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5000
标示量(mg)2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%
19.813071330827307863110030647308150.57
29.913126931130312000.32
单位质量响应值RSD%判断
3141.183148.340.17数据可信
中间条件6月-供试品溶液-2025072421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%
5min110694-1069430.51035.447.7430.5135.447.74
213318-1331837.99738.00
312921-1292136.86436.86
412613-1261335.98535.99
513009-1300937.11537.12
611978-1197834.17434.17
10min118135-1813551.74056.494.2251.7956.554.22
219935-1993556.87556.94
320315-2031557.95958.02
419968-1996856.96957.03
520347-2034758.05158.11
620104-2010457.35757.41
15min122245-2224563.46667.292.8963.6067.442.89
223540-2354067.16067.32
324074-2407468.68468.84
423930-2393068.27368.43
523829-2382967.98568.14
623891-2389168.16268.31
20min124143-2414368.88172.642.7869.1272.902.79
225433-2543372.56172.83
325463-2546372.64772.92
425609-2560973.06373.33
526174-2617474.67574.95
625943-2594374.01674.28
30min127533-2753378.55379.812.0678.9180.202.05
227072-2707277.23777.63
328151-2815180.31680.71
428273-2827380.66481.05
528143-2814380.29380.69
628675-2867581.81182.20
45min128669-2866981.79483.842.4382.2884.362.43
228440-2844081.14081.66
329610-2961084.47885.01
430361-3036186.62187.15
529534-2953484.26284.79
629707-2970784.75585.28
60min129772-2977284.94185.752.1585.5786.422.14
228938-2893882.56183.22
329987-2998785.55486.22
430627-3062787.38088.05
530507-3050787.03887.71
630511-3051187.04987.72
90min129958-2995885.47186.532.5886.2487.332.57
229178-2917883.24684.04
330646-3064687.43488.24
430933-3093388.25389.07
529937-2993785.41186.23
631318-3131889.35190.16
120min130675-3067587.51787.792.8388.4388.742.81
229132-2913283.11584.05
330915-3091588.20289.16
431586-3158690.11691.08
530958-3095888.32489.28
631364-3136489.48390.44
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131700-3170090.44189.742.7791.5090.842.75
229910-2991085.33486.40
331195-3119589.00090.10
431936-3193691.11592.23
531524-3152489.93991.04
632471-3247192.64193.75
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5000
标示量(mg)2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%
19.813085430676306273093530722307630.42
29.913126631497313820.53
单位质量响应值RSD%判断
3135.883166.700.70数据可信
中间条件6月-供试品溶液-2025072521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%
5min112777-1277736.37938.263.2736.3838.263.27
213171-1317137.50037.50
313779-1377939.23139.23
413248-1324837.72037.72
513806-1380639.30839.31
613848-1384839.42839.43
10min119922-1992256.72258.513.4556.7858.573.45
221820-2182062.12662.19
320914-2091459.54659.61
420079-2007957.16957.23
520302-2030257.80457.87
620257-2025757.67557.74
15min124003-2400368.34169.442.6668.5069.602.65
225568-2556872.79772.96
324587-2458770.00470.17
423713-2371367.51567.67
524189-2418968.87169.03
624268-2426869.09669.26
20min126113-2611374.34974.651.8274.6274.921.82
227124-2712477.22777.51
326250-2625074.73975.02
425956-2595673.90274.17
525747-2574773.30773.58
626121-2612174.37174.65
30min128727-2872781.79181.242.3582.1881.652.35
229801-2980184.84985.27
328268-2826880.48480.89
428281-2828180.52180.92
528171-2817180.20880.61
627961-2796179.61080.01
45min130146-3014685.83185.471.9686.3686.001.96
230977-3097788.19788.75
330230-3023086.07086.61
429876-2987685.06385.59
529603-2960384.28584.82
629275-2927583.35183.89
60min130537-3053786.94586.901.6387.6287.581.64
231345-3134589.24589.95
330805-3080587.70888.39
429946-2994685.26285.93
530265-3026586.17086.84
630240-3024086.09986.77
90min131617-3161790.02089.331.4790.8490.151.47
232162-3216291.57192.42
331375-3137589.33090.16
431099-3109988.54589.36
531087-3108788.51089.33
630905-3090587.99288.81
120min131740-3174090.37089.801.3991.3490.771.39
232037-3203791.21592.22
331922-3192290.88891.87
431292-3129289.09490.05
531350-3135089.25990.22
630889-3088987.94788.91
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131489-3148989.65591.021.2190.7792.141.21
232523-3252392.59993.76
331947-3194790.95992.09
431808-3180890.56391.67
532317-3231792.01393.13
631730-3173090.34191.45
