卡格列净非奈利酮片项目信息
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D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
120.146861706867326868396873416869336868030.07
220.236912446887446899940.26
单位质量响应值RSD%判断
34101.4434107.460.02数据可信
供试品溶液-5122201批-非奈利酮-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%
5min121917-219172.8893.1819.892.893.1919.90
220678-206782.7262.73
330790-307904.0594.06
421089-210892.7802.78
520632-206322.7202.72
629856-298563.9353.94
10min135898-358984.7325.1110.654.745.1210.64
236210-362104.7734.78
344494-444945.8655.87
435797-357974.7194.72
536662-366624.8334.84
643719-437195.7635.77
15min149624-496246.5416.758.056.556.768.04
249441-494416.5176.53
356492-564927.4477.46
446022-460226.0666.08
549836-498366.5696.58
655938-559387.3747.39
20min158513-585137.7138.046.757.748.066.75
259624-596247.8597.88
367771-677718.9338.96
456961-569617.5087.53
558826-588267.7547.78
664103-641038.4508.48
30min175951-7595110.01210.183.3910.0510.223.41
278177-7817710.30510.34
381081-8108110.68810.73
474063-740639.7639.80
575241-752419.9189.95
678947-7894710.40610.45
45min194909-9490912.51012.772.7512.5612.822.78
298353-9835312.96413.02
3100501-10050113.24813.31
493625-9362512.34112.39
595278-9527812.55912.61
698636-9863613.00213.06
60min1106787-10678714.07614.412.8814.1514.492.89
2110735-11073514.59714.67
3111975-11197514.76014.84
4105377-10537713.89013.96
5107849-10784914.21614.29
6113329-11332914.93915.02
90min1124806-12480616.45116.821.9216.5516.921.91
2130410-13041017.19017.29
3130634-13063417.22017.33
4126474-12647416.67116.77
5127714-12771416.83516.93
6125722-12572216.57216.68
120min1133614-13361417.61218.121.6117.7418.251.60
2138165-13816518.21218.34
3140068-14006818.46318.60
4136937-13693718.05018.17
5138811-13881118.29718.42
6137366-13736618.10718.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1142214-14221418.74618.880.6518.9019.040.67
2143799-14379918.95519.11
3144428-14442819.03819.21
4142117-14211718.73318.89
5142994-14299418.84919.01
6143635-14363518.93319.10
卡格列净非奈利酮片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
111.121740705174188017432161743712174414117427310.09
211.131781563177567817786200.24
单位质量响应值RSD%判断
156720.41159804.131.38数据可信
供试品溶液-5122201批-卡格列净-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%
5min119081-190811.0621.0317.361.061.0317.65
216589-165890.9240.92
322034-220341.2271.23
416638-166380.9260.93
514273-142730.7950.79
622182-221821.2351.24
10min165188-651883.6303.592.103.633.602.06
266147-661473.6833.68
365645-656453.6553.66
463005-630053.5083.51
562963-629633.5063.51
664327-643273.5823.58
15min190734-907345.0525.096.245.065.106.21
288994-889944.9554.96
390958-909585.0645.07
484406-844064.7004.71
5101739-1017395.6655.67
691525-915255.0965.10
20min199307-993075.5295.9015.155.555.9215.08
2100615-1006155.6025.62
3138587-1385877.7167.73
497174-971745.4115.43
598284-982845.4725.49
6101960-1019605.6775.69
30min1113705-1137056.3316.321.206.366.341.17
2115648-1156486.4396.46
3114094-1140946.3536.38
4113116-1131166.2986.32
5111579-1115796.2136.24
6112905-1129056.2866.31
45min1122789-1227896.8376.931.116.876.961.15
2125391-1253916.9827.02
3125308-1253086.9777.02
4125776-1257767.0037.04
5122624-1226246.8286.86
6124699-1246996.9436.98
60min1124401-1244016.9267.214.436.977.264.41
2128244-1282447.1407.19
3127761-1277617.1147.17
4130506-1305067.2667.31
5125874-1258747.0087.06
6140430-1404307.8197.87
90min1130493-1304937.2667.382.137.327.442.12
2134745-1347457.5027.56
3135425-1354257.5407.60
4134923-1349237.5127.57
5130647-1306477.2747.33
6128914-1289147.1787.24
120min1131599-1315997.3277.461.507.407.531.49
2132812-1328127.3957.47
3136548-1365487.6037.68
4136267-1362677.5877.66
5133519-1335197.4347.51
6133052-1330527.4087.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1139655-1396557.7767.740.297.867.820.32
