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%
112.014625734628694631344631234633424630080.07
212.064624654620504622580.07
单位质量响应值RSD%判断
38551.8738329.850.41数据可信
加速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%
5min1456643-45664385.27474.9710.7885.2774.9710.78
2403069-40306975.26975.27
3394486-39448673.66673.67
4325024-32502460.69560.70
5408896-40889676.35776.36
6420674-42067478.55778.56
10min1514748-51474896.12492.943.0996.2793.063.10
2505060-50506094.31594.44
3496042-49604292.63192.75
4469224-46922487.62387.72
5499483-49948393.27493.40
6501675-50167593.68393.81
15min1525498-52549898.13297.191.5198.4397.471.52
2523573-52357397.77298.05
3517937-51793796.72097.00
4505515-50551594.40094.65
5525374-52537498.10998.39
6524734-52473497.98998.28
20min1528880-52888098.76398.251.1499.2398.691.16
2528593-52859398.71099.16
3524783-52478397.99898.44
4514554-51455496.08896.49
5529831-52983198.94199.39
6530156-53015699.00299.45
30min1533207-53320799.57199.330.77100.2099.940.78
2532437-53243799.427100.04
3531891-53189199.32699.93
4524117-52411797.87498.44
5534195-53419599.756100.37
6535671-535671100.031100.65
45min1535224-53522499.94899.880.61100.74100.640.62
2533013-53301399.535100.31
3536016-536016100.096100.86
4529411-52941198.86299.59
5536758-536758100.234101.01
6538586-538586100.576101.36
60min1534839-53483999.87699.920.50100.84100.860.51
2532635-53263599.464100.41
3537103-537103100.299101.23
4531146-53114699.186100.08
5537212-537212100.319101.26
6537448-537448100.363101.31
极限1533584-53358499.642100.000.60100.77101.100.61
2534097-53409799.737100.84
3536192-536192100.129101.23
4531948-53194899.336100.39
5536104-536104100.112101.22
6541200-541200101.064102.18
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%
116.521528741529971530331529941529881529770.04
216.491529521526151527840.16
单位质量响应值RSD%判断
9260.119265.250.04数据可信
加速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
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
15min12244-22441.3601.5721.711.361.5721.62
21775-17751.0761.08
33121-31211.8921.89
42476-24761.5011.50
52634-26341.5961.60
63299-32991.9992.00
20min13330-33302.0182.075.352.022.075.26
23459-34592.0962.10
33567-35672.1622.16
43641-36412.2072.21
53323-33232.0142.02
63143-31431.9051.91
30min13708-37082.2472.549.792.252.549.80
24591-45912.7822.79
34699-46992.8482.85
43839-38392.3272.33
54312-43122.6132.62
63969-39692.4052.41
45min14908-49082.9753.184.452.983.194.48
25467-54673.3133.32
35427-54273.2893.30
45439-54393.2963.31
55046-50463.0583.07
65230-52303.1703.18
60min14755-47552.8823.5210.642.903.5310.55
26527-65273.9563.97
36188-61883.7503.77
46050-60503.6673.68
55745-57453.4823.50
65544-55443.3603.38
极限16169-61693.7393.6311.643.763.6511.52
26676-66764.0464.07
35294-52943.2083.23
46621-66214.0134.03
54990-49903.0243.05
66187-61873.7503.77
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%
112.014610094606694612954607824602664608040.09
212.064583634582744583180.02
单位质量响应值RSD%判断
38368.3638003.150.68数据可信
加速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%
5min1365154-36515468.64671.367.8668.6571.367.86
2356262-35626266.97466.97
3351388-35138866.05866.06
4378158-37815871.09071.09
5395774-39577474.40274.40
6430943-43094381.01381.01
10min1491651-49165192.42693.523.0592.5493.643.06
2484178-48417891.02191.13
3498182-49818293.65493.76
4483802-48380290.95091.07
5502646-50264694.49394.62
6524336-52433698.57098.71
15min1518456-51845697.46597.521.6197.7397.801.62
2512072-51207296.26596.53
3522766-52276698.27598.54
4509179-50917995.72195.99
5517551-51755197.29597.58
6532626-532626100.129100.43
20min1523532-52353298.41998.661.1398.8599.101.13
2522861-52286198.29398.72
3528523-52852399.35799.79
4517562-51756297.29797.73
5521965-52196598.12598.57
6534539-534539100.488100.95
30min1529736-52973699.58599.581.04100.18100.181.05
2529931-52993199.622100.21
3533547-533547100.302100.90
