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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
110.265676835705515691015704635712125698020.25
210.315715475714755715110.01
单位质量响应值RSD%判断
55536.2655432.690.14数据可信
长期12月-供试品溶液-2024053011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%
5min1415630-41563067.41866.852.2367.4266.852.23
2406010-40601065.85865.86
3420545-42054568.21668.22
4412628-41262866.93166.93
5397170-39717064.42464.42
6420828-42082868.26268.26
10min1538942-53894287.42186.621.6087.5386.741.60
2530206-53020686.00386.11
3539472-53947287.50787.62
4525644-52564485.26385.38
5524427-52442785.06685.17
6545520-54552088.48888.60
15min1565748-56574891.76991.271.3592.0391.521.35
2559388-55938890.73790.99
3568957-56895792.28992.55
4556819-55681990.32090.57
5552691-55269189.65189.90
6572322-57232292.83593.10
20min1580444-58044494.15292.891.2494.5693.301.24
2569934-56993492.44892.85
3575843-57584393.40693.82
4566096-56609691.82592.23
5563848-56384891.46091.86
6579766-57976694.04394.46
30min1599552-59955297.25295.161.5697.8295.721.56
2582935-58293594.55795.11
3589317-58931795.59296.16
4578188-57818893.78794.34
5576247-57624793.47294.02
6593586-59358696.28496.86
45min1603481-60348197.88996.601.3598.6297.321.35
2590779-59077995.82996.54
3602648-60264897.75498.48
4587811-58781195.34796.06
5586372-58637295.11495.82
6601981-60198197.64698.38
60min1604563-60456398.06597.281.3798.9698.161.37
2590798-59079895.83296.71
3609955-60995598.93999.83
4595533-59553396.60097.47
5591409-59140995.93196.80
6606122-60612298.31899.21
极限1607037-60703798.46699.471.2399.52100.521.22
2617943-617943100.235101.27
3614145-61414599.619100.68
4610674-61067499.056100.09
5604690-60469098.08599.11
6625053-625053101.388102.45
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
110.265728515741505736625737115747395738230.13
210.315798525780525789520.22
单位质量响应值RSD%判断
55928.1756154.410.29数据可信
长期12月-供试品溶液-2024053011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%
5min1408619-40861965.62367.113.1265.6267.113.12
2442943-44294371.13571.14
3413937-41393766.47766.48
4420749-42074967.57167.57
5411072-41107266.01766.02
6410042-41004265.85165.85
10min1553189-55318988.84088.622.6688.9588.732.66
2577259-57725992.70692.82
3556434-55643489.36189.47
4547856-54785687.98488.10
5535422-53542285.98786.10
6540802-54080286.85186.96
15min1585112-58511293.96793.392.2394.2293.652.24
2599678-59967896.30696.58
3587735-58773594.38894.65
4580501-58050193.22693.49
5561099-56109990.11190.36
6575066-57506692.35492.61
20min1595921-59592195.70395.131.7296.1295.541.72
2606030-60603097.32697.76
3598066-59806696.04796.46
4590672-59067294.86095.27
5576461-57646192.57892.98
6586960-58696094.26494.67
30min1605348-60534897.21796.471.3097.7997.051.30
2611993-61199398.28498.88
3602779-60277996.80497.38
4595927-59592795.70496.28
5589636-58963694.69395.25
6598675-59867596.14596.71
45min1610720-61072098.08097.081.5398.8297.811.54
2616037-61603798.93399.69
3606910-60691097.46898.21
4602687-60268796.78997.52
5589133-58913394.61395.33
6601376-60137696.57997.30
60min1611922-61192298.27397.241.4899.1798.131.48
2615090-61509098.78199.71
3609896-60989697.94798.85
4602280-60228096.72497.62
5590368-59036894.81195.68
6603215-60321596.87497.76
极限1612523-61252398.36997.811.3999.4398.861.39
2616001-61600198.928100.02
3615755-61575598.88899.95
4605064-60506497.17198.23
5593846-59384695.37096.40