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5000
标示量(mg)2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%
19.813135931231314263138531353313510.24
29.913185331577317150.62
单位质量响应值RSD%判断
3195.823200.300.10数据可信
中间条件6月-供试品溶液-2025072522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%
5min113297-1329737.30431.7212.1637.3031.7212.15
29380-938026.31526.32
311779-1177933.04633.05
411458-1145832.14532.15
511771-1177133.02333.02
610161-1016128.50728.51
10min120265-2026556.85350.456.3656.9250.506.37
217648-1764849.51149.56
317487-1748749.05949.11
417429-1742948.89748.95
517897-1789750.21050.26
617175-1717548.18448.23
15min124076-2407667.54560.356.3767.7060.496.37
221928-2192861.51961.64
320434-2043457.32757.46
421247-2124759.60859.74
520869-2086958.54858.69
620524-2052457.58057.71
20min125947-2594772.79466.465.2173.0666.705.21
224278-2427868.11168.34
322904-2290464.25764.49
423225-2322565.15765.39
523027-2302764.60264.84
622753-2275363.83364.06
30min128276-2827679.32872.944.6879.7273.294.69
226467-2646774.25374.60
325233-2523370.79171.13
425412-2541271.29371.64
525532-2553271.63071.97
625079-2507970.35970.69
45min129234-2923482.01577.783.2482.5478.253.25
228160-2816079.00279.47
327139-2713976.13876.60
427369-2736976.78377.25
527753-2775377.86178.32
626685-2668574.86475.31
60min129677-2967783.25880.402.4283.9281.002.43
229295-2929582.18782.78
328104-2810478.84579.43
428346-2834679.52480.11
528592-2859280.21480.81
627926-2792678.34678.92
90min130346-3034685.13582.921.6485.9383.661.66
229868-2986883.79484.53
329531-2953182.84983.56
429014-2901481.39882.12
529368-2936882.39183.12
629221-2922181.97982.68
120min130246-3024684.85583.231.6185.7984.101.63
230055-3005584.31985.19
329451-2945182.62483.48
429566-2956682.94783.80
529783-2978383.55684.42
628907-2890781.09881.94
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131280-3128087.75585.751.4588.8486.761.47
230842-3084286.52787.54
330466-3046685.47286.46
430473-3047385.49186.49
530315-3031585.04886.05
630014-3001484.20485.18
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5000
标示量(mg)2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%
19.813150531846312823137431650315310.72
29.913192131891319060.07
单位质量响应值RSD%判断
3214.173219.580.12数据可信
中间条件6月-供试品溶液-H147S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%
5min112566-1256635.04828.5712.2235.0528.5712.22
210773-1077330.04730.05
39580-958026.71926.72
49238-923825.76525.77
59707-970727.07427.07
69600-960026.77526.78
10min119789-1978955.19348.339.7255.2548.379.72
219006-1900653.00953.06
315718-1571843.83943.88
415871-1587144.26544.31
516732-1673246.66746.71
616847-1684746.98847.03
15min124771-2477169.08861.038.7869.2461.168.79
223606-2360665.83965.98
320348-2034856.75256.87
419840-1984055.33555.45
521192-2119259.10659.23
621524-2152460.03260.16
20min127276-2727676.07568.227.2076.3468.457.21
225969-2596972.43072.68
323043-2304364.26964.48
422949-2294964.00764.22
523645-2364565.94866.17
623879-2387966.60066.82
30min130068-3006883.86277.066.3484.2577.406.35
229351-2935181.86282.23
326254-2625473.22473.54
425639-2563971.50971.82
526903-2690375.03575.37
627553-2755376.84777.18
45min131852-3185288.83884.273.8589.3784.743.88
231398-3139887.57188.08
329090-2909081.13481.58
429218-2921881.49181.93
529569-2956982.47082.93
630150-3015084.09184.55
60min132784-3278491.43787.463.2092.1288.073.22
232283-3228390.04090.69
330577-3057785.28285.86
430264-3026484.40984.98
530800-3080085.90486.50
631435-3143587.67588.28
90min133921-3392194.60890.992.6595.4491.752.68
232899-3289991.75892.56
331958-3195889.13389.85
431692-3169288.39189.10
532065-3206589.43290.17
633217-3321792.64593.39
120min134364-3436495.84491.612.9796.8392.522.99
232651-3265191.06692.02
332324-3232490.15491.02
431928-3192889.05089.91
532106-3210689.54690.43
633710-3371094.02094.92
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134302-3430295.67193.002.4496.8294.062.46
233953-3395394.69895.80
332675-3267591.13392.15
432593-3259390.90491.91
532571-3257190.84391.88
633965-3396594.73195.79
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