替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851333061333041332391333781332471332950.05
213.841324411326511325460.12
单位质量响应值RSD%判断
9624.199577.020.35数据可信
供试品溶液-24112101批-氢氯噻嗪-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%
5min196071-9607172.04972.101.8572.0572.101.85
297806-9780673.35073.35
397708-9770873.27773.28
493321-9332169.98769.99
594852-9485271.13571.13
697055-9705572.78772.79
10min1110634-11063482.97181.463.2483.3781.863.23
2111755-11175583.81184.22
3111437-11143783.57383.98
4103013-10301377.25577.64
5105780-10578079.33079.73
6109119-10911981.83582.24
15min1113209-11320984.90283.052.2685.7683.902.26
2113813-11381385.35586.23
3110986-11098683.23584.11
4107584-10758480.68381.50
5108415-10841581.30782.14
6110407-11040782.80183.66
20min1117429-11742988.06784.133.3089.4085.453.28
2114787-11478786.08587.43
3112472-11247284.34985.68
4106670-10667079.99881.26
5110813-11081383.10584.39
6110940-11094083.20084.52
30min1112321-11232184.23684.362.1886.0686.142.18
2115814-11581486.85688.68
3114521-11452185.88687.69
4108846-10884681.63083.34
5111330-11133083.49385.24
6112069-11206984.04785.83
45min1116383-11638387.28283.712.9489.5785.962.92
2112927-11292784.69087.00
3112241-11224184.17686.46
4106446-10644679.83081.99
5110176-11017682.62784.84
6111522-11152283.63785.88
60min1115881-11588186.90683.443.2089.6886.153.17
2113686-11368685.26088.04
3111945-11194583.95486.70
4105475-10547579.10281.71
5110017-11001782.50885.18
6110530-11053082.89385.61
极限1114636-11463685.97283.372.3889.2386.552.38
2113002-11300284.74788.00
3111639-11163983.72486.94
4107188-10718880.38683.43
5109351-10935182.00985.14
6111192-11119283.38986.56
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.044304664306444307244305204309144306540.05
211.084289384291994290680.05
单位质量响应值RSD%判断
39008.5138724.550.52数据可信
供试品溶液-24112101批-替米沙坦-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%
5min1101355-10135523.47023.045.3723.4723.045.37
2107603-10760324.91724.92
393798-9379821.72021.72
497828-9782822.65422.65
594035-9403521.77521.78
6102400-10240023.71223.71
10min1188394-18839443.62542.865.1543.7642.995.15
2200007-20000746.31546.45
3186914-18691443.28343.40
4182750-18275042.31842.44
5171005-17100539.59939.72
6181518-18151842.03342.16
15min1253038-25303858.59557.365.3858.9757.725.38
2267338-26733861.90662.30
3245723-24572356.90157.26
4253111-25311158.61258.97
5229353-22935353.11053.45
6237549-23754955.00855.37
20min1310665-31066571.93969.215.0372.6469.895.02
2320650-32065074.25174.99
3299074-29907469.25569.93
4296829-29682968.73569.42
5281684-28168465.22865.86
6284284-28428465.83066.50
30min1350933-35093381.26484.534.7182.3685.604.69
2388238-38823889.90291.05
3373384-37338486.46387.52
4378702-37870287.69488.76
5350833-35083381.24182.24
6348258-34825880.64481.68
45min1412754-41275495.57994.462.4597.1395.992.45
2409450-40945094.81496.47
3420101-42010197.28198.82
4412970-41297095.62997.18
5393297-39329791.07492.52
6398839-39883992.35793.84
60min1417582-41758296.69795.521.4798.7897.581.47
2410325-41032595.01797.20
3420877-42087797.46099.54
4411935-41193595.39097.48
5410528-41052895.06497.02
6403703-40370393.48395.48
极限1412249-41224995.46295.021.2598.0897.621.25
2407388-40738894.33797.04
3417506-41750696.68099.30
4414183-41418395.91098.53
5406719-40671994.18296.67
6404078-40407893.57096.09
