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%
110.081381607138167913831901384370138289913827490.09
210.111388788138874713887680.01
单位质量响应值RSD%判断
137177.48137365.780.10数据可信
长期12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%
5min1839470-83947055.03955.945.0455.0455.945.04
2808636-80863653.01753.02
3908566-90856659.56959.57
4882405-88240557.85457.85
5802704-80270452.62852.63
6877330-87733057.52157.52
10min11207286-120728679.15480.542.5579.2580.632.55
21215391-121539179.68579.77
31247925-124792581.81881.92
41255502-125550282.31582.41
51182880-118288077.55477.64
61261511-126151182.70982.80
15min11346902-134690288.30888.872.1888.5389.092.18
21345577-134557788.22188.44
31373306-137330690.03990.27
41356629-135662988.94589.18
51311077-131107785.95986.18
61399042-139904291.72691.96
20min11419034-141903493.03792.481.5693.4192.861.56
21404412-140441292.07892.45
31412913-141291392.63593.02
41403576-140357692.02392.41
51378542-137854290.38290.74
61445228-144522894.75495.14
30min11476422-147642296.79995.881.2097.3396.411.20
21459979-145997995.72196.24
31454555-145455595.36695.91
41452948-145294895.26095.80
51441175-144117594.48895.00
61489142-148914297.63398.18
45min11510016-151001699.00297.711.1499.6998.401.14
21485409-148540997.38998.07
31484567-148456797.33398.03
41481636-148163697.14197.84
51468913-146891396.30796.98
61511477-151147799.09899.80
60min11518766-151876699.57698.271.23100.4399.121.23
21490364-149036497.71398.56
31485669-148566997.40698.27
41493258-149325897.90398.76
51480115-148011597.04197.87
61524566-152456699.956100.83
极限11528549-1528549100.21799.431.16101.24100.451.16
21499484-149948498.31199.32
31502475-150247598.50799.53
41520822-152082299.710100.73
51504578-150457898.64599.64
61543629-1543629101.206102.24
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%
110.081411634141386214140461414209141481814137140.09
210.111406902140705114069760.01
单位质量响应值RSD%判断
140249.40139166.770.55数据可信
长期12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%
5min1829927-82992753.46556.1210.7553.4656.1210.75
2904388-90438858.26258.26
3747777-74777748.17348.17
4875091-87509156.37456.37
5841084-84108454.18354.18
61028829-102882966.27866.28
10min11271818-127181881.93281.884.9082.0281.984.90
21335704-133570486.04786.14
31196069-119606977.05277.13
41290838-129083883.15783.25
51198554-119855477.21277.30
61333391-133339185.89886.01
15min11417114-141711491.29289.113.9491.5289.343.94
21431246-143124692.20292.44
31343025-134302586.51986.73
41395672-139567289.91190.14
51292625-129262583.27283.49
61420137-142013791.48791.74
20min11466999-146699994.50692.043.7494.8892.413.75
21465647-146564794.41894.81
31406942-140694290.63790.99
41440389-144038992.79193.17
51330060-133006085.68486.04
61461916-146191694.17894.58
30min11502495-150249596.79294.423.4097.3394.953.40
21493035-149303596.18396.73
31467629-146762994.54695.05
41481227-148122795.42295.96
51366947-136694788.06088.56
61482352-148235295.49596.06
45min11517460-151746097.75695.592.8998.4596.282.89
21501567-150156796.73297.44
31497912-149791296.49797.16
41499932-149993296.62797.32
51398818-139881890.11390.76
61487620-148762095.83496.56
60min11524012-152401298.17896.122.5599.0496.962.55
21502723-150272396.80797.68
31509592-150959297.24998.07
41504683-150468396.93397.79
51417229-141722991.29992.10
61493727-149372796.22797.11
极限11529362-152936298.52397.200.9099.5598.210.89
21506250-150625097.03498.07
31518570-151857097.82898.81
41506983-150698397.08198.10
51501775-150177596.74697.70
61490265-149026596.00497.05
