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%
1 10.304411644252441274413343961441180.24
2 10.294424444111441780.22
单位质量响应值RSD%判断
4283.304293.290.17数据可信
供试品溶液-2022082101批-培哚普利-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%
5min144021-4402187.58485.483.2587.5885.483.26
241784-4178483.13483.13
343348-4334886.24586.25
440753-4075381.08281.08
543571-4357186.68986.69
644318-4431888.17588.18
10min148280-4828096.05894.591.2197.0395.541.22
246981-4698193.47494.40
347432-4743294.37195.33
447027-4702793.56594.47
548215-4821595.92996.89
647330-4733094.16895.15
15min148157-4815795.81393.811.6297.8595.811.62
246735-4673592.98494.95
347084-4708493.67895.69
446071-4607191.66393.60
547865-4786595.23297.26
646977-4697793.46695.49
20min147795-4779595.09393.021.4598.2096.071.46
246254-4625492.02795.02
346951-4695193.41496.46
445822-4582291.16894.13
546749-4674993.01296.10
646959-4695993.43096.49
30min147429-4742994.36593.481.2598.5397.551.26
246180-4618091.88095.90
347527-4752794.56098.65
446387-4638792.29296.26
547449-4744994.40598.53
646920-4692093.35297.45
45min147389-4738994.28593.021.0899.5098.141.10
246052-4605291.62596.66
346757-4675793.02898.16
446292-4629292.10397.10
546962-4696293.43698.61
647072-4707293.65598.79
极限147408-4740894.32395.372.08100.58101.522.00
247141-4714193.79299.85
349390-4939098.267104.44
446785-4678593.08499.10
548632-4863296.758102.97
648257-4825796.012102.19
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%
114.121686981689131687601685501685451686930.10
214.211680861687301684080.28
单位质量响应值RSD%判断
11947.1011851.370.57数据可信
供试品溶液-2022082101批-氨氯地平-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%
5min183244-8324445.35146.346.4845.3546.346.49
277963-7796342.47442.47
392099-9209950.17550.17
480902-8090244.07544.07
585530-8553046.59646.60
690633-9063349.37649.38
10min1129729-12972970.67570.062.5271.1870.572.53
2126725-12672569.03969.51
3132701-13270172.29572.85
4123255-12325567.14867.64
5129518-12951870.56071.08
6129639-12963970.62671.18
15min1140282-14028276.42575.211.9877.7176.501.99
2136865-13686574.56375.80
3140911-14091176.76778.13
4133397-13339772.67473.91
5138926-13892675.68676.99
6137951-13795175.15576.49
20min1145663-14566379.35677.302.0781.4979.422.07
2140322-14032276.44678.51
3144026-14402678.46480.68
4137530-13753074.92576.97
5140750-14075076.68078.82
6143004-14300477.90880.08
30min1149694-14969481.55280.201.8484.5783.181.87
2145013-14501379.00281.92
3150645-15064582.07085.16
4143539-14353978.19981.07
5146839-14683979.99782.99
6147506-14750680.36083.39
45min1152687-15268783.18381.481.6187.1185.361.64
2147874-14787480.56184.36
3151557-15155782.56786.56
4146319-14631979.71483.46
5148530-14853080.91884.80
6150456-15045681.96785.89
极限1165132-16513289.96390.302.3494.8195.082.32
2162994-16299488.79893.49
3171466-17146693.41398.33
4160437-16043787.40592.04
5168100-16810091.58096.36
6166349-16634990.62695.46
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%
1 10.304416644337442444411444036441790.27
2 10.294398144136440580.25
单位质量响应值RSD%判断
4289.224281.630.13数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142361-4236184.33883.606.4684.3483.606.46
239241-3924178.12678.13
342634-4263484.88284.88
438355-3835576.36276.36
543980-4398087.56187.56
645371-4537190.33190.33
10min147318-4731894.20794.062.9295.1494.982.96
245684-4568490.95491.82
347479-4747994.52895.47
445674-4567490.93491.78
548112-4811295.78896.76
649191-4919197.93698.94
15min147762-4776295.09193.762.7197.0795.732.74
245010-4501089.61291.49
347586-4758694.74196.73
446081-4608191.74493.60
547726-4772695.01997.06
648388-4838896.33798.43
20min146762-4676293.10092.992.4096.1496.012.45
245305-4530590.19993.07
347502-4750294.57397.62
445440-4544090.46893.35
547170-4717093.91297.01
648070-4807095.70498.87
