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%
110.941909511901931907971900391908661905690.23
211.031913531918981916260.21
单位质量响应值RSD%判断
17419.4717373.160.19数据可信
供试品溶液-2025111511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%
5min1771-7710.3980.3851.220.400.3851.23
21047-10470.5400.54
3-0.0000.00
4762-7620.3930.39
5954-9540.4920.49
6853-8530.4400.44
10min11491-14910.7690.805.000.770.804.96
21546-15460.7980.80
31602-16020.8270.83
41449-14490.7480.75
51557-15570.8030.80
61667-16670.8600.86
15min11706-17060.8800.849.340.880.849.09
21759-17590.9080.91
31826-18260.9420.94
41488-14880.7680.77
51540-15400.7950.80
61466-14660.7560.76
20min11354-13540.6990.796.580.700.806.74
21504-15040.7760.78
31642-16420.8470.85
41538-15380.7940.80
51537-15370.7930.80
61613-16130.8320.84
30min11419-14190.7320.739.160.740.749.05
21312-13120.6770.68
31608-16080.8300.83
41288-12880.6650.67
51553-15530.8010.81
61364-13640.7040.71
45min11176-11760.6070.643.540.610.643.57
21235-12350.6370.64
31265-12650.6530.66
41296-12960.6690.67
51197-11970.6180.62
61236-12360.6380.64
60min11166-11660.6020.614.840.610.624.84
21250-12500.6450.65
31278-12780.6590.67
41134-11340.5850.59
51161-11610.5990.61
61160-11600.5990.61
极限11126-11260.5810.5613.170.590.5612.56
21212-12120.6250.63
31232-12320.6360.64
41046-10460.5400.55
5852-8520.4400.45
61005-10050.5190.53
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%
110.941910331906471903511913381907131908160.20
211.031909431908031908730.06
单位质量响应值RSD%判断
17442.0517304.900.56数据可信
供试品溶液-2025111511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%
5min1544-5440.2810.2279.980.280.2280.04
2588-5880.3040.30
3-0.0000.00
4632-6320.3270.33
5-0.0000.00
6796-7960.4110.41
10min11769-17690.9140.798.980.910.798.63
21383-13830.7150.72
31424-14240.7360.74
41579-15790.8160.82
51493-14930.7710.77
61507-15070.7790.78
15min11634-16340.8440.894.810.850.904.89
21759-17590.9090.91
31717-17170.8870.89
41826-18260.9430.95
51789-17890.9240.93
61621-16210.8380.84
20min11715-17150.8860.837.160.890.847.34
21748-17480.9030.91
31550-15500.8010.80
41672-16720.8640.87
51554-15540.8030.81
61448-14480.7480.75
30min11295-12950.6690.708.540.670.708.36
21528-15280.7900.79
31273-12730.6580.66
41486-14860.7680.77
51266-12660.6540.66
61312-13120.6780.68
45min11211-12110.6260.668.520.630.668.28
21321-13210.6830.69
31253-12530.6470.65
41448-14480.7480.75
51312-13120.6780.68
61128-11280.5830.59
60min11229-12290.6350.578.530.640.588.58
21197-11970.6180.63
31093-10930.5650.57
4991-9910.5120.52
51060-10600.5480.55
61031-10310.5330.54
极限11045-10450.5400.579.120.550.589.26
21102-11020.5690.58
31050-10500.5430.55
41195-11950.6170.63
5959-9590.4960.50
61228-12280.6340.64
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%
110.941911471917251910141918391918681915190.22
211.031926801914851920820.44
单位质量响应值RSD%判断
17506.3117414.510.38数据可信
供试品溶液-2025111611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%
5min14963-49632.5521.8054.882.551.8054.89
24740-47402.4372.44
31265-12650.6500.65
41773-17730.9120.91
55877-58773.0213.02
62410-24101.2391.24
10min13827-38271.9681.5542.071.971.5641.90
24980-49802.5602.56
31959-19591.0071.01
41783-17830.9170.92
53430-34301.7631.77
62147-21471.1041.11
15min12548-25481.3101.1511.651.321.1511.74
22482-24821.2761.28
32110-21101.0851.09
41943-19430.9991.00
52323-23231.1941.20
61971-19711.0131.02
20min12144-21441.1021.019.161.111.029.49
22159-21591.1101.12
31750-17500.9000.90
41790-17900.9200.92
52066-20661.0621.07
61890-18900.9720.98
30min11824-18240.9380.888.830.950.889.01
21862-18620.9570.97
31499-14990.7710.78
41667-16670.8570.86
51814-18140.9330.94
61568-15680.8060.81
45min11446-14460.7430.724.740.760.734.85
21328-13280.6830.70
31376-13760.7070.71
41392-13920.7160.72
51511-15110.7770.79
61357-13570.6980.71
60min11315-13150.6760.685.890.690.696.17
21408-14080.7240.74
31194-11940.6140.62
41319-13190.6780.69
51400-14000.7200.73
61303-13030.6700.68
极限11303-13030.6700.646.360.690.656.75
21357-13570.6980.71
31182-11820.6080.62
41194-11940.6140.62
51262-12620.6490.66
61153-11530.5930.60
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%
