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%
111.262000762001882001602001171996042000290.13
211.322015432008662012040.24
单位质量响应值RSD%判断
17764.5617774.200.04数据可信
供试品溶液-24091301批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169940-6994035.33248.5215.0435.3348.5215.04
2110825-11082555.98655.99
3104626-10462652.85452.85
496821-9682148.91148.91
591286-9128646.11546.12
6102809-10280951.93651.94
10min1115478-11547858.33671.0510.1858.4071.1310.18
2155044-15504478.32478.42
3150403-15040375.97976.07
4145108-14510873.30573.39
5133382-13338267.38167.46
6144461-14446172.97873.06
15min1135012-13501268.20482.369.1368.3682.569.13
2175307-17530788.56088.78
3171033-17103386.40186.62
4169491-16949185.62285.83
5158081-15808179.85880.05
6169319-16931985.53585.74
20min1146260-14626073.88687.278.1374.1687.618.14
2185345-18534593.63194.00
3182049-18204991.96692.32
4177792-17779289.81690.16
5170059-17005985.90986.23
6175043-17504388.42788.78
30min1157498-15749879.56493.427.4979.9693.907.50
2194685-19468598.34998.88
3193661-19366197.83298.34
4189565-18956595.76396.26
5185937-18593793.93094.40
6188244-18824495.09695.59
45min1164237-16423782.96896.247.1283.4996.887.14
2200823-200823101.450102.14
3199837-199837100.952101.63
4196395-19639599.21399.87
5190335-19033596.15296.77
6191471-19147196.72697.38
60min1168016-16801684.87797.476.9485.5498.266.96
2202829-202829102.464103.32
3204848-204848103.484104.33
4198552-198552100.303101.12
5192385-19238597.18897.97
6191012-19101296.49497.31
极限1169603-16960385.67998.456.5686.4899.416.59
2202814-202814102.456103.49
3203126-203126102.614103.63
4200106-200106101.088102.08
5194301-19430198.15599.10
6199303-199303100.682101.66
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%
111.262011892011802010952012672013372012140.05
211.322010002006602008300.12
单位质量响应值RSD%判断
17869.8017741.170.52数据可信
供试品溶液-24091301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%
5min188642-8864244.68941.3715.2544.6941.3815.25
265171-6517132.85632.86
397778-9777849.29549.30
471405-7140535.99936.00
591001-9100145.87945.88
678410-7841039.53139.53
10min1124333-12433362.68359.576.1362.7659.646.14
2113317-11331757.12957.18
3127504-12750464.28264.36
4108768-10876854.83654.90
5120989-12098960.99761.07
6114054-11405457.50157.57
15min1139411-13941170.28569.002.7170.4669.172.72
2134371-13437167.74467.89
3141671-14167171.42471.61
4131644-13164466.36966.52
5138694-13869469.92370.10
6135421-13542168.27368.43
20min1150404-15040475.82774.882.0676.1275.162.08
2147255-14725574.23974.50
3152324-15232476.79577.10
4143561-14356172.37772.64
5149894-14989475.57075.86
6147699-14769974.46374.74
30min1164835-16483583.10281.911.7483.5282.321.75
2162606-16260681.97982.37
3165781-16578183.57984.02
4157785-15778579.54879.93
5162428-16242881.88982.31
6161391-16139181.36681.77
45min1174724-17472488.08887.221.4688.6587.771.46
2175805-17580588.63389.16
3174509-17450987.98088.56
4169395-16939585.40185.92
5170659-17065986.03986.60
6172921-17292187.17987.71
60min1181145-18114591.32590.251.8492.0390.941.84
2180170-18017090.83491.50
3181476-18147691.49292.21
4172599-17259987.01787.67
5178885-17888590.18690.89
6179807-17980790.65191.33
极限1190689-19068996.13795.340.7897.0096.180.80
2189561-18956195.56896.39
3190354-19035495.96896.84
4186621-18662194.08694.89
