缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.942418652418322419162416642415652417680.07
213.982410102408112409100.06
单位质量响应值RSD%判断
17343.4717232.470.46数据可信
供试品溶液-25042401批-氨氯地平-pH4.5(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132430-3243012.16011.803.7112.1611.803.72
230166-3016611.31211.31
331785-3178511.91911.92
10min142329-4232915.87215.235.4415.8915.255.45
241390-4139015.52015.54
338122-3812214.29514.31
15min169695-6969526.13425.652.2326.1825.692.24
266724-6672425.02025.06
368767-6876725.78625.83
20min188261-8826133.09632.881.3533.1932.971.35
288473-8847333.17533.26
386327-8632732.37132.46
30min199338-9933837.24937.083.5637.3937.223.55
295180-9518035.69035.83
3102174-10217438.31338.45
45min1128072-12807248.02447.082.0348.2347.292.01
2125592-12559247.09447.30
3122998-12299846.12146.33
60min1124454-12445446.66746.391.7446.9546.671.73
2121299-12129945.48445.76
3125403-12540347.02347.30
极限1153531-15353157.57057.370.3957.9457.740.39
2153110-15311057.41357.77
3152375-15237557.13757.50
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
116.109256698925655792563819252642925354792551650.03
216.029252384925092992516560.02
单位质量响应值RSD%判断
574854.97577506.620.33数据可信
供试品溶液-25042401批-缬沙坦-pH4.5(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13017472-301747229.19328.522.3229.1928.522.32
22880871-288087127.87227.87
32944367-294436728.48628.49
10min13428268-342826833.16832.432.5133.2232.482.51
23366384-336638432.56932.62
33262055-326205531.56031.61
15min14711434-471143445.58244.861.7645.6944.961.76
24549845-454984544.01944.12
34647681-464768144.96545.07
20min15279919-527991951.08250.780.8151.2650.960.81
25266352-526635250.95151.12
35200661-520066150.31550.49
30min15753080-575308055.66055.001.6255.9255.261.61
25580855-558085553.99354.25
35721174-572117455.35155.61
45min16438405-643840562.29062.040.3662.6562.390.36
26398874-639887461.90762.26
36399839-639983961.91762.27
60min16515938-651593863.04062.321.5363.5062.771.53
26330080-633008061.24261.69
36477817-647781762.67163.13
极限17218407-721840769.83669.640.3370.4070.200.33
27172911-717291169.39669.95
37202271-720227169.68070.24
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.942404772406682407142407882404272406150.07
213.982401722402282402000.02
单位质量响应值RSD%判断
17260.7617181.690.33数据可信
供试品溶液-25042401批-氨氯地平-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191591-9159134.47734.310.7234.4834.310.72
291444-9144434.42234.42
390392-9039234.02634.03
10min171886-7188627.06037.7124.4727.1237.7724.43
2114742-11474243.19243.25
3113931-11393142.88742.94
15min1140401-14040152.85152.751.4452.9552.871.44
2142010-14201053.45653.59
3138019-13801951.95452.08
20min1118588-11858844.64057.1118.9544.8357.3218.91
2166746-16674662.76862.99
3169839-16983963.93264.15
30min1168042-16804263.25662.981.5463.5263.291.52
2169444-16944463.78364.11
3164459-16445961.90762.23
45min1142734-14273453.72966.6816.8854.1067.0816.83
2191725-19172572.17172.60
3196917-19691774.12574.55
60min1185463-18546369.81369.511.7470.2770.031.71
2187379-18737970.53571.08
3181128-18112868.18268.73
极限1158341-15834159.60472.1715.1760.1872.8115.11
2205393-20539377.31677.98
3211470-21147079.60380.26
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
116.109246954924915092470949250592924746692482510.02
216.029267445926573492665900.02
单位质量响应值RSD%判断
574425.53578438.830.50数据可信
供试品溶液-25042401批-缬沙坦-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13427141-342714133.14232.980.5133.1432.980.51
23392441-339244132.80732.81
33411906-341190632.99533.00
10min12612291-261229125.26233.2320.7825.3233.2920.75
23861238-386123837.34037.40
33836391-383639137.10037.16
15min15090984-509098449.23349.210.7149.3349.320.72
25122555-512255549.53849.66
35050899-505089948.84548.96
20min14205042-420504240.66550.8517.4040.8451.0417.36
25720728-572072855.32355.52
35850166-585016656.57556.77
30min16188602-618860259.84759.121.3260.0959.391.28
26121603-612160359.20059.49
36028422-602842258.29858.59
45min15141013-514101349.71761.0816.2050.0661.4516.15
26796015-679601565.72266.11
37010768-701076867.79868.19
60min16798517-679851765.74665.570.9966.1866.050.97
26835770-683577066.10666.61
36706635-670663564.85765.36
极限15776348-577634855.86167.5915.1456.4068.1815.07
27475324-747532472.29172.90
37716794-771679474.62675.24
