坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.977687276923769747724677316770660.27
215.947759976841772200.70
单位质量响应值RSD%判断
4825.674844.420.28数据可信
供试品溶液-2025030221批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118716-1871621.73022.069.6021.7322.069.60
216455-1645519.10519.11
319902-1990223.10723.11
421592-2159225.07025.07
519747-1974722.92722.93
617597-1759720.43120.43
10min135555-3555541.28145.098.3441.3245.138.34
238198-3819844.35044.38
337759-3775943.84043.88
442566-4256649.42249.46
543037-4303749.96850.01
635912-3591241.69641.73
15min152637-5263761.11567.057.6961.2267.167.68
259349-5934968.90869.01
354276-5427663.01863.13
461240-6124071.10371.23
563933-6393374.23074.35
655055-5505563.92264.03
20min165338-6533875.86180.865.5076.0781.095.51
272259-7225983.89784.12
365477-6547776.02376.24
473011-7301184.77085.01
573736-7373685.61285.86
668058-6805879.01979.23
30min175729-7572987.92690.953.1188.2691.303.12
279440-7944092.23592.59
375234-7523487.35187.69
481293-8129394.38694.77
580110-8011093.01293.40
678186-7818690.77991.12
45min179195-7919591.95093.451.7192.4393.961.73
280076-8007692.97393.49
378864-7886491.56692.05
482467-8246795.74996.29
581415-8141594.52895.07
680898-8089893.92794.42
60min178986-7898691.70792.661.4492.3493.321.46
279465-7946592.26492.93
378181-7818190.77391.41
481362-8136294.46695.17
580436-8043693.39194.09
680398-8039893.34794.00
极限179649-7964992.47792.501.4893.2693.311.49
278877-7887791.58192.40
377737-7773790.25791.05
480830-8083093.84894.71
580390-8039093.33894.19
680503-8050393.46994.27
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.977728877575775177772877163774540.30
215.947779477945778700.14
单位质量响应值RSD%判断
4849.974885.190.52数据可信
供试品溶液-2025030221批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121577-2157724.88523.3313.6724.8823.3213.66
222355-2235525.78225.78
317920-1792020.66720.67
416922-1692219.51619.52
518707-1870721.57521.57
623874-2387427.53427.53
10min144014-4401450.76245.3813.9550.8045.4213.95
243597-4359750.28150.32
333712-3371238.88038.91
433022-3302238.08538.12
536725-3672542.35542.39
645012-4501251.91351.96
15min162964-6296472.61766.2311.0972.7466.3411.09
262787-6278772.41372.54
350720-5072058.49658.60
450203-5020357.90058.00
554381-5438162.71862.82
663482-6348273.21473.35
20min172795-7279583.95578.678.3584.2078.898.36
273534-7353484.80785.05
361658-6165871.11171.31
461602-6160271.04671.24
566608-6660876.82077.03
673053-7305384.25384.51
30min178338-7833890.34888.494.1690.7388.844.18
279630-7963091.83892.23
371223-7122382.14282.46
475436-7543687.00187.31
576244-7624487.93388.27
679484-7948491.67092.06
45min178602-7860290.65290.752.9091.1991.252.91
280267-8026792.57393.11
374281-7428185.66986.12
479231-7923191.37891.83
579198-7919891.34091.83
680538-8053892.88593.43
60min177857-7785789.79390.462.9890.4891.112.99
279665-7966591.87892.57
373942-7394285.27885.87
479660-7966091.87392.48
579341-7934191.50592.14
680128-8012892.41293.11
极限177445-7744589.31890.601.5290.1691.401.53
279549-7954991.74592.59
376714-7671488.47589.21
479267-7926791.41992.18
578832-7883290.91891.71
679508-7950891.69792.55
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.977770776945775067725677533773890.39
215.947860678168783870.40
单位质量响应值RSD%判断
4845.904917.631.04数据可信
供试品溶液-12412515批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115360-1536017.66417.135.6917.6617.135.68
214048-1404816.15516.16
314810-1481017.03217.03
415638-1563817.98417.98
515764-1576418.12918.13
613740-1374015.80115.80
10min128859-2885933.18835.113.8233.2235.133.82
230503-3050335.07935.11
330201-3020134.73134.76
432158-3215836.98237.01
531482-3148236.20436.23
629954-2995434.44734.47
15min143519-4351950.04754.814.9150.1354.904.91
248380-4838055.63755.72
347623-4762354.76754.85
450508-5050858.08458.18
548815-4881556.13756.23
647145-4714554.21754.30
20min155237-5523763.52370.535.4363.6970.715.43
262940-6294072.38172.56
361765-6176571.03071.21
465064-6506474.82475.01
562355-6235571.70971.89
660626-6062669.72069.89
30min170956-7095681.60088.644.4381.8788.944.43
279253-7925391.14191.44
378422-7842290.18690.48
480347-8034792.39992.71
578020-7802089.72390.03
675495-7549586.82087.11
45min179466-7946691.38694.552.0591.8094.992.06
283625-8362596.16996.62
383678-8367896.23096.68
483315-8331595.81396.28
582088-8208894.40294.85
681114-8111493.28293.72
60min180713-8071392.82094.401.4293.3895.001.44
282862-8286295.29295.90
383355-8335595.85996.47
482846-8284695.27395.90
582123-8212394.44295.05
680634-8063492.73093.32
极限181078-8107893.24093.631.3593.9694.391.35
281730-8173093.99094.76
383107-8310795.57396.34
481903-8190394.18994.97
580816-8081692.93993.71
679879-7987991.86192.61
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.977724177371777807741777357774330.27
215.947777478121779480.32
单位质量响应值RSD%判断
4848.654890.090.61数据可信
供试品溶液-12412515批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113750-1375015.85217.508.7715.8517.508.78
216398-1639818.90518.91
313859-1385915.97815.98
417055-1705519.66319.66
515078-1507817.38317.38
614938-1493817.22217.22
10min130325-3032534.96135.364.1534.9935.394.15
231164-3116435.92935.96
330568-3056835.24235.27
432808-3280837.82437.86
528981-2898133.41233.44
630156-3015634.76734.80
15min148580-4858056.00755.183.8656.0955.273.85
247193-4719354.40854.50
349667-4966757.26157.35
449415-4941556.97057.07
544649-4464951.47551.56
647685-4768554.97655.06
20min162638-6263872.21570.624.2772.3970.804.26
259221-5922168.27568.46
364516-6451674.38074.56
462015-6201571.49771.69
557211-5721165.95866.13
661938-6193871.40871.59
30min178800-7880090.84888.263.5891.1588.563.57
272871-7287184.01284.31
378364-7836490.34590.65
476101-7610187.73688.05
573827-7382785.11485.39
679354-7935491.48691.78
45min182907-8290795.58394.282.0896.0394.722.08
279017-7901791.09891.53
382273-8227394.85295.31
481368-8136893.80894.26
581153-8115393.56193.98
683941-8394196.77597.22
60min182419-8241995.02093.921.5895.6394.521.57
279503-7950391.65892.25
381543-8154394.01094.62
480523-8052392.83493.45
581735-8173594.23294.81
683043-8304395.73996.35
极限181949-8194994.47892.881.6295.2593.631.61
279387-7938791.52592.26
380002-8000292.23493.00
478993-7899391.07091.84
580975-8097593.35594.09
682048-8204894.59295.36
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