厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.809624696604974089683396054966290.55
213.049704497842974430.58
单位质量响应值RSD%判断
7549.147472.620.73数据可信
供试品溶液-6042201批-氢氯噻嗪-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%
5min130416-3041632.30030.6116.9532.3030.6116.96
222198-2219823.57323.57
331272-3127233.20933.21
425061-2506126.61426.61
536040-3604038.27338.27
627979-2797929.71229.71
10min166244-6624470.34873.893.4770.5174.043.46
268958-6895873.23073.35
373142-7314277.67377.84
471470-7147075.89876.03
569167-6916773.45273.64
668508-6850872.75272.90
15min172870-7287077.38581.423.5877.9081.943.57
275993-7599380.70181.19
380179-8017985.14685.70
479274-7927484.18584.70
576911-7691181.67682.23
674786-7478679.41979.93
20min175716-7571680.40784.182.4981.3185.112.46
280625-8062585.62086.51
379279-7927984.19185.17
481395-8139586.43887.37
578885-7888583.77284.74
679709-7970984.64785.56
30min179101-7910184.00285.782.8385.3087.132.78
282772-8277287.90089.22
377276-7727682.06483.46
483384-8338488.55089.92
581177-8117786.20687.59
680938-8093885.95287.29
45min180047-8004785.00688.102.5886.7389.882.53
285188-8518890.46692.22
380609-8060985.60387.41
483847-8384789.04290.85
583439-8343988.60890.43
684629-8462989.87291.63
60min181397-8139786.44089.341.6688.5991.561.66
284857-8485790.11492.32
384425-8442589.65591.89
485094-8509490.36692.62
584032-8403289.23891.50
684970-8497090.23492.45
极限183677-8367788.86192.171.9891.4494.841.97
286783-8678392.16094.82
388474-8847493.95596.64
488084-8808493.54196.25
587381-8738192.79595.50
686363-8636391.71394.38
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.662645012702312656652679042683612673320.85
215.732697232693482695360.10
单位质量响应值RSD%判断
17071.0117135.160.27数据可信
供试品溶液-6042201批-厄贝沙坦-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%
5min138490-3849015.00313.5316.0215.0013.5316.03
227780-2778010.82810.83
336164-3616414.09714.10
430259-3025911.79511.79
542857-4285716.70516.71
632739-3273912.76112.76
10min199435-9943538.75940.314.4038.8340.384.40
2102261-10226139.86139.91
3110129-11012942.92843.00
4105188-10518841.00241.06
5105752-10575241.22241.31
697725-9772538.09338.16
15min1129332-12933250.41353.564.5050.6853.834.50
2135271-13527152.72852.98
3146007-14600756.91357.20
4141730-14173055.24655.51
5139539-13953954.39254.68
6132533-13253351.66151.91
20min1148617-14861757.93061.853.6058.4562.383.59
2160244-16024462.46262.98
3163103-16310363.57764.15
4163164-16316463.60064.14
5161501-16150162.95263.51
6155347-15534760.55361.07
30min1177493-17749369.18671.542.7170.0072.382.70
2184726-18472672.00572.83
3182049-18204970.96271.85
4191756-19175674.74575.60
5185153-18515372.17273.05
6179950-17995070.14470.96
45min1200503-20050378.15581.452.0079.3182.662.00
2211005-21100582.24983.44
3210855-21085582.19083.43
4211090-21109082.28283.51
5209674-20967481.73082.97
6210665-21066582.11683.28
60min1211414-21141482.40886.582.9683.9688.192.96
2219015-21901585.37186.97
3227893-22789388.83190.48
4227282-22728288.59390.24
5227279-22727988.59290.24
6219820-21982085.68587.26
极限1221909-22190986.49990.232.3488.4692.272.35
2229284-22928489.37491.40
3237390-23739092.53394.63
4234941-23494191.57993.67
5233130-23313090.87392.96
6232173-23217390.50092.50
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.809617595984963959664695491961380.46
213.049676996732967500.03
单位质量响应值RSD%判断
7510.787419.480.87数据可信
供试品溶液-6042202批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121076-2107622.51929.0828.8122.5229.0828.81
221652-2165223.13523.13
338103-3810340.71240.71
424337-2433726.00326.00
536322-3632238.80938.81
621834-2183423.32923.33
10min175807-7580780.99886.075.0881.1186.225.12
276727-7672781.98182.10
383021-8302188.70688.91
481795-8179587.39687.53
586663-8666392.59792.79
679307-7930784.73784.85
15min186949-8694992.90394.962.7893.4295.542.81
286734-8673492.67393.20
388703-8870394.77795.42
490851-9085197.07297.64
592810-9281099.16599.82
687216-8721693.18893.73
20min188635-8863594.70495.701.8895.6996.761.91
289482-8948295.60996.60
388324-8832494.37295.49
490578-9057896.78097.83
592432-9243298.76199.91
687978-8797894.00295.01
30min188993-8899395.08795.811.9296.5497.341.96
288913-8891395.00196.47
390224-9022496.40297.99
489903-8990396.05997.60
592560-9256098.898100.54
687423-8742393.40994.89
45min187689-8768993.69395.752.3095.6297.762.34
288151-8815194.18796.13
389773-8977395.92097.99
490897-9089797.12199.14
593011-9301199.380101.52
688163-8816394.20096.14
60min190049-9004996.21595.551.2798.6198.041.31
288468-8846894.52696.94
389644-8964495.78298.34
489773-8977395.92098.42
590889-9088997.11399.75
687748-8774893.75696.17
极限189423-8942395.54695.851.5998.4398.821.63
289307-8930795.42298.31
389774-8977495.92198.95
488921-8892195.01097.99
592442-9244298.772101.90
688397-8839794.45097.33
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.662693622685192672512696392687142686970.35
215.732708252703652705950.13
单位质量响应值RSD%判断
17158.1717202.480.19数据可信
供试品溶液-6042202批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118930-189307.34610.2428.497.3510.2428.48
221120-211208.1958.20
337102-3710214.39714.40
423708-237089.2009.20
534514-3451413.39313.39
623012-230128.9308.93
10min189640-8964034.78437.208.0734.8237.268.09
288536-8853634.35634.40
3105248-10524840.84140.91
492691-9269135.96836.01
5105924-10592441.10341.17
693228-9322836.17636.22
15min1127471-12747149.46451.894.6749.6752.134.71
2128085-12808549.70249.92
3140758-14075854.62054.90
4133822-13382251.92852.15
5141749-14174955.00455.28
6130530-13053050.65150.88
20min1152378-15237859.12960.672.3559.5961.162.39
2155556-15555660.36260.82
3159523-15952361.90262.45
4154675-15467560.02060.51
5161991-16199162.85963.41
6153898-15389859.71960.20
30min1180715-18071570.12571.382.2870.8872.182.32
2182811-18281170.93871.70
3189077-18907773.37074.23
4183527-18352771.21672.00
5188774-18877473.25274.11
6178828-17882869.39370.17
45min1201739-20173978.28380.392.1379.3981.542.16
2204249-20424979.25780.37
3211024-21102481.88683.11
4209659-20965981.35682.50
5212413-21241382.42583.65
6203905-20390579.12480.25
60min1220429-22042985.53685.721.3687.0387.281.39
2219996-21999685.36886.88
3224453-22445387.09788.73
4221884-22188486.10087.65
5222914-22291486.50088.14
6215813-21581383.74485.26
极限1231699-23169989.90990.351.2691.8392.331.29
2231496-23149689.83091.77
3234796-23479691.11193.18
4230025-23002589.25991.24
5237803-23780392.27794.35
6231127-23112789.68791.63
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