阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.042969712967542954402962252960242962830.21
211.202963182969592966380.16
单位质量响应值RSD%判断
26837.2326485.540.94数据可信
供试品溶液-20220124批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17484-74842.5194.0034.432.524.0034.46
211140-111403.7493.75
311298-112983.8033.80
410517-105173.5403.54
511230-112303.7803.78
619716-197166.6366.64
10min156432-5643218.99321.2416.9919.0121.2617.00
247917-4791716.12716.15
365648-6564822.09522.12
467492-6749222.71622.74
561600-6160020.73320.75
679582-7958226.78526.82
15min1144998-14499848.80251.614.2748.9251.744.26
2160931-16093154.16454.27
3156277-15627752.59852.74
4145476-14547648.96349.11
5156654-15665452.72552.86
6155631-15563152.38152.57
20min1174037-17403758.57561.674.1658.9762.104.15
2193970-19397065.28465.70
3184442-18444262.07762.51
4174830-17483058.84259.26
5186878-18687862.89763.33
6185284-18528462.36162.84
30min1196333-19633366.08068.823.7466.8069.593.73
2215852-21585272.64973.42
3204681-20468168.88969.67
4195549-19554965.81666.56
5208092-20809270.03770.82
6206391-20639169.46570.29
45min1204606-20460668.86472.894.7569.9574.054.69
2208608-20860870.21171.39
3227033-22703376.41277.58
4229209-22920977.14578.26
5210124-21012470.72171.89
6219859-21985973.99875.21
60min1218985-21898573.70470.933.4275.1772.493.34
2203583-20358368.52070.09
3205106-20510669.03270.62
4205053-20505369.01470.55
5212466-21246671.50973.07
6219307-21930773.81275.43
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.042960572968612960102961162961002962290.13
211.202945262973612959440.68
单位质量响应值RSD%判断
26832.3426423.571.09数据可信
供试品溶液-20220126批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112077-120774.0703.1926.134.073.1926.15
29468-94683.1913.19
37603-76032.5622.56
411355-113553.8273.83
510749-107493.6223.62
65579-55791.8801.88
10min166548-6654822.42621.355.4522.4521.375.45
259492-5949220.04920.07
367010-6701022.58222.60
465691-6569122.13822.16
559774-5977420.14420.16
661686-6168620.78820.80
15min1152382-15238251.35249.792.4451.5049.922.45
2144157-14415748.58048.71
3146495-14649549.36849.51
4150995-15099550.88551.03
5148784-14878450.14050.27
6143581-14358148.38648.51
20min1183178-18317861.73059.433.5362.1659.843.53
2169455-16945557.10657.50
3174318-17431858.74559.16
4182362-18236261.45561.88
5179415-17941560.46260.87
6169344-16934457.06857.46
30min1201648-20164867.95566.512.9868.7367.252.99
2191445-19144564.51665.23
3193711-19371165.28066.02
4204225-20422568.82369.59
5201935-20193568.05168.80
6191188-19118864.43065.14
45min1214386-21438672.24769.423.5173.4070.533.50
2198934-19893467.04068.11
3200932-20093267.71368.82
4211363-21136371.22972.38
5211692-21169271.33972.46
6198668-19866866.95068.02
60min1222375-22237574.94074.452.1676.4975.942.10
2220706-22070674.37775.82
3214970-21497072.44473.92
4216005-21600572.79374.34
5224061-22406175.50877.03
6227347-22734776.61578.06
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.042979302975752977892968192979522976130.16
211.202982262975152978700.17
单位质量响应值RSD%判断
26957.7026595.540.96数据可信
供试品溶液-20220127批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18707-87072.9183.6653.512.923.6653.44
217213-172135.7685.77
316990-169905.6945.69
46796-67962.2772.28
52704-27040.9060.91
613073-130734.3814.38
10min165177-6517721.84221.8615.8821.8621.8815.92
280701-8070127.04527.08
369565-6956523.31323.34
454899-5489918.39818.41
552541-5254117.60817.61
668419-6841922.92922.95
15min1157696-15769652.84750.935.4552.9851.075.49
2161984-16198454.28454.47
3154121-15412151.64951.81
4139629-13962946.79346.91
5144857-14485748.54548.65
6153486-15348651.43651.59
20min1190696-19069663.90661.314.1064.3461.734.13
2192332-19233264.45564.94
3182732-18273261.23761.69
4176424-17642459.12359.50
5173543-17354358.15858.53
6181917-18191760.96461.40
30min1210176-21017670.43468.573.0771.2269.333.11
2213810-21381071.65272.49
3202885-20288567.99168.78
4199542-19954266.87167.57
5197385-19738566.14866.84
6203859-20385968.31769.09
45min1221709-22170974.29972.432.8875.4873.572.92
2224791-22479175.33276.57
3214070-21407071.73972.91
4211794-21179470.97772.05
5208161-20816169.75970.82
6216217-21621772.45973.61
60min1215830-21583072.32972.334.4073.9273.884.28
2210196-21019670.44172.10
3229870-22987077.03478.60
4220306-22030673.82975.30
5217051-21705172.73874.19
6201722-20172267.60169.16
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