坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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 12.174812844800404807904795664790434801450.19
2 12.194767804771244769520.06
单位质量响应值RSD%判断
39453.1639126.500.59数据可信
中间条件18月-供试品溶液-2024082821批-氢氯噻嗪-含0.35%吐温20的磷酸盐缓冲液(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%
5min1414416-41441675.71771.3810.3575.7271.3810.36
2326492-32649259.65259.65
3385430-38543070.42170.42
4369305-36930567.47567.47
5404630-40463073.92973.93
6443691-44369181.06581.07
10min1480175-48017587.73190.023.1587.8690.143.16
2476572-47657287.07387.17
3485721-48572188.74588.86
4492306-49230689.94890.06
5504331-50433192.14592.27
6517255-51725594.50694.64
15min1494225-49422590.29892.781.9590.5793.051.95
2505247-50524792.31292.56
3508522-50852292.91093.18
4502973-50297391.89792.16
5512175-51217593.57893.85
6523693-52369395.68295.97
20min1498559-49855991.09093.741.8491.5194.161.85
2514040-51404093.91994.32
3519753-51975394.96295.38
4506305-50630592.50592.92
5514674-51467494.03594.47
6524929-52492995.90896.36
30min1504018-50401892.08894.501.7392.6695.081.73
2520861-52086195.16595.72
3522708-52270895.50296.08
4509793-50979393.14393.71
5517475-51747594.54695.14
6528452-52845296.55297.16
45min1505412-50541292.34294.811.7793.0795.541.77
2524202-52420295.77596.49
3526044-52604496.11296.85
4511164-51116493.39394.12
5517857-51785794.61695.36
6528740-52874096.60497.38
60min1505694-50569492.39495.101.7493.2896.001.74
2526847-52684796.25997.13
3527815-52781596.43597.33
4514210-51421093.95094.83
5520479-52047995.09596.00
6528026-52802696.47497.41
极限1546512-54651299.85299.530.79100.89100.580.77
2544386-54438699.463100.50
3548489-548489100.213101.27
4548996-548996100.305101.34
5537738-53773898.24899.31
6542329-54232999.087100.18
坎地沙坦酯氢氯噻嗪片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.993009683010313011953010683009653010450.04
216.043008003014413011200.16
单位质量响应值RSD%判断
18827.0818773.070.21数据可信
中间条件18月-供试品溶液-2024082821批-坎地沙坦酯-含0.35%吐温20的磷酸盐缓冲液(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%
5min1142784-14278442.63640.7410.5042.6440.7410.50
2111758-11175833.37133.37
3136620-13662040.79540.80
4131222-13122239.18339.18
5142070-14207042.42342.42
6154211-15421146.04846.05
10min1224272-22427266.96866.934.0267.0467.004.03
2209737-20973762.62862.68
3220079-22007965.71665.78
4224815-22481567.13067.20
5229642-22964268.57268.64
6236376-23637670.58370.66
15min1258883-25888377.30378.592.3277.4978.772.32
2255615-25561576.32776.49
3260200-26020077.69777.87
4264702-26470279.04179.22
5267793-26779379.96480.15
6271947-27194781.20481.40
20min1277315-27731582.80784.781.6483.1285.091.65
2280304-28030483.70083.99
3282799-28279984.44584.75
4285895-28589585.36985.68
5287264-28726485.77886.10
6289860-28986086.55386.88
30min1294160-29416087.83790.111.3988.2990.561.39
2302521-30252190.33490.76
3300669-30066989.78190.23
4303327-30332790.57491.03
5303490-30349090.62391.08
6306493-30649391.52091.99
45min1296351-29635188.49191.901.9489.0992.501.93
2310462-31046292.70593.28
3307348-30734891.77592.37
4308795-30879592.20792.81
5310122-31012292.60393.22
6313474-31347493.60494.23
60min1298063-29806389.00392.261.8089.7593.021.79
2311759-31175993.09293.82
3309419-30941992.39393.14
4310103-31010392.59893.35
5311077-31107792.88993.66
6313481-31348193.60694.39
极限1315603-31560394.24094.490.7195.1395.400.69
2318413-31841395.07995.97
3318103-31810394.98795.89
4317810-31781094.89995.81
5312509-31250993.31694.24
