恩格列净片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.135682755686745680185684865679295682760.06
210.255662565666945664750.06
单位质量响应值RSD%判断
56098.3255265.851.06数据可信
供试品溶液-2024052811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%
5min1480418-48041876.87172.853.9776.8772.853.97
2439689-43968970.35470.35
3436515-43651569.84669.85
4462759-46275974.04574.05
5442941-44294170.87470.87
6469260-46926075.08675.09
10min1569069-56906991.05688.722.1691.1888.842.16
2549178-54917887.87387.99
3540765-54076586.52786.64
4564032-56403290.25090.37
5542265-54226586.76786.89
6561344-56134489.82089.94
15min1587378-58737893.98592.161.7594.2792.431.76
2571903-57190391.50991.77
3562652-56265290.02990.29
4582228-58222893.16193.44
5567382-56738290.78691.05
6584272-58427293.48893.76
20min1589333-58933394.29892.761.4194.7393.181.41
2576044-57604492.17292.59
3566441-56644190.63591.05
4585506-58550693.68694.11
5577643-57764392.42892.84
6583236-58323693.32393.75
30min1591157-59115794.59093.561.1595.1894.141.15
2586229-58622993.80294.37
3571914-57191491.51192.07
4588585-58858594.17994.76
5585037-58503793.61194.18
6585575-58557593.69794.28
45min1593148-59314894.90993.721.4095.6694.451.40
2582550-58255093.21393.94
3571632-57163291.46692.18
4592703-59270394.83795.58
5589879-58987994.38695.11
6584357-58435793.50294.24
60min1591845-59184594.70093.531.4095.6194.421.40
2580130-58013092.82693.71
3570504-57050491.28592.15
4591951-59195194.71795.62
5586585-58658593.85894.74
6586051-58605193.77394.67
极限1618368-61836898.94497.701.58100.0198.741.57
2610449-61044997.67798.71
3604802-60480296.77397.79
4621258-62125899.406100.46
5594989-59498995.20396.24
6613642-61364298.18899.24
恩格列净片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.135687755692045693485674135686645686810.14
210.255814225774425794320.49
单位质量响应值RSD%判断
56138.3056529.950.50数据可信
供试品溶液-2024052811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%
5min1449997-44999771.16771.410.7971.1771.400.79
2455987-45598772.11472.11
3453457-45345771.71471.71
4452101-45210171.49971.50
5452018-45201871.48671.49
6445482-44548270.45370.45
10min1572047-57204790.46990.251.3390.5990.371.33
2566366-56636689.57089.69
3567444-56744489.74189.86
4573158-57315890.64590.76
5583510-58351092.28292.40
6561573-56157388.81288.93
15min1599597-59959794.82693.241.8395.1093.511.83
2582819-58281992.17292.44
3581965-58196592.03792.31
4590669-59066993.41493.68
5604737-60473795.63995.91
6577551-57755191.33991.60
20min1606997-60699795.99693.651.8496.4294.081.84
2583163-58316392.22792.65
3585563-58556392.60693.03
4591726-59172693.58194.01
5603922-60392295.51095.94
6581731-58173192.00092.42
30min1595511-59551194.18093.741.3694.7794.321.36
2586986-58698692.83193.41
3584959-58495992.51193.09
4594872-59487294.07994.66
5606519-60651995.92196.51
6587433-58743392.90293.47
45min1610336-61033696.52494.791.5597.2795.521.55
2595408-59540894.16394.89
3590893-59089393.44994.18
4599930-59993094.87995.62
5610290-61029096.51797.27
6589301-58930193.19893.92
60min1607643-60764396.09894.971.5497.0095.861.54
2598390-59839094.63595.52
3593093-59309393.79794.68
4605284-60528495.72596.62
5611372-61137296.68897.60
6587323-58732392.88593.77
极限1618612-61861297.83397.671.5198.9098.721.51
2611544-61154496.71597.76
3612354-61235496.84397.89
4622413-62241398.43499.49
5633142-633142100.131101.20
6607497-60749796.07597.11
