左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.83 3885163900893885633906543907803897200.29
217.893886783896813891800.19
单位质量响应值RSD%判断
21857.5421754.050.34数据可信
供试品溶液-24073102批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114620-114620106.202104.801.41106.20104.801.41
2113921-113921105.554105.55
3111793-111793103.582103.58
4110761-110761102.626102.63
5114644-114644106.224106.22
6112878-112878104.588104.59
10min1113867-113867105.504104.371.37106.68105.531.37
2113198-113198104.884106.06
3110570-110570102.449103.60
4111285-111285103.112104.25
5114586-114586106.170107.35
6112335-112335104.085105.25
15min1114241-114241105.851103.781.45108.20106.101.44
2112682-112682104.406106.74
3110245-110245102.148104.44
4110345-110345102.241104.53
5113161-113161104.850107.21
6111352-111352103.174105.49
20min1112597-112597104.327102.681.34107.86106.161.33
2110978-110978102.827106.33
3110787-110787102.650106.07
4108509-108509100.540103.96
5112077-112077103.845107.37
6109946-109946101.871105.34
30min1111823-111823103.610101.101.45108.30105.721.43
2108412-108412100.450105.09
3107854-10785499.933104.50
4107513-10751399.617104.16
5109735-109735101.675106.35
6109359-109359101.327105.92
45min1108945-108945100.94399.511.21106.78105.251.20
2108331-108331100.375106.13
3105378-10537897.638103.31
4106972-10697299.115104.76
5108045-108045100.110105.92
6106735-10673598.896104.62
60min1108549-108549100.57798.641.25107.54105.481.24
2106958-10695899.102105.97
3105049-10504997.334104.09
4105753-10575397.986104.73
5107085-10708599.220106.14
6105352-10535297.614104.44
90min1106733-10673398.89497.251.03106.97105.201.04
2104676-10467696.988104.96
3104435-10443596.765104.61
4103777-10377796.155103.99
5105742-10574297.976106.00
6104420-10442096.751104.66
极限1105205-10520597.47896.140.94106.65105.160.95
2103785-10378596.162105.21
3102710-10271095.166104.08
4102687-10268795.145104.05
5104311-10431196.650105.76
6103873-10387396.244105.23
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.8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%
116.19 3921663895473895433917643907403907520.32
216.173890903899363895130.16
单位质量响应值RSD%判断
24135.3924088.620.14数据可信
供试品溶液-24073102批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138039-3803932.37230.763.0332.3730.763.02
235434-3543430.15530.16
334908-3490829.70829.71
436641-3664131.18331.18
535899-3589930.55130.55
635932-3593230.57930.58
10min153798-5379845.78444.642.9546.1444.982.94
250988-5098843.39243.73
350149-5014942.67843.01
453844-5384445.82346.17
552670-5267044.82445.16
653289-5328945.35045.69
15min159388-5938850.54150.932.9551.4151.772.93
258841-5884150.07550.89
357335-5733548.79449.60
462018-6201852.77953.63
559838-5983850.92451.76
661654-6165452.46953.31
20min165393-6539355.65155.082.2657.0856.482.23
262107-6210752.85554.23
365057-6505755.36556.71
465496-6549655.73957.18
564076-6407654.53155.93
666210-6621056.34757.77
30min168689-6868958.45650.6220.6360.5052.6319.84
263345-6334553.90855.87
349354-4935442.00243.96
439483-3948333.60135.66
566418-6641856.52458.53
669593-6959359.22661.28
45min170033-7003359.60057.302.8062.3059.882.86
265610-6561055.83658.40
365369-6536955.63158.06
466199-6619956.33758.77
568635-6863558.41061.05
668123-6812357.97560.69
60min170687-7068760.15759.273.3963.5262.483.26
268225-6822558.06161.24
367540-6754057.47960.52
472480-7248061.68364.74
566998-6699857.01760.30
671923-7192361.20964.56
90min172064-7206461.32960.622.9965.3664.502.96
268816-6881658.56462.39
369220-6922058.90862.59
472253-7225361.48965.24
570576-7057660.06263.98
674478-7447863.38367.42
极限188730-8873075.51275.601.8280.2280.141.84
287568-8756874.52379.00
387966-8796674.86279.20
489094-8909475.82280.25
587727-8772774.65879.25
