托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品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10000
标示量(mg)15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%
116.449861298570984629842698368984880.11
216.399824098244982420.01
单位质量响应值RSD%判断
5990.755994.020.04数据可信
供试品溶液-2K72SDB2批-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%
5min16420-64206.4285.5415.806.435.5415.83
26331-63316.3396.34
35650-56505.6575.66
44188-41884.1934.19
54826-48264.8324.83
65813-58135.8205.82
10min118055-1805518.07817.323.4018.1117.353.41
217905-1790517.92817.96
316971-1697116.99317.02
416791-1679116.81216.84
516660-1666016.68116.71
617413-1741317.43517.47
15min126109-2610926.14225.612.8226.2825.742.84
225548-2554825.58025.72
325549-2554925.58125.71
424525-2452524.55624.67
525160-2516025.19225.31
626593-2659326.62726.76
20min132304-3230432.34531.681.7132.6331.951.73
231988-3198832.02932.31
331623-3162331.66331.93
431028-3102831.06731.32
530980-3098031.01931.28
631917-3191731.95832.23
30min141930-4193041.98340.981.4842.4441.431.50
241108-4110841.16041.62
340898-4089840.95041.39
440154-4015440.20540.63
540495-4049540.54640.98
641013-4101341.06541.52
45min150781-5078150.84650.520.8551.5451.190.85
249958-4995850.02150.71
350300-5030050.36451.04
450033-5003350.09750.75
550631-5063150.69551.35
651022-5102251.08751.77
60min158893-5889358.96859.141.9759.9460.091.93
260622-6062260.69961.66
359318-5931859.39360.34
460005-6000560.08161.01
557892-5789257.96658.90
657668-5766857.74158.71
90min168396-6839668.48368.740.5469.7970.020.54
268582-6858268.66969.97
369054-6905469.14270.42
468397-6839768.48469.75
568307-6830768.39469.65
669160-6916069.24870.54
120min174474-7447474.56974.691.2776.2576.351.23
272954-7295473.04774.73
375188-7518875.28476.95
475472-7547275.56877.21
574187-7418774.28175.92
675278-7527875.37477.05
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min181502-8150281.60682.090.8683.7084.170.83
281222-8122281.32583.41
382860-8286082.96585.05
482737-8273782.84284.90
582154-8215482.25884.31
681455-8145581.55883.65
240min186289-8628986.39986.670.7988.9589.200.76
286177-8617786.28688.82
386204-8620486.31488.86
487888-8788888.00090.52
586151-8615186.26088.77
686643-8664386.75389.30
300min187840-8784087.95288.100.8090.9891.120.78
289027-8902789.14092.16
388235-8823588.34791.37
487946-8794688.05891.07
586864-8686486.97489.96
688016-8801688.12891.15
360min187138-8713887.24988.701.2490.7792.211.18
287425-8742587.53691.05
388495-8849588.60792.12
489547-8954789.66193.16
589600-8960089.71493.19
689336-8933689.44992.97
极限185392-8539285.50087.561.8489.5191.561.76
286266-8626686.37690.37
387781-8778187.89391.90
489769-8976989.88393.88
586862-8686286.97290.94
688633-8863388.74692.76
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品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10000
标示量(mg)15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%
116.449909199034990519902699069990540.03
216.399844198430984360.01
单位质量响应值RSD%判断
6025.186005.860.23数据可信
供试品溶液-3A75SDB1批-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%
5min15070-50705.0575.3911.125.065.3911.13
25825-58255.8105.81
35485-54855.4715.47
44354-43544.3434.34
55857-58575.8425.84
65854-58545.8395.84
10min118089-1808918.04217.503.4418.0717.543.45
217067-1706717.02317.06
318312-1831218.26518.30
416711-1671116.66816.69
517475-1747517.43017.46
617641-1764117.59617.63
15min125647-2564725.58125.332.5225.7125.462.53
225024-2502424.96025.09
326281-2628126.21326.35
424754-2475424.69024.81
525912-2591225.84525.97
624776-2477624.71224.84
20min131517-3151731.43631.691.2931.7131.961.30
231338-3133831.25731.52
331984-3198431.90232.18
431389-3138931.30831.56
532245-3224532.16232.43
632185-3218532.10232.37
30min141313-4131341.20741.150.9341.6541.600.90
241141-4114141.03541.47
340944-4094440.83841.29
441996-4199641.88842.32
541081-4108140.97541.43
641083-4108340.97741.42
45min151928-5192851.79450.481.7552.4751.151.73
249878-4987849.74950.42
349922-4992249.79350.47
451309-5130951.17751.84
549812-4981249.68450.36
650793-5079350.66251.34
60min157882-5788257.73357.991.8558.6958.941.82
257954-5795457.80558.75
359343-5934359.19060.15
459276-5927659.12360.07
557909-5790957.76058.71
656448-5644856.30357.26
90min168827-6882768.65068.241.6769.9369.521.63
268148-6814867.97269.24
366962-6696266.78968.08
470377-7037770.19671.47
568253-6825368.07769.35
667923-6792367.74869.02
120min173220-7322073.03173.731.6274.7075.381.59
272522-7252272.33573.98
372840-7284072.65274.31
475288-7528875.09476.76
574653-7465374.46176.11
674990-7499074.79776.44
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min180185-8018579.97880.552.2682.0582.622.21
277965-7796577.76479.81
380751-8075180.54382.60
483175-8317582.96185.04
582274-8227482.06284.13
680218-8021880.01182.07
240min186552-8655286.32986.151.7288.8488.661.68
286356-8635686.13388.61
384875-8487584.65687.17
488959-8895988.73091.27
586527-8652786.30488.83
684975-8497584.75687.26
300min186369-8636986.14687.251.9389.1490.241.89
285818-8581885.59788.55
387532-8753287.30690.29
489742-8974289.51192.55
589263-8926389.03392.04
686122-8612285.90088.88
360min185152-8515284.93387.142.5188.4090.622.45
284662-8466284.44487.87
387930-8793087.70391.17
490606-9060690.37293.90
588289-8828988.06191.56
687573-8757387.34790.80
极限186098-8609885.87687.701.9989.8291.661.94
285557-8555785.33689.24
388324-8832488.09692.05
490088-9008889.85693.89
588898-8889888.66992.66
688615-8861588.38792.32
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