盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.941923381923991917201919521918281920470.16
211.031922091919221920660.11
单位质量响应值RSD%判断
17554.5717413.060.58数据可信
供试品溶液-2025111511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%
5min142836-4283621.99317.0044.3621.9917.0044.36
248247-4824724.77224.77
316388-163888.4148.41
439559-3955920.31120.31
513032-130326.6916.69
638639-3863919.83819.84
10min183738-8373842.99440.5311.8843.0340.5611.90
283120-8312042.67642.72
372174-7217437.05637.07
485864-8586444.08544.12
562915-6291532.30332.31
685877-8587744.09244.13
15min195545-9554549.05648.275.9449.1648.365.96
295146-9514648.85148.96
390254-9025446.33946.42
498833-9883350.74450.85
584805-8480543.54243.61
699460-9946051.06651.17
20min199996-9999651.34151.094.7951.5351.264.82
299436-9943651.05451.25
396918-9691849.76149.91
4102882-10288252.82353.01
592038-9203847.25547.39
6105783-10578354.31254.50
30min1103163-10316352.96753.223.9053.2453.483.92
2103116-10311652.94353.22
3102260-10226052.50452.74
4106008-10600854.42854.71
597619-9761950.12150.34
6109751-10975156.35056.63
45min1104618-10461853.71453.952.8054.0854.302.83
2104205-10420553.50253.87
3104470-10447053.63853.96
4107098-10709854.98855.36
5100676-10067651.69051.99
6109361-10936156.14956.53
60min1103973-10397353.38354.232.8153.8454.672.83
2104001-10400153.39753.85
3105219-10521954.02354.44
4107223-10722355.05255.51
5102529-10252952.64253.03
6110738-11073856.85657.33
极限1104630-10463053.72054.212.4454.2654.742.47
2104369-10436953.58654.13
3104837-10483753.82754.33
4107345-10734555.11455.67
5102502-10250252.62853.10
6109780-10978056.36556.93
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.941921691920271925721923821920061922310.13
211.031917911921821919860.15
单位质量响应值RSD%判断
17571.3917405.800.67数据可信
供试品溶液-2025111511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%
5min152307-5230726.84920.8226.2726.8520.8226.27
234815-3481517.87017.87
323168-2316811.89211.89
442195-4219521.65821.66
550094-5009425.71325.71
640754-4075420.91920.92
10min191801-9180147.12143.2210.8047.1743.2510.82
273845-7384537.90437.93
373959-7395937.96337.98
485257-8525743.76243.80
596118-9611849.33749.38
684181-8418143.21043.24
15min1101488-10148852.09350.095.8752.2250.205.89
290173-9017346.28546.38
393574-9357448.03148.11
496829-9682949.70249.81
5106353-10635354.59054.72
697134-9713449.85849.97
20min1104574-10457453.67752.504.3853.8952.694.40
296451-9645149.50849.68
3100297-10029751.48251.65
4102245-10224552.48252.67
5109623-10962356.26956.48
6100501-10050151.58751.78
30min1107770-10777055.31854.313.3055.6254.593.32
2101016-10101651.85152.10
3105018-10501853.90554.15
4105528-10552854.16754.45
5111338-11133857.14957.46
6104194-10419453.48253.76
45min1108378-10837855.63055.002.3556.0255.362.38
2103576-10357653.16553.50
3106818-10681854.82955.17
4106897-10689754.87055.24
5111143-11114357.04957.45
6106049-10604954.43454.80
60min1107802-10780255.33454.662.0355.8255.122.05
2103956-10395653.36053.79
3106364-10636454.59655.03
4105762-10576254.28754.75
5110001-11000156.46356.96
6105015-10501553.90454.36
极限1107239-10723955.04554.831.5655.6255.381.59
2104434-10443453.60554.12
3107582-10758255.22155.74
4106725-10672554.78155.33
5109277-10927756.09156.69
6105654-10565454.23254.78
