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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.321931111935781932751928021929221931380.16
211.321945801944181944990.06
单位质量响应值RSD%判断
17061.6617181.890.50数据可信
供试品溶液-BXK34K1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%
5min126572-2657213.96814.3615.0013.9714.3615.00
233078-3307817.38817.39
330661-3066116.11716.12
427079-2707914.23414.23
525045-2504513.16513.16
621508-2150811.30611.31
10min160591-6059131.85034.729.7131.8734.749.71
277086-7708640.52040.55
366610-6661035.01435.04
463968-6396833.62533.65
568540-6854036.02836.05
659486-5948631.26931.29
15min186052-8605245.23348.327.7145.3148.407.71
2104509-10450954.93555.03
390785-9078547.72147.81
490428-9042847.53447.61
594676-9467649.76749.85
685097-8509744.73144.80
20min1102558-10255853.91057.826.4154.0657.986.42
2121844-12184464.04864.24
3108099-10809956.82356.99
4109670-10967057.64857.81
5113739-11373959.78759.95
6104096-10409654.71854.86
30min1128650-12865067.62570.904.1967.8771.164.20
2143821-14382175.60075.89
3130860-13086068.78769.05
4136346-13634671.67171.93
5138154-13815472.62172.89
6131482-13148269.11469.35
45min1151307-15130779.53581.932.5979.8982.302.60
2161386-16138684.83385.25
3151659-15165979.72080.09
4158615-15861583.37683.75
5157608-15760882.84783.23
6154567-15456781.24981.60
60min1162871-16287185.61487.691.9786.1088.211.98
2170252-17025289.49390.06
3163472-16347285.93086.44
4170588-17058889.67090.18
5167533-16753388.06488.59
6166260-16626087.39587.88
极限1175026-17502692.00392.731.4292.6393.401.43
2177220-17722093.15693.87
3173187-17318791.03691.69
4180202-18020294.72495.39
5177826-17782693.47594.15
6175025-17502592.00292.64
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.321946901947901945451949141947561947390.07
211.321942441942691942560.01
单位质量响应值RSD%判断
17203.0917160.420.18数据可信
供试品溶液-BXK3152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%
5min146375-4637524.29215.4832.0024.2915.4831.99
218573-185739.7299.73
332181-3218116.85716.86
429222-2922215.30715.31
526673-2667313.97213.97
624265-2426512.71012.71
10min190471-9047147.39039.5111.1247.4339.5311.13
266320-6632034.73934.76
378723-7872341.23641.26
472997-7299738.23738.26
572902-7290238.18738.21
671099-7109937.24337.26
15min1115824-11582460.67054.137.5960.7954.237.61
293395-9339548.92149.00
3107349-10734956.23156.33
4100334-10033452.55652.65
5104872-10487254.93355.02
698308-9830851.49551.58
20min1132949-13294969.64064.135.9169.8664.315.93
2113014-11301459.19859.35
3126305-12630566.16066.35
4119205-11920562.44162.62
5125750-12575065.86966.05
6117345-11734561.46761.64
30min1154190-15419080.76776.743.8581.1077.023.87
2139968-13996873.31773.57
3149731-14973178.43178.73
4143409-14340975.11975.40
5150090-15009078.61978.91
6141576-14157674.15974.43
45min1170218-17021889.16286.332.9389.6386.752.95
2159447-15944783.52083.90
3167382-16738287.67788.11
4162836-16283685.29585.70
5169376-16937688.72189.14
6159614-15961483.60884.00
60min1178176-17817693.33190.722.2493.9591.282.26
2169990-16999089.04389.56
3175111-17511191.72592.30
4172395-17239590.30390.85
5175696-17569692.03292.60
6167813-16781387.90288.44
极限1185190-18519097.00594.871.5497.7895.581.56
2179359-17935993.95094.61
3181699-18169995.17695.91
4180408-18040894.50095.20
5182806-18280695.75696.48