4521207-52120797.98298.57
5526721-52672199.01999.63
6537074-537074100.965101.60
45min1532965-532965100.192100.270.91100.95101.040.92
2535794-535794100.724101.48
3537118-537118100.973101.74
4524801-52480198.65899.41
5531629-53162999.941100.71
6537974-537974101.134101.94
60min1533401-533401100.274100.120.93101.20101.050.93
2534716-534716100.522101.44
3536040-536040100.770101.70
4523345-52334598.38499.30
5531333-53133399.886100.82
6536590-536590100.874101.84
极限1532542-532542100.11399.970.53101.21101.070.53
2533916-533916100.371101.46
3533630-533630100.317101.42
4526894-52689499.051100.13
5530088-53008899.652100.76
6533544-533544100.301101.44
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%
116.521527441530111529741528971526461528540.11
216.491520621520311520460.02
单位质量响应值RSD%判断
9252.669220.500.25数据可信
加速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
10min11748-17481.0620.8949.511.060.8849.53
2-0.0000.00
31734-17341.0541.05
41855-18551.1271.13
51851-18511.1251.12
61569-15690.9540.95
15min12431-24311.4781.7513.391.481.7613.43
22450-24501.4891.49
33009-30091.8291.83
43446-34462.0942.10
52982-29821.8121.81
62998-29981.8221.82
20min12872-28721.7462.2512.981.752.2512.96
24015-40152.4402.44
34282-42822.6022.61
43751-37512.2802.29
53707-37072.2532.26
63543-35432.1532.16
30min14017-40172.4412.838.672.452.848.64
24896-48962.9762.98
35124-51243.1143.12
44930-49302.9963.01
54582-45822.7852.79
64431-44312.6932.70
45min14258-42582.5883.3812.872.603.3912.85
25528-55283.3603.37
36267-62673.8093.82
46009-60093.6523.67
55921-59213.5993.61
65381-53813.2703.28
60min16011-60113.6533.7210.413.673.7410.40
27093-70934.3114.33
36307-63073.8333.85
45108-51083.1053.12
56204-62043.7713.79
66032-60323.6663.68
极限16257-62573.8034.045.133.824.065.17
26527-65273.9673.99
37077-70774.3014.33
47049-70494.2844.31
56561-65613.9884.01
66402-64023.8913.92
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%
112.014590594593124594674593714592814592980.04
212.064587714585264586480.04
单位质量响应值RSD%判断
38242.9638030.510.40数据可信
加速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%
5min1296395-29639555.79057.8711.8855.7957.8711.88
2297939-29793956.08156.08
3288444-28844454.29454.29
4294681-29468155.46855.47
5285946-28594653.82353.82
6381350-38135071.78171.78
10min1473746-47374689.17389.162.9989.2789.263.00
2461947-46194786.95287.05
3471429-47142988.73788.83
4458582-45858286.31986.41
5478088-47808889.99090.08
6498366-49836693.80793.93
15min1521294-52129498.12397.231.3598.3697.481.35
2512152-51215296.40296.64
3515417-51541797.01797.26
4505675-50567595.18395.42
5524573-52457398.74098.98
6520346-52034697.94498.22
20min1528664-52866499.51098.931.1199.9299.331.12
2521829-52182998.22498.62
3527287-52728799.25199.65
4515680-51568097.06697.46
5531781-531781100.097100.50
6528094-52809499.40399.84
30min1532723-532723100.27499.920.88100.85100.490.89
2527472-52747299.28699.85
3531839-531839100.108100.67
4523162-52316298.47499.03
5535394-535394100.777101.35
6534386-534386100.587101.19
45min1533227-533227100.369100.290.80101.11101.030.80
2530795-53079599.911100.64
3534129-534129100.539101.27
4525445-52544598.90499.63
5536837-536837101.049101.79
6536293-536293100.946101.72
60min1532433-532433100.220100.030.66101.12100.930.66
2529680-52968099.701100.60
3533036-533036100.333101.23
4525376-52537698.89199.78
5535435-535435100.785101.69
6532442-532442100.221101.16
极限1530726-53072699.89899.810.67100.97100.890.68
2528436-52843699.467100.53
3531420-531420100.029101.10
4524216-52421698.67399.72
5533338-533338100.390101.47
6533552-533552100.430101.54
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%
116.521527361528381529971527141526881527950.09
216.491530091528161529120.09
单位质量响应值RSD%判断
9249.099273.010.19数据可信
加速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
10min1-0.0000.58111.930.000.58111.95
2-0.0000.00
3-0.0000.00
