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100309-201404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%
112.379660596585965839668196669966250.05
212.589644996414964320.03
单位质量响应值RSD%判断
7811.247665.501.34数据可信
供试品溶液-2023061621批-氢氯噻嗪-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%
5min138331-3833139.51239.806.7739.5139.806.77
241676-4167642.96042.96
340762-4076242.01742.02
434356-3435635.41435.41
537355-3735538.50638.51
639167-3916740.37340.37
10min179707-7970782.16284.971.8582.3685.161.85
282341-8234184.87785.09
382709-8270985.25685.47
482293-8229384.82885.00
583236-8323685.80085.99
684285-8428586.88187.08
15min190683-9068393.47692.770.6094.0893.390.58
290207-9020792.98593.62
389124-8912491.86992.51
489684-8968492.44693.05
590162-9016292.93993.56
690106-9010692.88193.52
20min191911-9191194.74294.101.2495.8295.181.22
292889-9288995.75096.85
389931-8993192.70193.80
491855-9185594.68495.75
590827-9082793.62494.71
690288-9028893.06994.17
30min191151-9115193.95895.021.2195.5196.581.19
293786-9378696.67598.26
391826-9182694.65496.21
492660-9266095.51497.05
592811-9281195.67097.22
690859-9085993.65795.22
45min192763-9276395.62095.310.6697.6497.350.63
291676-9167694.50096.57
391747-9174794.57396.61
493128-9312895.99698.01
592888-9288895.74997.78
692583-9258395.43597.47
60min193909-9390996.80196.121.2399.3098.631.19
293317-9331796.19198.73
393252-9325296.12498.63
494901-9490197.824100.32
592558-9255895.40997.92
691561-9156194.38196.89
极限192127-9212794.96495.350.9797.9598.340.95
293548-9354896.42999.45
392319-9231995.16298.15
491934-9193494.76697.75
593633-9363396.51799.51
691458-9145894.27597.26
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100607-201804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%
114.812648852649132648552646522649672648540.05
214.932647202646942647070.01
单位质量响应值RSD%判断
17883.4617729.870.61数据可信
供试品溶液-2023061621批-厄贝沙坦-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%
5min13763-37631.4091.5019.881.411.5019.90
23830-38301.4341.43
35578-55782.0882.09
43276-32761.2271.23
53748-37481.4031.40
63864-38641.4471.45
10min18221-82213.0783.3511.083.083.3611.06
210910-109104.0854.09
38732-87323.2693.28
48662-86623.2433.25
58326-83263.1173.12
68841-88413.3103.32
15min110719-107194.0134.010.464.044.030.49
210744-107444.0234.05
310710-107104.0104.04
410690-106904.0024.02
510615-106153.9744.00
610746-107464.0234.05
20min112215-122154.5734.551.224.624.601.21
212169-121694.5564.60
311956-119564.4764.52
412305-123054.6074.65
512011-120114.4974.54
612302-123024.6064.65
30min113726-137265.1395.211.035.205.281.06
213809-138095.1705.24
313988-139885.2375.31
414078-140785.2715.34
514066-140665.2665.33
613877-138775.1965.26
45min115257-152575.7125.691.635.805.781.57
214781-147815.5345.63
315086-150865.6485.74
415432-154325.7785.87
515240-152405.7065.80
615438-154385.7805.87
60min115830-158305.9276.032.406.056.162.31
215660-156605.8635.99
316080-160806.0206.14
416782-167826.2836.40
516111-161116.0326.15
616224-162246.0746.20
极限116726-167266.2626.241.096.416.401.02
216550-165506.1966.35
316566-165666.2026.36
416719-167196.2606.41
516992-169926.3626.51
616505-165056.1796.33
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100309-201404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%
112.379679696479964519644096488965310.16
212.589653296508965200.02
单位质量响应值RSD%判断
7803.647672.501.20数据可信
供试品溶液-2023061621批-氢氯噻嗪-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%
5min141884-4188443.17540.1814.8543.1740.1814.85
242281-4228143.58443.58
328363-2836329.23729.24
436364-3636437.48537.48
541064-4106442.33042.33
643896-4389645.24945.25
10min184870-8487087.48685.932.4987.7086.142.51
282981-8298185.53985.76
381270-8127083.77583.92
481614-8161484.13084.32
582735-8273585.28585.50
686717-8671789.39089.62
15min189923-8992392.69591.661.5893.3592.291.60
288340-8834091.06391.71
386322-8632288.98389.55
489746-8974692.51293.12
589333-8933392.08692.72
689827-8982792.59693.27
20min190767-9076793.56593.391.3994.6894.481.40
289553-8955392.31393.41
388850-8885091.58992.60
491287-9128794.10195.17
592380-9238095.22796.33
690748-9074893.54594.68
30min193126-9312695.99694.321.4897.5895.871.47
289368-8936892.12393.69
390768-9076893.56695.03
