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100309-201404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2000
标示量(mg)6.25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%
112.132412582411682411692414192414012412830.06
212.152382252382742382500.02
单位质量响应值RSD%判断
19891.4319609.051.02数据可信
中间条件24月-供试品溶液-2023020821批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122449-12244944.50745.792.8544.5145.792.85
2125210-12521045.51145.51
3132338-13233848.10248.10
4125095-12509545.46945.47
5123253-12325344.80044.80
6127576-12757646.37146.37
10min1240076-24007687.26289.122.9987.3489.202.99
2234388-23438885.19585.27
3243893-24389388.65088.73
4247614-24761490.00290.08
5250713-25071391.12991.20
6254515-25451592.51092.59
15min1272402-27240299.01298.781.1699.2399.011.16
2265807-26580796.61596.83
3273861-27386199.54299.77
4271177-27117798.56798.79
5272892-27289299.19099.42
6274473-27447399.765100.00
20min1273081-27308199.25999.031.0699.6499.421.06
2266849-26684996.99497.37
3274630-27463099.822100.22
4272398-27239899.01199.40
5273370-27337099.36499.76
6274416-27441699.744100.14
30min1274537-27453799.78899.111.21100.3499.661.21
2266346-26634696.81197.35
3274446-27444699.755100.32
4272089-27208998.89899.45
5273364-27336499.36299.92
6275167-275167100.017100.58
45min1273804-27380499.52298.761.08100.2499.481.08
2266291-26629196.79197.49
3273116-27311699.272100.00
4270656-27065698.37799.10
5272266-27226698.96399.69
6274049-27404999.611100.34
60min1273455-27345599.39598.831.10100.2899.721.10
2266098-26609896.72197.58
3273405-27340599.377100.27
4271703-27170398.75899.64
5272576-27257699.07599.96
6274247-27424799.683100.58
极限1272946-27294699.21098.581.00100.2699.631.00
2266104-26610496.72397.75
3272351-27235198.993100.05
4270695-27069598.39299.44
5271619-27161998.72799.78
6273605-27360599.449100.51
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%
115.821495351498301497151498171499211497640.10
215.881496031494841495440.06
单位质量响应值RSD%判断
9466.759417.130.38数据可信
中间条件24月-供试品溶液-2023020821批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133157-3315719.71420.462.7019.7120.462.70
235233-3523320.94820.95
335408-3540821.05221.05
434399-3439920.45220.45
533472-3347219.90119.90
634818-3481820.70120.70
10min187373-8737351.94852.641.3451.9852.681.34
287202-8720251.84751.88
387979-8797952.30952.34
489243-8924353.06053.09
589377-8937753.14053.17
690075-9007553.55553.59
15min1122341-12234172.73972.091.0972.8672.221.09
2119204-11920470.87471.00
3120617-12061771.71471.84
4120752-12075271.79471.92
5121797-12179772.41572.54
6122789-12278973.00573.13
20min1139404-13940482.88481.751.4183.1281.991.41
2134115-13411579.73979.98
3136628-13662881.23381.48
4137465-13746581.73181.97
5138419-13841982.29882.54
6138913-13891382.59282.84
30min1155362-15536292.37290.451.6492.7590.821.63
2148157-14815788.08888.46
3150639-15063989.56489.94
4152139-15213990.45690.83
5153259-15325991.12191.50
6153191-15319191.08191.46
45min1160396-16039695.36594.191.3295.9094.721.32
2155230-15523092.29392.81
3157743-15774393.78794.31
4157273-15727393.50894.04
5160688-16068895.53896.07
6159182-15918294.64395.18
60min1163942-16394297.47395.851.4698.1696.531.46
2157446-15744693.61194.28
3160203-16020395.25095.93
4160462-16046295.40496.09
5163133-16313396.99297.68
6162062-16206296.35597.05
极限1162615-16261596.68495.981.1697.5496.831.16
2158471-15847194.22095.05
3160497-16049795.42596.27
4160805-16080595.60896.45
5163409-16340997.15698.01
6162834-16283496.81497.67