41810-18101.0971.10
51635-16350.9910.99
62307-23071.3981.40
15min13314-33142.0091.7813.642.011.7813.57
22635-26351.5971.60
33503-35032.1232.12
42961-29611.7951.80
52459-24591.4911.49
62784-27841.6881.69
20min13754-37542.2762.407.412.282.417.51
23583-35832.1722.17
34410-44102.6732.68
43900-39002.3642.37
53975-39752.4102.41
64162-41622.5232.53
30min15292-52923.2082.959.203.212.969.17
24843-48432.9362.94
34445-44452.6942.70
44227-42272.5622.57
55299-52993.2123.22
65078-50783.0783.09
45min15355-53553.2463.457.793.263.467.77
25759-57593.4913.50
36479-64793.9273.94
45397-53973.2713.28
55841-58413.5413.55
65323-53233.2273.24
60min15840-58403.5403.707.503.563.727.50
25766-57663.4953.51
35541-55413.3593.38
46678-66784.0484.07
56544-65443.9673.99
66253-62533.7903.81
极限16536-65363.9624.183.203.994.213.16
26826-68264.1384.16
37203-72034.3664.39
46914-69144.1914.22
56891-68914.1774.20
67015-70154.2524.28
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%
112.014578004578714578944577194584124579390.06
212.064557204557514557360.01
单位质量响应值RSD%判断
38129.8137789.050.64数据可信
加速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%
5min1330877-33087762.57259.1717.1562.5759.1717.15
2250222-25022247.32047.32
3287336-28733654.33854.34
4408536-40853677.25977.26
5302562-30256257.21857.22
6297863-29786356.32956.33
10min1462988-46298887.55687.334.7887.6687.434.79
2444400-44440084.04184.12
3465980-46598088.12288.21
4502669-50266995.06095.19
5444361-44436184.03484.13
6450311-45031185.15985.25
15min1500535-50053594.65796.121.7194.9196.371.72
2514338-51433897.26797.49
3515901-51590197.56397.80
4517894-51789497.93998.23
5498308-49830894.23694.47
6502735-50273595.07395.31
20min1514116-51411697.22598.231.2497.6398.631.24
2525242-52524299.32999.71
3527814-52781499.815100.22
4521932-52193298.70399.15
5512826-51282696.98197.37
6514586-51458697.31497.71
30min1524619-52461999.21199.560.9699.78100.130.95
2532738-532738100.747101.29
3532846-532846100.767101.33
4521870-52187098.69199.31
5521910-52191098.69999.25
6524944-52494499.27399.83
45min1526176-52617699.506100.181.10100.24100.911.08
2536095-536095101.381102.10
3535285-535285101.228101.96
4520634-52063498.45899.24
5529031-529031100.046100.76
6531148-531148100.446101.17
60min1524257-52425799.143100.101.27100.04101.001.24
2535619-535619101.291102.17
3534619-534619101.102102.01
4518405-51840598.03698.98
5530164-530164100.260101.15
6532749-532749100.749101.64
极限1534465-534465101.073100.840.58102.14101.900.57
2534036-534036100.992102.04
3532943-532943100.785101.86
4531727-531727100.555101.66
5528486-52848699.942100.99
6537683-537683101.682102.74
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%
116.521530611528481530781528781530571529840.08
216.491521111524941523020.18
单位质量响应值RSD%判断
9260.539236.020.19数据可信
加速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
10min11838-18381.1161.0251.971.121.0251.95
21925-19251.1681.17
31603-16030.9730.97
42395-23951.4541.45
52274-22741.3801.38
6-0.0000.00
15min13871-38712.3501.9218.782.351.9218.79
22753-27531.6711.67
32565-25651.5571.56
43802-38022.3082.31
53326-33262.0192.02
62621-26211.5911.59
20min14429-44292.6882.6312.862.692.6412.93
24649-46492.8222.83
34108-41082.4942.50
44975-49753.0203.03
54522-45222.7452.75
63359-33592.0392.04
30min15698-56983.4593.265.843.473.265.86
25435-54353.2993.31
35184-51843.1473.16
45063-50633.0733.08
55754-57543.4933.50
65053-50533.0673.07
45min16482-64823.9353.658.643.953.668.72
26360-63603.8613.88
36274-62743.8083.82
46176-61763.7493.77
55612-56123.4073.42
65146-51463.1243.13
60min16395-63953.8823.916.403.903.936.36
26412-64123.8923.91
36303-63033.8263.85
46900-69004.1884.21
56841-68414.1534.17
65768-57683.5013.52
极限17493-74934.5484.396.194.584.426.25
27434-74344.5124.54
37202-72024.3724.40
47501-75014.5534.58
57408-74084.4974.53
66345-63453.8513.87
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