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%
19.805414895416485420025418925422345418530.06
29.825458255459075458660.02
单位质量响应值RSD%判断
55291.1255587.170.38数据可信
供试品溶液-F56971批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1431763-43176369.38564.008.6169.3964.008.61
2385294-38529461.91761.92
3436354-43635470.12370.12
4381462-38146261.30261.30
5408537-40853765.65365.65
6345943-34594355.59455.59
10min1526230-52623084.56684.126.3584.6884.236.35
2528768-52876884.97485.08
3526932-52693284.67984.80
4500136-50013680.37380.47
5578624-57862492.98693.10
6480161-48016177.16377.26
15min1540171-54017186.80685.432.8987.0685.682.90
2539935-53993586.76887.01
3537888-53788886.44086.70
4520862-52086283.70383.94
5545371-54537187.64287.91
6505381-50538181.21681.44
20min1541516-54151687.02386.182.0887.4286.562.09
2541706-54170687.05387.44
3539272-53927286.66287.06
4526148-52614884.55384.93
5549364-54936488.28488.69
6519533-51953383.49083.85
30min1542423-54242387.16887.111.2687.7187.641.27
2543109-54310987.27987.81
3541687-54168787.05087.60
4529784-52978485.13785.65
5550507-55050788.46789.03
6544946-54494687.57488.07
45min1544205-54420587.45588.011.9888.1588.691.96
2545070-54507087.59488.27
3544279-54427987.46788.16
4533695-53369585.76686.42
5552721-55272188.82389.53
6566019-56601990.96091.60
60min1545854-54585487.72088.021.6888.5688.841.67
2546270-54627087.78788.61
3544333-54433387.47588.31
4534959-53495985.96986.77
5552206-55220688.74089.59
6562644-56264490.41891.21
极限1595223-59522395.65395.711.4496.6496.681.45
2600703-60070396.53497.51
3603391-60339196.96697.95
4584495-58449593.92994.87
5603612-60361297.00198.00
6585989-58598994.16995.11
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%
19.805485705488095492835494205495595491280.08
29.825513935518245516080.06
单位质量响应值RSD%判断
56033.4756171.890.18数据可信
供试品溶液-F56971批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1402152-40215263.86265.253.3563.8665.253.35
2392801-39280162.37762.38
3427647-42764767.91067.91
4402383-40238363.89863.90
5422900-42290067.15767.16
6417478-41747866.29666.30
10min1552424-55242487.72584.072.7087.8384.182.69
2536754-53675485.23785.34
3526014-52601483.53183.64
4517091-51709182.11482.22
5531063-53106384.33384.44
6513022-51302281.46881.58
15min1569433-56943390.42686.222.9090.6886.472.89
2550536-55053687.42587.67
3540983-54098385.90886.16
4531551-53155184.41084.65
5540396-54039685.81586.07
6524697-52469783.32283.57
20min1576374-57637491.52886.773.0991.9387.163.08
2551368-55136887.55787.95
3544863-54486386.52486.92
4533140-53314084.66385.05
5543989-54398986.38686.78
6528684-52868483.95584.34
30min1576887-57688791.61087.252.9092.1787.792.89
2552763-55276387.77988.32
3550462-55046287.41387.95
4537213-53721385.30985.83
5548509-54850987.10387.64
6530865-53086584.30184.83
45min1582395-58239592.48487.933.2293.1988.623.21
2554443-55444388.04688.73
3563074-56307489.41690.10
4539635-53963585.69486.36
5550786-55078687.46588.15
6532120-53212084.50185.17
60min1584251-58425192.77988.483.5093.6489.313.48
2554641-55464188.07788.91
3575655-57565591.41492.25
4541365-54136585.96986.78
5553392-55339287.87988.71
6533807-53380784.76985.58
极限1627551-62755199.65595.662.38100.6796.642.37
2598563-59856395.05296.03
3610830-61083097.00097.99
4590835-59083593.82594.78
5593281-59328194.21395.19
6593182-59318294.19795.15
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%
