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1000
标示量(mg)10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 11.041896871897491894151895201894901895720.08
2 11.101887751883981885860.15
单位质量响应值RSD%判断
17171.3816989.730.76数据可信
供试品溶液-2025060821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%
5min142114-4211422.17324.7213.0322.1724.7213.03
254255-5425528.56628.57
353520-5352028.17928.18
438834-3883420.44620.45
545898-4589824.16624.17
647131-4713124.81524.81
10min184914-8491444.70849.766.1644.7449.806.17
298366-9836651.79151.84
3100366-10036652.84452.89
492052-9205248.46648.50
598762-9876251.99952.04
692563-9256348.73548.78
15min1108956-10895657.36661.294.1257.4861.414.12
2118336-11833662.30562.44
3122306-12230664.39564.53
4114683-11468360.38260.50
5119965-11996563.16363.29
6114166-11416660.10960.23
20min1125434-12543466.04268.432.3366.2568.662.34
2131762-13176269.37469.61
3133407-13340770.24070.48
4128727-12872767.77667.99
5132320-13232069.66869.90
6128195-12819567.49667.72
30min1144919-14491976.30176.410.6576.6276.750.66
2146306-14630677.03177.38
3145823-14582376.77777.14
4144898-14489876.29076.62
5145232-14523276.46676.81
6143572-14357275.59275.93
45min1159394-15939483.92282.730.9784.3783.200.95
2157648-15764883.00383.48
3155665-15566581.95982.45
4158096-15809683.23983.69
5155539-15553981.89382.37
6156439-15643982.36682.83
60min1166440-16644087.63286.011.4088.2286.621.38
2163536-16353686.10386.72
3160980-16098084.75785.38
4165116-16511686.93587.53
5160601-16060184.55885.17
6163533-16353386.10186.70
极限1171835-17183590.47389.720.5991.2090.470.57
2170028-17002889.52190.28
3168952-16895288.95589.72
4171131-17113190.10290.84
5170011-17001189.51290.27
6170466-17046689.75290.49
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1000
标示量(mg)10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 11.041886231886461887261884781886651886280.05
2 11.101878841873961876400.19
单位质量响应值RSD%判断
17085.8716904.500.76数据可信
供试品溶液-2025060921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%
5min143679-4367923.11319.9411.2623.1119.9411.27
237244-3724419.70819.71
338444-3844420.34320.34
430566-3056616.17416.17
539150-3915020.71620.72
637006-3700619.58219.58
10min193615-9361549.53747.075.5949.5847.105.59
292562-9256248.97949.01
384787-8478744.86544.90
484011-8401144.45544.48
584561-8456144.74644.78
694207-9420749.85049.88
15min1115479-11547961.10659.233.5261.2359.343.52
2114934-11493460.81860.93
3108170-10817057.23857.35
4109245-10924557.80757.91
5107768-10776857.02657.13
6116042-11604261.40461.52
20min1129246-12924668.39166.612.6968.6166.822.69
2128423-12842367.95568.17
3122538-12253864.84165.05
4124735-12473566.00466.20
5121568-12156864.32864.53
6128740-12874068.12368.34
30min1144630-14463076.53175.571.9576.8775.891.95
2144821-14482176.63276.96
3141200-14120074.71675.03
4144643-14464376.53876.85
5137861-13786172.95073.26
6143735-14373576.05876.39
45min1155952-15595282.52282.651.7482.9983.091.73
2156930-15693083.04083.50
3156828-15682882.98683.42
4160331-16033184.84085.27
5152033-15203380.44980.88
6155041-15504182.04082.50
60min1163110-16311086.31086.461.8486.9187.041.83
2163508-16350886.52187.12
3165344-16534487.49288.07
4167910-16791088.85089.43
5159629-15962984.46885.04
6160823-16082385.10085.70
极限1168216-16821689.01289.251.6989.7689.981.68
2165457-16545787.55288.29
3170153-17015390.03790.76
4173563-17356391.84192.57
5167449-16744988.60689.31
6167165-16716588.45689.19
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1000
