坎地氢噻片项目信息
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%
112.064647074644944649154649324650124648120.05
212.124620744623324622030.04
单位质量响应值RSD%判断
38541.6338135.560.75数据可信
加速3月-供试品溶液-2024090121批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318013-31801359.54560.054.7759.5560.054.77
2320865-32086560.07960.08
3301736-30173656.49856.50
4348516-34851665.25765.26
5319299-31929959.78659.79
6315742-31574259.12059.12
10min1427611-42761180.06781.253.1080.1781.353.10
2449364-44936484.14084.24
3415058-41505877.71677.81
4444612-44461283.25083.36
5424795-42479579.54079.64
6442200-44220082.79882.90
15min1455065-45506585.20786.432.4885.4486.662.48
2468461-46846187.71687.96
3448999-44899984.07284.30
4480960-48096090.05690.30
5459599-45959986.05686.29
6456338-45633885.44685.68
20min1466592-46659287.36688.692.5587.7489.062.55
2478987-47898789.68790.07
3459856-45985686.10486.47
4494200-49420092.53592.93
5474517-47451788.85089.23
6467679-46767987.56987.95
30min1480076-48007689.89091.202.5990.4191.732.59
2491064-49106491.94892.48
3472069-47206988.39188.90
4508520-50852095.21695.77
5489527-48952791.66092.18
6481229-48122990.10690.63
45min1491510-49151092.03193.372.8492.7094.052.83
2502676-50267694.12294.81
3481792-48179290.21290.87
4522727-52272797.87798.59
5501880-50188093.97394.65
6491241-49124191.98192.66
60min1497375-49737593.13094.542.8993.9595.372.89
2508005-50800595.12095.97
3486338-48633891.06391.87
4529518-52951899.148100.02
5508793-50879395.26896.10
6499281-49928193.48694.31
极限1519405-51940597.25597.771.1598.2398.761.17
2525722-52572298.43799.44
3514420-51442096.32197.28
4531173-53117399.458100.50
5523767-52376798.07199.06
6518369-51836997.06198.04
坎地氢噻片项目信息
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%
115.442903062903292902572905772909932904920.11
215.422894722899342897030.12
单位质量响应值RSD%判断
18814.2518787.480.11数据可信
加速3月-供试品溶液-2024090121批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110270-11027032.92633.753.9432.9333.763.94
2113888-11388834.00634.01
3109940-10994032.82732.83
4121406-12140636.25136.25
5113040-11304033.75333.75
6109726-10972632.76332.76
10min1202259-20225960.39361.492.8360.4561.552.83
2210616-21061662.88862.94
3197676-19767659.02459.08
4211468-21146863.14263.20
5202747-20274760.53860.59
6210923-21092362.98063.03
15min1244104-24410472.88774.372.1573.0474.532.15
2252579-25257975.41875.58
3242147-24214772.30372.46
4256287-25628776.52576.69
5248025-24802574.05874.21
6251307-25130775.03875.20
20min1266394-26639479.54381.172.0979.8281.462.10
2274831-27483182.06282.35
3264397-26439778.94679.22
4279737-27973783.52783.82
5271749-27174981.14281.42
6274038-27403881.82582.11
30min1284679-28467985.00286.622.0285.4187.042.02
2292761-29276187.41687.84
3282954-28295484.48784.89
4298958-29895889.26689.70
5292142-29214287.23187.65
6289140-28914086.33486.76
45min1292028-29202887.19788.792.0087.7589.352.00
2299958-29995889.56490.13
3290046-29004686.60587.15
4306207-30620791.43092.01
5299935-29993589.55890.12
6296024-29602488.39088.95
60min1294499-29449987.93489.321.9888.6390.031.98
2301622-30162290.06190.78
3291312-29131286.98387.67
4308032-30803291.97592.71
5301302-30130289.96690.68
6298092-29809289.00789.72
极限1303544-30354490.63591.111.2091.4891.971.21
2308030-30803091.97592.84
3300280-30028089.66190.50
4310369-31036992.67393.56
5305603-30560391.25092.11
6302964-30296490.46291.32
坎地氢噻片项目信息
