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对照品来源中检所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%
1 15.903911139066388693908238979390210.26
2 15.983916438630388970.98
单位质量响应值RSD%判断
2454.152434.110.58数据可信
供试品溶液-2025030422批-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%
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
15min11322-13223.0361.8478.923.041.8478.93
21131-11312.5982.60
3-0.0000.00
41346-13463.0923.09
5-0.0000.00
61020-10202.3432.34
20min12558-25585.8754.9412.935.884.9412.90
22134-21344.9024.91
32358-23585.4165.42
42030-20304.6634.67
52068-20684.7504.75
61756-17564.0334.04
30min13140-31407.2126.847.457.236.867.44
23260-32607.4887.50
32946-29466.7676.78
42784-27846.3946.41
53072-30727.0567.06
62673-26736.1406.15
45min13581-35818.2258.382.488.258.402.48
23795-37958.7178.74
33718-37188.5408.56
43611-36118.2948.32
53633-36338.3458.36
63558-35588.1728.19
60min13576-35768.2148.4610.948.258.5010.88
23040-30406.9827.02
33487-34878.0098.04
43837-38378.8138.85
54132-41329.4919.52
64032-40329.2619.30
120min14231-42319.7189.828.929.779.878.87
23641-36418.3638.41
34690-469010.77210.82
44077-40779.3649.42
54447-444710.21410.26
64560-456010.47410.52
240min14435-443510.1879.935.8510.2610.005.81
24296-42969.8679.93
34677-467710.74210.81
43918-39188.9999.07
54220-42209.6939.76
64401-440110.10910.18
极限14289-42899.8519.986.459.9410.066.41
24442-444210.20310.28
34862-486211.16711.25
44097-40979.4109.49
54232-42329.7209.80
64149-41499.5309.61
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对照品来源中检所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%
1 15.903886339006389893900638885389500.18
2 15.983896439032389980.13
单位质量响应值RSD%判断
2449.692440.430.27数据可信
供试品溶液-2025030422批-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%
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
15min11198-11982.7512.928.312.752.928.29
21336-13363.0673.07
31381-13813.1713.17
41372-13723.1503.15
51127-11272.5882.59
61214-12142.7872.79
20min12337-23375.3665.319.195.375.319.21
22351-23515.3985.40
32640-26406.0616.07
42343-23435.3795.38
52212-22125.0795.08
61988-19884.5644.57
30min12912-29126.6866.778.066.706.788.06
23259-32597.4837.50
33017-30176.9276.94
43107-31077.1347.15
52586-25865.9375.95
62799-27996.4266.44
45min13163-31637.2627.918.727.297.938.67
23792-37928.7068.73
33074-30747.0587.08
43311-33117.6027.63
53694-36948.4818.50
63626-36268.3258.35
60min14137-41379.4989.444.449.549.484.41
24183-41839.6049.65
33771-37718.6588.70
44284-42849.8369.87
54228-42289.7079.74
64071-40719.3479.38
120min14253-42539.76510.162.879.8210.222.85
24450-445010.21710.27
34620-462010.60710.66
44346-43469.97810.03
54497-449710.32510.38
64398-439810.09810.15
240min14484-448410.29510.1711.6510.3610.2411.55
24538-453810.41910.49
34765-476510.94011.01
44220-42209.6899.76
55028-502811.54411.61
63535-35358.1168.19
极限14970-497011.41111.243.5711.5011.333.53
24623-462310.61410.71
35022-502211.53011.62
45062-506211.62211.71
54958-495811.38311.47
64738-473810.87810.96
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对照品来源中检所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%
1 15.903919039323391583939039224392570.25
2 15.983910138834389680.49
单位质量响应值RSD%判断
2468.992438.550.88数据可信
供试品溶液-KC031批-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%
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
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min11083-10832.4782.1550.212.482.1550.21
21286-12862.9422.94
31205-12052.7572.76
41011-10112.3132.31
51048-10482.3982.40
6-0.0000.00
30min11583-15833.6223.8616.003.633.8716.00
22033-20334.6514.66
31969-19694.5054.51
41579-15793.6133.62
51657-16573.7913.80
61310-13102.9973.00
45min12434-24345.5695.117.045.585.127.07
22275-22755.2055.22
32306-23065.2765.29
42136-21364.8874.90
52270-22705.1945.20
61978-19784.5254.53
60min12544-25445.8205.6210.045.845.6410.09
22526-25265.7795.80
32760-27606.3156.34
42483-24835.6815.70
52402-24025.4965.51
62015-20154.6104.62
120min13104-31047.1026.326.817.136.356.78
22574-25745.8895.92
32807-28076.4226.45
42667-26676.1026.13
52772-27726.3426.37
62648-26486.0586.08
240min13215-32157.3567.299.517.407.339.45
23391-33917.7587.80
33646-36468.3428.38
43068-30687.0197.06
52787-27876.3766.42
63010-30106.8876.92
极限13157-31577.2237.464.917.287.504.89
23322-33227.6007.65
33452-34527.8987.95
43415-34157.8137.86
53145-31457.1957.24
63062-30627.0067.05
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对照品来源中检所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%
1 15.903911439024390213921138859390460.34
2 15.983932039107392140.39
单位质量响应值RSD%判断
2455.722453.940.06数据可信
供试品溶液-KC031批-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%
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
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min11237-12372.8290.89155.282.830.89155.29
2-0.0000.00
3-0.0000.00
4-0.0000.00
51107-11072.5322.53
6-0.0000.00
30min11719-17193.9313.6110.163.943.6110.10
21725-17253.9453.94
31503-15033.4373.44
41529-15293.4973.50
51313-13133.0033.01
61671-16713.8213.82
45min12028-20284.6384.818.434.654.828.43
22348-23485.3695.38
31963-19634.4894.49
42211-22115.0565.06
52197-21975.0245.03
61876-18764.2904.30
60min12424-24245.5435.3114.565.565.3314.51
22201-22015.0335.05
31694-16943.8743.89
42590-25905.9235.94
52569-25695.8755.89
62461-24615.6285.64
120min12526-25265.7766.525.875.806.545.86
22884-28846.5956.62
32955-29556.7586.78
42997-29976.8546.88
52874-28746.5726.60
62871-28716.5656.59
240min13181-31817.2747.149.647.317.189.58
22608-26085.9646.00
33273-32737.4857.52
43454-34547.8997.93
53277-32777.4947.53
62953-29536.7536.79
极限13332-33327.6207.146.237.677.186.25
23081-30817.0467.09
32947-29476.7396.78
43206-32067.3327.38
53304-33047.5567.61
62854-28546.5276.57
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