非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.053790553797203812383798323796163798920.22
211.123787573788153787860.02
单位质量响应值RSD%判断
34379.3734063.490.66数据可信
供试品溶液-1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%
5min16571-65718.6349.665.588.639.665.59
27590-75909.9739.97
37309-73099.6049.60
47648-764810.04910.05
57357-73579.6679.67
67640-764010.03910.04
10min112009-1200915.77917.084.1415.8317.144.13
213210-1321017.35717.41
312919-1291916.97517.03
413610-1361017.88317.94
513180-1318017.31817.37
613067-1306717.16917.23
15min116379-1637921.52123.814.8321.6623.964.82
218532-1853224.35024.50
318403-1840324.18024.33
418818-1881824.72624.88
518292-1829224.03524.18
618289-1828924.03124.18
20min126463-2646334.77138.446.6435.0338.726.61
232092-3209242.16742.45
329317-2931738.52138.80
430627-3062740.24240.53
528572-2857237.54237.83
628469-2846937.40737.69
30min147604-4760462.54970.135.9363.0070.625.92
255045-5504572.32672.85
353624-5362470.45970.95
454703-5470371.87772.39
552524-5252469.01369.51
656743-5674374.55775.05
45min160978-6097880.12288.475.3980.9289.365.38
270059-7005992.05392.98
367905-6790589.22390.11
467293-6729388.41989.33
566365-6636587.20088.08
671411-7141193.83094.74
60min168087-6808789.46297.254.8090.7098.624.80
276461-76461100.465101.90
374965-7496598.50099.88
472762-7276295.60597.01
573429-7342996.48197.84
678374-78374102.979104.41
极限178111-78111102.633105.142.00104.37107.052.04
281434-81434107.000108.99
379124-79124103.964105.89
480862-80862106.248108.19
578645-78645103.335105.23
681927-81927107.647109.65
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.053785313789983785133784463789773786930.08
211.123784833780573782700.08
单位质量响应值RSD%判断
34270.8634017.090.53数据可信
供试品溶液-2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%
5min13120-31204.1094.6315.734.114.6315.76
23859-38595.0825.08
33207-32074.2234.22
42873-28733.7833.78
54365-43655.7485.75
63667-36674.8294.83
10min19415-941512.39913.1118.8012.4213.1318.80
211196-1119614.74414.77
39051-905111.91911.94
47403-74039.7499.77
512840-1284016.90916.94
69814-981412.92412.95
15min119385-1938525.52831.0318.2925.6231.1318.27
226738-2673835.21235.32
318120-1812023.86223.95
422393-2239329.49029.56
528986-2898638.17238.30
625759-2575933.92234.02
20min128667-2866737.75247.6115.0237.9947.8815.00
237233-3723349.03349.34
330068-3006839.59739.82
439470-3947051.97952.22
540652-4065253.53553.87
640834-4083453.77554.06
30min140170-4017052.90063.9512.7953.3464.4812.78
249045-4904564.58865.17
341870-4187055.13955.58
455291-5529172.81373.34
551769-5176968.17568.81
653217-5321770.08270.67
45min151021-5102167.19078.3411.5067.9379.2311.50
259526-5952678.39179.33
351713-5171368.10168.85
467796-6779689.28190.21
562611-6261182.45383.47
664258-6425884.62285.60
60min158955-5895577.63986.839.5178.7588.159.54
266219-6621987.20588.58
357981-5798176.35677.48
473415-7341596.68198.11
568294-6829489.93791.41
670725-7072593.13994.58
极限176392-76392100.602102.743.91102.14104.554.02
279806-79806105.098106.95
372512-7251295.49297.04
480070-80070105.445107.41
579076-79076104.136106.11
680252-80252105.685107.65
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