492634-9263495.48997.03
591313-9131394.12795.70
691767-9176794.59596.20
45min192776-9277695.63695.420.9297.7097.450.91
291079-9107993.88695.91
393102-9310295.97297.91
492235-9223595.07897.10
592696-9269695.55397.60
693530-9353096.41398.49
60min190303-9030393.08694.741.6395.6397.241.58
290210-9021092.99095.48
393182-9318296.05498.47
491685-9168594.51197.00
593907-9390796.80199.32
692169-9216995.01097.57
极限192538-9253895.39095.401.2098.4098.381.16
292033-9203394.87097.83
392399-9239995.24798.14
494336-9433697.244100.21
590996-9099693.80196.81
692977-9297795.84398.88
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100607-201804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%
114.812648732644602648452648332648552647730.07
214.932650672650272650470.02
单位质量响应值RSD%判断
17877.9917752.650.50数据可信
供试品溶液-2023061621批-厄贝沙坦-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%
5min13840-38401.4371.3714.771.441.3714.78
23868-38681.4471.45
32564-25640.9590.96
43871-38711.4491.45
53766-37661.4091.41
64006-40061.4991.50
10min18421-84213.1513.152.933.163.152.95
28546-85463.1983.21
37975-79752.9842.99
48490-84903.1773.18
58327-83273.1163.12
68695-86953.2543.26
15min110440-104403.9073.901.993.933.921.96
210496-104963.9283.95
310067-100673.7673.79
410290-102903.8513.87
510641-106413.9824.00
610551-105513.9483.97
20min111675-116754.3694.361.434.414.401.40
211669-116694.3674.41
311407-114074.2694.31
411534-115344.3164.36
511892-118924.4504.49
611722-117224.3874.43
30min113594-135945.0875.001.425.155.061.39
213106-131064.9044.97
313245-132454.9565.02
413286-132864.9725.04
513330-133304.9885.05
613558-135585.0745.14
45min114842-148425.5545.531.555.645.621.53
214706-147065.5035.59
314940-149405.5915.68
414409-144095.3925.48
514758-147585.5235.61
615076-150765.6425.73
60min115401-154015.7635.965.035.886.084.97
215441-154415.7785.89
315524-155245.8095.92
417506-175066.5516.67
515955-159555.9716.09
615738-157385.8896.01
极限116424-164246.1466.071.976.296.211.94
216035-160356.0016.15
315951-159515.9696.11
416227-162276.0726.22
515907-159075.9536.10
616735-167356.2626.41
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100309-201404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%
112.379680496772966309668496656967090.08
212.589729197289972900.01
单位质量响应值RSD%判断
7818.037733.700.77数据可信
供试品溶液-DA619批-氢氯噻嗪-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%
5min133176-3317634.03130.9119.3534.0330.9119.35
238063-3806339.04439.04
333294-3329434.15234.15
426070-2607026.74226.74
528313-2831329.04329.04
621885-2188522.44922.45
10min178106-7810680.11978.122.7680.2978.272.77
276908-7690878.89079.08
375162-7516277.09977.27
476098-7609878.05978.19
578086-7808680.09880.24
672565-7256574.43574.55
15min187935-8793590.20187.551.6090.7788.101.59
284530-8453086.70887.30
384124-8412486.29286.85
484760-8476086.94487.47
585469-8546987.67188.22
685305-8530587.50387.99
20min188614-8861490.89790.171.2691.9291.161.25
287836-8783690.09991.12
386785-8678589.02190.01
489751-8975192.06493.02
587237-8723789.48590.47
687226-8722689.47490.40
30min189239-8923991.53990.081.4093.0191.511.39
286599-8659988.83090.30
386454-8645488.68290.11
489180-8918091.47892.90
588091-8809190.36191.79
687331-8733189.58190.95
45min188230-8823090.50491.040.9092.4492.920.86
288362-8836290.63992.56
387892-8789290.15792.03
489872-8987292.18894.06
588557-8855790.83992.72
689600-8960091.90993.73
60min190144-9014492.46791.861.2694.8594.201.22
288846-8884691.13593.51
387879-8787990.14392.47
489117-8911791.41393.75
590603-9060392.93895.28
690717-9071793.05595.33
极限190842-9084293.18392.130.7196.0394.930.71
289843-8984392.15894.98
388870-8887091.16093.94
489613-8961391.92294.72
589796-8979692.11094.91
689958-8995892.27695.02
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100607-201804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%
114.812653452656762648382657322653512653880.14
214.932669992671922670960.06
单位质量响应值RSD%判断
17919.5117889.890.12数据可信
供试品溶液-DA619批-厄贝沙坦-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%
5min13696-36961.3761.2915.911.381.3015.73
24173-41731.5541.55
33773-37731.4051.40
43317-33171.2351.24
53353-33531.2481.25
62546-25460.9480.95
10min18753-87533.2593.145.103.273.145.13
