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100546-202105 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5000
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%
116.781834191832211837191834291834241834420.10
216.841829621829671829640.01
单位质量响应值RSD%判断
10932.1810864.850.44数据可信
供试品溶液-24052301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%
5min1107694-10769499.825100.041.5799.82100.041.58
2108214-108214100.307100.31
3107454-10745499.60299.60
4108560-108560100.628100.63
5105211-10521197.52397.52
6110413-110413102.345102.35
10min1106649-10664998.85699.460.9399.97100.580.93
2108908-108908100.950102.06
3106997-10699799.179100.29
4107347-10734799.503100.62
5106069-10606998.31999.40
6107852-10785299.971101.11
15min1107129-10712999.30198.321.20101.51100.531.19
2106330-10633098.561100.80
3106088-10608898.336100.54
4106553-10655398.767100.99
5103587-10358796.01898.19
6106706-10670698.909101.16
20min1105759-10575998.03197.291.07101.34100.601.07
2105836-10583698.103101.43
3105024-10502497.350100.65
4105193-10519397.507100.83
5102779-10277995.26998.51
6105148-10514897.465100.81
30min1102697-10269795.19395.982.0099.59100.361.94
2103618-10361896.047100.47
3102151-10215194.68799.07
4107118-10711899.291103.70
5101282-10128293.88198.18
6104379-10437996.752101.18
45min1101406-10140693.99695.101.4499.45100.561.39
2104665-10466597.017102.51
3103464-10346495.904101.34
4101652-10165294.22499.73
5100949-10094993.57398.92
6103443-10344395.885101.39
极限1102534-10253495.04294.431.32101.54100.951.30
2103276-10327695.730102.30
3101580-10158094.158100.66
4102383-10238394.902101.46
599387-9938792.12598.51
6102095-10209594.635101.21
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20000
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%
116.141933631932861934351931861929201932380.11
216.011920301924851922580.17
单位质量响应值RSD%判断
11972.6112008.620.22数据可信
供试品溶液-24052301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%
5min13289-32892.8149.8148.942.819.8148.95
215114-1511412.93312.93
315311-1531113.10113.10
417523-1752314.99414.99
511177-111779.5649.56
66393-63935.4705.47
10min131887-3188727.28525.265.2227.3225.375.14
229235-2923525.01625.16
328013-2801323.97024.12
430439-3043926.04626.21
529769-2976925.47225.58
627793-2779323.78223.84
15min142683-4268336.52331.807.9036.8632.197.76
236907-3690731.58032.00
334585-3458529.59330.01
437213-3721331.84232.30
536848-3684831.53031.92
634768-3476829.75030.07
20min148316-4831641.34335.937.8942.0836.677.75
241999-4199935.93736.71
339200-3920033.54234.28
440856-4085634.95935.77
541954-4195435.89936.64
639603-3960333.88734.54
30min153582-5358245.84940.846.7247.0541.986.65
247047-4704740.25741.43
344753-4475338.29439.41
447913-4791340.99842.20
548095-4809541.15342.29
644969-4496938.47939.51
45min157257-5725748.99344.576.6850.7046.176.54
253246-5324645.56147.18
351091-5109143.71745.26
447743-4774340.85242.51
554054-5405446.25247.85
649161-4916142.06643.53
极限160369-6036951.65646.787.0153.9148.876.88
256040-5604047.95250.08
353433-5343345.72147.75
450212-5021242.96545.07
556856-5685648.65050.76
651096-5109643.72145.65
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100546-202105 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5000
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%
116.781832331835261828071831671831471831760.14
216.841821181821481821330.02
单位质量响应值RSD%判断
10916.3310815.500.66数据可信
供试品溶液-24052301批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107107-10710799.58099.230.8699.5899.230.86
2105519-10551998.10398.10
3106316-10631698.84498.84
4107721-107721100.151100.15
5106047-10604798.59498.59
6107703-107703100.134100.13
10min1107073-10707399.54899.751.09100.65100.851.09
2106582-10658299.092100.18
3106530-10653099.043100.14
4108009-108009100.418101.53
5106243-10624398.77799.87
6109308-109308101.626102.74
15min1106710-10671099.21198.381.54101.42100.591.52
2104682-10468297.32599.52
3105325-10532597.923100.12
4106434-10643498.954101.18
5103594-10359496.31498.51
6108158-108158100.557102.80
20min1102660-10266095.44597.071.9198.76100.381.87
2102959-10295995.72399.00
3102803-10280395.57898.87
4105151-10515197.761101.09
5105197-10519797.804101.07
6107696-107696100.127103.49
30min1103244-10324495.98896.552.60100.36100.932.54
