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%
111.834611264608344606944603714602804606610.08
211.944588944587104588020.03
单位质量响应值RSD%判断
38940.0738425.630.95数据可信
供试品溶液-2024082721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%
5min1365840-36584067.89266.8713.7267.8966.8713.72
2328766-32876661.01261.01
3289205-28920553.67053.67
4348888-34888864.74664.75
5421306-42130678.18578.19
6408060-40806075.72775.73
10min1474462-47446288.05087.875.9488.1687.985.95
2450620-45062083.62683.73
3433691-43369180.48480.57
4475980-47598088.33288.44
5509522-50952294.55694.69
6496557-49655792.15092.28
15min1511274-51127494.88293.842.4195.1494.102.43
2493503-49350391.58491.82
3489862-48986290.90891.13
4506359-50635993.97094.22
5522583-52258396.98097.27
6510380-51038094.71695.00
20min1524261-52426197.29296.131.1597.7196.541.16
2511620-51162094.94695.34
3517225-51722595.98696.36
4514911-51491195.55795.97
5526178-52617897.64798.10
6513683-51368395.32995.77
30min1534301-53430199.15597.611.5399.7498.181.52
2521156-52115696.71697.27
3535577-53557799.39299.93
4518307-51830796.18796.76
5528797-52879798.13498.75
6517571-51757196.05096.65
45min1536839-53683999.62697.991.73100.3798.731.71
2523451-52345197.14197.85
3540593-540593100.323101.02
4520424-52042496.58097.31
5528898-52889898.15298.93
6517961-51796196.12396.88
60min1536504-53650499.56497.881.82100.4898.781.80
2522847-52284797.02997.90
3540709-540709100.344101.21
4519523-51952396.41297.30
5528285-52828598.03998.98
6516590-51659095.86896.78
极限1550796-550796102.216100.711.81103.29101.781.79
2533784-53378499.059100.10
3554799-554799102.959103.99
4536382-53638299.541100.59
5548467-548467101.784102.89
6531960-53196098.72199.80
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%
116.171539791539521541081541001540471540370.05
216.221539951540491540220.03
单位质量响应值RSD%判断
9526.109495.810.23数据可信
供试品溶液-2024082721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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.46244.950.000.46244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
64631-46312.7332.73
20min14958-49582.9263.186.942.933.186.82
25610-56103.3113.31
35583-55833.2953.30
45349-53493.1573.16
55886-58863.4743.47
64965-49652.9312.94
30min16406-64063.7813.826.653.793.836.65
26615-66153.9043.91
36080-60803.5893.59
47039-70394.1554.16
56811-68114.0204.03
65914-59143.4913.50
45min17047-70474.1594.054.444.174.064.41
26539-65393.8603.87
36825-68254.0284.04
46461-64613.8143.83
57217-72174.2604.27
67054-70544.1644.18
60min17462-74624.4044.405.584.424.425.54
27869-78694.6454.66
36744-67443.9814.00
47621-76214.4984.52
57805-78054.6074.63
67257-72574.2834.31
极限18430-84304.9764.615.425.004.645.31
27829-78294.6214.65
38165-81654.8194.84
47688-76884.5384.56
57440-74404.3914.42
67330-73304.3264.36
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%
111.834580374578374577674576474576014577780.04
211.944566324563134564720.05
单位质量响应值RSD%判断
38696.3738230.490.86数据可信
供试品溶液-2024082721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%
5min1287541-28754153.66659.167.3453.6759.167.34
2345560-34556064.49464.49
3341126-34112663.66663.67
4318379-31837959.42159.42
5296468-29646855.33255.33
6312823-31282358.38458.38
10min1441531-44153182.40685.382.6982.5085.482.69
2472579-47257988.20088.31
3469973-46997387.71487.82
4456732-45673285.24385.34
5446767-44676783.38383.48
6457120-45712085.31585.41
15min1496242-49624292.61794.531.1292.8494.771.13
2510973-51097395.36695.62
3512014-51201495.56095.81
4504832-50483294.22094.46
5507064-50706494.63694.87
6507839-50783994.78195.02
20min1513826-51382695.89896.880.6796.2897.280.67
2522910-52291097.59498.01
3520693-52069397.18097.59
4517193-51719396.52796.93
5522045-52204597.43297.82
6517698-51769896.62197.02
30min1524736-52473697.93598.500.4698.4899.060.47
2531234-53123499.14799.72
3528629-52862998.66199.23
4525483-52548398.07498.63
5529014-52901498.73399.28
6527422-52742298.43698.99
45min1533196-53319699.51499.770.23100.22100.490.25
2536627-536627100.154100.90
3535098-53509899.869100.61
4533786-53378699.624100.35
5533917-53391799.648100.36
6534712-53471299.797100.52
60min1535443-53544399.933100.030.25100.80100.920.26
2537663-537663100.347101.26
3535687-53568799.979100.88
4535974-535974100.032100.92
5533943-53394399.653100.53
6537009-537009100.225101.11
极限1534964-53496499.84499.860.33100.88100.920.33
