盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
1 11.151937941925751940631939301924631933650.41
2 11.131939641934551937100.19
单位质量响应值RSD%判断
17342.1517404.310.26数据可信
供试品溶液-1批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107730-10773055.66355.937.3355.6655.937.33
2109334-10933456.49256.49
393477-9347748.29948.30
4115949-11594959.91059.91
5108828-10882856.23156.23
6114152-11415258.98258.98
10min1142690-14269073.72774.172.3473.8274.272.34
2145883-14588375.37775.47
3137838-13783871.22071.30
4146962-14696275.93476.03
5142375-14237573.56473.66
6145585-14558575.22375.32
15min1160041-16004182.69282.701.8482.9182.911.84
2161935-16193583.67183.89
3154729-15472979.94780.15
4162755-16275584.09484.32
5159087-15908782.19982.42
6161734-16173483.56783.79
20min1170118-17011887.89987.921.4488.2588.271.44
2171860-17186088.79989.16
3165726-16572685.62985.96
4171177-17117788.44688.81
5169534-16953487.59787.95
6172538-17253889.14989.51
30min1179903-17990392.95593.400.9493.4593.900.95
2182131-18213194.10694.61
3177828-17782891.88292.36
4180975-18097593.50994.02
5181442-18144293.75094.25
6182341-18234194.21494.73
45min1188397-18839797.34397.420.8498.0098.070.85
2189896-18989698.11898.78
3185865-18586596.03596.66
4187791-18779197.03097.70
5189175-18917597.74598.40
6190121-19012198.23498.90
60min1192128-19212899.27199.150.60100.0999.970.61
2192414-19241499.419100.25
3190150-19015098.24999.04
4190945-19094598.66099.49
5192334-19233499.378100.20
6193363-19336399.909100.74
极限1195486-195486101.006101.150.74101.99102.140.74
2197561-197561102.078103.07
3193515-19351599.988100.94
4195058-195058100.785101.78
5196041-196041101.293102.28
6196928-196928101.751102.75
盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
1 11.151936531922181937411931391920681929640.41
2 11.131925441943371934400.66
单位质量响应值RSD%判断
17306.1917380.050.31数据可信
供试品溶液-2批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105448-10544854.57958.004.0254.5858.004.02
2115620-11562059.84459.84
3108451-10845156.13356.13
4111734-11173457.83257.83
5117462-11746260.79760.80
6113605-11360558.80158.80
10min1143234-14323474.13776.252.8074.2376.342.80
2148606-14860676.91777.02
3141385-14138573.18073.27
4151182-15118278.25078.35
5151260-15126078.29178.39
6148180-14818076.69776.79
15min1159961-15996182.79484.332.0083.0184.562.01
2163607-16360784.68184.91
3158385-15838581.97982.19
4163027-16302784.38184.61
5166658-16665886.26186.49
6165946-16594685.89286.12
20min1170860-17086088.43689.571.7288.7989.931.72
2174013-17401390.06890.44
3168696-16869687.31687.67
4172815-17281589.44789.81
5174831-17483190.49190.87
6177041-17704191.63592.00
30min1182266-18226694.33994.451.7594.8494.961.75
2183134-18313494.78895.31
3177431-17743191.83792.33
4181313-18131393.84694.36
5183504-18350494.98095.51
6187198-18719896.89297.41
45min1190167-19016798.42997.941.4499.0998.611.44
2189147-18914797.90198.58
3184468-18446895.47996.13
4190004-19000498.34499.02
5188758-18875897.69998.38
6192797-19279799.790100.47
60min1193394-193394100.09999.371.62100.92100.201.61
2192680-19268099.729100.57
3187706-18770697.15597.96
4191958-19195899.356100.19
5189574-18957498.12298.97
6196606-196606101.761102.61
极限1196485-196485101.699101.131.70102.69102.131.70
2194874-194874100.865101.87
3189909-18990998.29599.27
4195664-195664101.274102.28
5195149-195149101.007102.02
6200192-200192103.618104.64
盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
1 11.151924361939891937901922831927781930550.41
2 11.131929101950281939690.78
单位质量响应值RSD%判断
17314.3517427.580.47数据可信
供试品溶液-1批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159282-5928230.63531.148.9430.6331.148.94
257377-5737729.65029.65
353187-5318727.48527.49
464340-6434033.24933.25
558872-5887230.42330.42
668444-6844435.36935.37
10min197983-9798350.63449.943.8450.6949.993.85
296899-9689950.07450.12
391886-9188647.48347.53
499218-9921851.27251.33
592574-9257447.83947.89
6101233-10123352.31452.37
15min1118486-11848661.22960.262.8261.3660.392.82
2116492-11649260.19960.33
3115106-11510659.48359.61
4118204-11820461.08461.22
5110992-11099257.35757.49
6120355-12035562.19562.34
20min1132854-13285468.65467.452.3268.8967.692.32
2130294-13029467.33167.56
3129293-12929366.81467.04
4132132-13213268.28168.52
5125250-12525064.72564.95
6133371-13337168.92169.17
30min1150936-15093677.99877.152.1278.3577.502.12
2147629-14762976.28976.63
3148533-14853376.75777.09
4154182-15418279.67680.03
5144858-14485874.85775.19
6149639-14963977.32877.69
45min1167364-16736486.48884.991.1986.9785.461.19
2163663-16366384.57585.05
3163993-16399384.74685.21
4166293-16629385.93486.42
5162279-16227983.86084.32
6163171-16317184.32184.81
60min1178170-17817092.07290.491.2192.7091.111.20
2174712-17471290.28590.90
3174046-17404689.94190.55
4177083-17708391.51092.14
5174164-17416490.00290.60
6172525-17252589.15589.79
极限1184540-18454095.36493.951.0896.1494.721.07
2183250-18325094.69795.46
3180818-18081893.44094.19
4181966-18196694.03494.82
5181302-18130293.69094.44
6178932-17893292.46693.25
盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
1 11.151919291925961931891920981919651923550.28
2 11.131935611924491930050.41
单位质量响应值RSD%判断
17251.5717340.970.37数据可信
供试品溶液-2批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154662-5466228.36928.949.2128.3728.949.22
265348-6534833.91533.92
355268-5526828.68428.68
453865-5386527.95627.96
549873-4987325.88425.88
655551-5555128.83128.83
10min186292-8629244.78546.925.4944.8346.975.49
299863-9986351.82851.88
388586-8858645.97646.02
491447-9144747.46047.51
587201-8720145.25745.30
689084-8908446.23446.28
15min1105471-10547154.73957.324.4454.8657.454.45
2119439-11943961.98862.13
3108655-10865556.39156.52
4111657-11165757.94958.08
5107320-10732055.69855.82
6110184-11018457.18557.31
20min1119220-11922061.87464.613.6962.0964.833.70
2132479-13247968.75669.00
3122714-12271463.68863.91
4126244-12624465.52065.74
5121734-12173463.17963.39
6124555-12455564.64364.86
30min1138787-13878772.03074.152.5172.3574.482.52
2148769-14876977.21077.57
3140522-14052272.93073.25
4144792-14479275.14675.48
5141040-14104073.19973.52
6143282-14328274.36274.69
45min1156171-15617181.05283.131.9381.4983.581.94
2164751-16475185.50585.99
3157763-15776381.87882.32
4161928-16192884.04084.50
5159359-15935982.70683.15
6161079-16107983.59984.05
60min1168005-16800587.19489.061.3287.7689.651.33
2173519-17351990.05590.69
3169664-16966488.05588.64
4172946-17294689.75890.35
5172082-17208289.31089.89
6173385-17338589.98690.58
极限1178165-17816592.46793.901.0493.1894.641.04
2181066-18106693.97294.75
3179197-17919793.00293.73
4182823-18282394.88495.63
5181990-18199094.45295.18
6182351-18235194.63995.38
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