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%
110.153558203564313561363560743562623561450.07
210.103545903538683542290.15
单位质量响应值RSD%判断
35088.1835072.180.04数据可信
供试品溶液-BXJUS91批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15901-59017.5649.7020.277.569.7020.27
29799-979912.56012.56
38318-831810.66210.66
48100-810010.38210.38
55793-57937.4257.43
67490-74909.6009.60
10min122397-2239728.70730.7911.1128.7530.8511.12
226263-2626333.66333.73
326427-2642733.87333.93
426434-2643433.88233.94
520407-2040726.15726.20
622214-2221428.47328.53
15min130352-3035238.90439.978.8139.1140.198.82
233063-3306342.37842.64
333098-3309842.42342.67
434239-3423943.88644.13
527104-2710434.74134.93
629235-2923537.47237.68
20min136491-3649146.77247.347.9647.1947.797.97
237704-3770448.32748.82
339257-3925750.31850.80
440856-4085652.36752.86
533738-3373843.24443.62
633565-3356543.02243.44
30min146198-4619859.21458.826.3159.8959.536.33
247316-4731660.64761.41
347754-4775461.20961.97
449293-4929363.18163.96
542651-4265154.66855.29
642131-4213154.00154.66
45min153400-5340068.44568.104.7769.4569.144.80
254066-5406669.29970.40
355943-5594371.70572.81
454651-5465170.04971.18
552052-5205266.71867.64
648693-4869362.41263.37
60min157840-5784074.13676.194.0775.5277.614.10
259268-5926875.96777.45
362552-6255280.17681.68
461860-6186079.28980.81
559002-5900275.62676.92
656146-5614671.96573.27
极限163732-6373281.68881.531.9483.4983.372.00
265136-6513683.48885.39
364332-6433282.45884.40
463882-6388281.88183.84
563034-6303480.79482.51
661535-6153578.87280.58
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%
110.153532813536583529683537503540743535460.13
210.103538423539603539010.03
单位质量响应值RSD%判断
34832.1235039.700.43数据可信
供试品溶液-BXJUS91批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16777-67778.7229.0618.818.729.0618.80
27092-70929.1289.13
37803-780310.04310.04
49164-916411.79511.79
55581-55817.1837.18
65827-58277.5007.50
10min126573-2657334.20128.9313.3634.2528.9813.36
220181-2018125.97426.02
323863-2386330.71330.77
424858-2485831.99432.06
519680-1968025.32925.37
619726-1972625.38825.43
15min134186-3418643.99938.8211.2844.2439.0411.29
228018-2801836.06136.26
332697-3269742.08342.31
432700-3270042.08742.33
526892-2689234.61134.79
626491-2649134.09534.28
20min139563-3956350.92045.249.6151.4045.669.63
233324-3332442.89043.29
337449-3744948.19948.66
437247-3724747.93948.42
531738-3173840.84941.22
631564-3156440.62541.00
30min147739-4773961.44356.257.3762.2156.937.41
243346-4334655.78956.42
346411-4641159.73360.46
444574-4457457.36958.11
540817-4081752.53453.13
639348-3934850.64351.24
45min157600-5760074.13467.357.2375.2468.347.26
251347-5134766.08667.03
355447-5544771.36372.42
453000-5300068.21469.28
548296-4829662.16063.05
648295-4829562.15863.04
60min161880-6188079.64373.925.2281.1675.285.28
256301-5630172.46273.77
359987-5998777.20678.66
457078-5707873.46274.90
555689-5568971.67572.91
653671-5367169.07770.30
极限167376-6737686.71779.904.8388.6881.684.88
262310-6231080.19681.91
362556-6255680.51382.40
461364-6136478.97980.83
560488-6048877.85179.49
658396-5839675.15976.77
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%
110.153536613542093529623532773539753536170.15
210.103524123526093525100.04
单位质量响应值RSD%判断
34839.1134901.980.13数据可信
供试品溶液-BXJUS91批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16338-63388.1738.198.658.178.198.62
26322-63228.1528.15
36727-67278.6748.67
46774-67748.7358.73
56650-66508.5758.57
65304-53046.8396.84
10min120957-2095727.02326.267.4427.0726.307.43
222470-2247028.97429.02
320430-2043026.34426.39
420198-2019826.04426.09
520332-2033226.21726.26
617790-1779022.93922.98
15min129810-2981038.43936.408.2838.6336.598.27
230953-3095339.91340.12
328008-2800836.11536.31
428038-2803836.15436.35
528483-2848336.72836.92
624082-2408231.05331.22
20min134720-3472044.77043.306.8645.1843.696.86
236943-3694347.63648.06