2138896-1388967.7347.82
3139364-1393647.7607.85
4138763-1387637.7267.81
5138648-1386487.7207.80
6138814-1388147.7297.81
卡格列净非奈利酮片项目信息
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D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
120.146896926892546884286882596881746887610.10
220.236864466869796867120.06
单位质量响应值RSD%判断
34198.6633945.230.53数据可信
供试品溶液-5122202批-非奈利酮-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0001.40244.950.001.40244.95
263814-638148.4208.42
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0007.9349.080.007.9449.08
272580-725809.5769.59
372730-727309.5969.60
474476-744769.8279.83
571923-719239.4909.49
669077-690779.1149.11
30min165078-650788.58710.9510.968.5910.9611.00
284574-8457411.15911.19
387286-8728611.51711.53
490876-9087611.99012.01
585694-8569411.30711.32
684304-8430411.12311.14
45min189982-8998211.87312.783.9111.8912.813.95
296475-9647512.72912.78
398388-9838812.98213.02
4101178-10117813.35013.39
596418-9641812.72212.76
698509-9850912.99813.03
60min199048-9904813.06913.442.2113.1013.502.28
2104632-10463213.80513.88
3101445-10144513.38513.44
4104480-10448013.78513.84
5100355-10035513.24113.30
6101242-10124213.35813.41
90min1108088-10808814.26115.183.0914.3215.263.13
2117459-11745915.49815.59
3116878-11687815.42115.50
4115719-11571915.26815.35
5114996-11499615.17315.25
6117227-11722715.46715.54
120min1116975-11697515.43416.262.6615.5116.372.72
2125840-12584016.60416.72
3125711-12571116.58716.69
4124205-12420516.38816.50
5123856-12385616.34216.45
6122959-12295916.22416.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1121918-12191816.08617.022.8816.1917.152.92
2128767-12876716.99017.14
3130265-13026517.18817.32
4132676-13267617.50617.64
5130753-13075317.25217.38
6129427-12942717.07717.21
卡格列净非奈利酮片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
111.121746356174585417432021742567174142917438820.13
211.131737345173829917378220.04
单位质量响应值RSD%判断
156823.92156138.540.31数据可信
供试品溶液-5122202批-卡格列净-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0005.1249.020.005.1249.02
2111378-1113786.2716.27
3109567-1095676.1696.17
4109761-1097616.1806.18
5108785-1087856.1256.13
6106630-1066306.0046.00
120min1108756-1087566.1246.121.976.126.131.95
2112447-1124476.3326.34
3108899-1088996.1326.14
4106884-1068846.0186.03
5108841-1088416.1296.14
6106388-1063885.9906.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1112804-1128046.3526.561.846.366.581.92
2117139-1171396.5966.62
3115931-1159316.5286.55
4119258-1192586.7156.74
5117423-1174236.6126.63
6116413-1164136.5556.57
卡格列净非奈利酮片项目信息
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D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
120.146854656844836851436852176853856851390.06
220.236829216833766831480.05
单位质量响应值RSD%判断
34018.8233769.060.53数据可信
供试品溶液-5122203批-非奈利酮-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0004.24109.580.004.24109.58
2-0.0000.00
362917-629178.3458.35
463423-634238.4128.41
565272-652728.6578.66
6-0.0000.00
20min168687-686879.1109.996.159.119.996.19
273808-738089.7909.79
380111-8011110.62610.64
472898-728989.6699.68
580954-8095410.73710.75
675241-752419.9809.98
30min182082-8208210.88711.583.4610.9011.613.51
289121-8912111.82111.84
391103-9110312.08412.12
487042-8704211.54511.58
586755-8675511.50711.54
687748-8774811.63911.66
45min193738-9373812.43313.283.6012.4713.323.60
2103917-10391713.78313.82
3101453-10145313.45613.51
498686-9868613.08913.14
5102485-10248513.59313.64
6100454-10045413.32413.36
60min197650-9765012.95213.623.4413.0113.683.43
2107510-10751014.26014.32
3102642-10264213.61413.69
499746-9974613.23013.30
5104693-10469313.88613.96
6103689-10368913.75313.81
90min1114406-11440615.17415.703.4015.2515.793.42
2113494-11349415.05315.14
3118864-11886415.76615.86
4118924-11892415.77415.87