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100309-201404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2000
标示量(mg)6.25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%
112.132387692389072387422388182387852388040.03
212.152387632389252388440.05
单位质量响应值RSD%判断
19687.0619657.940.11数据可信
中间条件24月-供试品溶液-2023020921批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129638-12963847.30444.297.0147.3044.297.00
2131137-13113747.85147.85
3123319-12331944.99945.00
4120633-12063344.01844.02
5113756-11375641.50941.51
6109746-10974640.04640.05
10min1266657-26665797.30294.492.0397.3894.572.03
2260184-26018494.94095.02
3261118-26111895.28195.36
4250734-25073491.49291.57
5257338-25733893.90193.97
6257724-25772494.04294.11
15min1278267-278267101.53899.681.33101.7899.911.33
2268322-26832297.90998.15
3276170-276170100.773101.01
4271882-27188299.20899.43
5273448-27344899.780100.01
6270905-27090598.85299.08
20min1278072-278072101.46799.671.31101.88100.061.31
2268193-26819397.86298.26
3276246-276246100.801101.20
4271890-27189099.21199.60
5273255-27325599.709100.10
6271178-27117898.95299.34
30min1277934-277934101.41799.481.36102.00100.051.36
2268024-26802497.80198.36
3275976-275976100.702101.27
4271782-27178299.17299.73
5272017-27201799.25899.82
6270084-27008498.55299.11
45min1277190-277190101.14599.311.32101.89100.041.32
2267114-26711497.46998.20
3275076-275076100.374101.11
4270949-27094998.86899.59
5272269-27226999.350100.07
6270386-27038698.66399.38
60min1276449-276449100.87599.141.22101.79100.031.22
2267171-26717197.48998.38
3274293-274293100.088100.99
4270036-27003698.53599.42
5271730-27173099.153100.04
6270454-27045498.68799.57
极限1276323-276323100.82998.811.34101.9199.871.34
2266392-26639297.20598.26
3273446-27344699.779100.85
4269568-26956898.36499.41
5270905-27090598.85299.91
6268116-26811697.83498.88
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%
115.821497221496801497571497951499231497750.07
215.881495311497741496520.12
单位质量响应值RSD%判断
9467.459423.930.33数据可信
中间条件24月-供试品溶液-2023020921批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133226-3322619.74718.228.0819.7518.228.08
233613-3361319.97719.98
331180-3118018.53118.53
430003-3000317.83117.83
528249-2824916.78916.79
627689-2768916.45616.46
10min191247-9124754.23053.461.4754.2653.491.48
290687-9068753.89753.93
390618-9061853.85653.89
487501-8750152.00452.03
589752-8975253.34253.37
689893-8989353.42553.45
15min1123127-12312773.17771.931.1773.3072.051.17
2119709-11970971.14671.27
3122153-12215372.59872.72
4119823-11982371.21371.33
5121357-12135772.12572.24
6120012-12001271.32671.44
20min1137813-13781381.90580.791.0682.1581.031.06
2133647-13364779.42979.67
3136995-13699581.41981.66
4135289-13528980.40580.64
5136102-13610280.88881.13
6135776-13577680.69580.93
30min1151731-15173190.17788.761.2290.5689.141.22
2146411-14641187.01587.39
3150647-15064789.53389.91
4149268-14926888.71389.08
5149394-14939488.78889.16
6148671-14867188.35888.73
45min1158882-15888294.42793.231.3094.9693.751.29
2153499-15349991.22891.75
3158502-15850294.20194.73
4156713-15671393.13893.65
5157894-15789493.84094.36
6155685-15568592.52793.04
60min1160811-16081195.57494.551.2296.2695.231.22
2155602-15560292.47893.15
3160300-16030095.27095.95
4158498-15849894.19994.87
5160447-16044795.35796.03
6158911-15891194.44495.12
极限1162690-16269096.69094.821.4697.5495.651.46
2156109-15610992.77993.60
3160757-16075795.54196.38
4159221-15922194.62995.46
5160590-16059095.44296.28
6157884-15788493.83494.66