332838-3283842.34342.74
432880-3288042.39742.79
534063-3406343.92344.32
630026-3002638.71739.06
30min144134-4413456.90952.647.3657.5753.277.35
243105-4310555.58256.27
339171-3917150.50951.14
439431-3943150.84551.47
542794-4279455.18155.82
636307-3630746.81647.37
45min152249-5224967.37363.777.1368.3564.707.12
253903-5390369.50670.51
347761-4776161.58662.50
447535-4753561.29462.21
550913-5091365.65066.60
644382-4438257.22958.04
60min158886-5888675.93171.825.2677.2873.105.29
258426-5842675.33876.73
354145-5414569.81871.07
453926-5392669.53570.79
557266-5726673.84275.15
651548-5154866.46967.60
极限164189-6418982.76978.573.2784.5480.253.29
261289-6128979.02980.84
358721-5872175.71877.36
459363-5936376.54678.18
561948-6194879.87981.60
660105-6010577.50379.00
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%
110.153521893509793520053513543517273516510.14
210.103486833481103483960.12
单位质量响应值RSD%判断
34645.4234494.650.31数据可信
供试品溶液-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16101-61017.9357.557.807.947.567.80
26190-61908.0518.05
35407-54077.0337.03
46145-61457.9937.99
55909-59097.6867.69
65094-50946.6266.63
10min118797-1879724.44926.747.9924.4926.787.98
222189-2218928.86128.91
321575-2157528.06228.10
422081-2208128.72028.76
520227-2022726.30926.35
618497-1849724.05824.10
15min125980-2598033.79138.768.5833.9738.958.57
232213-3221341.89842.10
331747-3174741.29241.49
431333-3133340.75440.96
530173-3017339.24539.43
627364-2736435.59235.76
20min131675-3167541.19946.247.0741.5746.657.07
236856-3685647.93748.38
337621-3762148.93349.36
438235-3823549.73150.16
535162-3516245.73446.14
633771-3377143.92544.29
30min140089-4008952.14358.538.2252.7459.208.21
248399-4839962.95163.66
348067-4806762.51963.22
447686-4768662.02462.73
544759-4475958.21758.88
640998-4099853.32553.94
45min150873-5087366.16970.504.7767.0671.494.80
256807-5680773.88774.94
356810-5681073.89174.93
455767-5576772.53473.59
552927-5292768.84169.82
652052-5205267.70268.61
60min158464-5846476.04279.805.1977.3081.185.19
267161-6716187.35488.82
362264-6226480.98582.44
461423-6142379.89181.35
559322-5932277.15878.53
659475-5947577.35778.64
极限168397-6839788.96288.426.0190.6490.245.93
274778-7477897.26299.21
369670-6967090.61892.52
463359-6335982.40984.31
564530-6453083.93285.73
667136-6713687.32289.04
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%
110.153474263495143489793475843495323486070.30
210.103529203524113526660.11
单位质量响应值RSD%判断
34345.5234917.431.17数据可信
供试品溶液-BXJUS91批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15616-56167.2925.6736.837.295.6736.81
23403-34034.4194.42
37002-70029.0929.09
42957-29573.8403.84
54046-40465.2545.25
63179-31794.1284.13
10min115683-1568320.36418.4620.5220.4018.5020.53
214162-1416218.38918.41
318954-1895424.61124.66
411882-1188215.42815.45
513949-1394918.11218.14
610692-1069213.88313.91
15min121641-2164128.10027.1713.2128.2527.3013.26
220672-2067226.84126.97
325708-2570833.38033.57
418866-1886624.49624.60
520961-2096127.21727.35
617689-1768922.96823.07
20min125953-2595333.69933.3810.0834.0133.6610.15
225866-2586633.58633.86
330412-3041239.48839.86
424095-2409531.28631.53
525095-2509532.58432.87
622815-2281529.62429.85
30min134015-3401544.16743.606.4944.6644.066.58
232699-3269942.45842.92
337670-3767048.91249.50
432348-3234842.00242.42
533238-3323843.15843.62
631479-3147940.87441.27
45min142565-4256555.26854.594.2356.0155.314.32
241971-4197154.49755.20
345262-4526258.77059.63
440810-4081052.99053.64
541416-4141653.77654.48
640254-4025452.26852.89
60min148280-4828062.68962.564.3763.7463.584.41
245080-4508058.53459.53
351188-5118866.46567.66
448851-4885163.43064.38
549035-4903563.66964.67
646670-4667060.59861.51
极限159230-5923076.90773.302.8778.3074.662.86
254385-5438570.61671.94
356464-5646473.31574.87
456836-5683673.79875.10
556287-5628773.08674.44
655514-5551472.08273.33
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