培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.954139941465414194143641385414210.08
29.994148941485414870.01
单位质量响应值RSD%判断
4162.914152.850.18数据可信
供试品溶液-2022081001批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137679-3767977.31876.4712.6877.3276.4712.68
231988-3198865.64065.64
333105-3310567.93267.93
444790-4479091.90991.91
535951-3595173.77273.77
640077-4007782.23882.24
10min145829-4582994.04193.964.7594.9094.814.76
243229-4322988.70689.44
347202-4720296.85997.61
448984-48984100.516101.54
545902-4590294.19195.01
643598-4359889.46390.38
15min145725-4572593.82894.663.2595.7396.563.26
244654-4465491.63093.35
347736-4773697.95599.79
447612-4761297.70099.84
546831-4683196.09897.96
644232-4423290.76492.67
20min145890-4589094.16795.482.6497.1198.432.62
246723-4672395.87698.61
347549-4754997.571100.49
447727-4772797.936101.16
546886-4688696.21099.14
644417-4441791.14494.06
30min145836-4583694.05694.611.7298.0598.611.75
245783-4578393.94797.75
346666-4666695.75999.76
446850-4685096.137100.45
546695-4669595.81999.82
644795-4479591.92095.85
45min145461-4546193.28694.462.0998.3299.522.11
246189-4618994.78099.62
346258-4625894.92299.99
447474-4747497.417102.80
546219-4621994.84299.91
644588-4458891.49596.45
极限145650-4565093.67495.621.7399.75101.721.66
247703-4770397.887103.78
347014-4701496.473102.60
447076-4707696.600103.06
546340-4634095.090101.21
645798-4579893.97899.94
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931613681617381615401616241614821615500.09
214.001615341612291613820.14
单位质量响应值RSD%判断
11597.2711527.290.43数据可信
供试品溶液-2022081001批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117908-11790866.10765.1412.9966.1165.1412.99
2100699-10069956.45856.46
3102130-10213057.26157.26
4142117-14211779.68079.68
5113689-11368963.74163.74
6120574-12057467.60267.60
10min1159582-15958289.47288.976.0390.2189.706.04
2147428-14742882.65883.29
3164526-16452692.24492.88
4172819-17281996.89497.78
5158894-15889489.08689.79
6148916-14891683.49284.24
15min1161900-16190090.77291.234.7692.5092.944.76
2154895-15489586.84488.39
3168512-16851294.47996.14
4170381-17038195.52797.49
5168474-16847494.45896.16
6152131-15213185.29586.97
20min1163112-16311291.45192.413.9394.1995.143.92
2165155-16515592.59795.11
3167493-16749393.90896.62
4170929-17092995.83498.86
5169344-16934494.94597.69
6152914-15291485.73488.36
30min1160714-16071490.10791.213.3293.8694.963.36
2158981-15898189.13592.67
3164324-16432492.13195.89
4168284-16828494.35198.44
5168693-16869394.58098.38
6155107-15510786.96390.54
45min1162486-16248691.10091.493.5695.8596.263.59
2160966-16096690.24894.78
3163064-16306491.42496.20
4170933-17093395.836100.97
5167600-16760093.96898.82
6154074-15407486.38490.93
极限1168314-16831494.36896.211.54100.13102.001.52
2175204-17520498.231103.76
3171981-17198196.424102.22
4173402-17340297.221103.42
5171855-17185596.353102.25
6168877-16887794.684100.19
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.954145341480414574143441399414450.08
29.994148441479414820.01
单位质量响应值RSD%判断
4165.334152.350.23数据可信
供试品溶液-2022081001批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141462-4146285.06179.007.0485.0679.007.05
238972-3897279.95379.95
339140-3914080.29780.30
440314-4031482.70682.71
533708-3370869.15369.15
637461-3746176.85376.85
10min144770-4477091.84789.683.7392.7990.563.76
244576-4457691.44992.34
344443-4444391.17792.07
444813-4481391.93692.85
540691-4069183.47984.25
643003-4300388.22289.08
15min144463-4446391.21890.692.4393.1892.572.48
244923-4492392.16194.07
344496-4449691.28593.19
445177-4517792.68294.62
542187-4218786.54888.24
643997-4399790.26292.10
20min145273-4527392.87990.782.0895.8693.672.13
244709-4470991.72294.65
344467-4446791.22694.15
444799-4479991.90794.88
542918-4291888.04890.71
643339-4333988.91291.75
