XXYYYY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%
110.172825328232281592813228203281960.18
210.502873428706287200.07
单位质量响应值RSD%判断
2772.472735.240.96数据可信
供试品溶液-1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%
5min110591-1059134.50735.722.8734.5135.722.86
211320-1132036.88236.88
310607-1060734.55934.56
411156-1115636.34836.35
511207-1120736.51436.51
610903-1090335.52435.52
10min116254-1625452.95853.151.0653.0253.211.06
216376-1637653.35653.42
316047-1604752.28452.34
416561-1656153.95854.02
516383-1638353.37953.44
616250-1625052.94553.00
15min119746-1974664.33662.931.8864.4863.071.87
219291-1929162.85363.00
318883-1888361.52461.67
419500-1950063.53463.68
519571-1957163.76663.92
618888-1888861.54061.69
20min121253-2125369.24668.871.2769.5069.121.27
221361-2136169.59869.85
321246-2124669.22369.47
421084-2108468.69568.95
521256-2125669.25669.51
620623-2062367.19367.44
30min123223-2322375.66474.801.4776.0375.161.47
223127-2312775.35275.72
322547-2254773.46273.82
423075-2307575.18275.55
523253-2325375.76276.13
622514-2251473.35473.72
45min124650-2465080.31479.471.7480.8179.961.74
224633-2463380.25880.76
323893-2389377.84778.33
424517-2451779.88080.38
524826-2482680.88781.39
623826-2382677.62978.11
60min125538-2553883.20782.131.7283.8482.751.71
225330-2533082.52983.16
324776-2477680.72481.34
425380-2538082.69283.32
525641-2564183.54384.18
624573-2457380.06380.68
90min126132-2613285.14284.311.9185.9185.071.90
226104-2610485.05185.82
325335-2533582.54683.30
426130-2613085.13685.90
526373-2637385.92886.70
625177-2517782.03182.78
120min126556-2655686.52486.192.5987.4387.092.58
226463-2646386.22187.13
325969-2596984.61185.50
427485-2748589.55190.46
526759-2675987.18588.10
625485-2548583.03483.92
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126921-2692187.71386.761.6888.7787.801.68
226892-2689287.61988.67
326339-2633985.81786.84
426700-2670086.99388.05
527043-2704388.11189.17
625867-2586784.27985.30
XXYYYY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%
110.172862428779286222856828549286280.32
210.502901329086290500.18
单位质量响应值RSD%判断
2814.952766.671.23数据可信
供试品溶液-2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%
5min112005-1200538.59737.044.5438.6037.044.54
212181-1218139.16339.16
311435-1143536.76536.76
411364-1136436.53736.54
510713-1071334.44434.44
611424-1142436.73036.73
10min117411-1741155.97854.562.6956.0454.622.69
217295-1729555.60555.67
316829-1682954.10754.17
417011-1701154.69254.75
516141-1614151.89551.95
617135-1713555.09155.15
15min120449-2044965.74664.212.0865.9064.362.08
220212-2021264.98465.14
319998-1999864.29664.45
419813-1981363.70163.85
519246-1924661.87862.02
620101-2010164.62764.78
20min122343-2234371.83569.871.8572.1070.141.85
221935-2193570.52470.79
321703-2170369.77870.04
421642-2164269.58269.84
521122-2112267.91068.16
621654-2165469.62069.88
30min124366-2436678.34076.041.9278.7376.411.92
223847-2384776.67177.05
323716-2371676.25076.62
423446-2344675.38275.76
523008-2300873.97374.33
623518-2351875.61375.99
45min125776-2577682.87380.961.3283.3981.461.32
224913-2491380.09880.61
325139-2513980.82581.33
425307-2530781.36581.86
524886-2488680.01180.49
625056-2505680.55881.06
60min126398-2639884.87382.891.3085.5383.531.30
225502-2550281.99282.64
325761-2576182.82583.46
425538-2553882.10882.74
525610-2561082.33982.96
625876-2587683.19483.83
90min127050-2705086.96985.401.2987.7786.181.29
226284-2628484.50685.29
326801-2680186.16886.94
426299-2629984.55485.33
526224-2622484.31385.07
626719-2671985.90586.68
120min127328-2732887.86386.141.6488.8087.061.63
226178-2617884.16585.09
327173-2717387.36488.28
426721-2672185.91186.82
526433-2643384.98585.88
626918-2691886.54587.46
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127768-2776889.27787.760.9490.3788.820.95
227399-2739988.09189.15
327196-2719687.43888.50
427176-2717687.37488.43
527054-2705486.98288.02
627188-2718887.41388.48
XXYYYY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%
110.172832728324282582836828337283230.15
210.502967829628296530.12
单位质量响应值RSD%判断
2784.962824.100.99数据可信
供试品溶液-3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%
5min19534-953430.50230.615.5930.5030.615.59
210155-1015532.48932.49
310122-1012232.38332.38
48848-884828.30728.31
59672-967230.94430.94
69072-907229.02429.02
10min116049-1604951.34652.106.4251.4052.156.41
216468-1646852.68652.74
315924-1592450.94651.00
415266-1526648.84148.89
515742-1574250.36350.42
618261-1826158.42358.47
15min119112-1911261.14560.980.6561.2861.120.65
219283-1928361.69261.83
318990-1899060.75560.89
419053-1905360.95661.08
518946-1894660.61460.75
618980-1898060.72360.87
20min121004-2100467.19866.801.1767.4467.041.17
221211-2121167.86068.11
320758-2075866.41166.65
420509-2050965.61565.84
520813-2081366.58766.82
620988-2098867.14767.39
30min122997-2299773.57473.360.8073.9273.710.81
223217-2321774.27874.64
322685-2268572.57672.93
422798-2279872.93873.28
522901-2290173.26773.61
622986-2298673.53973.90
45min124647-2464778.85378.290.8179.3378.760.81
224542-2454278.51779.00
324150-2415077.26377.74
424322-2432277.81478.27
524518-2451878.44178.91
624644-2464478.84479.33
60min125256-2525680.80280.860.8581.4181.470.85
225523-2552381.65682.27
325152-2515280.46981.07
425010-2501080.01580.61
525171-2517180.53081.13
625538-2553881.70482.32
90min125936-2593682.97783.191.2383.7283.931.22
226155-2615583.67884.43
325487-2548781.54182.28
425849-2584982.69983.42
526188-2618883.78384.52
626394-2639484.44285.19
120min126519-2651984.84284.411.6085.7285.281.59
226625-2662585.18286.07
325660-2566082.09482.96
426183-2618383.76784.63
526441-2644184.59385.47
626870-2687085.96586.86
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126683-2668385.36785.491.2386.3986.501.22
226891-2689186.03387.06
326142-2614283.63684.64
426641-2664185.23386.23
526880-2688085.99787.01
627090-2709086.66987.70
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