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851329831329561326741327911325931327990.13
213.841323621324481324050.05
单位质量响应值RSD%判断
9588.389566.840.16数据可信
供试品溶液-24112102批-氢氯噻嗪-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%
5min195667-9566771.91877.725.2671.9277.725.26
2110730-11073083.24283.24
399495-9949574.79674.80
4107730-10773080.98780.99
5103190-10319077.57477.57
6103480-10348077.79277.79
10min1104935-10493578.88584.894.5379.2885.324.53
2118949-11894989.42089.88
3111603-11160383.89884.31
4117108-11710888.03688.49
5110158-11015882.81283.24
6114812-11481286.31086.74
15min1108530-10853081.58886.213.7182.4387.123.72
2118842-11884289.34090.30
3113913-11391385.63586.52
4118748-11874889.26990.21
5111079-11107983.50484.40
6116970-11697087.93388.84
20min1109788-10978882.53487.463.4783.8288.843.49
2119750-11975090.02391.48
3115497-11549786.82588.18
4120894-12089490.88392.32
5114433-11443386.02687.38
6117680-11768088.46689.87
30min1111334-11133483.69687.563.2385.4589.433.25
2119460-11946089.80591.76
3115021-11502186.46888.31
4120993-12099390.95792.90
5113534-11353485.35087.18
6118520-11852089.09890.99
45min1106195-10619579.83385.333.8182.0587.693.81
2117355-11735588.22290.68
3112626-11262684.66786.99
4117386-11738688.24590.69
5111619-11161983.91086.22
6115879-11587987.11389.50
60min1108897-10889781.86485.753.3384.5288.583.34
2116647-11664787.69090.63
3113578-11357885.38388.17
4118229-11822988.87991.81
5110332-11033282.94385.72
6116722-11672287.74690.62
极限1108415-10841581.50185.683.0884.6188.983.11
2117302-11730288.18291.61
3114018-11401885.71488.98
4117672-11767288.46091.89
5111663-11166383.94387.18
6114757-11475786.26989.63
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.044307214312844305284304274303074306530.09
211.084294504292114293300.04
单位质量响应值RSD%判断
39008.4238748.190.48数据可信
供试品溶液-24112102批-替米沙坦-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%
5min194230-9423021.81424.8610.8421.8124.8610.84
2125985-12598529.16529.16
3101712-10171223.54623.55
4113636-11363626.30626.31
598498-9849822.80222.80
6110253-11025325.52325.52
10min1172942-17294240.03542.668.2640.1642.808.27
2210487-21048748.72748.89
3174808-17480840.46740.60
4189373-18937343.83943.98
5169765-16976539.30039.43
6188370-18837043.60743.75
15min1234065-23406554.18556.506.7754.5356.886.78
2271856-27185662.93363.37
3234215-23421554.21954.58
4247390-24739057.26957.66
5225823-22582352.27752.62
6251064-25106458.12058.50
20min1281285-28128565.11668.035.3165.7668.725.34
2319352-31935273.92874.71
3283769-28376965.69166.35
4297162-29716268.79169.50
5279044-27904464.59765.23
6302565-30256570.04270.75
30min1364910-36491084.47584.172.9785.4885.243.01
2380912-38091288.17989.37
3350118-35011881.05082.07
4364967-36496784.48885.58
5354293-35429382.01783.01
6366409-36640984.82285.92
45min1393438-39343891.07993.362.0492.5594.902.08
2408064-40806494.46496.15
3396124-39612491.70093.17
4406944-40694494.20595.76
5400049-40004992.60994.06
6415240-41524096.12697.69
60min1403410-40341093.38794.472.0595.3796.522.05
2406138-40613894.01996.23
3409742-40974294.85396.83
4413427-41342795.70697.79
5395800-39580091.62593.59
6419941-41994197.21499.32
极限1400755-40075592.77293.691.2395.2796.271.28
2406919-40691994.19996.93
3405114-40511493.78296.29
4408459-40845994.55697.17
5397016-39701691.90794.38
6410106-41010694.93797.58
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