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400
标示量(mg)25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%
19.851330850132724113273261326921132854413281760.13
29.861331057133267113318640.09
单位质量响应值RSD%判断
134840.20135077.480.13数据可信
加速6月-供试品溶液-2024052411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%
5min11014625-101462567.66263.659.4367.6663.659.43
2864495-86449557.65157.65
3864316-86431657.63957.64
41036897-103689769.14869.15
51054178-105417870.30070.30
6891883-89188359.47759.48
10min11288392-128839285.91982.675.6586.0382.785.66
21169622-116962277.99978.09
31201106-120110680.09880.19
41312593-131259387.53387.65
51305034-130503487.02987.15
61161296-116129677.44377.54
15min11343964-134396489.62587.434.9089.8887.674.90
21254888-125488883.68583.91
31287093-128709385.83286.06
41387381-138738192.52092.78
51365411-136541191.05591.32
61227622-122762281.86682.09
20min11362950-136295090.89189.504.4191.3089.894.41
21312046-131204687.49687.86
31315439-131543987.72388.10
41418774-141877494.61495.03
51387494-138749492.52892.94
61255680-125568083.73884.10
30min11380319-138031992.04990.694.1192.6191.234.12
21310208-131020887.37487.89
31330139-133013988.70389.22
41435125-143512595.70496.28
51406694-140669493.80894.38
61296827-129682786.48286.99
45min11384877-138487792.35391.463.7493.0692.153.76
21333656-133365688.93889.59
31341152-134115289.43790.10
41439818-143981896.01796.75
51418794-141879494.61595.34
61310660-131066087.40488.05
60min11390850-139085092.75291.463.8493.6292.303.85
21322026-132202688.16288.97
31342821-134282189.54990.36
41443967-144396796.29497.19
51413520-141352094.26395.15
61315411-131541187.72188.51
极限11503543-1503543100.267100.401.58101.29101.401.59
21464558-146455897.66798.62
31494247-149424799.647100.61
41522770-1522770101.549102.60
51526477-1526477101.796102.84
61521970-1521970101.496102.44
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400
标示量(mg)25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%
19.851329603132858513275511327463132849013283380.07
29.861334564133553013350470.06
单位质量响应值RSD%判断
134856.65135400.300.29数据可信
加速6月-供试品溶液-2024052511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%
5min1851353-85135356.70358.717.2256.7058.717.22
2941316-94131662.69562.69
3785872-78587252.34252.34
4962158-96215864.08364.08
5873014-87301458.14658.15
6875223-87522358.29358.29
10min11169261-116926177.87778.581.5277.9778.681.52
21197525-119752579.75979.86
31153432-115343276.82376.91
41201321-120132180.01280.12
51177109-117710978.40078.50
61180551-118055178.62978.73
15min11254879-125487983.57984.060.7483.8084.290.75
21263777-126377784.17284.41
31250585-125058583.29383.51
41277341-127734185.07585.32
51260448-126044883.95084.18
61265769-126576984.30584.53
20min11288257-128825785.80285.560.9686.1785.930.96
21271824-127182484.70885.09
31271919-127191984.71485.07
41304666-130466686.89587.28
51282959-128295985.45085.82
61287661-128766185.76386.13
30min11306532-130653287.02086.990.9887.5387.500.98
21291759-129175986.03686.55
31293178-129317886.13086.63
41326091-132609188.32288.85
51311758-131175887.36887.88
61307336-130733687.07387.58
45min11324838-132483888.23987.541.1788.8988.201.16
21298704-129870486.49887.16
31299324-129932486.54087.18
41336258-133625889.00089.67
51306486-130648687.01787.67
61320752-132075287.96788.62
60min11324438-132443888.21288.001.1189.0188.801.11
21303785-130378586.83787.64
31311059-131105987.32188.10
41345620-134562089.62390.45
51316167-131616787.66188.46
61326007-132600788.31789.12
极限11485447-148544798.936100.291.4299.88101.241.41
21490104-149010499.246100.20
31523272-1523272101.455102.38
41525863-1525863101.628102.60
51483864-148386498.83199.78
61526372-1526372101.662102.61
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400
标示量(mg)25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%
19.851320168132045713191651319828131888613197010.06
29.861330689133240813315480.10
单位质量响应值RSD%判断
133979.80135045.440.57数据可信
加速6月-供试品溶液-2024052611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%
5min1967583-96758364.74068.997.7164.7468.997.71
21011263-101126367.66367.66
31094562-109456273.23673.24
41121358-112135875.02975.03
51074846-107484671.91771.92
6916958-91695861.35361.35
10min11253329-125332983.85988.424.4883.9788.534.48
21319199-131919988.26788.38
31330883-133088389.04889.17
41416530-141653094.77994.90
51344099-134409989.93390.05
61264792-126479284.62684.73
15min11321481-132148188.41992.102.6388.6792.362.63
21382612-138261292.51092.77
31366642-136664291.44191.71
41430312-143031295.70195.98
51393719-139371993.25393.52
61364189-136418991.27791.52
20min11350364-135036490.35293.452.3890.7593.862.39
21396946-139694693.46993.88
31377800-137780092.18892.61
41450869-145086997.07797.52
51405411-140541194.03594.46
61398352-139835293.56393.96
30min11381410-138141092.42995.202.4292.9795.772.42
21405626-140562694.04994.62
31398251-139825193.55694.13
41472327-147232798.51299.12
51427661-142766195.52496.11
61451474-145147497.11797.67
45min11403072-140307293.87995.732.6094.5896.462.59
21409197-140919794.28895.01
31390653-139065393.04893.78
41471936-147193698.48699.25
51430287-143028795.69996.44
61479162-147916298.97099.68
60min11413379-141337994.56896.373.3295.4297.263.30
21409584-140958494.31495.20
31391374-139137493.09693.98
41476714-147671498.80699.74
51433112-143311295.88896.79
61517530-1517530101.537102.42
极限11498477-1498477100.262102.011.51101.28103.071.51
21537086-1537086102.845103.89
31497711-1497711100.211101.25
41523026-1523026101.905103.00
51555330-1555330104.066105.13
61536409-1536409102.800103.85
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