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%
110.941920881920811916461917131912871917630.18
211.031929041927971928500.04
单位质量响应值RSD%判断
17528.6117484.130.18数据可信
供试品溶液-2025111711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%
5min141646-4164621.35520.6123.2521.3520.6123.26
253719-5371927.54527.55
340497-4049720.76520.77
425001-2500112.82012.82
536933-3693318.93818.94
643334-4333422.22022.22
10min189525-8952545.90542.868.2745.9442.908.28
290417-9041746.36246.41
381958-8195842.02542.06
471947-7194736.89236.91
580810-8081041.43641.47
686899-8689944.55944.60
15min1101379-10137951.98349.355.1252.1049.455.13
2100537-10053751.55251.67
395200-9520048.81548.92
487884-8788445.06445.15
594589-9458948.50248.60
697815-9781550.15650.27
20min1105691-10569154.19451.784.0854.3951.974.10
2103444-10344453.04253.25
399152-9915250.84151.03
494326-9432648.36748.52
599640-9964051.09251.27
6103664-10366453.15553.35
30min1107626-10762655.18753.153.5355.4853.433.55
2106092-10609254.40054.70
399487-9948751.01351.28
499180-9918050.85651.09
5103198-10319852.91653.18
6106393-10639354.55454.84
45min1108286-10828655.52554.162.1555.9154.532.18
2106817-10681754.77255.16
3104536-10453653.60253.96
4101794-10179452.19652.52
5105566-10556654.13054.49
6106767-10676754.74655.12
60min1107954-10795455.35554.142.0055.8354.602.03
2107237-10723754.98755.47
3103695-10369553.17153.62
4102483-10248352.54952.96
5105723-10572354.21154.66
6106428-10642854.57255.04
极限1107872-10787255.31354.171.5655.8854.711.59
2106494-10649454.60655.18
3104120-10412053.38953.92
4103461-10346153.05153.55
5105406-10540654.04854.58
6106468-10646854.59355.15
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%
110.941924641925481926391917381917931922360.23
211.031923191922811923000.02
单位质量响应值RSD%判断
17571.8517434.270.56数据可信
供试品溶液-2025111711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%
5min136368-3636818.65220.9813.1318.6520.9813.12
235909-3590918.41718.42
345829-4582923.50423.50
435839-3583918.38118.38
544791-4479122.97222.97
646702-4670223.95223.95
10min178939-7893940.48543.447.4740.5243.487.47
283667-8366742.91042.94
386265-8626544.24244.28
481020-8102041.55241.58
581772-8177241.93841.98
696583-9658349.53449.57
15min191906-9190647.13650.085.3547.2350.185.35
297281-9728149.89249.99
396434-9643449.45849.57
496177-9617749.32649.43
596519-9651949.50149.61
6107544-10754455.15655.28
20min196800-9680049.64652.644.8249.8252.834.83
2102053-10205352.34052.52
3101255-10125551.93052.13
4101541-10154152.07752.26
5102306-10230652.46952.66
6111835-11183557.35657.57
30min1100431-10043151.50854.383.9051.7754.663.91
2106644-10664454.69454.97
3104917-10491753.80854.09
4105061-10506153.88254.15
5105954-10595454.34054.62
6113196-11319658.05458.36
45min1102554-10255452.59754.953.1652.9455.323.18
2107068-10706854.91255.28
3105857-10585754.29154.66
4106913-10691354.83255.19
5107438-10743855.10155.47
6112997-11299757.95258.36
60min1103595-10359553.13054.942.6753.5655.402.69
2107263-10726355.01255.47
3105600-10560054.15954.62
4106971-10697154.86255.31
5107065-10706554.91055.37
6112207-11220757.54758.05
极限1103711-10371153.19054.932.3453.7155.482.36
2107692-10769255.23255.78
3105533-10553354.12454.68
4107068-10706854.91255.45
5107406-10740655.08555.64
6111218-11121857.04057.64
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%