恩格列净片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.135742605726785702945704375702505715840.32
210.255709215709165709180.01
单位质量响应值RSD%判断
56424.8855699.320.92数据可信
供试品溶液-2024052911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%
5min1478428-47842876.03371.665.0976.0371.665.08
2451653-45165371.77771.78
3446039-44603970.88570.89
4476231-47623175.68375.68
5428855-42885568.15468.15
6424168-42416867.40967.41
10min1550217-55021787.44187.571.5587.5787.691.55
2551019-55101987.56987.69
3548468-54846887.16387.28
4566794-56679490.07690.20
5548821-54882187.21987.33
6541013-54101385.97986.09
15min1562873-56287389.45390.151.2089.7390.421.20
2566789-56678990.07590.34
3564164-56416489.65889.92
4579706-57970692.12892.40
5569267-56926790.46990.73
6560751-56075189.11589.37
20min1566060-56606089.95990.661.1190.3891.081.11
2569779-56977990.55090.97
3566949-56694990.10090.51
4581573-58157392.42492.85
5573764-57376491.18391.59
6564853-56485389.76790.17
30min1569381-56938190.48791.121.0091.0691.691.00
2571592-57159290.83891.40
3569834-56983490.55991.12
4583370-58337092.71093.29
5576984-57698491.69592.26
6569118-56911890.44591.00
45min1573016-57301691.06591.570.8891.7992.290.88
2573703-57370391.17491.89
3575835-57583591.51392.23
4584963-58496392.96393.70
5578701-57870191.96892.68
6571024-57102490.74891.45
60min1576403-57640391.60391.670.8292.4892.550.82
2574350-57435091.27792.15
3573369-57336991.12191.99
4585140-58514092.99193.88
5579096-57909692.03192.90
6572733-57273391.02091.88
极限1593492-59349294.31995.941.1895.3596.961.17
2604469-60446996.06397.09
3598259-59825995.07696.09
4609244-60924496.82297.87
5613001-61300197.41998.44
6603679-60367995.93896.95
恩格列净片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.135703655699925699065700425698365700280.04
210.255710775711265711020.01
单位质量响应值RSD%判断
56271.2755717.270.70数据可信
供试品溶液-2024052911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%
5min1459048-45904873.04070.904.8473.0470.904.84
2454848-45484872.37172.37
3422825-42282567.27667.28
4414679-41467965.98065.98
5454088-45408872.25172.25
6468201-46820174.49674.50
10min1574194-57419491.36188.812.1291.4888.922.12
2553915-55391588.13488.25
3540473-54047385.99586.11
4552595-55259587.92488.03
5566351-56635190.11390.23
6561348-56134889.31789.44
15min1590451-59045193.94791.361.9494.2291.621.94
2572867-57286791.15091.42
3555827-55582788.43888.69
4573255-57325591.21191.47
5577828-57782891.93992.21
6574851-57485191.46591.74
20min1593805-59380594.48192.071.6094.9192.491.61
2576457-57645791.72192.14
3565231-56523189.93590.34
4578075-57807591.97892.39
5581748-58174892.56392.99
6576643-57664391.75092.18
30min1595704-59570494.78392.291.8895.3792.861.88
2579111-57911192.14392.72
3561971-56197189.41689.97
4578362-57836292.02492.59
5584300-58430092.96993.55
6580695-58069592.39592.97
45min1598051-59805195.15792.501.9495.9093.231.93
2579814-57981492.25592.98
3562919-56291989.56790.27
4580736-58073692.40293.12
5583870-58387092.90093.63
6582852-58285292.73893.47
60min1597785-59778595.11492.641.8796.0293.531.87
2580547-58054792.37293.25
3564055-56405589.74790.60
4582090-58209092.61793.49
5585548-58554893.16794.06
6583544-58354492.84893.74
极限1615101-61510197.86996.831.2598.9397.861.25
2602570-60257095.87696.91
3598038-59803895.15596.16
4611264-61126497.25998.28
5606420-60642096.48897.53
6617865-61786598.30999.35
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