28574-85743.1923.20
38655-86553.2233.23
48364-83643.1143.12
58606-86063.2043.21
67587-75872.8252.83
15min111403-114034.2464.092.404.274.112.43
210955-109554.0794.10
310822-108224.0294.05
410975-109754.0864.11
511062-110624.1194.14
610616-106163.9533.97
20min112700-127004.7294.661.634.774.701.62
212539-125394.6694.71
312311-123114.5844.63
412726-127264.7384.78
512561-125614.6774.72
612224-122244.5524.59
30min114344-143445.3415.292.275.415.362.25
213895-138955.1745.24
313945-139455.1925.26
414643-146435.4525.52
514461-144615.3845.45
613924-139245.1845.25
45min115243-152435.6765.832.775.775.932.72
215328-153285.7075.80
315379-153795.7265.82
416369-163696.0956.19
515807-158075.8865.98
615883-158835.9146.00
60min116772-167726.2456.310.946.376.440.91
216855-168556.2766.40
316997-169976.3296.45
417238-172386.4186.54
516960-169606.3156.44
616930-169306.3046.42
极限117442-174426.4946.541.186.656.691.14
217436-174366.4926.65
317834-178346.6406.79
417822-178226.6366.79
517476-174766.5076.66
617381-173816.4726.62
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100309-201404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%
112.379670296613965999660196646966320.05
212.589651896526965220.01
单位质量响应值RSD%判断
7811.807672.661.28数据可信
供试品溶液-DA619批-氢氯噻嗪-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%
5min122699-2269923.38627.9118.9723.3927.9118.97
225407-2540726.17626.18
328253-2825329.10829.11
421998-2199822.66422.66
536126-3612637.22037.22
628060-2806028.91028.91
10min171675-7167573.84579.434.6573.9679.564.66
274637-7463776.89777.03
378372-7837280.74580.89
478241-7824180.61080.72
582151-8215184.63884.82
677481-7748179.82779.97
15min184934-8493487.50688.601.1287.9989.141.17
285323-8532387.90688.42
386240-8624088.85189.40
485550-8555088.14088.66
587643-8764390.29790.91
686271-8627188.88389.43
20min187777-8777790.43590.962.9091.3691.942.88
287054-8705489.69090.64
386902-8690289.53390.53
486390-8639089.00689.96
588293-8829390.96692.03
693330-9333096.15697.14
30min188141-8814190.81091.851.6492.1993.281.65
288242-8824290.91492.32
388465-8846591.14392.58
488107-8810790.77592.18
590402-9040293.13994.65
691519-9151994.29095.76
45min188374-8837491.05092.321.1992.8894.221.21
288849-8884991.53993.40
388890-8889091.58193.48
489941-8994192.66494.52
590677-9067793.42295.40
690933-9093393.68695.63
60min188708-8870891.39492.071.2193.6894.421.24
288976-8897691.67093.99
388756-8875691.44393.80
489034-8903491.73094.05
591541-9154194.31396.76
689156-8915691.85594.26
极限189419-8941992.12691.452.0694.8794.272.03
288195-8819590.86593.64
386577-8657789.19892.01
488462-8846291.14093.92
591984-9198494.76997.69
687961-8796190.62493.49
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100607-201804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%
114.812651292650782650762650062651382650850.02
214.932649312652092650700.08
单位质量响应值RSD%判断
17899.0517754.190.58数据可信
供试品溶液-DA619批-厄贝沙坦-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%
5min12690-26901.0061.2418.231.011.2418.19
23329-33291.2451.24
33798-37981.4201.42
42772-27721.0371.04
54218-42181.5771.58
63024-30241.1311.13
10min17726-77262.8893.105.222.893.105.23
28021-80213.0003.01
38329-83293.1153.12
48355-83553.1253.13
59022-90223.3743.38
68279-82793.0963.10
15min110659-106593.9864.102.664.014.122.66
210746-107464.0194.04
310978-109784.1064.13
410847-108474.0574.08
511460-114604.2864.31
611118-111184.1584.18
20min112277-122774.5914.651.514.634.691.55
212382-123824.6314.67
312391-123914.6344.68
412280-122804.5924.63
512765-127654.7744.82
612540-125404.6904.73
30min113590-135905.0825.395.185.145.455.16
214031-140315.2475.31
314309-143095.3515.42
414127-141275.2835.35
514633-146335.4725.54
615757-157575.8935.96
45min115060-150605.6325.852.915.725.942.87
215286-152865.7175.81
315477-154775.7885.88
415890-158905.9436.03
515819-158195.9166.01
616308-163086.0996.19
60min116412-164126.1386.241.066.256.361.13
216607-166076.2116.33
316602-166026.2096.33
416705-167056.2476.37
516930-169306.3316.46
616781-167816.2766.40
极限116980-169806.3506.402.146.506.552.10
216848-168486.3016.45
316779-167796.2756.43
417141-171416.4106.56
517797-177976.6566.81
617106-171066.3976.55
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