5124568-12456816.52216.62
6119852-11985215.89715.98
120min1121169-12116916.07116.712.2116.1716.822.22
2125709-12570916.67416.78
3125711-12571116.67416.80
4127550-12755016.91817.04
5126055-12605516.71916.84
6129574-12957417.18617.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1128914-12891417.09917.724.3217.2317.864.31
2130592-13059217.32117.46
3144999-14499919.23219.38
4132044-13204417.51417.66
5131916-13191617.49717.65
6133272-13327217.67717.81
卡格列净非奈利酮片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
111.121734671173548617351231735333173600017353230.03
211.131729358172976617295620.02
单位质量响应值RSD%判断
156054.23155396.410.30数据可信
供试品溶液-5122203批-卡格列净-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1107859-1078596.1036.223.086.106.213.09
2112623-1126236.3726.37
3108390-1083906.1336.13
4106299-1062996.0146.01
5115286-1152866.5236.52
6108722-1087226.1526.15
120min1107056-1070566.0576.293.226.076.303.20
2114590-1145906.4846.49
3109268-1092686.1826.19
4108011-1080116.1116.12
5115566-1155666.5396.55
6112609-1126096.3716.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1115537-1155376.5376.661.696.566.681.71
2119134-1191346.7416.76
3120457-1204576.8166.84
4115475-1154756.5346.55
5117943-1179436.6736.70
6117228-1172286.6336.65
卡格列净非奈利酮片项目信息
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D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
120.146932996949166936476934666946586939970.11
220.236853636871066862340.18
单位质量响应值RSD%判断
34458.6433921.601.12数据可信
供试品溶液-5122203批-非奈利酮-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0002.79154.960.002.79154.96
2-0.0000.00
3-0.0000.00
4-0.0000.00
564720-647208.5108.51
662447-624478.2118.21
20min168881-688819.0579.165.649.069.165.67
269057-690579.0819.08
362491-624918.2178.22
471700-717009.4289.43
573076-730769.6099.62
672637-726379.5519.56
30min176549-7654910.06610.422.9710.0810.443.03
280512-8051210.58710.60
376125-7612510.01010.02
479600-7960010.46710.48
581164-8116410.67310.70
681500-8150010.71710.75
45min183715-8371511.00811.503.8311.0411.543.88
286868-8686811.42311.46
383802-8380211.01911.05
489632-8963211.78611.82
592160-9216012.11812.17
688676-8867611.66011.71
60min191135-9113511.98412.032.4612.0312.092.52
291899-9189912.08412.14
388239-8823911.60311.65
491222-9122211.99512.05
595286-9528612.52912.60
691362-9136212.01412.08
90min1118327-11832715.55915.394.6715.6315.474.64
2114823-11482315.09815.17
3122954-12295416.16816.24
4112273-11227314.76314.84
5110493-11049314.52914.62
6123507-12350716.24016.33
120min1125137-12513716.45516.853.7316.5516.953.72
2129483-12948317.02617.12
3133096-13309617.50117.60
4124052-12405216.31216.41
5123023-12302316.17716.29
6134138-13413817.63817.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1133854-13385417.60117.424.1417.7217.554.11
2128070-12807016.84016.97
3140786-14078618.51218.64
4127589-12758916.77716.90
5127999-12799916.83116.97
6136441-13644117.94118.08
卡格列净非奈利酮片项目信息
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101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
111.121755394175684517559791754705175687817559600.06
211.131735549173608917358190.03
单位质量响应值RSD%判断
157910.07155958.580.88数据可信
供试品溶液-5122203批-卡格列净-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min198387-983875.5245.542.255.525.542.25
297471-974715.4735.47
395419-954195.3575.36
498600-986005.5365.54
5100919-1009195.6665.67
6101384-1013845.6925.69
120min195508-955085.3625.754.215.375.764.22
2107173-1071736.0176.03
398990-989905.5585.57
4104118-1041185.8465.86
5104547-1045475.8705.88
6104157-1041575.8485.86
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1108322-1083226.0826.091.576.106.111.59
2106874-1068746.0016.02
3106536-1065365.9826.00
4108147-1081476.0726.09
5111069-1110696.2366.26
6109633-1096336.1566.17
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