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.941926161927321924541923781917761923910.20
211.031937371940231938800.11
单位质量响应值RSD%判断
17586.0117577.520.04数据可信
供试品溶液-2025111611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%
5min151629-5162926.36021.4239.9026.3621.4239.90
256644-5664428.92028.92
340002-4000220.42420.42
420309-2030910.36910.37
523976-2397612.24112.24
659159-5915930.20430.20
10min194762-9476248.38242.0114.9248.4342.0414.94
290090-9009045.99746.04
383756-8375642.76342.80
464129-6412932.74232.76
570522-7052236.00636.03
690403-9040346.15646.21
15min1105978-10597854.10848.719.2454.2348.829.26
299672-9967250.88951.01
397627-9762749.84549.95
482735-8273542.24142.31
586778-8677844.30644.39
699633-9963350.86951.00
20min1108976-10897655.63950.927.2755.8551.107.31
2102414-10241452.28952.50
3102126-10212652.14252.33
489354-8935445.62145.76
592812-9281247.38647.54
6102711-10271152.44052.65
30min1111174-11117456.76153.005.5057.0753.285.53
2104593-10459353.40153.70
3107091-10709154.67754.95
495858-9585848.94249.16
598364-9836450.22150.45
6105807-10580754.02154.32
45min1111258-11125856.80453.794.0157.2154.154.05
2105643-10564353.93754.32
3107860-10786055.06955.44
499356-9935650.72851.03
5101984-10198452.06952.39
6106003-10600354.12154.51
60min1111312-11131256.83253.624.5557.3354.074.59
2106641-10664154.44754.92
3107594-10759454.93455.39
497929-9792949.99950.38
5101197-10119751.66752.07
6105459-10545953.84354.32
极限1110701-11070156.52054.013.2757.1154.553.33
2106439-10643954.34454.91
3107434-10743454.85255.40
4100955-10095551.54452.01
5102813-10281352.49352.98
6106345-10634554.29654.87
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.941934831937481932971933241933981934500.10
211.031927691926561927120.05
单位质量响应值RSD%判断
17682.8217471.620.85数据可信
供试品溶液-2025111611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%
5min143439-4343922.18525.0915.1322.1825.0815.14
247021-4702124.01424.01
350958-5095826.02526.02
460815-6081531.05931.06
539815-3981520.33420.33
652695-5269526.91226.91
10min178013-7801339.84242.977.7239.8843.017.72
284391-8439143.10043.14
382930-8293042.35342.40
495292-9529248.66748.72
577691-7769139.67839.71
686473-8647344.16344.21
15min190730-9073046.33748.755.3546.4448.865.36
295263-9526348.65248.76
393671-9367147.83947.95
4103971-10397153.09953.23
590634-9063446.28846.39
698419-9841950.26450.38
20min196205-9620549.13350.954.7449.3151.144.76
2100173-10017351.16051.35
396868-9686849.47249.67
4107465-10746554.88455.11
595058-9505848.54748.72
6102780-10278052.49152.69
30min1100479-10047951.31652.933.6251.5853.213.64
2104212-10421253.22253.50
3101482-10148251.82852.10
4109454-10945455.90056.21
599893-9989351.01751.27
6106342-10634254.31054.60
45min1102037-10203752.11253.522.7852.4653.892.81
2104950-10495053.59953.97
3102842-10284252.52352.89
4109038-10903855.68756.09
5102405-10240552.30052.64
6107493-10749354.89855.28
60min1102985-10298552.59653.602.2953.0354.052.31
2105708-10570853.98754.44
3102690-10269052.44552.90
4107988-10798855.15155.65
5102915-10291552.56052.99
6107381-10738154.84155.31
极限1103728-10372852.97553.561.7453.5054.111.78
2104836-10483653.54154.09
3103837-10383753.03153.57
4107570-10757054.93755.53
5102796-10279652.49953.02
6106503-10650354.39354.96
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