5188684-18868495.12695.98
6188747-18874795.15895.99
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%
111.262009232007722011172010442008512009410.07
211.322032522032492032500.01
单位质量响应值RSD%判断
17845.5617954.950.44数据可信
供试品溶液-24091301批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126204-2620413.14112.4417.2213.1412.4417.22
226122-2612213.10013.10
321626-2162610.84510.85
428940-2894014.51314.51
517794-177948.9238.92
628138-2813814.11114.11
10min146992-4699223.56623.039.9823.5923.059.98
248663-4866324.40424.43
342718-4271821.42221.44
450927-5092725.53925.56
538368-3836819.24119.26
647874-4787424.00824.03
15min161079-6107930.63031.8711.3630.6931.9311.36
265340-6534032.76732.83
358309-5830929.24129.29
477177-7717738.70338.77
557629-5762928.90028.95
661817-6181731.00031.06
20min171805-7180536.00944.1513.9636.1244.2613.93
286539-8653943.39843.52
3107470-10747053.89454.00
496051-9605148.16848.30
582991-8299141.61941.71
683403-8340341.82541.94
30min1101103-10110350.70158.627.0250.8758.817.01
2120234-12023460.29560.48
3120457-12045760.40760.60
4124214-12421462.29162.50
5115725-11572558.03458.20
6119647-11964760.00160.19
45min1141367-14136770.89373.091.7971.1573.371.81
2147086-14708673.76174.05
3147983-14798374.21174.50
4147553-14755373.99574.31
5143789-14378972.10872.37
6146712-14671273.57473.86
60min1160117-16011780.29681.431.0080.6781.841.02
2163572-16357282.02982.44
3164123-16412382.30582.72
4162888-16288881.68682.12
5160687-16068780.58280.96
6162938-16293881.71182.12
极限1177012-17701288.76989.372.1289.2889.912.11
2176548-17654888.53689.09
3177351-17735188.93989.49
4174918-17491887.71988.29
5177804-17780489.16689.68
6185655-18565593.10393.65
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%
111.262009352008092004852008402010822008300.11
211.322004632001242002940.12
单位质量响应值RSD%判断
17835.7017693.820.57数据可信
供试品溶液-24091301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%
5min137255-3725518.82515.9419.0618.8315.9419.08
227046-2704613.66713.67
336466-3646618.42718.43
437202-3720218.79918.80
526564-2656413.42313.42
624706-2470612.48412.48
10min154226-5422627.40124.4712.1427.4324.5012.14
245331-4533122.90622.93
352816-5281626.68926.72
453734-5373427.15227.18
543881-4388122.17422.20
640594-4059420.51320.53
15min163283-6328331.97829.678.5132.0529.748.52
255931-5593128.26328.32
362425-6242531.54431.62
463380-6338032.02732.10
555831-5583128.21228.27
651480-5148026.01326.07
20min169109-6910934.92233.046.5835.0533.166.59
264144-6414432.41332.52
368485-6848534.60634.73
469142-6914234.93835.07
562875-6287531.77131.88
658537-5853729.57929.68
30min177397-7739739.11037.494.1739.3037.664.20
273435-7343537.10837.27
376167-7616738.48838.67
476312-7631238.56138.75
572805-7280536.78936.95
669037-6903734.88535.03
45min182353-8235341.61440.742.3741.8740.982.40
279893-7989340.37140.59
381740-8174041.30441.55
482482-8248241.67941.93
579703-7970340.27540.50
677596-7759639.21039.42
60min186112-8611243.51342.432.1043.8442.732.14
283436-8343642.16142.45
384610-8461042.75443.07
485449-8544943.17843.50
582863-8286341.87242.16
681353-8135341.10941.38
极限187883-8788344.40844.030.9044.8044.400.94
286689-8668943.80544.17
387914-8791444.42444.81
487538-8753844.23444.63
586843-8684343.88344.24
685947-8594743.43043.77
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