非奈利酮片项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.153813333811303809633808543808093810180.06
2 11.103765583767903766740.05
单位质量响应值RSD%判断
34172.0233934.590.50数据可信
供试品溶液-24122601批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min147058-4705812.42711.4722.7512.4311.4722.74
239522-3952210.43710.44
358120-5812015.34915.35
442094-4209411.11611.12
545671-4567112.06112.06
628052-280527.4087.41
10min1148372-14837239.18336.0318.9339.2036.0418.94
2130317-13031734.41534.43
3175872-17587246.44546.47
4123055-12305532.49732.52
5141782-14178237.44237.46
699138-9913826.18126.19
15min1251857-25185766.51162.1611.3366.6062.2411.34
2243230-24323064.23364.31
3268627-26862770.94071.04
4213657-21365756.42356.50
5239903-23990363.35463.44
6195078-19507851.51751.57
20min1294325-29432577.72674.926.3477.9275.106.36
2291187-29118776.89877.08
3301775-30177579.69479.91
4281656-28165674.38174.55
5283033-28303374.74474.93
6250295-25029566.09966.24
30min1325008-32500885.82984.293.2086.1684.603.22
2324679-32467985.74286.05
3328898-32889886.85687.21
4320670-32067084.68484.97
5315102-31510283.21383.53
6300683-30068379.40579.66
45min1344415-34441590.95489.661.9091.4290.101.92
2343138-34313890.61791.07
3346068-34606891.39191.89
4339220-33922089.58290.01
5334844-33484488.42788.88
6329299-32929986.96287.35
60min1352647-35264793.12892.361.3593.7592.961.38
2352285-35228593.03393.64
3354969-35496993.74194.39
4350531-35053192.56993.15
5344715-34471591.03391.63
6343237-34323790.64391.17
极限1360045-36004595.08294.611.0595.8695.361.07
2362343-36234395.68996.45
3361952-36195295.58596.39
4357005-35700594.27995.01
5353856-35385693.44794.20
6354368-35436893.58394.26
非奈利酮片项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.153763403764813763333765653760913763620.05
2 11.103748913749893749400.02
单位质量响应值RSD%判断
33754.4433778.380.06数据可信
供试品溶液-24122601批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152659-5265914.02412.2126.1214.0212.2126.12
255882-5588214.88314.88
330663-306638.1668.17
453496-5349614.24714.25
552136-5213613.88513.89
630310-303108.0728.07
10min1124434-12443433.14032.0611.0633.1632.0811.07
2133274-13327435.49435.52
3105618-10561828.12928.14
4130380-13038034.72334.75
5126803-12680333.77133.79
6101851-10185127.12527.14
15min1168696-16869644.92844.075.4945.0144.145.51
2175377-17537746.70746.79
3157640-15764041.98342.04
4171601-17160145.70145.78
5168102-16810244.77044.85
6151396-15139640.32040.38
20min1194815-19481551.88451.264.0252.0451.414.04
2199619-19961953.16353.33
3188564-18856450.21950.35
4198700-19870052.91953.08
5194242-19424251.73151.89
6178888-17888847.64247.77
30min1224895-22489559.89560.022.6560.1360.252.66
2230085-23008561.27761.53
3228882-22888260.95761.17
4229572-22957261.14161.39
5224491-22449159.78760.03
6214239-21423957.05757.26
45min1250894-25089466.81967.121.7667.1667.451.77
2254710-25471067.83568.19
3255438-25543868.02968.34
4255864-25586468.14368.49
5250989-25098966.84467.18
6244182-24418265.03165.33
60min1265061-26506170.59271.231.3471.0471.671.35
2269755-26975571.84272.31
3270521-27052172.04672.48
4271144-27114472.21272.67
5266072-26607270.86171.31
6262184-26218469.82670.23
极限1275930-27593073.48773.790.8374.0674.350.84
2278193-27819374.08974.67
3279851-27985174.53175.08
4278927-27892774.28574.87
5275568-27556873.39073.96
