艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.333703283704233703163704523700803703200.04
214.473699443693203696320.12
单位质量响应值RSD%判断
25842.2925544.710.82数据可信
供试品溶液-2026032321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%
5min1252529-25252967.87270.593.9067.8770.593.90
2267555-26755571.91171.91
3272635-27263573.27673.28
4250267-25026767.26467.26
5274029-27402973.65173.65
6258864-25886469.57569.57
10min1303455-30345581.56084.042.8681.6784.162.86
2313505-31350584.26184.38
3321306-32130686.35786.48
4302077-30207781.18981.30
5323814-32381487.03287.15
6311958-31195883.84583.96
15min1320551-32055186.15588.762.6586.4089.012.65
2328890-32889088.39688.66
3337668-33766890.75591.02
4320506-32050686.14286.39
5341715-34171591.84392.11
6332035-33203589.24189.50
20min1327416-32741688.00090.762.7788.3991.172.78
2338052-33805290.85891.27
3345631-34563192.89593.31
4327095-32709587.91388.30
5350166-35016694.11494.54
6337840-33784090.80191.21
30min1335693-33569390.22493.172.8290.7693.732.82
2346370-34637093.09493.65
3355057-35505795.42996.00
4336194-33619490.35990.90
5359922-35992296.73697.31
6346741-34674193.19493.75
45min1339476-33947691.24194.592.7691.9395.302.76
2353398-35339894.98395.70
3360652-36065296.93397.66
4341931-34193191.90192.59
5363670-36367097.74498.48
6352495-35249594.74095.45
60min1342541-34254192.06594.972.7092.9195.842.70
2353864-35386495.10895.98
3361859-36185997.25798.15
4342315-34231592.00492.85
5365228-36522898.16299.06
6354341-35434195.23696.11
极限1343990-34399092.45495.432.8493.4596.452.84
2357159-35715995.99497.02
3363567-36356797.71698.77
4342896-34289692.16093.15
5367735-36773598.83699.90
6354959-35495995.40296.43
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.333702333704673697963701123701553701530.07
214.473680273681683680980.03
单位质量响应值RSD%判断
25830.6425438.701.09数据可信
供试品溶液-2026032421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%
5min1264752-26475271.32369.631.6871.3269.631.68
2256004-25600468.96668.97
3256754-25675469.16869.17
4262940-26294070.83470.83
5256529-25652969.10769.11
6253814-25381468.37668.38
10min1315102-31510284.88783.851.4185.0183.971.41
2311037-31103783.79183.91
3311981-31198184.04684.16
4314272-31427284.66384.78
5302894-30289481.59881.71
6312249-31224984.11884.23
15min1332324-33232489.52688.741.2889.7989.001.28
2329392-32939288.73688.99
3329313-32931388.71588.97
4332745-33274589.63989.90
5321349-32134986.56986.82
6331338-33133889.26089.51
20min1341214-34121491.92190.981.2192.3391.381.21
2337698-33769890.97491.38
3337825-33782591.00891.41
4339987-33998791.59092.00
5329873-32987388.86689.26
6339670-33967091.50591.91
30min1349217-34921794.07793.441.1994.6494.001.19
2350420-35042094.40194.96
3345136-34513692.97893.53
4348160-34816093.79294.35
5339283-33928391.40191.94
6349008-34900894.02194.58
45min1354039-35403995.37694.751.1196.1095.461.11
2355149-35514995.67596.39
3349946-34994694.27394.98
4352596-35259694.98795.70
5344708-34470892.86293.56
6353944-35394495.35096.06
60min1353893-35389395.33795.121.3296.2295.991.31
2356994-35699496.17297.04
3350233-35023394.35195.22
4354744-35474495.56696.44
5345205-34520592.99693.85
6357423-35742396.28897.16
极限1355201-35520195.68995.501.2896.7396.521.28
2357276-35727696.24897.28
3351039-35103994.56895.59
4356726-35672696.10097.13
5347231-34723193.54294.55
6359479-35947996.84197.87
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.333676903674193672803675493675893675050.05
214.473678493679853679170.03
单位质量响应值RSD%判断
25645.8525426.190.61数据可信
供试品溶液-2026032521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%
5min1270429-27042973.13072.372.4073.1372.372.40
2268576-26857672.62972.63
3271884-27188473.52473.52
4259855-25985570.27170.27
5275177-27517774.41474.41
6259832-25983270.26570.26
10min1320093-32009386.56184.822.0686.6884.942.06
2314555-31455585.06385.18
3318101-31810186.02286.14
4305659-30565982.65782.77
5317858-31785885.95686.08
6305694-30569482.66782.78
15min1336480-33648090.99288.592.1691.2688.852.16
2327077-32707788.44988.71
3332093-33209389.80690.07
4319693-31969386.45386.71
5331147-33114789.55089.82
6318996-31899686.26486.52
20min1344129-34412993.06190.452.1193.4890.862.11
2333457-33345790.17590.58
3338090-33809091.42891.84
4326501-32650188.29488.69
5338148-33814891.44391.86
6326462-32646288.28388.68
30min1352309-35230995.27392.462.0895.8593.022.08
2341505-34150592.35192.91
3344541-34454193.17293.74
4334697-33469790.51091.06
5345064-34506493.31393.88
6333278-33327890.12690.67
45min1358754-35875497.01693.892.0897.7594.602.08
2346151-34615193.60794.32
3347013-34701393.84194.56
4340547-34054792.09292.79
5351451-35145195.04195.77
6339223-33922391.73492.43
60min1360409-36040997.46394.671.8498.3695.541.84
2348171-34817194.15495.02
3350513-35051394.78795.67
4344095-34409593.05193.90
5353909-35390995.70596.59
6343404-34340492.86593.71
极限1360317-36031797.43895.031.6398.4996.061.63
2350329-35032994.73795.76
3352649-35264995.36596.40
4346638-34663893.73994.74
5354205-35420595.78596.83
6344282-34428293.10294.11
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