691885-9188578.19782.94
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.83 3879443880763887963889993877163883060.15
217.893892323890043891180.05
单位质量响应值RSD%判断
21778.2421750.590.09数据可信
供试品溶液-24073103批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108300-108300100.536102.262.21100.54102.262.21
2110827-110827102.882102.88
3112904-112904104.810104.81
4111651-111651103.647103.65
5106261-10626198.64398.64
6110982-110982103.026103.03
10min1108332-108332100.566101.642.04101.68102.782.04
2109334-109334101.496102.64
3112004-112004103.975105.14
4111929-111929103.905105.06
5106162-10616298.55199.65
6109204-109204101.375102.52
15min1109780-109780101.910101.061.50104.14103.321.50
2109651-109651101.790104.06
3110306-110306102.398104.72
4108551-108551100.769103.08
5105768-10576898.186100.38
6109125-109125101.302103.57
20min1106148-10614898.53899.962.25101.91103.352.23
2106807-10680799.150102.55
3109803-109803101.931105.39
4109762-109762101.893105.32
5103976-10397696.52299.80
6109569-109569101.714105.11
30min1105676-10567698.10098.482.35102.56102.982.33
2106960-10696099.292103.80
3107268-10726899.578104.17
4107695-10769599.975104.53
5101237-10123793.97998.33
6107703-10770399.982104.51
45min1104462-10446296.97397.991.76102.52103.581.76
2106891-10689199.228104.83
3106824-10682499.166104.86
4106908-10690899.244104.91
5102311-10231194.976100.38
6105917-10591798.324103.96
60min1103251-10325195.84996.291.69102.48102.981.66
2104725-10472597.217103.93
3105923-10592398.330105.13
4104897-10489797.377104.15
5102210-10221094.883101.34
6101371-10137194.104100.83
90min1101807-10180794.50995.581.85102.20103.331.84
2104435-10443596.948104.74
3105114-10511497.579105.47
4102954-10295495.573103.43
599868-9986892.709100.22
6103579-10357996.154103.93
极限1100670-10067093.45394.391.74102.20103.201.69
2104566-10456697.070105.94
3101074-10107493.828102.80
4102570-10257095.217104.13
599443-9944392.314100.85
6101730-10173094.437103.28
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.8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%
116.19 3897233892893891963898613890183894170.10
216.173899663898773899220.02
单位质量响应值RSD%判断
24052.9324113.910.18数据可信
供试品溶液-24073103批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126272-2627222.38522.282.8922.3822.282.88
226194-2619422.31822.32
326846-2684622.87422.87
425406-2540621.64721.65
525159-2515921.43621.44
627048-2704823.04623.05
10min140082-4008234.15133.107.5134.4033.357.47
238558-3855832.85333.10
340926-4092634.87135.12
433564-3356428.59828.84
538239-3823932.58132.82
641734-4173435.55935.82
15min145948-4594839.15038.482.5839.7839.102.63
244470-4447037.89038.50
346142-4614239.31539.96
443509-4350937.07137.63
544497-4449737.91338.51
646407-4640739.54140.19
20min150495-5049543.02442.714.0744.0943.764.05
250388-5038842.93343.97
350189-5018942.76343.84
448376-4837641.21842.19
547758-4775840.69241.71
653569-5356945.64346.73
30min155611-5561147.38345.305.3648.9246.815.29
251847-5184744.17645.69
351978-5197844.28745.84
451462-5146243.84845.28
550360-5036042.90944.38
657712-5771249.17350.77
45min158481-5848149.82847.537.1751.9049.557.01
256572-5657248.20250.20
355496-5549647.28549.33
454383-5438346.33648.25
549034-4903441.77943.73
660715-6071551.73253.88
60min159557-5955750.74549.013.1753.3751.563.23
257426-5742648.92951.47
357060-5706048.61751.19
455526-5552647.31049.74
555774-5577447.52249.94
659805-5980550.95653.68
90min161161-6116152.11250.674.6455.3053.764.59
259774-5977450.93054.01
357331-5733148.84851.96
457198-5719848.73551.69
557318-5731848.83751.78
664013-6401354.54257.83
极限179893-7989368.07267.421.9271.8471.082.01
280140-8014068.28271.93
377526-7752666.05569.71
477876-7787666.35369.85
578071-7807166.52070.00
681285-8128569.25873.15