6177240-17724092.84093.52
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.323860243862363859683858373857443859620.05
211.323902043903153902600.03
单位质量响应值RSD%判断
34095.5834475.270.79数据可信
供试品溶液-BXK0LE1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%
5min124326-243266.3866.148.386.396.148.35
222810-228105.9885.99
323632-236326.2046.20
421214-212145.5695.57
526608-266086.9856.98
621714-217145.7005.70
10min167698-6769817.77115.938.4917.7815.948.49
260640-6064015.91915.93
363832-6383216.75716.77
457966-5796615.21715.23
561466-6146616.13516.15
652581-5258113.80313.81
15min1103877-10387727.26924.677.5327.3124.717.53
294292-9429224.75324.79
3100846-10084626.47326.51
486334-8633422.66422.70
590415-9041523.73523.77
688176-8817623.14723.18
20min1130939-13093934.37331.736.5734.4631.816.56
2120443-12044331.61831.70
3128880-12888033.83233.91
4109698-10969828.79728.87
5116331-11633130.53830.62
6119027-11902731.24631.32
30min1168112-16811244.13142.025.3744.2742.155.37
2160331-16033142.08942.22
3167637-16763744.00644.15
4145393-14539338.16738.29
5155490-15549040.81840.95
6163347-16334742.88043.00
45min1203038-20303853.30052.034.2053.5252.234.21
2199979-19997952.49752.70
3204194-20419453.60353.82
4182616-18261647.93948.12
5195389-19538951.29251.49
6203926-20392653.53353.73
60min1226944-22694459.57558.603.3759.8858.893.37
2225427-22542759.17759.47
3227889-22788959.82360.12
4208834-20883454.82155.08
5221548-22154858.15958.44
6228812-22881260.06660.35
极限1248949-24894965.35264.751.8865.7665.141.89
2247132-24713264.87565.26
3249139-24913965.40265.80
4239067-23906762.75863.11
5243633-24363363.95664.34
6252009-25200966.15566.54
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.323837633837883839983838473840363838860.04
211.323896353896673896510.01
单位质量响应值RSD%判断
33912.1934421.471.06数据可信
供试品溶液-BXK0LE1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%
5min121848-218485.7555.3915.325.765.3915.35
215689-156894.1334.13
319383-193835.1065.11
419386-193865.1075.11
521294-212945.6095.61
625077-250776.6066.61
10min162742-6274216.52816.0413.7316.5416.0513.72
247335-4733512.46912.48
369360-6936018.27118.28
454981-5498114.48414.49
562898-6289816.56916.58
668056-6805617.92817.94
15min196597-9659725.44624.8013.1425.4824.8313.14
274658-7465819.66719.69
3109796-10979628.92328.96
485578-8557822.54422.58
596683-9668325.46925.51
6101506-10150626.74026.78
20min1123099-12309932.42831.6611.8832.5131.7311.89
297559-9755925.70025.76
3138899-13889936.59036.68
4111049-11104929.25329.32
5122595-12259532.29532.37
6127844-12784433.67833.76
30min1163389-16338943.04141.819.5543.1741.949.56
2133103-13310335.06335.17
3177168-17716846.67146.82
4150396-15039639.61939.74
5163127-16312742.97243.11
6165084-16508443.48843.63
45min1201902-20190253.18751.957.4953.3952.147.51
2170720-17072044.97245.13
3212612-21261256.00856.23
4190509-19050950.18550.37
5203575-20357553.62753.83
6203830-20383053.69553.91
60min1226179-22617959.58258.646.2759.8858.936.29
2197141-19714151.93252.17
3236513-23651362.30462.62
4217284-21728457.23957.51
5228663-22866360.23660.53
6229831-22983160.54460.85
极限1247551-24755165.21265.123.2665.6165.513.29
2232606-23260661.27561.60
3255029-25502967.18267.60
4244576-24457664.42864.79
5251077-25107766.14166.54
6252455-25245566.50466.91
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