19.805398445397125396425395335403505398160.06
29.825446615448045447320.02
单位质量响应值RSD%判断
55083.2755471.690.50数据可信
供试品溶液-2024053011批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1453472-45347273.08769.066.3873.0969.066.38
2433260-43326069.83069.83
3398206-39820664.18064.18
4443783-44378371.52671.53
5451319-45131972.74072.74
6390889-39088963.00163.00
10min1537477-53747786.62787.522.2186.7587.632.22
2548769-54876988.44688.56
3535846-53584686.36486.47
4549618-54961888.58388.70
5559894-55989490.24090.36
6526445-52644584.84884.95
15min1573459-57345992.42692.441.2092.6992.701.20
2572185-57218592.22092.48
3571939-57193992.18192.43
4572495-57249592.27092.54
5586056-58605694.45694.73
6565112-56511291.08191.33
20min1586238-58623894.48594.251.0894.9194.671.08
2581365-58136593.70094.12
3585753-58575394.40794.81
4578667-57866793.26593.69
5596073-59607396.07196.50
6580717-58071793.59693.99
30min1594816-59481695.86895.510.9396.4596.080.93
2587682-58768294.71895.29
3592165-59216595.44196.00
4585697-58569794.39894.97
5601081-60108196.87897.47
6594065-59406595.74796.30
45min1605293-60529397.55796.561.2598.2997.291.25
2597273-59727396.26497.00
3596878-59687896.20096.92
4587204-58720494.64195.37
5608635-60863598.09598.85
6599457-59945796.61697.33
60min1601978-60197897.02296.340.9797.9297.240.97
2590765-59076595.21596.11
3597337-59733796.27497.16
4591251-59125195.29396.18
5604788-60478897.47598.39
6600436-60043696.77497.65
极限1602481-60248197.10397.270.7298.1798.320.71
2596221-59622196.09497.15
3602986-60298697.18598.23
4603776-60377697.31298.36
5606977-60697797.82898.90
6608656-60865698.09999.13
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%
19.805412315415335412435413265414535413570.03
29.825470275464125467200.08
单位质量响应值RSD%判断
55240.5155674.130.56数据可信
供试品溶液-2024053011批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1441618-44161870.94668.906.7870.9568.906.78
2432911-43291169.54769.55
3455077-45507773.10873.11
4411468-41146866.10266.10
5453125-45312572.79572.79
6379252-37925260.92760.93
10min1570013-57001391.57387.372.7891.6987.482.78
2548784-54878488.16288.28
3535146-53514685.97186.09
4541912-54191287.05887.17
5541833-54183387.04687.17
6525274-52527484.38584.49
15min1569826-56982691.54392.373.1891.8192.633.18
2611155-61115598.18298.45
3559064-55906489.81490.08
4569185-56918591.44091.70
5571768-57176891.85592.12
6568914-56891491.39691.64
20min1577419-57741992.76393.841.4793.1994.261.46
2588564-58856494.55394.98
3574202-57420292.24692.66
4580777-58077793.30293.71
5597799-59779996.03796.46
6586175-58617594.16994.56
30min1584655-58465593.92595.391.1794.5095.961.16
2597854-59785496.04596.63
3592251-59225195.14595.71
4586996-58699694.30194.86
5600424-60042496.45897.04
6600623-60062396.49097.04
45min1586415-58641594.20896.251.4194.9496.981.40
2600723-60072396.50697.25
3600530-60053096.47597.20
4592226-59222695.14195.86
5608603-60860397.77298.51
6606164-60616497.38098.09
60min1589643-58964394.72696.461.3795.6297.351.36
2601410-60141096.61797.52
3601765-60176596.67497.56
4591826-59182695.07795.96
5608415-60841597.74298.65
6609437-60943797.90698.78
极限1595684-59568495.69797.911.6696.7598.961.64
2603236-60323696.91097.98
3623429-623429100.154101.20
4604759-60475997.15598.19
5613391-61339198.54199.61
6616225-61622598.997100.03
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