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.83 3901613907843900713899513909683903870.12
217.893902003903973902980.04
单位质量响应值RSD%判断
21894.9521816.550.26数据可信
供试品溶液-24073104批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112847-112847104.320103.574.15104.32103.574.16
2105561-10556197.58497.58
3108502-108502100.303100.30
4114475-114475105.825105.82
5111944-111944103.485103.48
6118894-118894109.910109.91
10min1111790-111790103.343103.523.70104.50104.683.71
2106315-10631598.28199.37
3108620-108620100.412101.53
4114564-114564105.907107.08
5112717-112717104.200105.35
6117910-117910109.000110.22
15min1111983-111983103.521102.504.04105.83104.814.04
2105080-10508097.14099.32
3106888-10688898.811101.04
4112701-112701104.185106.54
5110966-110966102.581104.89
6117675-117675108.783111.22
20min1109978-109978101.667101.234.39105.13104.674.38
2103337-10333795.52898.78
3105056-10505697.117100.45
4112558-112558104.053107.56
5109644-109644101.359104.81
6116442-116442107.643111.28
30min1109221-109221100.968100.394.29105.55104.954.28
2102375-10237594.63998.96
3104277-10427796.397100.80
4111947-111947103.488108.15
5108873-108873100.646105.22
6114868-114868106.188111.03
45min1108904-108904100.67599.513.76106.38105.193.77
2102413-10241394.674100.04
3103380-10338095.568101.05
4110271-110271101.938107.75
5108022-10802299.859105.55
6112880-112880104.350110.37
60min1106452-10645298.40898.234.04105.24105.024.04
2100188-10018892.61799.04
3102777-10277795.011101.55
4109645-109645101.360108.31
5106658-10665898.598105.40
6111860-111860103.407110.58
90min1105823-10582397.82697.164.72105.75105.044.66
299121-9912191.63199.08
399041-9904191.55799.15
4108231-108231100.053108.13
5107441-10744199.322107.22
6110955-110955102.571110.90
极限1104098-10409896.23296.144.30105.24105.104.28
298127-9812790.71299.18
399696-9969692.162100.78
4106830-10683098.757107.94
5105118-10511897.175106.18
6110104-110104101.784111.25
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.8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%
116.19 3909273912903932313911493913583915910.24
216.173905073913203909140.15
单位质量响应值RSD%判断
24187.2124175.260.04数据可信
供试品溶液-24073104批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133160-3316028.13927.263.5128.1427.263.51
230734-3073426.08126.08
332728-3272827.77327.77
432791-3279127.82627.83
530634-3063425.99626.00
632687-3268727.73827.74
10min144747-4474737.97237.583.5938.2837.883.59
243041-4304136.52436.81
345394-4539438.52138.83
445306-4530638.44638.76
541654-4165435.34735.64
645581-4558138.68038.99
15min150988-5098843.26842.513.6444.0043.223.63
248355-4835541.03441.73
350718-5071843.03943.78
450351-5035142.72743.46
547586-4758640.38141.06
652541-5254144.58645.32
20min153073-5307345.03744.883.9446.2546.083.93
250392-5039242.76243.91
354197-5419745.99147.21
453983-5398345.81047.02
550352-5035242.72843.86
655355-5535546.97448.21
30min156838-5683848.23247.743.5249.9549.443.51
253972-5397245.80047.43
356529-5652947.97049.70
457596-5759648.87550.60
553862-5386245.70747.31
658778-5877849.87951.63
45min159614-5961450.58849.632.8752.8451.852.90
256666-5666648.08650.22
359250-5925050.27952.54
458908-5890849.98952.25
556168-5616847.66449.78
660313-6031351.18153.49
60min154342-5434246.11449.755.0448.9352.534.88
257121-5712148.47251.14
361243-6124351.97054.79
460651-6065151.46854.29
556822-5682248.21950.86
661595-6159552.26955.15
90min161359-6135952.06950.283.9755.3953.603.84
258361-5836149.52552.73
358678-5867849.79453.19
457344-5734448.66252.05
556905-5690548.28951.47
662837-6283753.32356.78
极限184654-8465471.83772.051.0075.7475.941.03
284238-8423871.48475.24
385598-8559872.63876.59
486299-8629973.23377.16
584261-8426171.50375.22
684403-8440371.62475.68