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.942393462396772391602394282395252394270.09
213.982390602392172391380.05
单位质量响应值RSD%判断
17175.5417105.720.29数据可信
供试品溶液-1批-氨氯地平-pH4.5(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134887-3488713.19412.813.8313.1912.813.83
232420-3242012.26112.26
334336-3433612.98612.99
10min139783-3978315.04615.020.5515.0715.040.56
239482-3948214.93214.95
339899-3989915.09015.11
15min172700-7270027.49527.481.8627.5427.531.86
271286-7128626.96027.01
373982-7398227.98028.03
20min184316-8431631.88831.800.3431.9831.890.35
283772-8377231.68231.77
384168-8416831.83231.93
30min1102027-10202738.58638.711.4938.7338.861.50
2101034-10103438.21138.35
3104018-10401839.33939.49
45min1118099-11809944.66544.960.6044.8845.170.59
2119010-11901045.00945.22
3119493-11949345.19245.40
60min1126267-12626747.75448.762.4248.0449.052.40
2128173-12817348.47548.76
3132348-13234850.05450.34
极限1146139-14613955.26955.070.5155.6355.440.52
2144768-14476854.75155.11
3145944-14594455.19655.57
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
116.109246962924700592444149244020924515192455100.02
216.029253525925805892557920.04
单位质量响应值RSD%判断
574255.28577764.790.44数据可信
供试品溶液-1批-缬沙坦-pH4.5(内含%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13403470-340347032.93832.242.7032.9432.242.70
23231079-323107931.26931.27
33360301-336030132.52032.52
10min13539788-353978834.25734.641.3434.3134.701.34
23632901-363290135.15835.21
33566660-356666034.51734.57
15min15124159-512415949.59049.351.5449.7049.461.54
25011835-501183548.50348.61
35162368-516236849.96050.07
20min15400403-540040352.26352.480.4052.4652.670.39
25423371-542337152.48652.68
35443432-544343252.68052.87
30min16145405-614540559.47359.291.1859.7559.571.17
26046620-604662058.51758.80
36186104-618610459.86760.15
45min16452970-645297062.45062.960.7562.8363.350.75
26518282-651828263.08263.46
36547311-654731163.36363.75
60min16831239-683123966.11066.211.1466.6066.701.13
26769757-676975765.51566.00
36923507-692350767.00367.49
极限17130066-713006669.00269.720.9169.6070.320.91
27227984-722798469.95070.54
37254490-725449070.20670.81
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.942397912396222391912393592394132394750.10
213.982386532388582387560.07
单位质量响应值RSD%判断
17178.9817078.400.42数据可信
供试品溶液-1批-氨氯地平-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183323-8332331.53532.775.3431.5332.775.35
284556-8455632.00132.00
391862-9186234.76634.77
10min1109219-10921941.33539.486.5641.3939.546.56
296512-9651236.52636.58
3107242-10724240.58740.65
15min1129680-12968049.07951.534.7249.2051.654.71
2136285-13628551.57951.69
3142522-14252253.93954.06
20min1158456-15845659.97058.985.1360.1759.195.13
2146888-14688855.59255.79
3162212-16221261.39161.61
30min1155509-15550958.85462.345.1259.1662.645.10
2166610-16661063.05663.35
3172028-17202865.10665.42
45min1182329-18232969.00568.404.2969.4168.814.28
2172310-17231065.21365.61
3187531-18753170.97371.40
60min1172862-17286265.42269.295.2765.9469.825.25
2184422-18442269.79770.30
3191991-19199172.66173.21
极限1195498-19549873.98973.694.0274.6174.334.01
2186533-18653370.59671.22
3202101-20210176.48877.15
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
116.109338417933481293342949333400933555793352960.03
216.029272550927381092731800.01
单位质量响应值RSD%判断
579832.05578850.190.12数据可信
供试品溶液-1批-缬沙坦-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13485669-348566933.53935.146.6633.5435.146.66
23538591-353859134.04834.05
33930698-393069837.82137.82
10min14159125-415912540.01938.624.3440.0738.684.32
23821410-382141036.76936.83
34061847-406184739.08339.15
15min15133765-513376549.39752.386.7749.5252.506.76
25346122-534612251.44051.56
35850818-585081856.29656.42
20min15982891-598289157.56756.614.0657.7756.824.06
25611002-561100253.98954.19
36055284-605528458.26458.49
30min16048256-604825658.19661.525.5258.5061.825.50
26380019-638001961.38861.68
36752596-675259664.97365.29
45min16982172-698217267.18266.283.7867.5866.683.77
26594465-659446563.45163.85
37087610-708761068.19668.62
60min16646135-664613563.94967.685.5764.4668.195.55
27025905-702590567.60368.10
37429003-742900371.48172.02
极限17536272-753627272.51371.893.4273.1372.523.42
27189523-718952369.17769.79
37687660-768766073.97074.63
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