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1000
标示量(mg)10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%
111.383935573935273935173934963938533935900.04
211.473944683944463944570.01
单位质量响应值RSD%判断
34586.1234390.320.41数据可信
供试品溶液-24121601-1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%
5min17753-775310.10814.5552.2810.1114.5552.29
26354-63548.2848.28
35925-59257.7257.72
410522-1052213.71813.72
516131-1613121.03121.03
620264-2026426.41926.42
10min135056-3505645.70539.4430.3145.7639.5230.31
222703-2270329.59929.65
325945-2594533.82633.87
427137-2713735.38035.46
523931-2393131.20031.32
646743-4674360.94261.09
15min155272-5527272.06156.3825.4272.3756.6825.43
232054-3205441.79142.00
336821-3682148.00648.24
443943-4394357.29157.56
533849-3384944.13144.42
657538-5753875.01675.50
20min159868-5986878.05461.2820.1078.7661.8920.13
241307-4130753.85454.30
339849-3984951.95452.45
442166-4216654.97455.57
540410-4041052.68553.22
658395-5839576.13377.04
30min165334-6533485.18070.6314.3286.3271.5814.43
249102-4910264.01764.76
347716-4771662.21063.00
449570-4957064.62765.52
550525-5052565.87266.70
662790-6279081.86383.19
45min172973-7297395.13981.4010.3396.7682.7410.46
260500-6050078.87779.97
358274-5827475.97577.11
459733-5973377.87779.13
555776-5577672.71973.91
667352-6735287.81189.59
60min175305-7530598.18085.558.75100.3387.358.86
265948-6594885.98087.52
361091-6109179.64881.20
462341-6234181.27882.97
560221-6022178.51480.11
668821-6882189.72691.99
极限175144-7514497.97098.392.90100.66100.662.61
278462-78462102.296104.31
375716-7571698.715100.71
477013-77013100.406102.55
574288-7428896.85498.89
672169-7216994.09196.86
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1000
标示量(mg)10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%
111.381972291971471971931971781970841971660.03
211.471993311992761993040.02
单位质量响应值RSD%判断
17325.6617376.110.21数据可信
供试品溶液-24121601-2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%
5min12728-27287.0698.8233.827.078.8233.83
25575-557514.44714.45
33658-36589.4809.48
43273-32738.4828.48
52773-27737.1867.19
62416-24166.2616.26
10min111486-1148629.76525.0323.3629.8025.0723.30
27031-703118.22118.30
312484-1248432.35232.40
49066-906623.49423.54
510646-1064627.58927.63
67231-723118.73918.77
15min124450-2445063.36158.2619.5163.5758.4519.50
219249-1924949.88350.06
329802-2980277.23177.46
420639-2063953.48553.66
523201-2320160.12460.32
617547-1754745.47245.61
20min133653-3365387.21072.6414.3187.7773.1614.21
222831-2283159.16659.62
326705-2670569.20569.87
426638-2663869.03169.51
526404-2640468.42568.95
631964-3196482.83383.22
30min133860-3386087.74784.377.3888.7985.287.38
228513-2851373.89074.68
334767-3476790.09791.14
432297-3229783.69684.55
531291-3129181.08982.00
634604-3460489.67590.53
45min137014-3701495.92094.396.1197.4595.776.04
233605-3360587.08688.28
335100-3510090.96092.51
439856-39856103.285104.61
535284-3528491.43792.79
637681-3768197.64999.00
60min140019-40019103.70898.453.50105.77100.363.45
237571-3757197.36499.05
336205-3620593.82495.88
437129-3712996.21898.12
538647-38647100.152102.02
638367-3836799.426101.32
极限141687-41687108.030100.424.72110.67102.884.67
237593-3759397.42199.64
336473-3647394.51897.09
438666-38666100.201102.63
538218-3821899.040101.46
639873-39873103.329105.77
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