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.83 3891863890003891653891903890963891270.03
217.893887153884533885840.05
单位质量响应值RSD%判断
21824.2821720.740.34数据可信
供试品溶液-24073105批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108927-108927101.08199.423.76101.0899.423.76
2104079-10407996.58296.58
3108272-108272100.473100.47
4103605-10360596.14296.14
5113875-113875105.673105.67
6104070-10407096.57496.57
10min1109103-109103101.24499.654.08102.37100.754.08
2103752-10375296.27997.35
3108904-108904101.060102.18
4104231-10423196.72397.79
5114681-114681106.421107.59
6103621-10362196.15797.23
15min1105624-10562498.01698.393.74100.26100.603.73
2102615-10261595.22497.37
3107064-10706499.352101.59
4102853-10285395.44597.59
5113339-113339105.175107.53
6104684-10468497.14499.29
20min1106412-10641298.74798.843.39102.08102.143.40
2104374-10437496.856100.06
3106983-10698399.277102.62
4102212-10221294.85098.05
5112966-112966104.829108.35
6106099-10609998.457101.68
30min1104119-10411996.61996.174.23101.05100.584.21
2100080-10008092.87197.15
3105098-10509897.528101.97
4100300-10030093.07697.33
5111486-111486103.456108.15
6100752-10075293.49597.81
45min1103160-10316095.73095.044.17101.24100.514.15
299825-9982592.63597.94
3104076-10407696.580102.11
498807-9880791.69096.98
5109830-109830101.919107.76
698789-9878991.67397.03
60min1101534-10153494.22194.024.41100.79100.554.37
297702-9770290.66597.00
3103603-10360396.141102.74
497739-9773990.69997.01
5109031-109031101.178108.15
698299-9829991.21997.59
90min1101905-10190594.56593.413.81102.18100.983.81
297783-9778390.74098.09
3101701-10170194.376102.05
498153-9815391.08398.40
5107275-10727599.548107.64
697119-9711990.12497.51
极限1101392-10139294.08992.103.15102.76100.713.19
295774-9577488.87697.23
3100801-10080193.540102.26
496500-9650089.54997.88
5103573-10357396.113105.31
697427-9742790.40998.80
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.8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%
116.19 3902213903643902433902913899443902130.05
216.173899903894473897180.10
单位质量响应值RSD%判断
24102.1024101.300.01数据可信
供试品溶液-24073105批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126304-2630422.39521.045.4222.4021.045.42
225430-2543021.65121.65
325983-2598322.12222.12
423667-2366720.15020.15
523408-2340819.92919.93
623493-2349320.00220.00
10min138292-3829232.60231.594.9632.8531.824.96
236778-3677831.31331.55
340194-4019434.22134.47
436322-3632230.92431.15
535237-3523730.00130.22
635781-3578130.46430.69
15min144035-4403537.49136.984.4138.1037.574.41
242847-4284736.48037.07
346846-4684639.88440.51
442707-4270736.36036.93
541144-4114435.03035.58
643041-4304136.64537.21
20min148515-4851541.30539.762.7642.3340.762.77
247442-4744240.39241.39
347270-4727040.24541.31
446414-4641439.51740.49
545281-4528138.55239.50
645283-4528338.55439.52
30min152242-5224244.47844.025.1345.9745.465.07
250929-5092943.36144.80
356764-5676448.32849.84
450742-5074243.20144.61
549440-4944042.09343.47
650101-5010142.65644.05
45min155768-5576847.48046.756.3249.4648.686.22
254706-5470646.57648.50
361293-6129352.18454.24
451782-5178244.08745.98
552184-5218444.42946.27
653707-5370745.72647.60
60min156601-5660148.19048.575.7650.7051.025.68
255850-5585047.55049.99
363511-6351154.07356.71
456231-5623147.87550.26
554107-5410746.06648.40
655994-5599447.67350.05
90min159655-5965550.79050.514.5653.8353.504.56
258863-5886350.11653.09
364109-6410954.58257.82
459411-5941150.58253.49
555942-5594247.62950.47
657980-5798049.36452.27
极限177304-7730465.81664.973.1169.4268.523.13
275182-7518264.00967.54
379175-7917567.40971.25
477703-7770366.15669.63
572366-7236661.61264.99
676113-7611364.80268.26
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