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100309-201404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2000
标示量(mg)6.25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%
112.132384582384452384762384902385252384790.02
212.152394202392962393580.04
单位质量响应值RSD%判断
19660.2619700.250.15数据可信
中间条件24月-供试品溶液-2023021021批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122584-12258444.71345.299.3444.7145.299.35
2132542-13254248.34548.34
3114966-11496641.93441.93
4143409-14340952.30952.31
5114363-11436341.71441.71
6117189-11718942.74542.74
10min1253707-25370792.54093.553.9492.6193.623.95
2260528-26052895.02895.11
3258021-25802194.11494.18
4271121-27112198.89298.98
5240106-24010687.57987.65
6255344-25534493.13793.21
15min1279261-279261101.861101.500.76102.09101.730.77
2277920-277920101.372101.61
3275171-275171100.369100.60
4280368-280368102.265102.52
5276548-276548100.871101.09
6280327-280327102.250102.48
20min1279567-279567101.973101.680.86102.37102.080.86
2277910-277910101.368101.78
3275255-275255100.400100.79
4279748-279748102.039102.46
5277807-277807101.331101.71
6282370-282370102.995103.39
30min1280028-280028102.141101.790.89102.71102.360.89
2277459-277459101.204101.78
3275900-275900100.635101.20
4279973-279973102.121102.71
5278127-278127101.447102.00
6282968-282968103.213103.78
45min1279301-279301101.876101.720.73102.61102.460.73
2277785-277785101.323102.07
3276203-276203100.746101.47
4279104-279104101.804102.57
5278530-278530101.594102.32
6282285-282285102.964103.70
60min1279141-279141101.817101.640.90102.73102.550.90
2277412-277412101.187102.10
3275639-275639100.540101.44
4278804-278804101.694102.63
5277826-277826101.338102.23
6283077-283077103.253104.17
极限1278460-278460101.569101.310.91102.65102.390.90
2277383-277383101.176102.26
3274646-274646100.178101.24
4276719-276719100.934102.04
5277141-277141101.088102.15
6282202-282202102.934104.02
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%
115.821494781494241492461494831494251494110.07
215.881498501495511497000.15
单位质量响应值RSD%判断
9444.449426.950.14数据可信
中间条件24月-供试品溶液-2023021021批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132452-3245219.30719.759.9119.3119.759.91
235443-3544321.08721.09
330648-3064818.23418.23
438761-3876123.06123.06
530372-3037218.07018.07
631458-3145818.71618.72
10min188782-8878252.82153.845.0552.8553.885.05
293284-9328455.49955.53
388575-8857552.69852.73
498118-9811858.37558.41
585021-8502150.58350.61
689236-8923653.09153.12
15min1123011-12301173.18573.642.1073.3173.772.10
2124645-12464574.15774.29
3121781-12178172.45372.57
4127729-12772975.99276.13
5120467-12046771.67271.79
6125048-12504874.39774.52
20min1138905-13890582.64183.351.7082.8883.601.70
2139900-13990083.23383.48
3137963-13796382.08182.32
4142707-14270784.90385.17
5137831-13783182.00282.24
6143277-14327785.24285.49
30min1154474-15447491.90492.171.0192.2892.551.01
2154710-15471092.04592.43
3153092-15309291.08291.46
4155585-15558592.56592.97
5154024-15402491.63692.01
6157640-15764093.78894.17
45min1163570-16357097.31697.041.0997.8597.581.09
2162586-16258696.73097.27
3159937-15993795.15495.68
4163604-16360497.33697.89
5163776-16377697.43897.96
6165190-16519098.28098.82
60min1164251-16425197.72198.261.0998.4298.961.09
2164945-16494598.13498.84
3162679-16267996.78697.47
4164736-16473698.00998.73
5166414-16641499.00899.69
6167881-16788199.881100.59
极限1167338-16733899.55898.491.58100.4299.361.57
2164576-16457697.91498.78
3161877-16187796.30997.16
4164089-16408997.62598.51
5166168-16616898.86199.71
6169257-169257100.699101.57