标示量(mg)10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 11.041881881881731878591879701876931879770.12
2 11.101876901878901877900.08
单位质量响应值RSD%判断
17026.9016918.020.46数据可信
供试品溶液-2025061021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%
5min131862-3186216.88219.5825.0816.8819.5825.08
233504-3350417.75217.75
354387-5438728.81728.82
437954-3795420.11020.11
527679-2767914.66614.67
636325-3632519.24719.25
10min185867-8586745.49746.156.9745.5246.186.99
291277-9127748.36348.39
395743-9574350.73050.78
485373-8537345.23545.27
577758-7775841.20041.22
686569-8656945.86945.90
15min1107764-10776457.09958.184.6457.2058.294.65
2114441-11444160.63760.75
3115654-11565461.28061.41
4108384-10838457.42757.54
5101655-10165553.86253.96
6110889-11088958.75558.86
20min1120439-12043963.81565.623.9764.0165.823.98
2127751-12775167.68967.90
3128916-12891668.30668.54
4122950-12295065.14565.35
5116193-11619361.56561.75
6126815-12681567.19367.40
30min1137622-13762272.91974.933.4973.2275.253.50
2146465-14646577.60577.93
3145072-14507276.86777.22
4141172-14117274.80075.11
5133735-13373570.86071.15
6144482-14448276.55476.87
45min1154194-15419481.70082.332.3682.1382.772.37
2159314-15931484.41384.87
3156382-15638282.85983.34
4156318-15631882.82583.26
5148712-14871278.79579.20
6157357-15735783.37683.82
60min1162388-16238886.04286.342.0886.6086.922.09
2167045-16704588.50989.10
3163141-16314186.44187.06
4164059-16405986.92787.50
5156844-15684483.10483.64
6164228-16422887.01787.60
极限1169013-16901389.55289.471.5790.2690.201.58
2171741-17174190.99791.74
3168128-16812889.08389.84
4170562-17056290.37391.09
5164105-16410586.95187.62
6169654-16965489.89290.62
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1000
标示量(mg)10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 11.041874421873181874511874531874091874150.04
2 11.101875601873851874720.07
单位质量响应值RSD%判断
16976.0016889.370.37数据可信
供试品溶液-2025060921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%
5min147718-4771825.34323.8033.3225.3423.8033.32
257761-5776130.67730.68
344312-4431223.53423.53
458342-5834230.98530.99
543351-4335123.02323.02
617377-173779.2299.23
10min1130798-13079869.46663.9317.7169.5163.9717.71
2139651-13965174.16874.22
3122636-12263665.13165.17
4129981-12998169.03269.08
5119926-11992663.69263.73
679240-7924042.08442.10
15min1155793-15579382.74178.129.0082.9078.269.03
2156527-15652783.13183.31
3149300-14930079.29279.44
4150505-15050579.93280.10
5149532-14953279.41679.56
6120846-12084664.18164.27
20min1163384-16338486.77282.976.7987.0783.256.82
2162543-16254386.32686.64
3157684-15768483.74584.03
4158064-15806483.94784.25
5160586-16058685.28685.56
6135087-13508771.74471.94
30min1170765-17076590.69287.615.1391.1388.025.16
2168670-16867089.58090.04
3166832-16683288.60489.02
4165500-16550087.89688.34
5169798-16979890.17990.60
6148168-14816878.69179.00
45min1174883-17488392.87990.594.0693.4791.154.10
2173541-17354192.16792.77
3171886-17188691.28891.85
4171223-17122390.93691.52
5175114-17511493.00293.57
6156806-15680683.27983.72
60min1177414-17741494.22492.083.6194.9792.793.65
2175138-17513893.01593.77
3174846-17484692.86093.58
4173918-17391892.36793.10
5177929-17792994.49795.22
6161025-16102585.52086.10
极限1182183-18218396.75696.020.9497.6696.880.98
2180329-18032995.77296.69
3180612-18061295.92296.80
4179418-17941895.28896.18
5183364-18336497.38498.27
6178857-17885794.99095.71
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