110.941934971934241937211934941938451935960.10
211.031930501930981930740.02
单位质量响应值RSD%判断
17696.1617504.440.78数据可信
供试品溶液-2022082601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%
5min142944-4294421.90320.068.7521.9020.068.75
240554-4055420.68420.68
343439-4343922.15622.16
437073-3707318.90918.91
536136-3613618.43118.43
635806-3580618.26318.26
10min186023-8602343.87540.327.7043.9140.357.69
284665-8466543.18343.22
380121-8012140.86540.90
477656-7765639.60839.64
569298-6929835.34535.38
676512-7651239.02439.05
15min1101901-10190151.97449.713.7552.0849.813.75
2100902-10090251.46451.57
398061-9806150.01550.12
496135-9613549.03349.13
591968-9196846.90747.00
695818-9581848.87148.97
20min1107439-10743954.79853.092.5054.9953.272.51
2106334-10633454.23554.43
3104659-10465953.38053.57
4102704-10270452.38352.56
5100328-10032851.17151.34
6103058-10305852.56452.74
30min1111333-11133356.78455.621.5857.0755.891.59
2111059-11105956.64556.93
3108592-10859255.38655.66
4107916-10791655.04255.31
5107287-10728754.72154.97
6108145-10814555.15855.42
45min1113025-11302557.64756.591.5658.0356.951.57
2113272-11327257.77358.15
3109931-10993156.06956.44
4110025-11002556.11756.48
5109363-10936355.78056.12
6110085-11008556.14856.50
60min1112537-11253757.39856.621.1657.8857.081.18
2112612-11261257.43757.91
3109798-10979856.00156.46
4109776-10977655.99056.44
5110400-11040056.30856.75
6110896-11089656.56157.01
极限1112760-11276057.51256.710.8158.0957.260.83
2111275-11127556.75557.32
3111511-11151156.87557.43
4110359-11035956.28856.83
5110754-11075456.48957.02
6110432-11043256.32556.87
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%
110.941933641933041931941930161931111931980.08
211.031923631924321923980.03
单位质量响应值RSD%判断
17659.7817443.160.88数据可信
供试品溶液-2022082601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%
5min134407-3440717.59818.704.7617.6018.704.76
237397-3739719.12719.13
338775-3877519.83219.83
434651-3465117.72317.72
537678-3767819.27119.27
636519-3651918.67818.68
10min174209-7420937.95539.973.8537.9840.003.85
281150-8115041.50541.54
380633-8063341.24141.27
474640-7464038.17638.21
578670-7867040.23740.27
679530-7953040.67740.71
15min193618-9361847.88249.262.4947.9749.362.49
296822-9682249.52149.62
399657-9965750.97151.07
493446-9344647.79447.89
596760-9676049.48949.59
697540-9754049.88849.99
20min1101331-10133151.82752.901.7452.0053.081.75
2103750-10375053.06453.25
3105500-10550053.95954.15
4101254-10125451.78851.96
5103749-10374953.06453.25
6105017-10501753.71253.89
30min1106779-10677954.61455.411.4454.8755.681.45
2107817-10781755.14555.42
3110590-11059056.56356.84
4106615-10661554.53054.79
5108738-10873855.61655.89
6109454-10945455.98256.25
45min1109201-10920155.85256.601.1056.2056.961.11
2110777-11077756.65857.02
3111776-11177657.16957.54
4109117-10911755.80956.16
5111547-11154757.05257.42
6111527-11152757.04257.41
60min1109660-10966056.08756.720.9056.5357.170.91
2111153-11115356.85157.31
3111959-11195957.26357.73
4109802-10980256.16056.60
5110896-11089656.71957.18
6111874-11187457.22057.68
极限1109644-10964456.07956.690.8856.6257.240.88
2110578-11057856.55757.11
3111439-11143956.99757.56
4110195-11019556.36156.90
5110749-11074956.64457.20
6112398-11239857.48858.04
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