30min146606-4660692.78992.581.8696.8696.631.93
245361-4536190.31194.19
346800-4680093.17697.27
445577-4557790.74194.62
547165-4716593.90298.04
647511-4751194.59198.82
45min147403-4740394.37693.481.5099.4898.561.57
245918-4591891.42096.30
347333-4733394.23799.37
446194-4619491.96996.86
547420-4742094.41099.59
647444-4744494.45899.73
极限148271-4827196.10494.751.33102.26100.861.19
247242-4724294.05699.95
347888-4788895.342101.52
448129-4812995.822101.74
547411-4741194.392100.62
646591-4659192.76099.09
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%
114.121691021684381691541686731687221688180.18
214.211685501689141687320.16
单位质量响应值RSD%判断
11955.9511874.170.49数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179135-7913543.05544.447.1643.0544.447.16
275494-7549441.07441.07
384421-8442145.93145.93
475459-7545941.05541.05
586261-8626146.93246.93
689343-8934348.60948.61
10min1124042-12404267.48769.985.1367.9770.485.14
2120592-12059265.61066.07
3129757-12975770.59671.11
4125336-12533668.19168.65
5133723-13372372.75473.28
6138316-13831675.25375.79
15min1137837-13783774.99375.894.7576.2277.164.76
2128120-12812069.70670.89
3141497-14149776.98478.28
4137829-13782974.98876.20
5145368-14536879.09080.42
6146236-14623679.56280.94
20min1142439-14243977.49678.224.1179.5680.344.14
2134169-13416972.99774.96
3146335-14633579.61681.77
4140934-14093476.67778.72
5148271-14827180.66982.88
6150518-15051881.89284.15
30min1144788-14478878.77480.173.6581.7083.163.69
2138778-13877875.50478.28
3149028-14902881.08184.12
4145975-14597579.42082.32
5152436-15243682.93586.04
6153120-15312083.30786.48
45min1151021-15102182.16582.602.7785.9686.482.85
2145367-14536779.08982.70
3152200-15220082.80786.74
4149707-14970781.45185.23
5156657-15665785.23289.26
6156011-15601184.88088.98
极限1166541-16654190.60989.891.7895.3294.691.65
2162990-16299088.67793.17
3166176-16617690.41195.27
4168965-16896591.92896.61
5166024-16602490.32895.30
6160659-16065987.40992.45
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%
1 10.302187221897219722201521893219300.28
2 10.292198321822219020.52
单位质量响应值RSD%判断
2129.132128.470.03数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121700-2170086.97185.074.7186.9785.084.71
221344-2134485.54485.54
319777-1977779.26479.26
420990-2099084.12684.13
522774-2277491.27691.28
620776-2077683.26883.27
10min123844-2384495.56497.572.9296.5398.522.91
224432-2443297.92198.87
323413-2341393.83794.72
425492-25492102.169103.10
524621-2462198.67899.69
624268-2426897.26498.19
15min124089-2408996.54697.993.0198.57100.023.00
224582-2458298.522100.56
323199-2319992.97994.90
425348-25348101.592103.66
524793-2479399.368101.48
624687-2468798.943100.95
20min124405-2440597.81397.012.48100.91100.132.48
224509-2450998.229101.36
323078-2307892.49495.45
424834-2483499.532102.73
524210-2421097.031100.25
624195-2419596.971100.08
30min124080-2408096.51096.712.89100.70100.912.86
224197-2419796.979101.20
323140-2314092.74396.73
425307-25307101.428105.73
523894-2389495.765100.06
624161-2416196.835101.02
45min123973-2397396.08196.162.55101.34101.432.52
224123-2412396.682101.98
323127-2312792.69197.71
424857-2485799.624105.06
523526-2352694.29099.65
624353-2435397.604102.86
极限123706-2370695.01195.222.96101.34101.562.91
223636-2363694.731101.11
322857-2285791.60897.65
424926-2492699.901106.44
523344-2334493.56099.96
624076-2407696.494102.84
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%
114.128517384979853748486785130851050.23
214.218481984515846670.26
单位质量响应值RSD%判断
6027.275958.270.82数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149113-4911353.12852.666.5853.1352.666.58
246402-4640250.19650.20
346302-4630250.08850.09
449257-4925753.28453.28
554589-5458959.05259.05
646445-4644550.24250.24
10min167953-6795373.50974.784.5174.1075.364.52