30min144783-4478391.87490.612.0095.8994.502.06
244751-4475191.80895.76
344605-4460591.50995.44
444791-4479191.89095.88
542910-4291088.03291.67
643164-4316488.55392.38
45min144441-4444191.17290.701.3696.2095.601.44
244339-4433990.96395.93
344673-4467391.64896.60
444868-4486892.04897.06
543423-4342389.08493.70
643532-4353289.30894.12
极限144427-4442791.14491.950.8897.1997.860.88
244990-4499092.29998.28
345423-4542393.18799.16
444948-4494892.21398.25
544777-4477791.86297.47
644366-4436691.01996.82
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931612681613951613971614231610861613140.09
214.001613531614521614020.05
单位质量响应值RSD%判断
11580.3311528.710.32数据可信
供试品溶液-2022081001批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130736-13073673.34867.397.4173.3567.397.41
2121580-12158068.21168.21
3119894-11989467.26567.27
4126708-12670871.08871.09
5105091-10509158.96058.96
6116714-11671465.48165.48
10min1156169-15616987.61784.553.8888.4385.303.90
2155116-15511687.02687.78
3149929-14992984.11684.86
4153164-15316485.93186.72
5140050-14005078.57479.23
6149805-14980584.04784.77
15min1156543-15654387.82786.382.9689.6288.072.99
2157737-15773788.49790.22
3152234-15223485.40987.09
4157155-15715588.17089.91
5145662-14566281.72283.25
6154476-15447686.66788.33
20min1159317-15931789.38386.442.5292.1589.092.57
2156162-15616287.61390.32
3152725-15272585.68588.32
4155874-15587487.45190.18
5148230-14823083.16385.60
6152125-15212585.34887.97
30min1157822-15782288.54486.192.4492.3089.802.50
2155693-15569387.35091.03
3152435-15243585.52289.11
4156482-15648287.79391.49
5147765-14776582.90286.26
6151579-15157985.04288.61
45min1157744-15774488.50186.641.9793.2491.212.05
2155096-15509687.01591.67
3154247-15424786.53991.07
4157261-15726188.23092.90
5149586-14958683.92488.20
6152656-15265685.64690.16
极限1161875-16187590.81892.310.9596.5497.840.85
2164871-16487192.49998.12
3166746-16674693.55199.05
4164805-16480592.46298.11
5164572-16457292.33197.55
6164374-16437492.22097.69
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.954144941457415124142741435414560.09
29.994145241423414380.05
单位质量响应值RSD%判断
4166.434147.950.32数据可信
供试品溶液-2022081302批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140158-4015882.41987.064.5882.4287.064.58
244248-4424890.81390.81
342635-4263587.50287.50
445046-4504692.45192.45
540708-4070883.54783.55
641712-4171285.60885.61
10min143345-4334588.95991.712.5089.8892.682.51
244663-4466391.66492.67
344386-4438691.09692.07
446727-4672795.90196.93
544287-4428790.89391.82
644697-4469791.73492.69
15min143712-4371289.71391.612.1591.6293.592.16
244169-4416990.65192.68
344407-4440791.13993.12
446482-4648295.39897.49
544560-4456091.45393.39
644476-4447691.28193.25
20min143409-4340989.09191.062.2091.9994.062.21
244430-4443091.18694.22
343790-4379089.87392.87
446182-4618294.78297.93
543938-4393890.17793.13
644469-4446991.26694.25
30min143651-4365189.58791.252.4893.4895.272.48
244243-4424390.80294.85
343834-4383489.96393.96
446558-4655895.55499.76
543760-4376089.81193.77
644722-4472291.78695.78
45min143370-4337089.01190.312.2393.9095.342.22
243674-4367489.63594.69
343968-4396890.23895.23
445814-4581494.02799.29
544187-4418790.68895.64
643015-4301588.28293.30
极限144143-4414390.59791.371.4596.4797.401.49
244046-4404690.39896.45
344061-4406190.42996.43
445730-4573093.854100.17
544703-4470391.74797.71
644432-4443291.19097.19
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.937994279955798657993879757798910.11
214.007965179684796680.03
单位质量响应值RSD%判断
5735.185690.570.56数据可信
供试品溶液-2022081302批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161698-6169870.01176.756.9170.0176.756.91
271776-7177681.44781.45
368833-6883378.10778.11
473874-7387483.82883.83
564372-6437273.04573.05
665264-6526474.05774.06
10min173772-7377283.71287.963.5184.4988.813.54
