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%
110.121429634143028914312531430359143039914303870.05
210.271436437143590714361720.03
单位质量响应值RSD%判断
141342.59139841.480.76数据可信
供试品溶液-24032501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%
5min1905269-90526957.36751.8312.2257.3751.8312.22
2861617-86161754.60154.60
3738011-73801146.76846.77
4672875-67287542.64042.64
5930126-93012658.94258.94
6799353-79935350.65550.66
10min11297265-129726582.20875.577.2582.3075.667.26
21180849-118084974.83174.92
31201581-120158176.14576.22
41060443-106044367.20167.27
51271700-127170080.58880.69
61143279-114327972.45072.53
15min11409278-140927889.30682.756.2889.5482.966.29
21265465-126546580.19380.41
31345651-134565185.27485.48
41203146-120314676.24476.43
51373306-137330687.02787.26
61237990-123799078.45278.66
20min11448060-144806091.76485.456.1692.1585.806.16
21293087-129308781.94382.29
31393113-139311388.28288.63
41264118-126411880.10780.42
51424474-142447490.26990.65
61267545-126754580.32580.66
30min11469250-146925093.10787.406.2293.6487.896.22
21311479-131147983.10983.59
31411868-141186889.47089.96
41296640-129664082.16882.61
51481614-148161493.89094.42
61304105-130410582.64183.11
45min11475415-147541593.49788.226.2594.1988.866.25
21315622-131562283.37184.00
31416640-141664089.77390.42
41317290-131729083.47784.06
51508264-150826495.57996.26
61319167-131916783.59684.20
60min11502222-150222295.19694.470.6996.0495.250.72
21500125-150012595.06395.83
31478369-147836993.68594.48
41478791-147879193.71194.43
51493897-149389794.66995.51
61490757-149075794.47095.22
极限11531603-153160397.05896.830.7398.0697.770.71
21534671-153467197.25398.17
31538172-153817297.47498.42
41535405-153540597.29998.17
51514001-151400195.94396.94
61514063-151406395.94796.85
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%
110.121428439142961814296141428960142854014290340.04
210.271427059142802314275410.05
单位质量响应值RSD%判断
141208.89139001.071.12数据可信
供试品溶液-24032502批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1814366-81436651.78849.947.2751.7949.947.27
2792672-79267250.40850.41
3822246-82224652.28952.29
4836259-83625953.18053.18
5765652-76565248.69048.69
6680303-68030343.26243.26
10min11247385-124738579.32577.482.0479.4177.572.04
21192736-119273675.84975.93
31243379-124337979.07079.16
41213048-121304877.14177.23
51188757-118875775.59675.68
61225342-122534277.92377.99
15min11367254-136725486.94787.591.1887.1787.801.17
21362304-136230486.63386.84
31393322-139332288.60588.82
41360655-136065586.52886.74
51382954-138295487.94688.15
61397616-139761688.87889.08
20min11400038-140003889.03290.551.1089.4090.911.09
21426929-142692990.74291.10
31435097-143509791.26291.63
41410530-141053089.69990.06
51430018-143001890.93991.29
61440906-144090691.63191.98
30min11412343-141234389.81592.271.5890.3392.781.56
21472438-147243893.63694.14
31454183-145418392.47592.99
41438330-143833091.46791.98
51456563-145656392.62793.13
61472119-147211993.61694.12
45min11415429-141542990.01193.062.0090.6793.721.98
21496113-149611395.14295.80
31464458-146445893.12993.80
41447659-144765992.06192.72
51468535-146853593.38894.05
61487901-148790194.62095.28
60min11418286-141828690.19393.362.1891.0094.182.16
21507751-150775195.88296.70
31467649-146764993.33294.16
41447194-144719492.03192.85
51476981-147698193.92594.74
61490604-149060494.79295.61
极限11542817-154281798.11298.880.9999.0799.850.99
21551181-155118198.64499.62
31572159-157215999.978100.96
41533794-153379497.53898.51
51558000-155800099.077100.05
61571284-157128499.922100.90
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%