2536466-536466100.124101.20
3533910-53391099.647100.72
4534731-53473199.800100.86
5532666-53266699.415100.46
6537559-537559100.328101.38
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%
116.171541901541621541701541091541131541490.03
216.221536611536181536400.02
单位质量响应值RSD%判断
9533.029472.260.46数据可信
供试品溶液-2024082721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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min15064-50642.9923.034.682.993.034.73
24977-49772.9402.94
35519-55193.2603.26
45141-51413.0373.04
54815-48152.8452.84
65225-52253.0873.09
20min16505-65053.8433.635.533.853.635.58
26445-64453.8073.81
36391-63913.7763.78
45851-58513.4573.46
55908-59083.4903.49
65753-57533.3993.40
30min16956-69564.1093.928.894.123.938.82
26731-67313.9763.99
37216-72164.2634.27
45511-55113.2563.27
56792-67924.0124.02
66599-65993.8983.91
45min17857-78574.6424.485.224.664.505.20
27802-78024.6094.63
37763-77634.5864.60
46923-69234.0904.11
57285-72854.3044.32
67904-79044.6694.69
60min18611-86115.0874.756.725.114.786.68
28432-84324.9815.01
37652-76524.5214.55
47239-72394.2774.30
58444-84444.9885.01
67882-78824.6564.68
极限17700-77004.5494.829.954.584.869.90
29140-91405.4005.43
39076-90765.3625.40
47404-74044.3744.40
58326-83264.9194.95
67334-73344.3334.37
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%
111.834566394565034566554564704565584565650.02
211.944571624570674571140.02
单位质量响应值RSD%判断
38593.8338284.250.57数据可信
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%
5min1290931-29093154.33261.075.9254.3361.075.92
2339377-33937763.37963.38
3329797-32979761.59061.59
4344314-34431464.30164.30
5321655-32165560.06960.07
6335982-33598262.74562.74
10min1454927-45492784.95889.303.5385.0589.403.54
2474881-47488188.68488.79
3491063-49106391.70691.81
4494892-49489292.42192.53
5462074-46207486.29386.39
6491120-49112091.71791.82
15min1514718-51471896.12497.211.1496.3697.461.14
2514476-51447696.07996.33
3526698-52669898.36198.62
4525794-52579498.19298.45
5516402-51640296.43896.68
6525013-52501398.04798.30
20min1525522-52552298.14298.800.6198.5399.210.62
2527164-52716498.44898.86
3533038-53303899.54599.96
4531927-53192799.33899.76
5526131-52613198.25598.66
6530620-53062099.09499.51
30min1534539-53453999.826100.200.30100.38100.780.31
2538510-538510100.567101.14
3537794-537794100.433101.02
4537539-537539100.386100.98
5535726-535726100.047100.62
6535320-53532099.971100.56
45min1540956-540956101.024101.090.52101.75101.830.51
2546413-546413102.043102.79
3540706-540706100.977101.73
4540531-540531100.945101.70
5541190-541190101.068101.80
6537963-537963100.465101.22
60min1542506-542506101.313101.090.84102.20102.000.83
2549249-549249102.573103.49
3539350-539350100.724101.64
4538782-538782100.618101.54
5541876-541876101.196102.10
6536054-536054100.108101.03
极限1540694-540694100.975100.900.91102.03101.980.90
2549564-549564102.631103.72
3537839-537839100.442101.53
4537392-537392100.358101.45
5540373-540373100.915101.99
6535794-535794100.060101.15
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%
116.171537431538501537751537221537281537640.04
216.221540481540391540440.01
单位质量响应值RSD%判断
9509.219497.160.09数据可信
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%
5min14804-48042.8380.47244.952.840.47244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min15857-58573.4603.039.303.463.039.33
24593-45932.7132.71
35198-51983.0713.07
45464-54643.2283.23
54903-49032.8962.90
64744-47442.8022.80
15min16004-60043.5473.266.313.563.266.31
25046-50462.9812.99
35351-53513.1613.17
45685-56853.3583.36
55709-57093.3723.38
65286-52863.1233.13
20min16153-61533.6353.748.343.653.758.28
25487-54873.2413.25
36962-69624.1134.12
46653-66533.9303.94
56641-66413.9233.93
66108-61083.6083.62
30min15974-59743.5293.947.043.553.967.01
26573-65733.8833.90
37447-74474.3994.42
46687-66873.9503.97
56669-66693.9403.96
66639-66393.9223.94
45min17465-74654.4104.765.334.444.785.30
27856-78564.6414.66
38474-84745.0065.03
48637-86375.1025.13
57926-79264.6824.71
67993-79934.7224.74
60min18285-82854.8944.993.364.935.023.28
28719-87195.1515.18
38088-80884.7784.81
48232-82324.8634.90
58523-85235.0355.07
68793-87935.1945.22
极限18975-89755.3025.064.005.355.104.07
28235-82354.8654.90
38895-88955.2545.30
48319-83194.9144.95
58732-87325.1585.20
68230-82304.8624.90
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