坎地沙坦酯氨氯地平片项目信息
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)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.676932269532690666926068702691760.46
213.766825668147682020.12
单位质量响应值RSD%判断
5060.424956.541.47数据可信
供试品溶液-6041501批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127086-2708635.06633.825.6735.0733.825.68
223893-2389330.93230.93
324782-2478232.08332.08
427331-2733135.38335.38
527466-2746635.55835.56
626176-2617633.88833.89
10min137090-3709048.01848.125.1048.0848.185.09
235698-3569846.21646.27
337090-3709048.01848.07
440680-4068052.66552.72
535319-3531945.72545.78
637157-3715748.10448.16
15min140198-4019852.04150.413.6652.1850.553.65
240038-4003851.83451.96
337312-3731248.30548.44
440384-4038452.28252.43
537511-3751148.56348.70
638181-3818149.43049.57
20min142050-4205054.43952.004.3054.6652.224.27
240475-4047552.40052.61
341006-4100653.08753.30
438413-3841349.73049.96
541333-4133353.51153.73
637704-3770448.81349.03
30min136134-3613446.78051.006.2447.1051.316.20
237876-3787649.03549.34
341246-4124653.39853.70
442992-4299255.65955.98
539626-3962651.30151.61
638504-3850449.84850.15
45min142915-4291555.55950.986.2255.9551.386.18
238124-3812449.35649.74
340490-4049052.41952.81
438919-3891950.38650.80
540171-4017152.00652.40
635658-3565846.16446.55
60min144626-4462657.77449.699.2858.2650.179.20
239892-3989251.64552.11
334962-3496245.26345.74
437018-3701847.92448.42
538331-3833149.62450.10
635458-3545845.90546.37
极限147936-4793662.05952.059.5562.6452.619.47
238655-3865550.04450.60
338222-3822249.48350.04
438191-3819149.44350.02
539876-3987651.62452.18
638353-3835349.65350.19
坎地沙坦酯氨氯地平片项目信息
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)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.676913069385690936921669175692000.17
213.766988569629697570.26
单位质量响应值RSD%判断
5062.185069.550.11数据可信
供试品溶液-6041502批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127645-2764535.38131.0223.4835.3831.0223.48
228339-2833936.26936.27
318246-1824623.35223.35
419925-1992525.50025.50
519510-1951024.96924.97
631762-3176240.65040.65
10min139800-3980050.93748.1714.8251.0048.2214.82
235082-3508244.89944.96
335137-3513744.96945.01
434257-3425743.84343.89
533459-3345942.82242.86
648080-4808061.53461.60
15min143428-4342855.58053.0218.7155.7253.1518.70
245443-4544358.15958.29
331173-3117339.89640.01
435931-3593145.98546.10
539323-3932350.32750.44
653267-5326768.17268.34
20min144408-4440856.83457.7115.5257.0757.9315.52
245849-4584958.67958.91
341518-4151853.13653.32
440036-4003651.23951.43
540177-4017751.41951.62
658553-5855374.93875.22
30min143828-4382856.09257.6820.7756.4258.0020.74
245558-4555858.30658.64
339146-3914650.10050.37
440395-4039551.69851.98
538215-3821548.90849.19
663295-6329581.00681.42
45min144773-4477357.30255.2023.1257.7355.6123.07
241252-4125252.79553.22
332206-3220641.21841.57
438006-3800648.64149.00
540963-4096352.42552.79
661579-6157978.81079.35
60min143874-4387456.15156.0720.6956.6756.5820.66
242749-4274954.71155.23
338032-3803248.67449.10
436525-3652546.74647.19
540264-4026451.53151.98
661429-6142978.61879.29
极限139030-3903049.95256.5525.9150.5757.1525.82
243905-4390556.19156.80
338565-3856549.35649.86
435780-3578045.79246.31
540949-4094952.40752.94
666890-6689085.60786.41
坎地沙坦酯氨氯地平片项目信息
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)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.676819568179682946788568261681630.24
213.766812067729679240.41
单位质量响应值RSD%判断
4986.324936.340.72数据可信
供试品溶液-6041401批-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%
5min147280-4728061.78760.058.7561.7960.048.75
252661-5266168.81968.82
341467-4146754.19054.19
446827-4682761.19561.19
542486-4248655.52255.52
644967-4496758.76458.76
10min167323-6732387.97985.582.7188.0885.682.72
267793-6779388.59388.71
363376-6337682.82182.91
464749-6474984.61584.72
564071-6407183.72983.82
665628-6562885.76485.86
15min168338-6833889.30688.551.5189.5688.791.52
268050-6805088.92989.19
366638-6663887.08487.31
466710-6671087.17887.42
567512-6751288.22688.46
669302-6930290.56590.81
20min168409-6840989.39889.140.8689.8089.540.86
267961-6796188.81389.22
367954-6795488.80489.18
467354-6735488.02088.41
568561-6856189.59789.98
669043-6904390.22790.62
30min168576-6857689.61789.241.3790.1689.781.36
267685-6768588.45289.01
368337-6833789.30489.83
466814-6681487.31487.85
568847-6884789.97190.50
669487-6948790.80791.35
45min167476-6747688.17988.621.0888.8889.311.07
267585-6758588.32289.03
368141-6814189.04889.72
467366-6736688.03588.72
567163-6716387.77088.45
669134-6913490.34691.04
60min168203-6820389.12988.881.1889.9789.711.17
267575-6757588.30989.16
368220-6822089.15189.97
466633-6663387.07787.90
568596-6859689.64390.47
668837-6883789.95890.80
极限167807-6780788.61288.811.0889.6089.791.07
267554-6755488.28189.28
368364-6836489.34090.31
466865-6686587.38188.35
568142-6814289.04990.02
669000-6900090.17191.16
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