110.121421644142175814205481420135141940114206970.08
210.271415623141661014161160.05
单位质量响应值RSD%判断
140385.08137888.611.27数据可信
供试品溶液-24032502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%
5min1889865-88986556.98462.6611.7956.9862.6611.79
21196625-119662576.62876.63
3999969-99996964.03464.03
4943382-94338260.41160.41
5957137-95713761.29261.29
6883956-88395656.60556.61
10min11301956-130195683.37387.804.3983.4787.914.40
21482007-148200794.90295.03
31375425-137542588.07788.18
41355727-135572786.81686.92
51344133-134413386.07386.18
61367456-136745687.56787.66
15min11416264-141626490.69292.382.6390.9392.632.64
21513666-151366696.93097.22
31432955-143295591.76192.01
41433744-143374491.81292.06
51408463-140846390.19390.44
61450804-145080492.90493.14
20min11440032-144003292.21493.532.1992.6093.932.20
21519706-151970697.31697.76
31441796-144179692.32792.73
41449534-144953492.82393.22
51437713-143771392.06692.46
61474251-147425194.40694.80
30min11452857-145285793.03694.311.8593.5794.871.86
21520387-152038797.36097.97
31451484-145148492.94893.51
41458950-145895093.42693.98
51462894-146289493.67894.23
61490028-149002895.41695.97
45min11453955-145395593.10694.611.5393.8095.331.55
21514732-151473296.99897.77
31473971-147397194.38895.10
41459763-145976393.47894.19
51470197-147019794.14694.85
61492480-149248095.57396.28
60min11452014-145201492.98294.251.3393.8395.121.35
21506820-150682096.49197.42
31469005-146900594.07094.94
41456808-145680893.28994.15
51467707-146770793.98794.85
61478510-147851094.67895.55
极限11498478-149847895.95796.031.1796.9697.061.18
21529480-152948097.94299.04
31493534-149353495.64096.67
41491307-149130795.49896.52
51478042-147804294.64895.67
61506969-150696996.50197.53
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%
110.121410622141070114106251411072141117514108390.02
210.271413325141476214140440.08
单位质量响应值RSD%判断
139410.97137686.850.88数据可信
供试品溶液-24032502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%
5min1941092-94109260.51755.2315.6060.5255.2315.61
2746450-74645048.00148.00
3802527-80252751.60751.61
4760493-76049348.90448.90
51093457-109345770.31570.32
6809265-80926552.04052.04
10min11269929-126992981.66379.266.4981.7679.356.49
21139518-113951873.27773.36
31177388-117738875.71275.80
41183011-118301176.07476.16
51354703-135470387.11587.23
61270741-127074181.71681.80
15min11351345-135134586.89987.234.3587.1487.464.35
21278678-127867882.22682.43
31330265-133026585.54385.76
41327319-132731985.35485.56
51433665-143366592.19292.45
61417816-141781691.17391.40
20min11377809-137780988.60190.652.7588.9891.022.76
21376939-137693988.54588.88
31391036-139103689.45189.81
41394621-139462189.68290.03
51459862-145986293.87794.29
61457588-145758893.73194.11
30min11421021-142102191.37994.031.6791.9194.551.66
21476138-147613894.92495.41
31456293-145629393.64894.15
41453542-145354293.47193.97
51477533-147753395.01395.59
61489162-148916295.76196.29
45min11483044-148304495.36895.780.7996.0596.450.79
21504952-150495296.77797.42
31483847-148384795.41996.08
41473250-147325094.73895.39
51491289-149128995.89896.63
61500031-150003196.46097.15
60min11492923-149292396.00396.060.8196.8496.900.82
21506645-150664596.88597.69
31483055-148305595.36896.19
41476269-147626994.93295.75
51500010-150001096.45997.35
61504028-150402896.71797.57
极限11525761-152576198.11598.391.0599.1299.391.01
21546989-154698999.480100.45
31528733-152873398.30699.28
41550848-155084899.728100.70
51511367-151136797.18998.24
61516558-151655897.52398.54
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