6273864-27386472.93773.46
非奈利酮片项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.153764503765233764633764503764223764620.01
2 11.103761043759623760330.03
单位质量响应值RSD%判断
33763.4133876.850.24数据可信
供试品溶液-24122601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%
5min1-0.0001.50108.830.001.50108.71
216827-168274.4744.47
35753-57531.5301.53
4-0.0000.00
55561-55611.4791.48
65737-57371.5251.53
10min115261-152614.0585.6959.124.065.6959.10
246808-4680812.44612.45
318305-183054.8674.87
412879-128793.4253.42
518776-187764.9935.00
616256-162564.3224.33
15min130776-307768.1839.7230.688.199.7330.74
258445-5844515.54115.57
332960-329608.7648.77
426652-266527.0877.09
535920-359209.5519.56
634511-345119.1779.19
20min138032-3803210.11311.7222.7310.1311.7522.79
263006-6300616.75316.81
341194-4119410.95410.98
434144-341449.0799.10
543901-4390111.67311.70
644232-4423211.76111.79
30min147164-4716412.54114.1815.1412.5814.2315.21
267989-6798918.07818.16
350379-5037913.39613.44
445651-4565112.13912.17
553186-5318614.14214.19
655565-5556514.77514.82
45min157210-5721015.21216.319.4115.2716.389.49
270998-7099818.87818.99
357975-5797515.41615.48
455503-5550314.75814.81
561684-6168416.40216.47
664570-6457017.16917.24
60min161932-6193216.46817.585.8416.5517.685.93
272539-7253919.28819.43
363736-6373616.94817.04
464095-6409517.04317.12
565875-6587517.51617.61
668560-6856018.23018.33
极限172579-7257919.29920.163.0319.4120.292.96
273221-7322119.47019.65
377830-7783020.69520.81
476981-7698120.46920.58
577248-7724820.54020.67
677070-7707020.49320.62
非奈利酮片项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.153797843794293795563792873792383794590.06
2 11.103739493736013737750.07
单位质量响应值RSD%判断
34032.2033673.420.75数据可信
供试品溶液-24122601批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min188245-8824523.44223.0331.5123.4423.0331.52
236106-361069.5929.59
383147-8314722.08822.09
491762-9176224.37724.38
5111068-11106829.50529.51
6109863-10986329.18529.19
10min1249554-24955466.29461.0424.4766.3361.0824.47
2129706-12970634.45734.47
3210709-21070955.97556.01
4228873-22887360.80060.84
5279564-27956474.26774.32
6280258-28025874.45174.50
15min1356010-35601094.57587.5813.3994.7287.7213.41
2241608-24160864.18464.26
3329653-32965387.57387.70
4347040-34704092.19292.33
5352113-35211393.53993.71
6351645-35164593.41593.59
20min1368136-36813697.79696.292.2698.1096.582.30
2347234-34723492.24392.42
3370254-37025498.35998.63
4365421-36542197.07597.37
5361818-36181896.11896.45
6362004-36200496.16796.50
30min1376046-37604699.89799.742.06100.37100.182.05
2372726-37272699.01599.35
3390271-390271103.676104.12
4374465-37446599.47799.93
5370099-37009998.31798.81
6369050-36905098.03998.53
45min1384679-384679102.191101.301.53102.83101.911.49
2384276-384276102.084102.58
3389086-389086103.361103.97
4380318-380318101.032101.66
5375276-37527699.693100.35
6374225-37422599.413100.07
60min1384145-384145102.049101.671.51102.86102.451.47
2385927-385927102.522103.19
3391187-391187103.919104.70
4382271-382271101.551102.34
5377100-377100100.177101.00
6375618-37561899.784100.60
极限1384809-384809102.225102.021.69103.20102.971.66
2385622-385622102.441103.28
3395024-395024104.939105.90
4383623-383623101.910102.87
5377761-377761100.353101.34
6377280-377280100.225101.21
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