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%
114.022464802460352461922460062460842461590.08
214.072472712474972473840.07
单位质量响应值RSD%判断
17557.7017582.370.10数据可信
供试品溶液-25042401批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142012-4201215.50015.084.6815.5015.084.69
241518-4151815.31815.32
338465-3846514.19214.19
438404-3840414.16914.17
542171-4217115.55915.56
642595-4259515.71615.72
10min180966-8096629.87329.652.9529.9029.682.94
282203-8220330.32930.35
376392-7639228.18528.21
478624-7862429.00929.03
581876-8187630.20830.23
682133-8213330.30330.33
15min1112533-11253341.51940.852.4441.5940.922.44
2113013-11301341.69641.77
3106218-10621839.18939.26
4108597-10859740.06740.14
5111831-11183141.26041.34
6112077-11207741.35141.43
20min1136575-13657550.39049.402.4150.5349.542.41
2137796-13779650.84050.99
3128871-12887147.54747.68
4131874-13187448.65548.79
5133972-13397249.42949.57
6134258-13425849.53549.68
30min1172612-17261263.68662.701.9163.9162.931.91
2172279-17227963.56363.79
3165756-16575661.15661.37
4165991-16599161.24361.46
5170609-17060962.94763.17
6172454-17245463.62763.86
45min1208859-20885977.05977.011.1677.3977.341.17
2211715-21171578.11378.45
3205061-20506175.65875.97
4206866-20686676.32476.65
5209387-20938777.25477.59
6210433-21043377.64077.97
60min1240047-24004788.56687.401.1289.0387.861.12
2238230-23823087.89688.36
3232146-23214685.65186.09
4237340-23734087.56788.02
5236477-23647787.24987.71
6237142-23714287.49487.96
90min1278084-278084102.600101.531.30103.21102.131.30
2280627-280627103.538104.15
3272359-272359100.488101.07
4273182-273182100.791101.39
5271487-271487100.166100.77
6275361-275361101.595102.20
120min1301424-301424111.211110.830.97111.99111.600.98
2304886-304886112.489113.27
3296057-296057109.231109.98
4300681-300681110.937111.70
5298894-298894110.278111.05
6300373-300373110.823111.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1323564-323564119.380118.731.15120.35119.691.15
2326823-326823120.582121.56
3315580-315580116.434117.37
4321080-321080118.463119.41
5322240-322240118.891119.85
6321486-321486118.613119.58
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%
114.022466172464332473282467622471022468480.15
214.072508362511282509820.09
单位质量响应值RSD%判断
17606.8517838.100.93数据可信
供试品溶液-1批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138655-3865514.14013.834.4514.1413.824.46
238011-3801113.90413.90
335463-3546312.97212.97
440350-4035014.76014.76
537657-3765713.77513.77
636641-3664113.40313.40
10min170714-7071425.86725.954.1025.8925.984.10
270962-7096225.95825.98
366671-6667124.38824.41
475513-7551327.62227.65
572136-7213626.38726.41
669666-6966625.48325.51
15min198036-9803635.86135.513.6935.9335.573.69
296884-9688435.44035.51
391594-9159433.50533.57
4101940-10194037.28937.36
599116-9911636.25636.32
694824-9482434.68634.75
20min1119041-11904143.54543.133.5243.6743.253.52
2116750-11675042.70742.83
3111568-11156840.81140.93
4123378-12337845.13145.26
5120868-12086844.21344.34
6115770-11577042.34842.47
30min1151425-15142555.39054.713.2355.5954.913.23
2148966-14896654.49154.69
3142576-14257652.15452.34
4156214-15621457.14257.35
5152198-15219855.67355.87
6146057-14605753.42753.62
45min1184175-18417567.37067.312.7467.6667.602.74
2181934-18193466.55166.84
3177205-17720564.82165.09
4190917-19091769.83670.14
5188554-18855468.97269.27
6181275-18127566.30966.59
60min1208644-20864476.32176.242.3576.7276.642.36
2206244-20624475.44375.84
3201914-20191473.85974.24
4215724-21572478.91179.33
5212041-21204177.56377.97
6205930-20593075.32875.72
90min1245601-24560189.84089.432.1290.3789.952.13
2242331-24233188.64389.17
3236077-23607786.35686.86
4249805-24980591.37791.93
5249746-24974691.35691.89
6243249-24324988.97989.50
120min1271547-27154799.33098.681.98100.0199.351.98
2269337-26933798.52299.19
3260534-26053495.30295.95
4276118-276118101.003101.71
5272916-27291699.831100.52
6268113-26811398.07498.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1292026-292026106.822106.191.23107.67107.041.24
2289902-289902106.045106.88
3285329-285329104.372105.18
4294796-294796107.835108.71
5292644-292644107.048107.90
