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%
111.132905762895392899282903982909372902760.19
211.192899562897832898700.05
单位质量响应值RSD%判断
26080.5025904.380.48数据可信
供试品溶液-2023101221批-阿齐沙坦-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%
5min113191-131914.5545.2018.724.555.2018.77
214204-142044.9044.90
318448-184486.3696.37
410933-109333.7743.77
516078-160785.5505.55
617500-175006.0416.04
10min175840-7584026.18129.978.3126.2130.008.31
290251-9025131.15631.18
397276-9727633.58233.62
488833-8883330.66730.69
583442-8344228.80628.84
685184-8518429.40729.44
15min1155017-15501753.51552.673.6753.6952.863.67
2157745-15774554.45754.66
3156689-15668954.09254.31
4149392-14939251.57351.76
5142806-14280649.29949.49
6153764-15376453.08253.28
20min1193287-19328766.72664.174.1067.1964.664.08
2192399-19239966.42066.92
3188722-18872265.15165.67
4182059-18205962.85063.33
5172848-17284859.67160.14
6185948-18594864.19364.68
30min1213568-21356873.72871.083.5974.5771.923.58
2210430-21043072.64573.52
3209491-20949172.32073.20
4200061-20006169.06569.89
5193974-19397466.96467.76
6207810-20781071.74072.59
45min1240882-24088283.15780.183.2884.4181.423.27
2238251-23825182.24983.52
3233214-23321480.51081.80
4227028-22702878.37579.59
5220118-22011875.98977.16
6233980-23398080.77582.02
60min1260289-26028989.85787.582.3291.5789.272.33
2257779-25777988.99090.72
3254529-25452987.86889.60
4249349-24934986.08087.73
5244361-24436184.35885.95
6255939-25593988.35590.05
极限1272285-27228593.99891.682.0796.2193.862.09
2268763-26876392.78295.01
3265659-26565991.71193.93
4263774-26377491.06093.18
5256084-25608488.40590.46
6266936-26693692.15294.34
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.056968670034703526978769860699440.38
215.086991069840698750.08
单位质量响应值RSD%判断
4647.444633.620.22数据可信
供试品溶液-2023101221批-氨氯地平-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%
5min144548-4454862.23942.3532.5662.2442.3532.56
228614-2861439.97739.98
340519-4051956.61056.61
421961-2196130.68230.68
521710-2171030.33230.33
624524-2452434.26334.26
10min135970-3597050.25559.9912.8950.6060.2312.75
240687-4068756.84557.07
341766-4176658.35358.67
450750-5075070.90471.07
540134-4013456.07256.24
648337-4833767.53367.72
15min158986-5898682.41189.115.7383.0489.685.71
262606-6260687.46988.01
368414-6841495.58396.22
464424-6442490.00990.57
560958-6095885.16685.65
667297-6729794.02394.59
20min164821-6482190.56395.104.8191.6596.164.82
267615-6761594.46795.49
373142-73142102.189103.36
467518-6751894.33195.40
564794-6479490.52691.48
670517-7051798.52199.61
30min166144-6614492.41296.634.8794.0098.224.87
268677-6867795.95197.50
374441-74441104.004105.74
467639-6763994.50096.09
566115-6611592.37193.83
671957-71957100.533102.17
45min167444-6744494.22898.184.9396.33100.314.93
270510-7051098.512100.59
375682-75682105.738108.05
468822-6882296.15398.27
566467-6646792.86394.83
672715-72715101.592103.79
60min168366-6836695.51698.734.4898.14101.414.49
270614-7061498.657101.29
375941-75941106.099109.00
468853-6885396.19798.84
567573-6757394.40896.89
672670-72670101.529104.29
极限168630-6863095.88599.214.3399.04102.434.35
270933-7093399.103102.28
376134-76134106.369109.86
469970-6997097.757100.94
567665-6766594.53797.55
672710-72710101.585104.91