278717-7871789.32390.23
376226-7622686.49687.36
481951-8195192.99393.92
577106-7710687.49588.31
677301-7730187.71688.54
15min175685-7568585.88388.682.9787.5990.502.99
277962-7796288.46690.36
376798-7679887.14688.97
482455-8245593.56595.53
578382-7838288.94390.73
677593-7759388.04889.85
20min175641-7564185.83388.593.2288.4991.403.24
278714-7871489.32092.20
375919-7591986.14888.95
482587-8258793.71596.72
577631-7763188.09190.86
677930-7793088.43091.21
30min176102-7610286.35688.853.2589.9792.643.26
278650-7865089.24793.12
376297-7629786.57790.33
482929-8292994.10398.15
577009-7700987.38591.14
678789-7878989.40593.16
45min176308-7630886.59088.753.1091.1793.543.11
278090-7809088.61293.48
376969-7696987.34092.06
482803-8280393.96099.05
578591-7859189.18093.90
676498-7649886.80591.56
极限181812-8181292.83592.831.3898.3798.601.46
281723-8172392.73498.58
380575-8057591.43197.12
483834-8383495.130101.26
581920-8192092.95898.67
680984-8098491.89697.61
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.954137341295414064133841287413400.13
29.994140241371413860.06
单位质量响应值RSD%判断
4154.774142.740.21数据可信
供试品溶液-2022081302批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141376-4137685.09184.828.2885.0984.828.29
238379-3837978.92778.93
344743-4474392.01592.02
437591-3759177.30777.31
545876-4587694.34594.35
639503-3950381.23981.24
10min143964-4396490.41394.003.4691.3694.943.49
244434-4443491.38092.26
346581-4658195.79596.82
445804-4580494.19795.06
548308-4830899.347100.39
645160-4516092.87393.78
15min144329-4432991.16493.573.3093.1195.553.29
244604-4460491.72993.62
344348-4434891.20393.29
445843-4584394.27796.18
548252-4825299.231101.38
645614-4561493.80695.74
20min144361-4436191.22994.623.0594.1997.653.07
244546-4454691.61094.52
346827-4682796.30199.40
446287-4628795.19098.14
548061-4806198.839102.09
645988-4598894.57597.55
30min144589-4458991.69893.514.0095.6797.593.96
242410-4241087.21791.15
345679-4567993.94098.11
446266-4626695.14799.16
547761-4776198.222102.57
646123-4612394.85398.88
45min144195-4419590.88893.662.4595.8898.782.50
244500-4450091.51596.41
345527-4552793.62798.84
445673-4567393.92899.00
547264-4726497.200102.64
646110-4611094.82699.91
极限144916-4491692.37194.081.8898.38100.231.94
244627-4462791.77697.69
345864-4586494.320100.57
445731-4573194.047100.16
546773-4677396.190102.71
646560-4656095.752101.89
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.937961079514799437978379835797370.22
214.007995879793798760.15
单位质量响应值RSD%判断
5724.125705.430.24数据可信
供试品溶液-2022081302批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167053-6705376.06175.189.5976.0675.189.59
259442-5944267.42867.43
371974-7197481.64381.64
459206-5920667.16067.16
574707-7470784.74484.74
665278-6527874.04874.05
10min177301-7730187.68690.403.9888.5391.234.01
276073-7607386.29387.04
380495-8049591.30992.22
478591-7859189.14989.90
585026-8502696.44997.39
680659-8065991.49592.32
15min178021-7802188.50390.594.1690.3292.434.15
277295-7729587.67989.39
376905-7690587.23789.16
479626-7962690.32392.06
585573-8557397.06999.08
681755-8175592.73894.58
20min178538-7853889.08992.083.6791.8994.923.70
277218-7721887.59290.27
381971-8197192.98395.87
481115-8111592.01294.75
585504-8550496.991100.08
682705-8270593.81696.69
30min178472-7847289.01491.155.1692.8195.025.12
273576-7357683.46187.12
380262-8026291.04594.97
481114-8111492.01195.77
585729-8572997.246101.42
683000-8300094.15198.06
45min178691-7869189.26391.743.0894.0496.623.15
278227-7822788.73693.32
380706-8070691.54896.48
480220-8022090.99795.78
584867-8486796.268101.52
682529-8252993.61698.57
极限182048-8204893.07195.181.8898.84101.082.00
282099-8209993.12998.70
384492-8449295.843101.80
483790-8379095.047100.84
585806-8580697.334103.65
685203-8520396.650102.65
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