多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.003139431439315703159331432314860.29
29.993191732172320440.57
单位质量响应值RSD%判断
3148.603207.611.32数据可信
供试品溶液-H139P批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113422-1342237.89536.914.6437.8936.914.64
213317-1331737.59837.60
312363-1236334.90534.90
412242-1224234.56334.56
513545-1354538.24238.24
613559-1355938.28238.28
10min122990-2299064.90963.012.8764.9763.072.86
221869-2186961.74461.81
322051-2205162.25862.32
421398-2139860.41460.47
522746-2274664.22064.28
622852-2285264.51964.58
15min126564-2656474.99974.102.4675.1774.262.46
225761-2576172.73272.90
325776-2577672.77472.94
425506-2550672.01272.17
526784-2678475.62075.79
627074-2707476.43976.61
20min128695-2869581.01680.361.8581.3180.651.85
228280-2828079.84480.13
328167-2816779.52579.81
427656-2765678.08278.36
528954-2895481.74782.04
629018-2901881.92882.23
30min130815-3081587.00186.801.7087.4387.231.71
230682-3068286.62687.05
330365-3036585.73186.15
429991-2999184.67585.08
531364-3136488.55188.98
631254-3125488.24188.68
45min131921-3192190.12490.621.2790.7091.181.27
231988-3198890.31390.88
331984-3198490.30290.86
431546-3154689.06589.61
532477-3247791.69492.27
632659-3265992.20892.79
60min132873-3287392.81292.631.9793.5493.341.97
232218-3221890.96291.68
333051-3305193.31494.02
431857-3185789.94390.64
533370-3337094.21594.95
633474-3347494.50995.24
90min132751-3275192.46792.212.2193.3593.082.18
232618-3261892.09292.96
333134-3313493.54994.41
432413-3241391.51392.36
533578-3357894.80295.69
631458-3145888.81789.71
120min133415-3341594.34293.921.4495.3894.951.44
233089-3308993.42294.44
332972-3297293.09194.11
432636-3263692.14393.14
534009-3400996.01997.07
633482-3348294.53195.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134005-3400596.00895.331.0697.2096.521.06
233604-3360494.87696.05
333974-3397495.92097.10
433156-3315693.61194.76
534125-3412596.34797.56
633725-3372595.21796.42
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.003179032084318863175431702318430.48
29.993198332001319920.04
单位质量响应值RSD%判断
3184.303202.400.41数据可信
供试品溶液-H139P批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13307-33079.2918.878.269.298.868.27
23277-32779.2079.21
32990-29908.4018.40
43050-30508.5698.57
52792-27927.8457.84
63518-35189.8849.88
10min16915-691519.42919.444.1919.4419.454.20
27308-730820.53320.55
36804-680419.11719.13
47024-702419.73519.75
56435-643518.08018.09
67019-701919.72119.74
15min19975-997528.02627.282.4828.0727.322.48
29931-993127.90327.95
39645-964527.09927.14
49666-966627.15827.21
59306-930626.14726.19
69726-972627.32727.38
20min112266-1226634.46333.552.3034.5633.652.30
212202-1220234.28334.38
311782-1178233.10333.19
412079-1207933.93834.03
511628-1162832.67132.76
611696-1169632.86232.96
30min115155-1515542.58041.641.6442.7341.791.64
214827-1482741.65941.81
314897-1489741.85542.00
414913-1491341.90042.05
514430-1443040.54340.68
614705-1470541.31641.47
45min118629-1862952.34151.151.6752.5651.361.67
218200-1820051.13551.36
318229-1822951.21751.43
418263-1826351.31251.53
517679-1767949.67249.88
618227-1822751.21151.43
60min120774-2077458.36757.520.9058.6857.820.91
220303-2030357.04457.35
320600-2060057.87958.18
420390-2039057.28957.59
520309-2030957.06157.35
620457-2045757.47757.78
90min124162-2416267.88765.661.7968.2966.061.79
223099-2309964.90065.30
323427-2342765.82166.22
423288-2328865.43165.83
522986-2298664.58264.97
623253-2325365.33365.73
120min126039-2603973.16071.941.3873.6872.451.38
225624-2562471.99472.51
325823-2582372.55373.06
425754-2575472.36072.87
525096-2509670.51171.01
625287-2528771.04771.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限126962-2696275.75473.431.8476.4074.061.83
226133-2613373.42474.06
326143-2614373.45274.08
426146-2614673.46174.09
525486-2548671.60772.22
625937-2593772.87473.50
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.003183431570316993153731722316720.39