110.941917571922221927971927871919121922950.26
211.031910891910171910530.03
单位质量响应值RSD%判断
17577.2417321.211.04数据可信
供试品溶液-2025111611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%
5min15630-56302.8961.9159.122.901.9159.21
21038-10380.5340.53
3894-8940.4600.46
45425-54252.7912.79
55226-52262.6892.69
64087-40872.1032.10
10min14086-40862.1021.8640.992.111.8640.96
22002-20021.0301.03
31758-17580.9040.91
45604-56042.8832.89
54462-44622.2962.30
63779-37791.9441.95
15min12833-28331.4571.2717.401.471.2817.52
22034-20341.0461.05
32011-20111.0351.04
43090-30901.5901.60
52461-24611.2661.27
62391-23911.2301.24
20min12030-20301.0441.074.211.061.084.12
22161-21611.1121.12
32128-21281.0951.10
42056-20561.0581.07
51950-19501.0031.01
62177-21771.1201.13
30min11654-16540.8510.8910.890.860.9010.67
21553-15530.7990.81
31748-17480.8990.91
41597-15970.8220.84
51781-17810.9160.93
62078-20781.0691.08
45min11556-15560.8010.7811.390.810.8011.33
21596-15960.8210.83
31471-14710.7570.76
41280-12800.6590.67
51444-14440.7430.76
61800-18000.9260.94
60min11409-14090.7250.6811.660.740.6911.44
21259-12590.6480.66
31268-12680.6520.66
41218-12180.6270.64
51181-11810.6080.62
61593-15930.8200.83
极限11311-13110.6740.673.600.690.683.78
21293-12930.6650.68
31266-12660.6510.66
41244-12440.6400.66
51303-13030.6700.69
61380-13800.7100.73
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%
110.941912811914191911351906691915171912040.18
211.031933291933101933200.01
单位质量响应值RSD%判断
17477.5117526.750.20数据可信
供试品溶液-2025111711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%
5min16635-66353.4031.9278.503.401.9278.58
2916-9160.4700.47
36708-67083.4403.44
41316-13160.6750.67
5996-9960.5110.51
65856-58563.0033.00
10min13600-36001.8461.4836.231.851.4836.41
22045-20451.0491.05
34409-44092.2612.27
42062-20621.0581.06
51859-18590.9530.95
63305-33051.6951.70
15min12464-24641.2641.2315.751.271.2415.93
22106-21061.0801.08
33023-30231.5501.56
42102-21021.0781.08
52096-20961.0751.08
62641-26411.3551.36
20min11960-19601.0051.0216.431.021.0316.65
22026-20261.0391.04
32414-24141.2381.25
41556-15560.7980.80
51704-17040.8740.88
62276-22761.1671.18
30min11917-19170.9830.9211.731.000.9311.91
21768-17680.9070.91
31778-17780.9120.93
41453-14530.7450.75
51736-17360.8900.90
62085-20851.0691.08
45min11648-16480.8450.823.910.860.844.47
21493-14930.7660.77
31646-16460.8440.86
41608-16080.8250.83
51580-15800.8100.82
61662-16620.8520.87
60min11532-15320.7860.755.280.800.765.16
21589-15890.8150.82
31432-14320.7340.75
41413-14130.7250.73
51386-13860.7110.72
61457-14570.7470.76
极限11508-15080.7730.743.170.790.753.21
21424-14240.7300.74
31405-14050.7210.74
41382-13820.7090.72
51466-14660.7520.76
61415-14150.7260.74
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%
110.941914021914461915241916251917051915400.07
211.031912081909081910580.12
单位质量响应值RSD%判断
17508.2317321.670.76数据可信
供试品溶液-2025111711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%
5min1957-9570.4930.92135.590.490.92135.72
2995-9950.5130.51
3595-5950.3070.31
4608-6080.3130.31
56690-66903.4483.45
6828-8280.4270.43
10min12104-21041.0851.1553.031.091.1653.04
21688-16880.8700.87
31690-16900.8710.87
41563-15630.8060.81
54629-46292.3862.39
61746-17460.9000.90
15min12015-20151.0391.0714.541.041.0814.85
21925-19250.9920.99
31903-19030.9810.98
41842-18420.9490.95
52660-26601.3711.38
62156-21561.1111.11
20min11874-18740.9660.998.970.971.008.95
21859-18590.9580.96
31867-18670.9620.97
41693-16930.8730.88
52138-21381.1021.11
62124-21241.0951.10
30min11513-15130.7800.8810.560.790.8910.50
21616-16160.8330.84
31575-15750.8120.82
41787-17870.9210.93
51802-18020.9290.94
62000-20001.0311.04
45min11372-13720.7070.7613.100.710.7613.23
21500-15000.7730.78
31274-12740.6570.66
41298-12980.6690.68
51601-16010.8250.84
61769-17690.9120.92
60min11448-14480.7460.7111.740.750.7211.31
21397-13970.7200.73
31160-11600.5980.61
41240-12400.6390.65
51424-14240.7340.75
61617-16170.8340.84
极限11316-13160.6780.7013.530.690.7113.56
21285-12850.6620.67
31196-11960.6170.63
41201-12010.6190.63
51497-14970.7720.79
61660-16600.8560.87
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