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%
111.132891992894372889342891582889992891450.07
211.192876632885562881100.22
单位质量响应值RSD%判断
25978.8925747.100.64数据可信
供试品溶液-2023101221批-阿齐沙坦-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%
5min113513-135134.6885.3824.334.695.3824.37
213011-130114.5144.51
322126-221267.6777.68
416902-169025.8645.86
515882-158825.5105.51
611629-116294.0354.03
10min186908-8690830.15329.833.1030.1829.863.08
285148-8514829.54229.57
382399-8239928.58828.63
490334-9033431.34131.37
584640-8464029.36629.40
686412-8641229.98130.00
15min1151320-15132052.50152.712.5952.6952.902.58
2146892-14689250.96451.15
3151809-15180952.67052.87
4148827-14882751.63651.84
5157578-15757854.67254.87
6155034-15503453.78953.98
20min1182884-18288463.45263.962.5663.9464.442.55
2180634-18063462.67163.14
3184743-18474364.09764.59
4178505-17850561.93262.43
5191211-19121166.34166.84
6188044-18804465.24265.73
30min1204911-20491171.09471.362.6671.9372.202.65
2201387-20138769.87170.69
3206355-20635571.59572.45
4198343-19834368.81569.65
5213440-21344074.05374.92
6209574-20957472.71273.56
45min1230520-23052079.97980.071.9381.2181.311.93
2227389-22738978.89380.10
3230471-23047179.96281.21
4225024-22502478.07279.29
5237409-23740982.36983.65
6233889-23388981.14882.40
60min1253470-25347087.94288.051.8889.6289.731.89
2250648-25064886.96288.61
3256503-25650388.99490.69
4246119-24611985.39187.04
5259146-25914689.91191.65
6256768-25676889.08690.79
极限1265444-26544492.09691.651.2694.2693.821.27
2262973-26297391.23993.37
3262621-26262191.11793.30
4259585-25958590.06392.19
5269493-26949393.50195.74
6264863-26486391.89494.09
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.057028070035696216959469658698380.44
215.086955469373694640.19
单位质量响应值RSD%判断
4640.404606.370.53数据可信
供试品溶液-2023101221批-氨氯地平-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%
5min142144-4214459.10049.9322.4759.1049.9322.46
240784-4078457.19357.19
339805-3980555.82055.82
430664-3066443.00143.00
538732-3873254.31554.31
621518-2151830.17530.18
10min147125-4712566.08557.4218.7366.4157.7018.62
227608-2760838.71539.03
343907-4390761.57261.88
435962-3596250.43150.67
544550-4455062.47462.78
646532-4653265.25365.42
15min162692-6269287.91587.882.4488.6188.482.48
260087-6008784.26284.79
364513-6451390.46891.12
462001-6200186.94687.46
563661-6366189.27489.92
663056-6305688.42588.96
20min165235-6523591.48192.871.6492.6693.961.66
264966-6496691.10492.10
367887-6788795.20096.35
466623-6662393.42794.43
566771-6677193.63594.78
665890-6589092.39993.42
30min166359-6635993.05795.181.9194.7596.781.91
266743-6674393.59695.10
369525-6952597.49799.18
468099-6809995.49797.02
569181-6918197.01498.68
667335-6733594.42695.96
45min167211-6721194.25296.221.8796.4698.351.87
267735-6773594.98797.01
370612-7061299.021101.25
469360-6936097.26599.32
569039-6903996.81599.02
667744-6774494.99997.06
60min167116-6711694.11996.922.1196.8599.582.10
268286-6828695.75998.31
371310-71310100.000102.78
469646-6964697.667100.26
569806-6980697.891100.63
668527-6852796.09798.68
极限167244-6724494.29896.822.4397.55100.022.39
268095-6809595.49298.58
371269-7126999.943103.27
470652-7065299.077102.21
569439-6943997.376100.66
667565-6756594.74897.87
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