269213-6921374.87275.43
365679-6567971.04971.61
472230-7223078.13578.73
573354-7335479.35180.01
666332-6633271.75572.31
15min174219-7421980.28782.333.8481.6983.743.86
276700-7670082.97184.36
372139-7213978.03779.38
478960-7896085.41686.88
579753-7975386.27387.81
674852-7485280.97282.33
20min176690-7669082.96084.543.6985.2686.873.69
280689-8068987.28689.60
374496-7449680.58782.80
481269-8126987.91390.32
580093-8009386.64189.14
675677-7567781.86484.12
30min178032-7803284.41286.054.0887.6389.324.07
281009-8100987.63290.91
375482-7548281.65384.76
483830-8383090.68494.07
582035-8203588.74292.20
676882-7688283.16886.33
45min178976-7897685.43387.193.4589.5991.413.47
281536-8153688.20292.46
376901-7690183.18887.20
484603-8460391.52095.91
582411-8241189.14993.59
679154-7915485.62589.71
极限183911-8391190.77190.602.8195.8895.802.79
284113-8411390.99096.23
380741-8074187.34292.28
487837-8783795.018100.43
582471-8247189.21494.65
683446-8344690.26895.31
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%
1 10.302191521903219422176121933218910.34
2 10.292171821660216890.19
单位质量响应值RSD%判断
2125.342107.770.59数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121794-2179487.85585.484.7787.8585.484.77
222202-2220289.49989.50
321584-2158487.00887.01
419483-1948378.53978.54
520523-2052382.73182.73
621640-2164087.23487.23
10min124237-2423797.70396.772.8598.6897.722.87
224760-2476099.811100.81
324273-2427397.84898.81
422973-2297392.60793.48
523372-2337294.21695.14
624422-2442298.44999.42
15min124683-2468399.50197.211.73101.5699.231.74
224238-2423897.70799.81
324231-2423197.67999.73
423851-2385196.14798.05
523461-2346194.57596.54
624224-2422497.65099.71
20min124429-2442998.47797.532.22101.64100.632.21
224045-2404596.929100.12
324520-2452098.844101.98
423659-2365995.37398.34
523564-2356494.99098.01
624947-24947100.565103.71
30min124748-2474899.76396.432.24104.02100.622.19
223722-2372295.62799.89
324406-2440698.384102.62
423623-2362395.22899.26
523689-2368995.49499.57
623346-2334694.11198.38
45min124103-2410397.16395.850.91102.53101.110.93
223811-2381195.986101.31
323892-2389296.312101.64
423768-2376895.812100.90
523506-2350694.75699.89
623589-2358995.091100.40
极限123925-2392596.44595.490.96102.89101.810.94
223608-2360895.167101.56
323954-2395496.562102.96
423619-2361995.212101.36
523675-2367595.437101.62
623347-2334794.115100.48
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%
114.128491685006845988477985171848940.26
214.218635685586859710.64
单位质量响应值RSD%判断
6012.326050.040.45数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147870-4787051.45352.224.9051.4552.224.90
248103-4810351.70351.70
348955-4895552.61952.62
445658-4565849.07549.08
548039-4803951.63451.63
652892-5289256.85156.85
10min168812-6881273.96274.403.6474.5374.983.65
270509-7050975.78676.36
369680-6968074.89575.48
466129-6612971.07871.62
567034-6703472.05172.62
673134-7313478.60879.24
15min173148-7314878.62380.372.9080.0281.782.91
275040-7504080.65682.07
375709-7570981.37582.79
473654-7365479.16780.50
572594-7259478.02779.40
678487-7848784.36185.87
20min177237-7723783.01883.533.7485.2885.833.73
277237-7723783.01885.33
378297-7829784.15786.48
476071-7607181.76483.98
574437-7443780.00882.25
682999-8299989.21191.65
30min181546-8154687.64985.422.2790.8488.652.27
279074-7907484.99288.23
380241-8024186.24789.50
478571-7857184.45287.57
576571-7657182.30285.43
680851-8085186.90290.34
45min181549-8154987.65286.461.7991.8290.641.83
280685-8068586.72490.90
380104-8010486.09990.31
479376-7937685.31789.38
578500-7850084.37588.42
682448-8244888.61993.02
极限185346-8534691.73490.671.0096.8795.810.98
284124-8412490.42095.56
385414-8541491.80796.98
483340-8334089.57794.59
584092-8409290.38695.37
683839-8383990.11495.50
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