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100309-201404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2000
标示量(mg)6.25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%
112.132394552394832395312393912395742394870.03
212.152392942391382392160.05
单位质量响应值RSD%判断
19743.3619688.560.20数据可信
中间条件24月-供试品溶液-GL031批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160179-16017958.32050.998.9858.3250.998.98
2134827-13482749.08949.09
3124030-12403045.15845.16
4133151-13315148.47948.48
5140754-14075451.24751.25
6147348-14734853.64853.65
10min1245342-24534289.32794.223.6089.4294.303.59
2254745-25474592.75092.83
3254613-25461392.70292.78
4266040-26604096.86396.94
5260326-26032694.78294.87
6271549-27154998.86998.96
15min1259927-25992794.63799.122.4194.8899.362.41
2271477-27147798.84299.08
3274574-27457499.970100.20
4272329-27232999.15399.39
5277093-277093100.887101.13
6278017-278017101.224101.48
20min1259440-25944094.46098.982.4694.8699.382.45
2270534-27053498.49998.90
3274700-274700100.016100.41
4271934-27193499.00999.42
5277482-277482101.029101.44
6276985-276985100.848101.27
30min1259833-25983394.60398.902.3695.1699.472.35
2270002-27000298.30598.87
3274542-27454299.958100.52
4271833-27183398.97299.54
5277230-277230100.937101.52
6276373-276373100.625101.22
45min1259526-25952694.49198.752.3795.2199.492.37
2269668-26966898.18498.91
3273857-27385799.709100.44
4270922-27092298.64099.38
5276576-276576100.699101.45
6276836-276836100.794101.55
60min1259085-25908594.33198.602.3295.2199.502.31
2269746-26974698.21299.11
3273895-27389599.723100.62
4270635-27063598.53699.44
5275539-275539100.321101.24
6275938-275938100.467101.39
极限1258761-25876194.21398.512.4395.2599.582.42
2269287-26928798.04599.10
3272954-27295499.380100.44
4269697-26969798.19499.26
5276059-276059100.511101.59
6276678-276678100.736101.83
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%
115.821496961499351498791497831497641498110.07
215.881489621489971489800.02
单位质量响应值RSD%判断
9469.729381.610.67数据可信
中间条件24月-供试品溶液-GL031批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137350-3735022.24518.4111.5122.2518.4111.52
230494-3049418.16218.16
327486-2748616.37116.37
428189-2818916.78916.79
529839-2983917.77217.77
632071-3207119.10119.10
10min193539-9353955.71154.683.7455.7554.713.75
289653-8965353.39753.43
385906-8590651.16551.19
494507-9450756.28856.32
592466-9246655.07255.10
694753-9475356.43456.47
15min1122681-12268173.06874.891.8973.2075.021.88
2124782-12478274.31974.44
3123826-12382673.75073.86
4126900-12690075.58175.70
5127383-12738375.86975.99
6128909-12890976.77776.90
20min1136460-13646081.27584.332.0681.5384.582.05
2140377-14037783.60883.85
3141698-14169884.39584.63
4142656-14265684.96585.21
5144454-14445486.03686.28
6143906-14390685.71085.96
30min1148861-14886188.66192.552.4689.0592.942.45
2154406-15440691.96392.35
3156165-15616593.01193.39
4154844-15484492.22492.61
5160009-16000995.30095.69
6158072-15807294.14794.54
45min1154595-15459592.07696.002.4092.6196.542.39
2159796-15979695.17495.71
3161989-16198996.48097.01
4160892-16089295.82696.37
5165305-16530598.45599.00
6164553-16455398.00798.56
60min1155078-15507892.36496.262.4093.0596.962.39
2159980-15998095.28395.98
3163119-16311997.15397.84
4161008-16100895.89596.60
5165559-16555998.60699.32
6164964-16496498.25298.97
极限1154725-15472592.15396.002.2793.0096.862.26
2160299-16029995.47396.33
3161924-16192496.44197.29
4160966-16096695.87096.73
5164804-16480498.15699.03
6164384-16438497.90698.79
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