6287164-287164105.043105.87
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%
114.022478862481392483362479022486282481780.13
214.072480602481132480860.02
单位质量响应值RSD%判断
17701.7117632.270.28数据可信
供试品溶液-25042401批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121160-211607.7648.177.527.768.187.50
224835-248359.1139.11
319882-198827.2957.30
422638-226388.3078.31
522857-228578.3878.39
622301-223018.1838.18
10min147247-4724717.33616.744.7717.3516.754.77
248625-4862517.84217.86
343655-4365516.01816.03
444182-4418216.21216.23
546617-4661717.10517.12
643384-4338415.91915.93
15min169427-6942725.47525.024.8125.5225.074.81
272361-7236126.55126.60
366764-6676424.49824.54
463530-6353023.31123.35
570864-7086426.00226.04
666245-6624524.30724.35
20min194334-9433434.61433.165.1234.7033.245.12
293967-9396734.47934.57
386695-8669531.81131.89
485114-8511431.23131.31
595304-9530434.97035.06
686832-8683231.86131.94
30min1128526-12852647.16046.232.8947.3046.362.89
2130252-13025247.79347.94
3121517-12151744.58844.72
4122350-12235044.89445.03
5128525-12852547.16047.30
6124732-12473245.76845.90
45min1158750-15875058.25057.912.3458.4758.132.35
2161559-16155959.28159.51
3151971-15197155.76355.97
4154768-15476856.78957.00
5159420-15942058.49658.72
6160498-16049858.89159.10
60min1181880-18188066.73766.032.5967.0566.342.59
2184411-18441167.66667.99
3172922-17292263.45063.75
4175678-17567864.46164.76
5180910-18091066.38166.70
6183985-18398567.50967.82
90min1209342-20934276.81475.962.8977.2476.382.88
2210536-21053677.25277.69
3195624-19562471.78072.19
4205932-20593275.56275.97
5208453-20845376.48876.92
6212207-21220777.86578.29
120min1227052-22705283.31283.192.4483.8783.742.44
2232877-23287785.44986.02
3218653-21865380.23080.76
4222034-22203481.47182.01
5227839-22783983.60184.16
6231862-23186285.07785.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1249879-24987991.68892.921.4692.3893.611.46
2258114-25811494.71095.42
3249284-24928491.47092.13
4253201-25320192.90793.58
5251816-25181692.39993.10
6257104-25710494.33995.03
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%
114.022438112437272429932434172437892435470.15
214.072493962496452495200.08
单位质量响应值RSD%判断
17371.4017734.191.47数据可信
供试品溶液-1批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118404-184046.7987.376.066.807.376.02
218779-187796.9366.94
319910-199107.3547.35
420606-206067.6117.61
520304-203047.4997.50
621672-216728.0058.00
10min137841-3784113.97714.546.0713.9914.566.05
235372-3537213.06513.08
340342-4034214.90114.91
441255-4125515.23815.25
539730-3973014.67414.69
641722-4172215.41015.42
15min156944-5694421.03321.586.7021.0721.616.69
252100-5210019.24319.28
360847-6084722.47422.51
460189-6018922.23122.27
557140-5714021.10521.14
663280-6328023.37323.41
20min176469-7646928.24428.714.6528.3128.784.65
273019-7301926.97027.04
379933-7993329.52429.60
478498-7849828.99429.07
575289-7528927.80827.88
683195-8319530.72830.81
30min1107396-10739639.66740.413.2639.7840.523.26
2104910-10491038.74938.86
3110076-11007640.65740.78
4109935-10993540.60540.73
5108527-10852740.08540.20
6115540-11554042.67542.80
45min1136229-13622950.31750.621.4350.5050.811.45
2134922-13492249.83450.01
3138218-13821851.05151.24
4137228-13722850.68650.88
5135484-13548450.04250.23
6140236-14023651.79752.00
60min1155014-15501457.25557.191.3157.5257.461.32
2154622-15462257.11057.37
3154813-15481357.18157.46
4153654-15365456.75357.03
5152416-15241656.29656.56
6158471-15847158.53258.82
90min1178719-17871966.01165.891.4766.3766.261.46
2181927-18192767.19667.55
3180961-18096166.83967.21
4175533-17553364.83465.20
5176178-17617865.07265.43
6177055-17705565.39665.78
120min1198391-19839173.27772.951.4573.7573.431.44
2200682-20068274.12374.59
3199304-19930473.61474.10
4192660-19266071.16071.64
5195885-19588572.35172.82
6198175-19817573.19773.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1223807-22380782.66480.983.0383.2681.583.01
2212959-21295978.65779.25
3230528-23052885.14785.75
4215417-21541779.56580.16
5215888-21588879.73980.33
6216840-21684080.09180.71
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