6316253-31625394.43495.37
坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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 12.174760174767934765394762554760494763310.07
2 12.194741094748394744740.11
单位质量响应值RSD%判断
39139.7738923.220.40数据可信
中间条件18月-供试品溶液-2024083021批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1356207-35620765.51257.7819.5065.5157.7819.50
2288501-28850153.06053.06
3383590-38359070.54870.55
4232591-23259142.77742.78
5361346-36134666.45766.46
6262821-26282148.33748.34
10min1463831-46383185.30582.365.4985.4182.465.51
2432664-43266479.57379.66
3470831-47083186.59386.71
4423910-42391077.96378.03
5474637-47463787.29387.40
6421069-42106977.44177.52
15min1481275-48127588.51388.532.3988.7688.762.41
2469250-46925086.30286.52
3495220-49522091.07891.34
4473854-47385487.14987.35
5495412-49541291.11391.37
6473050-47305087.00187.21
20min1484590-48459089.12390.771.9789.5291.161.98
2479577-47957788.20188.57
3503462-50346292.59493.01
4493175-49317590.70291.05
5502296-50229692.37992.79
6498249-49824991.63591.99
30min1490220-49022090.15992.682.5490.7193.222.53
2486699-48669989.51190.02
3513225-51322594.38994.96
4508089-50808993.44593.94
5506710-50671093.19193.75
6518764-51876495.40895.92
45min1508791-50879193.57494.132.2994.2794.822.27
2491198-49119890.33891.00
3516875-51687595.06195.79
4517978-51797895.26495.92
5510848-51084893.95294.67
6525310-52531096.61297.28
60min1493742-49374290.80694.183.0391.6695.023.01
2493094-49309490.68791.50
3521852-52185295.97696.86
4521685-52168595.94596.76
5512189-51218994.19995.07
6529877-52987797.45298.28
极限1540693-54069399.441100.320.82100.45101.320.80
2544983-544983100.230101.19
3539882-53988299.292100.34
4548460-548460100.870101.84
5547699-547699100.730101.76
6551100-551100101.355102.35
坎地沙坦酯氢氯噻嗪片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.993004053011473011713007163009433008760.11
216.043003433010563007000.17
单位质量响应值RSD%判断
18816.5118746.880.27数据可信
中间条件18月-供试品溶液-2024083021批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116642-11664234.86431.3418.4834.8631.3418.48
296791-9679128.93028.93
3129431-12943138.68638.69
480398-8039824.03124.03
5118123-11812335.30635.31
687727-8772726.22126.22
10min1208935-20893562.45058.837.5462.5158.887.55
2189997-18999756.78956.84
3210837-21083763.01863.08
4178931-17893153.48253.52
5210070-21007062.78962.85
6182220-18222054.46554.51
15min1246376-24637673.64172.403.2573.8072.553.27
2236729-23672970.75770.90
3250160-25016074.77274.94
4233237-23323769.71469.84
5250969-25096975.01475.18
6235804-23580470.48170.62
20min1266053-26605379.52279.691.7379.8179.961.75
2261390-26139078.12878.39
3271541-27154181.16281.46
4261887-26188778.27778.52
5272282-27228281.38481.67
6266567-26656779.67679.93
30min1283037-28303784.59986.211.6985.0286.621.68
2282697-28269784.49784.89
3290330-29033086.77887.21
4288602-28860286.26286.64
5290516-29051686.83487.26
6295383-29538388.28988.67
45min1296323-29632388.57089.501.6989.1390.051.68
2291786-29178687.21487.75
3301354-30135490.07390.65
4300543-30054389.83190.35
5299797-29979789.60890.18
6306783-30678391.69692.23
60min1291813-29181387.22289.952.3387.9390.642.31
2293672-29367287.77788.45
3304789-30478991.10091.82
4303762-30376290.79391.46
5301360-30136090.07590.79
6310183-31018392.71293.40
极限1312157-31215793.30294.210.9294.1595.050.91
2313637-31363793.74594.57
3312706-31270693.46694.34
4317332-31733294.84995.67
5315702-31570294.36295.23
6319568-31956895.51896.36
坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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 12.174742364745084743494745714744074744140.03
2 12.194730764735834733300.08
单位质量响应值RSD%判断
38982.2538829.370.28数据可信
中间条件18月-供试品溶液-2024090121批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1244053-24405345.03059.8014.9845.0359.8014.98
2341400-34140062.99162.99
3340630-34063062.84962.85
4378176-37817669.77669.78
5350552-35055264.68064.68
6289900-28990053.48953.49
10min1409686-40968675.59081.495.4675.6781.595.47
2440719-44071981.31681.42
3456165-45616584.16684.27
4474236-47423687.50087.62
5450571-45057183.13483.24
6418650-41865077.24477.33
15min1463050-46305085.43689.082.9085.6489.322.92
2481619-48161988.86289.10
3483912-48391289.28689.53
4498824-49882492.03792.30
5497452-49745291.78492.03
6472050-47205087.09787.31
20min1487519-48751989.95191.981.8490.2992.361.86
2494272-49427291.19791.59
3497455-49745591.78492.18
4509490-50949094.00594.42
5509707-50970794.04594.44
6492688-49268890.90591.27
30min1511506-51150694.37794.811.4094.8795.341.41
2508883-50888393.89394.43
3514464-51446494.92395.47
4521501-52150196.22196.79
5522469-52246996.40096.96
6504183-50418393.02693.54
45min1524479-52447996.77097.210.9497.4297.910.96
2523844-52384496.65397.35
3526792-52679297.19797.90
4531230-53123098.01698.75
5534082-53408298.54299.26
6520845-52084596.10096.77
60min1530464-53046497.87598.490.7898.6999.350.80
2532240-53224098.20299.06
3534150-53415098.55599.42
4536597-53659799.00699.90
5540343-54034399.698100.58
6529156-52915697.63398.46
极限1537076-53707699.09599.650.58100.07100.670.60
2537555-53755599.183100.20
3544067-544067100.385101.42
4540355-54035599.700100.76
5543539-543539100.287101.33
6537804-53780499.229100.22
坎地沙坦酯氢氯噻嗪片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.993004333003183001203002113004543003070.05
216.042991732996752994240.12
单位质量响应值RSD%判断
18780.9318667.330.43数据可信
中间条件18月-供试品溶液-2024090121批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183558-8355825.05232.5514.6125.0532.5514.62
2112875-11287533.84233.84
3112945-11294533.86333.86
4128029-12802938.38538.39
5117233-11723335.14835.15
696724-9672428.99929.00
10min1177418-17741853.19359.816.5053.2359.866.52
2203698-20369861.07261.13
3204120-20412061.19961.25
4215615-21561564.64564.71
5203022-20302260.86960.93
6193029-19302957.87357.92
15min1232067-23206769.57874.543.6569.7174.703.66
2250150-25015074.99975.16
3248957-24895774.64174.80
4258830-25883077.60177.77
5253998-25399876.15376.31
6247726-24772674.27274.42
20min1263765-26376579.08182.512.4679.3382.792.47
2273632-27363282.03982.32
3272221-27222181.61681.90
4280864-28086484.20884.51
5280585-28058584.12484.41
6280175-28017584.00184.27
30min1293118-29311887.88289.191.1388.2689.611.14
2296111-29611188.77989.20
3294667-29466788.34688.76
4299870-29987089.90690.35
5301688-30168890.45190.88
6299450-29945089.78090.19
45min1303765-30376591.07491.850.6991.6092.420.71
2305394-30539491.56292.13
3304959-30495991.43292.00
4307544-30754492.20792.80
5309666-30966692.84393.42
6306862-30686292.00292.56
60min1305119-30511991.48092.260.6092.1692.980.61
2306848-30684891.99892.72
3307281-30728192.12892.85
4308378-30837892.45793.20
5310599-31059993.12393.86
6308107-30810792.37693.09
极限1307626-30762692.23192.990.5893.0693.860.59
2308957-30895792.63093.50
3311174-31117493.29594.17
4310131-31013192.98293.88
5312811-31281193.78694.67
6310207-31020793.00593.87
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