2101419-10141994.29298.63
3101992-10199294.82499.17
4104751-10475197.389101.80
5102868-10286895.63999.99
6108826-108826101.178105.65
45min1102002-10200294.83496.051.60100.28101.501.58
2102627-10262795.415100.80
3102955-10295595.720101.12
4103197-10319795.945101.44
5102498-10249895.295100.71
6106555-10655599.067104.66
极限1102322-10232295.13194.352.03101.63100.871.97
2100774-10077493.692100.14
398068-9806891.17697.64
4101924-10192494.761101.32
5101473-10147394.342100.81
6104315-10431596.984103.68
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(%)91.2对照品水分(%)0对照品稀释倍数20000
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%
116.141921951920991918421919331922371920610.09
216.011901211902841902020.07
单位质量响应值RSD%判断
11899.6911880.200.12数据可信
供试品溶液-24052301批-叶酸-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18963-89637.7347.2313.937.737.2313.94
26806-68065.8735.87
310188-101888.7918.79
47880-78806.8006.80
58673-86737.4847.48
67757-77576.6946.69
10min114260-1426012.30512.607.2712.3912.687.28
214691-1469112.67712.74
316367-1636714.12314.22
413363-1336311.53111.61
515107-1510713.03613.12
613825-1382511.93012.00
15min117691-1769115.26615.697.6715.4915.917.68
218235-1823515.73515.94
320355-2035517.56517.82
416594-1659414.31914.52
519149-1914916.52416.75
617053-1705314.71514.92
20min120449-2044917.64618.388.2218.0418.778.19
221248-2124818.33518.72
323932-2393220.65121.10
419452-1945216.78517.15
522797-2279719.67220.08
619893-1989317.16617.54
30min125066-2506621.63022.638.1922.2223.238.17
226240-2624022.64323.23
329498-2949825.45426.13
423246-2324620.05920.61
527580-2758023.79924.43
625713-2571322.18822.75
45min130158-3015826.02426.565.3526.8527.415.27
232301-3230127.87328.71
330056-3005625.93626.90
428806-2880624.85725.63
533225-3322528.67029.56
630136-3013626.00526.81
极限135244-3524430.41330.898.1531.5332.048.09
235589-3558930.71031.86
340531-4053134.97536.23
432446-3244627.99829.05
537516-3751632.37333.59
633440-3344028.85629.95
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100546-202105 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5000
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%
116.781845391843171837191845361841881842600.19
216.841825571821711823640.15
单位质量响应值RSD%判断
10980.9310829.220.99数据可信
供试品溶液-24052301批-左氨氯地平-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%
5min1105827-10582798.03998.451.3198.0498.451.31
2106751-10675198.89598.90
3104293-10429396.61896.62
4107227-10722799.33699.34
5105369-10536997.61597.61
6108169-108169100.209100.21
10min1105719-10571997.93998.541.1199.0399.641.11
2106737-10673798.88299.98
3105957-10595798.16099.23
4105382-10538297.62798.73
5105821-10582198.03499.12
6108596-108596100.604101.72
15min1105481-10548197.71997.721.8899.9099.911.86
2106698-10669898.846101.04
3103861-10386196.21898.38
4105309-10530997.55999.75
5103022-10302295.44197.61
6108547-108547100.559102.79
20min1101963-10196394.46095.581.5897.7298.861.56
2104449-10444996.763100.06
3101127-10112793.68596.92
4103089-10308995.50398.78
5102853-10285395.28498.52
6105569-10556997.800101.15
30min1101029-10102993.59494.461.7197.9198.791.68
2102026-10202694.51898.89
399173-9917391.87596.15
4103178-10317895.58599.92
5102162-10216294.64498.94
6104185-10418596.518100.95
45min1100057-10005792.69493.431.1898.0598.821.18
2102018-10201894.51099.93
399666-9966692.33297.63
4101296-10129693.84299.24
599754-9975492.41397.76
6102323-10232394.793100.30
极限1100658-10065893.25193.611.6399.63100.031.60
2100725-10072593.31399.78
398703-9870391.43997.76
4101739-10173994.252100.69
5100737-10073793.32499.70
6103709-10370996.077102.64
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20000
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%
116.141915261916431914921920671913181916090.15
216.011882991883991883490.04
单位质量响应值RSD%判断
11871.6911764.460.65数据可信
供试品溶液-24052301批-叶酸-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%
5min127833-2783324.16425.012.7224.1625.012.73
229165-2916525.32025.32
329037-2903725.20925.21
427828-2782824.16024.16
529635-2963525.72925.73
629348-2934825.47925.48
10min136443-3644331.63932.492.7931.9132.772.78
237247-3724732.33732.62
336786-3678631.93732.22
436654-3665431.82232.09
538421-3842133.35633.64
638985-3898533.84634.13