29.993184931711317800.31
单位质量响应值RSD%判断
3167.203181.180.32数据可信
供试品溶液-H139P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%
5min16029-602917.04216.6110.2417.0416.6110.24
26458-645818.25418.25
35089-508914.38514.38
46370-637018.00518.01
55165-516514.59914.60
66153-615317.39217.39
10min111045-1104531.22030.995.4031.2531.025.41
211332-1133232.03132.06
310206-1020628.84828.87
411429-1142932.30532.34
510250-1025028.97329.00
611518-1151832.55732.59
15min114299-1429940.41740.894.4340.5040.974.43
214874-1487442.04342.13
313544-1354438.28338.36
414864-1486442.01442.10
513970-1397039.48739.56
615239-1523943.07443.16
20min116653-1665347.07148.344.5547.2248.494.55
217449-1744949.32149.48
316259-1625945.95846.09
417553-1755349.61549.77
516439-1643946.46646.60
618259-1825951.61151.77
30min119950-1995056.39158.204.1656.6258.434.16
220789-2078958.76259.00
319795-1979555.95256.16
421008-2100859.38159.62
519978-1997856.47056.69
622014-2201462.22562.47
45min123276-2327665.79267.433.7166.1167.763.72
223978-2397867.77668.11
323054-2305465.16465.47
424210-2421068.43268.77
523217-2321765.62565.93
625399-2539971.79372.14
60min125562-2556272.25373.673.6972.6874.113.70
225990-2599073.46373.91
325205-2520571.24471.66
426451-2645174.76675.22
525378-2537871.73372.15
627797-2779778.57179.04
90min127957-2795779.02381.734.3779.5782.294.37
228715-2871581.16681.74
328034-2803479.24179.77
428956-2895681.84782.42
528458-2845880.43980.98
631369-3136988.66789.26
120min129386-2938683.06286.003.6383.7486.703.64
230344-3034485.77086.47
329565-2956583.56884.23
431100-3110087.90788.62
529860-2986084.40285.08
632294-3229491.28292.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限130311-3031185.67787.882.8486.5088.722.85
230844-3084487.18388.03
330641-3064186.61087.41
431530-3153089.12289.98
530539-3053986.32187.13
632681-3268192.37693.27
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.003180031794319073190731715318250.26
29.993169731790317440.21
单位质量响应值RSD%判断
3182.503177.580.11数据可信
供试品溶液-H139P批-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%
5min123583-2358366.53775.057.6466.5475.067.64
227970-2797078.91478.91
325591-2559172.20272.20
426422-2642274.54774.55
526511-2651174.79874.80
629535-2953583.33083.33
10min130590-3059086.30690.673.8486.4290.803.85
232525-3252591.76591.90
332222-3222290.91191.03
431608-3160889.17889.30
531625-3162589.22689.35
634260-3426096.66196.80
15min132433-3243391.50693.592.0991.7693.862.10
233366-3336694.13894.42
333153-3315393.53793.81
432770-3277092.45792.73
532878-3287892.76193.03
634423-3442397.12097.42
20min132734-3273492.35594.111.8292.7694.541.83
233319-3331994.00694.45
333688-3368895.04795.47
432798-3279892.53692.96
533236-3323693.77194.20
634362-3436296.94897.41
30min133145-3314593.51595.091.7294.0895.681.72
233561-3356194.68895.29
333762-3376295.25695.84
433226-3322693.74394.32
533773-3377395.28795.87
634749-3474998.04098.66
45min133364-3336494.13395.701.6594.8596.451.66
233757-3375795.24196.00
333966-3396695.83196.58
433350-3335094.09394.83
534284-3428496.72897.47
634796-3479698.17398.96
60min133511-3351194.54795.671.6195.4296.581.62
233524-3352494.58495.50
334317-3431796.82197.73
433573-3357394.72295.62
533690-3369095.05295.96
634832-3483298.27499.22
90min133386-3338694.19595.361.3695.2396.431.37
233730-3373095.16596.24
334060-3406096.09697.16
433517-3351794.56495.62
533499-3349994.51395.58
634597-3459797.61198.73
120min133169-3316993.58295.481.6594.7796.701.65
233533-3353394.60995.84
334246-3424696.62197.85
433610-3361094.82796.04
533763-3376395.25896.48
634721-3472197.96199.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限133212-3321293.70495.601.7595.0596.981.76
233511-3351194.54795.94
334019-3401995.98197.37
433624-3362494.86696.23
534023-3402395.99297.37
634911-3491198.49799.94
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