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%
112.064633124633444630674631394633724632470.03
212.124638804642404640600.06
单位质量响应值RSD%判断
38411.8638288.780.23数据可信
加速3月-供试品溶液-2024090121批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1375031-37503170.19860.9811.6270.2060.9811.62
2339866-33986663.61663.62
3260360-26036048.73448.73
4327290-32729061.26261.26
5314974-31497458.95758.96
6337301-33730163.13663.14
10min1458649-45864985.85082.594.5885.9782.694.59
2459123-45912385.93986.04
3406150-40615076.02376.10
4448339-44833983.92084.02
5430228-43022880.53080.63
6444886-44488683.27483.38
15min1480238-48023889.89188.453.3190.1588.693.32
2485304-48530490.83991.09
3443476-44347683.01083.22
4484132-48413290.62090.86
5473840-47384088.69388.93
6468232-46823287.64487.89
20min1490507-49050791.81390.972.7892.2291.362.78
2497551-49755193.13293.53
3463009-46300986.66687.01
4498398-49839893.29093.68
5488690-48869091.47391.85
6478006-47800689.47389.86
30min1501105-50110593.79793.512.0994.3694.052.10
2510478-51047895.55196.11
3484096-48409690.61391.10
4508769-50876995.23195.78
5502698-50269894.09594.63
6490287-49028791.77292.31
45min1506107-50610794.73395.331.7095.4596.021.70
2519380-51938097.21897.93
3500212-50021293.63094.27
4518576-51857697.06797.77
5511416-51141695.72796.42
6499989-49998993.58894.28
60min1507499-50749994.99496.331.6495.8797.181.64
2524964-52496498.26399.14
3510573-51057395.56996.37
4524293-52429398.13799.01
5515189-51518996.43397.28
6505242-50524294.57195.42
极限1522769-52276997.85298.521.5698.8999.531.55
2538949-538949100.881101.92
3525667-52566798.39499.35
4527426-52742698.72499.76
5529155-52915599.047100.06
6513996-51399696.21097.22
坎地氢噻片项目信息
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%
115.442899922902382902232903522903852902380.06
215.422906292904832905560.04
单位质量响应值RSD%判断
18797.8018842.800.17数据可信
加速3月-供试品溶液-2024090121批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130681-13068138.98034.0010.8438.9834.0010.84
2118499-11849935.34635.35
393495-9349527.88827.89
4114900-11490034.27334.27
5108624-10862432.40132.40
6117767-11776735.12835.13
10min1215893-21589364.39761.864.5164.4661.924.51
2215989-21598964.42664.48
3194442-19444257.99958.05
4207482-20748261.88861.95
5197707-19770758.97259.03
6212816-21281663.47963.54
15min1255637-25563776.25275.322.6576.4275.482.66
2260519-26051977.70877.87
3242979-24297972.47672.62
4254849-25484976.01776.18
5245770-24577073.30973.46
6255312-25531276.15576.32
20min1276152-27615282.37182.401.9582.6782.681.96
2283588-28358884.58984.89
3268872-26887280.20080.46
4280228-28022883.58783.87
5271818-27181881.07881.35
6276752-27675282.55082.84
30min1293146-29314687.44088.111.4187.8888.541.41
2301614-30161489.96690.40
3292548-29254887.26287.66
4299761-29976189.41389.84
5292368-29236887.20887.62
6292967-29296787.38787.82
45min1298821-29882189.13390.081.2289.7290.651.21
2307319-30731991.66892.25
3302802-30280290.32090.86
4305055-30505590.99291.57
5299469-29946989.32689.88
6298487-29848789.03389.61
60min1301255-30125589.85990.481.3390.5991.201.32
2309153-30915392.21592.95
3304405-30440590.79991.49
4306081-30608191.29892.03
5301105-30110589.81490.52
6297987-29798788.88489.61
极限1305356-30535691.08291.551.5391.9692.421.52
2315022-31502293.96594.86
3307192-30719291.63092.47
4306658-30665891.47192.35
5306725-30672591.49192.34
6300509-30050989.63690.51
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