15min140157-4015734.86335.573.6435.4836.213.62
240837-4083735.45436.09
341010-4101035.60436.24
439086-3908633.93434.56
541148-4114835.72436.38
643589-4358937.84338.50
20min141596-4159636.11336.813.9537.1237.853.92
242244-4224436.67537.71
342263-4226336.69237.72
440098-4009834.81235.81
543078-4307837.39938.45
645150-4515039.19840.28
30min144144-4414438.32538.794.2039.7340.234.16
243643-4364337.89039.33
344340-4434038.49539.93
442567-4256736.95638.34
545354-4535439.37540.84
648020-4802041.69043.21
45min146556-4655640.41940.664.3742.2542.534.31
246096-4609640.02041.88
347105-4710540.89642.76
444299-4429938.45940.26
546395-4639540.27942.19
650523-5052343.86345.84
极限148760-4876042.33242.585.5544.6244.905.43
247245-4724541.01743.32
348661-4866142.24644.57
446493-4649340.36442.59
548850-4885042.41144.76
654236-5423647.08749.55
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100546-202105 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5000
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%
116.781834681826361828561828561827811829190.18
216.841829511823361826440.24
单位质量响应值RSD%判断
10901.0110845.840.36数据可信
供试品溶液-24052301批-左氨氯地平-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%
5min1214776-214776199.541196.482.12199.54196.482.12
2217100-217100201.700201.70
3211898-211898196.867196.87
4205511-205511190.933190.93
5212631-212631197.548197.55
6206940-206940192.261192.26
10min1217112-217112201.712197.092.07203.93199.272.07
2215662-215662200.364202.61
3211596-211596196.587198.77
4206589-206589191.935194.06
5214439-214439199.228201.42
6207409-207409192.697194.83
15min1213185-213185198.063195.331.85202.52199.701.85
2213600-213600198.449202.92
3209820-209820194.937199.31
4204494-204494189.989194.24
5213491-213491198.347202.76
6206848-206848192.176196.45
20min1211914-211914196.882193.601.96203.54200.141.97
2211981-211981196.944203.62
3208158-208158193.393199.93
4202779-202779188.395194.76
5211299-211299196.311202.92
6204141-204141189.661196.07
30min1210749-210749195.800192.062.01204.65200.752.01
2209937-209937195.045203.91
3206271-206271191.640200.33
4201040-201040186.780195.24
5209781-209781194.901203.69
6202540-202540188.173196.69
45min1208201-208201193.433190.241.90204.45201.071.90
2207351-207351192.643203.67
3205252-205252190.693201.51
4199044-199044184.925195.46
5207800-207800193.060204.02
6200968-200968186.713197.32
极限1200875-200875186.626184.121.85199.80197.061.85
2199795-199795185.623198.79
3199374-199374185.232198.17
4193539-193539179.811192.40
5201811-201811187.496200.60
6193640-193640179.904192.59
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20000
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%
116.141888331885311887331886291888741887200.08
216.011874951877641876300.11
单位质量响应值RSD%判断
11692.6911719.550.17数据可信
供试品溶液-24052301批-叶酸-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%
5min1203180-203180178.080172.163.02178.08172.163.02
2204204-204204178.978178.98
3191583-191583167.916167.92
4191721-191721168.037168.04
5191610-191610167.940167.94
6196282-196282172.034172.03
10min1206070-206070180.613174.413.41182.59176.323.40
2208336-208336182.599184.59
3192866-192866169.040170.91
4193278-193278169.402171.27
5194321-194321170.316172.18
6199092-199092174.497176.41
15min1204929-204929179.613174.243.21183.60178.093.21
2208040-208040182.340186.36
3193239-193239169.367173.11
4192608-192608168.814172.56
5195482-195482171.333175.09
6198474-198474173.956177.81
20min1205877-205877180.444174.023.25186.43179.803.24
2206689-206689181.156187.20
3192772-192772168.958174.58
4191728-191728168.043173.67
5195889-195889171.690177.35
6198295-198295173.799179.58
30min1206088-206088180.629174.763.04188.62182.483.05
2207085-207085181.503189.56
3194458-194458170.436177.94
4192215-192215168.470175.96
5197628-197628173.214180.78
6198858-198858174.292182.01
45min1206073-206073180.616176.322.52190.61185.982.55
2207607-207607181.960192.03
3197071-197071172.726182.12
4194409-194409170.393179.76
5200914-200914176.094185.59
6200955-200955176.130185.78
极限1203706-203706178.541180.410.78190.54192.030.71
2207178-207178181.584193.68
3207975-207975182.283193.60
4205945-205945180.504191.76
5205768-205768180.349191.80
6204444-204444179.188190.80
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