6610909-61090998.11099.16
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
110.265785395778165797025789245782375786440.13
210.315807845802735805280.07
单位质量响应值RSD%判断
56398.0556307.270.12数据可信
长期12月-供试品溶液批-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%
5min1373929-37392959.72060.055.2659.7260.055.26
2402981-40298164.36064.36
3367709-36770958.72658.73
4344017-34401754.94254.94
5385594-38559461.58361.58
6381721-38172160.96460.96
10min1519540-51954082.97582.251.6083.0782.351.60
2509596-50959681.38781.49
3504954-50495480.64680.74
4511870-51187081.75081.84
5515941-51594182.40082.50
6528239-52823984.36484.47
15min1552807-55280788.28887.712.4888.5387.952.47
2529421-52942184.55384.80
3541250-54125086.44286.67
4555992-55599288.79789.02
5546464-54646487.27587.51
6569245-56924590.91391.16
20min1565630-56563090.33689.662.6490.7290.052.63
2537315-53731585.81486.20
3558605-55860589.21489.59
4570012-57001291.03691.41
5556004-55600488.79989.18
6580944-58094492.78293.18
30min1582292-58229292.99791.732.9193.5392.262.89
2543962-54396286.87587.40
3575612-57561291.93092.46
4585800-58580093.55794.08
5568770-56877090.83791.37
6589735-58973594.18694.73
45min1589778-58977894.19393.092.8894.8893.782.87
2551121-55112188.01988.69
3587656-58765693.85494.53
4593023-59302394.71195.39
5578596-57859692.40793.09
6597098-59709895.36296.07
60min1593852-59385294.84393.882.9995.6994.722.97
2554177-55417788.50789.33
3598486-59848695.58396.42
4595973-59597395.18296.02
5583520-58352093.19394.03
6600760-60076095.94796.81
极限1596187-59618795.21696.180.7596.2297.180.75
2601329-60132996.03797.00
3602149-60214996.16897.16
4601679-60167996.09397.09
5601952-60195296.13797.13
6610183-61018397.45198.48
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
110.265767845773165772845766655762955768690.08
210.315797705807325802510.12
单位质量响应值RSD%判断
56225.0556280.410.07数据可信
长期12月-供试品溶液批-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%
5min1361170-36117057.78462.306.9657.7862.306.96
2413658-41365866.18266.18
3352043-35204356.32456.32
4414357-41435766.29466.29
5405610-40561064.89464.89
6389620-38962062.33662.34
10min1528598-52859884.57283.572.8684.6783.682.87
2533252-53325285.31685.43
3498626-49862679.77679.87
4528512-52851284.55884.67
5535916-53591685.74285.85
6509223-50922381.47281.58
15min1581095-58109592.97188.993.3193.2189.243.31
2568286-56828690.92191.17
3540866-54086686.53486.76
4555061-55506188.80589.06
5561650-56165089.86090.11
6530460-53046084.87085.11
20min1597682-59768295.62590.973.4496.0291.363.43
2576668-57666892.26292.67
3563328-56332890.12890.50
4567658-56765890.82191.22
5568739-56873990.99491.39
6537489-53748985.99486.38
30min1609567-60956797.52693.593.4198.0894.143.40
2590382-59038294.45795.01
3587354-58735493.97294.49
4583842-58384293.41093.96
5590117-59011794.41494.97
6548716-54871687.79088.31
45min1614668-61466898.34295.273.0499.0695.983.04
2597665-59766595.62296.34
3603503-60350396.55697.23
4596711-59671195.46996.18
5599339-59933995.89096.60
6561090-56109089.77090.44
60min1617060-61706098.72596.053.0299.6096.913.01
2604129-60412996.65697.53
3609059-60905997.44598.28
4603568-60356896.56697.43
5603304-60330496.52497.39
6565025-56502590.40091.22
极限1615962-61596298.54997.091.1399.5998.111.14
2612440-61244097.98699.02
3608354-60835497.33298.33
4604603-60460396.73297.76
5602842-60284296.45097.48
6597013-59701395.51796.49
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