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%
110.081381914138210713816221381723138135013817430.03
210.111411625141073114111780.05
单位质量响应值RSD%判断
137077.68139582.391.29数据可信
中间条件12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%
5min11059868-105986868.96359.1013.4968.9659.1013.49
2765732-76573249.82449.82
3858461-85846155.85855.86
41033125-103312567.22267.22
5937310-93731060.98860.99
6795175-79517551.74051.74
10min11347962-134796287.70882.185.2887.8282.285.28
21217086-121708679.19279.28
31197883-119788377.94378.04
41337083-133708387.00087.11
51270535-127053582.67082.77
61207720-120772078.58378.67
15min11427168-142716892.86288.473.8993.1288.703.90
21337215-133721587.00987.22
31305094-130509484.91985.14
41419251-141925192.34792.60
51358033-135803388.36388.60
61311259-131125985.32085.54
20min11463394-146339495.21991.393.2495.6391.773.25
21387564-138756490.28590.64
31367908-136790889.00689.37
41451887-145188794.47094.88
51406190-140619091.49791.88
61350183-135018387.85388.21
30min11480775-148077596.35094.052.2596.9294.582.27
21435163-143516393.38293.89
31420432-142043292.42392.94
41487189-148718996.76797.34
51443047-144304793.89594.43
61405960-140596091.48291.99
45min11494361-149436197.23495.531.8897.9796.221.90
21460952-146095295.06095.73
31453126-145312694.55195.22
41505607-150560797.96698.70
51464135-146413595.26795.96
61430771-143077193.09693.75
60min11499071-149907197.54096.191.6798.4497.041.69
21481340-148134096.38797.21
31460876-146087695.05595.88
41511479-151147998.34899.24
51472854-147285495.83496.69
61444263-144426393.97494.79
极限11505376-150537697.95097.820.9999.0198.831.00
21511658-151165898.35999.34
31479234-147923496.25097.23
41517279-151727998.72599.78
51491842-149184297.07098.08
61514606-151460698.55199.52
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%
110.081427537142883214261301426030142741214271880.09
210.111430878143211114314940.07
单位质量响应值RSD%判断
141586.11141591.890.01数据可信
中间条件12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%
5min1805292-80529251.18854.8916.3351.1954.8916.33
21072262-107226268.15868.16
3826952-82695252.56552.56
4696427-69642744.26844.27
5994516-99451663.21663.22
6785934-78593449.95749.96
10min11170763-117076374.41978.025.7274.5078.115.73
21332128-133212884.67684.79
31218286-121828677.43977.53
41169328-116932874.32774.40
51294994-129499482.31582.42
61178615-117861574.91875.00
15min11267468-126746880.56684.784.4280.7885.004.43
21407735-140773589.48289.74
31343789-134378985.41785.63
41326488-132648884.31784.51
51388971-138897188.28988.53
61268365-126836580.62380.83
20min11334020-133402084.79687.873.5885.1488.243.59
21433428-143342891.11591.52
31393725-139372588.59188.95
41395938-139593888.73289.07
51426048-142604890.64691.04
61311314-131131483.35383.70
30min11401800-140180089.10490.402.9389.5990.912.94
21456525-145652592.58393.14
31438536-143853691.43991.95
41435435-143543591.24291.73
51453681-145368192.40292.94
61347240-134724085.63686.12
45min11445917-144591791.90991.872.6892.5492.532.69
21473050-147305093.63394.34
31457835-145783592.66693.33
41453929-145392992.41893.06
51472002-147200293.56794.26
61369423-136942387.04687.67
60min11472767-147276793.61592.562.6794.4093.372.67
21482346-148234694.22495.09
31463126-146312693.00393.82
41459891-145989192.79793.59
51479739-147973994.05994.91
61379090-137909087.66188.43
极限11529577-152957797.22695.191.3998.1796.161.38
21505198-150519895.67796.70
31475034-147503493.75994.73
41475093-147509393.76394.71
51495364-149536495.05296.06
61505425-150542595.69196.61
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