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TAAF230001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(%)99.8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%
116.559814697830978559768497846978720.18
216.599843098300983650.10
单位质量响应值RSD%判断
5913.725929.170.19数据可信
供试品溶液-24050601批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19497-94979.6049.716.699.609.716.71
28525-85258.6218.62
39733-97339.8429.84
410077-1007710.19010.19
59392-93929.4989.50
610379-1037910.49610.50
10min122567-2256722.82122.913.3622.8722.963.38
221247-2124721.48621.53
322596-2259622.85022.90
423205-2320523.46623.52
522908-2290823.16623.22
623386-2338623.64923.71
15min128955-2895529.28029.802.4329.4629.982.43
228419-2841928.73828.91
329417-2941729.74829.93
430461-3046130.80330.99
529849-2984930.18530.37
629689-2968930.02330.21
20min134116-3411634.50035.152.7934.8435.492.79
233448-3344833.82434.15
335686-3568636.08736.43
435983-3598336.38736.75
534939-3493935.33235.68
634366-3436634.75235.11
30min142909-4290943.39143.282.2343.9343.822.23
241151-4115141.61442.13
342490-4249042.96843.52
443921-4392144.41544.97
543476-4347643.96544.51
642819-4281943.30043.85
45min149462-4946250.01850.002.6250.7950.782.62
247190-4719047.72048.47
349162-4916249.71550.50
451099-5109951.67352.48
550078-5007850.64151.43
649683-4968350.24251.03
60min155390-5539056.01354.812.6157.0755.872.60
251796-5179652.37853.39
354348-5434854.95956.02
455608-5560856.23357.33
554616-5461655.23056.30
653434-5343454.03555.10
90min156969-5696957.60959.513.3958.9760.883.36
256107-5610756.73858.04
358888-5888859.55060.92
461273-6127361.96263.37
560460-6046061.14062.52
659392-5939260.06061.43
120min164724-6472465.45265.022.5667.1466.722.53
261319-6131962.00863.63
364483-6448365.20866.91
463820-6382064.53766.29
565468-6546866.20467.92
665967-6596766.70968.41
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166974-6697467.72766.702.8869.7868.762.86
262437-6243763.13965.10
365447-6544766.18368.24
467763-6776368.52570.63
566170-6617066.91469.00
666961-6696167.71469.79
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TAAF230001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(%)99.8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%
116.559836198205982389817098393982730.10
216.599897799233991050.19
单位质量响应值RSD%判断
5937.955973.780.43数据可信
供试品溶液-24050602批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113829-1382913.90414.289.7013.9014.289.70
215409-1540915.49215.49
311656-1165611.71911.72
414917-1491714.99815.00
515144-1514415.22615.23
614252-1425214.32914.33
10min128778-2877828.93429.784.8729.0129.864.86
231990-3199032.16332.25
329204-2920429.36229.43
428260-2826028.41328.50
528752-2875228.90728.99
630751-3075130.91731.00
15min136237-3623736.43337.674.8636.6737.924.86
238558-3855838.76639.03
334803-3480334.99135.22
437037-3703737.23737.48
538294-3829438.50138.75
639889-3988940.10540.36
20min142830-4283043.06144.454.9943.5044.904.98
246429-4642946.68047.16
342380-4238042.60943.03
442699-4269942.93043.38
543381-4338143.61544.07
647553-4755347.81048.28
30min151581-5158151.86052.074.5852.5452.774.57
253341-5334153.62954.37
348776-4877649.04049.70
450363-5036350.63551.32
551128-5112851.40452.11
655534-5553455.83456.57
45min156976-5697657.28458.503.9758.2559.493.98
259322-5932259.64360.68
355008-5500855.30556.24
457189-5718957.49858.47
558958-5895859.27760.26
661675-6167562.00863.06
60min160895-6089561.22463.074.3662.5164.394.36
265259-6525965.61266.98
359708-5970860.03161.27
460761-6076161.08962.38
563284-6328463.62664.94
666508-6650866.86768.26
90min167297-6729767.66169.185.3769.2970.845.35
271327-7132771.71373.45
364756-6475665.10666.68
466269-6626966.62768.25
568334-6833468.70370.37
674850-7485075.25577.02
120min166988-6698867.35070.774.5769.3572.824.56
272639-7263973.03275.16
366886-6688667.24869.18
469971-6997170.34972.35
570741-7074171.12373.17
675134-7513475.54077.72
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172543-7254372.93574.293.1675.3176.733.17
274786-7478675.19077.73
369992-6999270.37072.68
473982-7398274.38276.77
576365-7636576.77879.22
675668-7566876.07778.68
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