奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10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%
116.107838278352781847836978264783100.11
216.127828278437783600.14
单位质量响应值RSD%判断
4863.984861.040.05数据可信
供试品溶液-24121401批-奥美沙坦酯-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%
5min158408-5840877.78978.602.0577.7978.602.05
259976-5997679.87879.88
359044-5904478.63678.64
458184-5818477.49177.49
557632-5763276.75676.76
660851-6085181.04381.04
10min166399-6639988.43289.061.9088.5689.191.90
268266-6826690.91991.05
365685-6568587.48187.61
465847-6584787.69787.83
566353-6635388.37188.50
668650-6865091.43091.57
15min167295-6729589.62590.642.2389.9090.922.23
269113-6911392.04792.33
367416-6741689.78690.06
466211-6621188.18288.46
567833-6783390.34290.62
670482-7048293.87094.16
20min169031-6903191.93792.311.2492.3692.741.25
270338-7033893.67894.12
368892-6889291.75292.18
468355-6835591.03791.46
568840-6884091.68392.11
670418-7041893.78594.23
30min169436-6943692.47792.691.4393.0693.271.43
270991-7099194.54895.14
369230-6923092.20292.78
468267-6826790.92091.49
569140-6914092.08392.66
670509-7050993.90694.51
45min168666-6866691.45193.481.2592.1994.221.25
271046-7104694.62195.37
370183-7018393.47294.20
470302-7030293.63094.36
569921-6992193.12393.85
671013-7101394.57795.33
60min169755-6975592.90293.511.2793.7994.401.27
271522-7152295.25596.16
369161-6916192.11193.00
470544-7054493.95294.83
569507-6950792.57193.46
670775-7077594.26095.17
极限172106-7210696.03395.591.0197.0796.641.01
272741-7274196.87897.95
371481-7148195.20096.24
470891-7089194.41595.45
571128-7112894.73095.77
672289-7228996.27697.35
奥美沙坦酯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OM230503W对照品来源原料药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250
标示量(mg)40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%
1 11.004566544565894565734564944564244565470.02
2 11.084554954577234566090.35
单位质量响应值RSD%判断
41504.2741210.200.51数据可信
供试品溶液-24121401批-氨氯地平-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%
5min1202329-20232943.98743.543.1943.9943.543.19
2207123-20712345.02945.03
3194788-19478842.34742.35
4198693-19869343.19643.20
5191684-19168441.67241.67
6207016-20701645.00645.01
10min1294531-29453164.03163.861.6964.1063.931.69
2298887-29888764.97865.05
3287626-28762662.53062.60
4289866-28986663.01763.09
5291693-29169363.41463.48
6299941-29994165.20865.28
15min1333514-33351472.50672.381.7272.6972.561.72
2332183-33218372.21772.40
3323586-32358670.34870.52
4331910-33191072.15872.33
5335180-33518072.86973.04
6341177-34117774.17274.36
20min1353352-35335276.81977.311.0877.1277.611.08
2357782-35778277.78278.09
3349714-34971476.02876.32
4354759-35475977.12577.42
5357559-35755977.73478.03
6360445-36044578.36178.67
30min1375311-37531181.59381.731.0182.0282.161.02
2378179-37817982.21782.65
3368926-36892680.20580.62
4375770-37577081.69382.12
5377727-37772782.11882.54
6379673-37967382.54182.98
45min1382820-38282083.22683.800.9583.7984.360.95
2387899-38789984.33084.90
3379564-37956482.51883.07
4385706-38570683.85384.41
5387559-38755984.25684.82
6389273-38927384.62885.20
60min1386106-38610683.94084.001.1284.6484.701.12
2389368-38936884.64985.36
3377931-37793182.16382.85
4387153-38715384.16884.87
5389355-38935584.64685.35
6388302-38830284.41785.13
极限1406897-40689788.46088.170.9389.3089.020.93
2410542-41054289.25290.10
3399533-39953386.85987.69
4405455-40545588.14688.99
5407503-40750388.59289.44
6403553-40355387.73388.59
奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10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%
116.107924779158786287851478580788250.45
216.127950479543795240.04
单位质量响应值RSD%判断
4895.964933.250.54数据可信
供试品溶液-24121402批-奥美沙坦酯-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%
5min159818-5981878.82477.261.9278.8277.261.92
258664-5866477.30377.30
359567-5956778.49378.49
458833-5883377.52677.53
556687-5668774.69874.70
658196-5819676.68776.69
10min168035-6803589.65288.851.3289.7888.981.32
267811-6781189.35689.49
368091-6809189.72589.86
466488-6648887.61387.74
566100-6610087.10287.23
668022-6802289.63489.76
15min170718-7071893.18790.922.1493.4791.202.14
269874-6987492.07592.35
367086-6708688.40188.68
469828-6982892.01492.29
567327-6732788.71988.99
669146-6914691.11691.39
20min169848-6984892.04191.791.1692.4892.221.16
270861-7086193.37693.81
370017-7001792.26392.69
468644-6864490.45490.88
568888-6888890.77691.19
669697-6969791.84292.27
30min171342-7134294.00993.441.5994.6094.021.58
271238-7123893.87294.46
370333-7033392.68093.26
471464-7146494.17094.75
568948-6894890.85591.42
672138-7213895.05895.64
45min171665-7166594.43593.251.3095.1893.991.29
271377-7137794.05594.80
370971-7097193.52094.26
470797-7079793.29194.03
569051-6905190.99091.71
670735-7073593.20993.95
60min171844-7184494.67193.501.2295.5794.391.22
270813-7081393.31294.21
370191-7019192.49393.38
471629-7162994.38895.28
569716-6971691.86792.74
671528-7152894.25495.15
极限172846-7284695.99195.220.9797.0596.260.97
272966-7296696.14997.20
371498-7149894.21595.26
472097-7209795.00496.05
571390-7139094.07395.10
672758-7275895.87596.93
奥美沙坦酯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OM230503W对照品来源原料药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250
标示量(mg)40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%
1 11.004626224622374586594580764579494599090.51
2 11.084633394640174636780.11
单位质量响应值RSD%判断
41809.9141848.190.07数据可信
供试品溶液-24121402批-氨氯地平-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%
5min1190436-19043640.93440.422.8340.9340.422.83
2194363-19436341.77841.78
3192869-19286941.45641.46
4180865-18086538.87638.88
5184074-18407439.56639.57
6185735-18573539.92339.92
10min1286340-28634061.54861.141.2261.6261.201.23
2288151-28815161.93762.01
3285852-28585261.44361.51
4282717-28271760.76960.83
5278330-27833059.82659.89
6285139-28513961.29061.36
15min1332928-33292871.56270.781.2171.7370.951.21
2333194-33319471.61971.79
3331070-33107071.16271.33
4328003-32800370.50370.67
5322672-32267269.35769.52
6327985-32798570.49970.67
20min1352671-35267175.80575.931.0376.1076.211.03
2357061-35706176.74977.04
3356049-35604976.53176.82
4352377-35237775.74276.03
5346859-34685974.55674.84
6354361-35436176.16976.45
30min1382727-38272782.26681.471.1282.6881.881.13
2381613-38161382.02682.45
3380666-38066681.82382.24
4378695-37869581.39981.81
5370878-37087879.71980.12
6379591-37959181.59282.00
45min1393385-39338584.55783.931.1685.1184.481.16
2394439-39443984.78385.34
3393585-39358584.60085.15
4391212-39121284.09084.64
5382989-38298982.32282.86
6387228-38722883.23383.78
60min1395949-39594985.10884.450.9985.8085.140.99
2396210-39621085.16485.86
3393329-39332984.54585.24
4393456-39345684.57285.26
5385503-38550382.86283.54
6392864-39286484.44585.13
极限1406691-40669187.41787.570.9288.2588.400.92
2412719-41271988.71289.55
3406715-40671587.42288.26
4407945-40794587.68688.51
5401318-40131886.26287.08
6409064-40906487.92788.76
奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10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%
116.107819678383783327813778250782600.13
216.127992079794798570.12
单位质量响应值RSD%判断
4860.874953.911.35数据可信
供试品溶液-24121403批-奥美沙坦酯-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%
5min156832-5683275.00576.701.9575.0076.701.95
259078-5907877.96977.97
357249-5724975.55575.56
458822-5882277.63177.63
557271-5727175.58475.58
659470-5947078.48678.49
10min164762-6476285.47186.981.7885.6087.101.77
266355-6635587.57387.70
365261-6526186.12986.26
466135-6613587.28387.41
564992-6499285.77485.90
667908-6790889.62389.75
15min166641-6664187.95188.991.7488.2289.271.74
267869-6786989.57189.85
366151-6615187.30487.57
467452-6745289.02189.30
567004-6700488.43088.70
669473-6947391.68891.97
20min167333-6733388.86490.721.2489.2891.141.24
269278-6927891.43191.86
368612-6861290.55290.97
469166-6916691.28391.71
568307-6830790.14990.57
669720-6972092.01492.45
30min168481-6848190.37991.153.4890.9491.723.46
270407-7040792.92193.50
364664-6466485.34185.91
469370-6937091.55292.13
569862-6986292.20192.77
671616-7161694.51695.10
45min168624-6862490.56892.032.2091.2892.752.20
271011-7101193.71894.45
369209-6920991.34092.05
469733-6973392.03192.76
567833-6783389.52490.24
671967-7196794.98095.72
60min167447-6744789.01491.782.1189.8892.662.10
270965-7096593.65794.55
368949-6894990.99791.86
469891-6989192.24093.12
568709-6870990.68091.55
671310-7131094.11295.01
极限171198-7119893.96595.121.7394.9896.161.73
273408-7340896.88197.93
370897-7089793.56794.58
472571-7257195.77796.81
570867-7086793.52894.55
673513-7351397.02098.08
奥美沙坦酯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OM230503W对照品来源原料药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250
标示量(mg)40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%
1 11.004547274565624556074558004556944556780.15
2 11.084658574648384653480.16
单位质量响应值RSD%判断
41425.2741998.920.98数据可信
供试品溶液-24121403批-氨氯地平-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%
5min1183385-18338539.53040.172.2039.5340.172.20
2188692-18869240.67440.67
3179681-17968138.73238.73
4187636-18763640.44740.45
5187678-18767840.45640.46
6190964-19096441.16441.16
10min1269119-26911958.01158.881.6458.0858.951.64
2274967-27496759.27259.34
3269323-26932358.05558.12
4274277-27427759.12359.19
5270563-27056358.32258.39
6280750-28075060.51860.59
15min1309582-30958266.73367.851.5366.9068.011.53
2317149-31714968.36468.53
3309240-30924066.66066.82
4316984-31698468.32968.49
5313942-31394267.67367.84
6321616-32161669.32769.50
20min1335139-33513972.24273.171.2372.5273.451.23
2342507-34250773.83174.11
3335602-33560272.34272.61
4340416-34041673.38073.66
5337356-33735672.72073.00
6345657-34565774.51074.79
30min1358468-35846877.27178.821.7477.6779.221.74
2372254-37225480.24380.65
3359239-35923977.43777.83
4367183-36718379.15079.55
5363428-36342878.34078.74
6373231-37323180.45380.86
45min1371716-37171680.12781.611.7680.6582.151.76
2385457-38545783.08983.63
3372715-37271580.34280.86
4377595-37759581.39481.93
5376406-37640681.13881.67
6387803-38780383.59484.14
60min1373264-37326480.46082.322.0181.1282.992.00
2389318-38931883.92184.60
3373833-37383380.58381.24
4384380-38438082.85783.53
5379505-37950581.80682.47
6391135-39113584.31385.00
极限1394980-39498085.14286.131.4785.9386.931.47
2406679-40667987.66388.48
3391923-39192384.48385.27
4400286-40028686.28587.09
5397817-39781785.75386.55
6405737-40573787.46088.28
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