062.212.288.04
27805-78052.2992.31
36602-66021.9441.95
48228-82282.4232.43
58165-81652.4052.41
68131-81312.3952.40
60min17817-78172.3022.446.862.322.456.71
28169-81692.4062.42
38895-88952.6202.63
48339-83392.4562.47
58927-89272.6292.64
67518-75182.2142.23
极限17963-79632.3452.636.302.362.656.27
29482-94822.7932.81
39355-93552.7552.77
48732-87322.5722.59
59250-92502.7242.74
68808-88082.5942.61
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(%)99.70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%
111.784474904473984473004471124473604473320.04
211.784455254454644454940.01
单位质量响应值RSD%判断
37973.8537817.830.30数据可信
中间条件6月-供试品溶液-2024083021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%
5min1250472-25047247.44651.1414.1947.4551.1414.19
2272288-27228851.57851.58
3223731-22373142.38042.38
4253618-25361848.04248.04
5283807-28380753.76053.76
6335950-33595063.63763.64
10min1416594-41659478.91380.376.2178.9980.456.21
2424652-42465280.44080.53
3387685-38768573.43773.51
4413556-41355678.33878.42
5436377-43637782.66182.75
6466720-46672088.40988.51
15min1476017-47601790.17090.391.4890.3890.611.50
2481119-48111991.13691.36
3464322-46432287.95488.15
4478019-47801990.54990.76
5478470-47847090.63490.86
6485223-48522391.91492.17
20min1494251-49425193.62493.700.9093.9894.080.88
2499799-49979994.67595.05
3495636-49563693.88694.23
4498907-49890794.50694.87
5491108-49110893.02893.41
6488342-48834292.50492.91
30min1501430-50143094.98495.901.9795.5096.421.94
2511932-51193296.97397.50
3519885-51988598.47998.98
4511814-51181496.95197.47
5499622-49962294.64195.17
6492829-49282993.35493.92
45min1504918-50491895.64497.042.2096.3297.722.17
2517950-51795098.11398.80
3527075-52707599.841100.50
4519996-51999698.50099.18
5506936-50693696.02696.72
6496860-49686094.11894.83
60min1503277-50327795.33396.902.4896.1797.742.44
2518363-51836398.19199.05
3527000-52700099.827100.65
4520677-52067798.62999.47
5506721-50672195.98696.84
6493156-49315693.41694.29
极限1501712-50171295.03797.451.6796.0398.461.65
2516200-51620097.78198.80
3526814-52681499.792100.78
4519588-51958898.42399.43
5511691-51169196.92797.94
6510714-51071496.74297.77
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642974552976262974232979902978832976750.09
215.602965182967702966440.07
单位质量响应值RSD%判断
19032.9319015.640.07数据可信
中间条件6月-供试品溶液-2024083021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
10min1-0.0000.6850.120.000.6850.08
23187-31870.9400.94
32427-24270.7160.72
42733-27330.8060.81
52744-27440.8100.81
62727-27270.8050.80
15min13979-39791.1741.367.521.171.367.63
24642-46421.3701.37
34832-48321.4261.43
44608-46081.3601.36
54541-45411.3401.34
64989-49891.4721.47
20min15619-56191.6581.766.411.661.766.48
25874-58741.7331.74
36137-61371.8111.81
45653-56531.6681.67
56654-66541.9631.97
65895-58951.7401.74
30min16581-65811.9422.085.451.952.095.31
27479-74792.2072.21
37269-72692.1452.15
47403-74032.1852.19
56673-66731.9691.98
66916-69162.0412.05
45min17749-77492.2872.363.582.292.363.61
27515-75152.2182.23
38117-81172.3952.41
48262-82622.4382.45
58091-80912.3882.40
68149-81492.4052.41
60min18527-85272.5162.593.992.532.604.01
29358-93582.7612.78
39015-90152.6602.67
48595-85952.5362.55
58429-84292.4872.50
68750-87502.5822.60
极限18168-81682.4102.478.932.432.498.85
28963-89632.6452.66
37903-79032.3322.35
49165-91652.7042.72
57225-72252.1322.15
68869-88692.6172.64
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