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%
110.281429828143114414316501431430143188914311880.06
210.211434266143559214349290.07
单位质量响应值RSD%判断
139220.62140541.530.67数据可信
供试品溶液-304468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%
5min1837092-83709253.31652.805.0553.3252.805.05
2744775-74477547.43647.44
3839211-83921153.45153.45
4852828-85282854.31854.32
5853462-85346254.35954.36
6846703-84670353.92853.93
10min11219161-121916177.65176.143.7477.7476.233.74
21113779-111377970.93971.02
31223118-122311877.90377.99
41229593-122959378.31578.41
51173555-117355574.74674.84
61213545-121354577.29377.38
15min11352271-135227186.12984.552.8486.3584.762.84
21275605-127560581.24681.44
31343415-134341585.56585.78
41358777-135877786.54386.76
51283036-128303681.71981.93
61351386-135138686.07286.29
20min11404567-140456789.46088.532.6089.8288.882.60
21354746-135474686.28686.62
31400023-140002389.17089.53
41427515-142751590.92191.29
51336617-133661785.13285.48
61415964-141596490.18690.55
30min11465683-146568393.35292.542.3393.8693.042.33
21423025-142302590.63591.11
31448522-144852292.25992.77
41495360-149536095.24295.76
51406203-140620389.56490.06
61478447-147844794.16594.68
45min11497063-149706395.35194.871.6596.0295.531.65
21463581-146358193.21893.85
31474580-147458093.91994.58
41525635-152563597.17197.85
51469037-146903793.56694.21
61507263-150726396.00196.67
60min11514787-151478796.48095.871.4397.3196.691.43
21479709-147970994.24695.03
31488182-148818294.78595.61
41533955-153395597.70198.54
51492986-149298695.09195.89
61521933-152193396.93597.76
极限11524621-152462197.10696.771.3198.0997.741.32
21498192-149819295.42396.36
31498181-149818195.42296.40
41539099-153909998.02899.03
51511834-151183496.29297.25
61544039-154403998.34399.33
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%
110.281424466142547114248951425027142513914250000.03
210.211444734144436314445480.02
单位质量响应值RSD%判断
138618.68141483.641.45数据可信
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%
5min1757889-75788948.21753.0412.0048.2253.0411.99
2733363-73336346.65646.66
3836201-83620153.19953.20
4848097-84809753.95653.96
51016368-101636864.66164.66
6809941-80994151.52851.53
10min11135403-113540372.23474.514.5972.3174.604.60
21108524-110852470.52470.60
31180595-118059575.10975.20
41172593-117259374.60074.69
51266340-126634080.56480.67
61163885-116388574.04674.13
15min11225643-122564377.97580.333.2778.1880.543.28
21217876-121787677.48177.68
31276031-127603181.18181.39
41255006-125500679.84380.06
51332405-133240584.76785.01
61268685-126868580.71480.92
20min11258436-125843680.06182.172.8280.3982.522.83
21254594-125459479.81780.14
31314054-131405483.60083.95
41279223-127922381.38481.73
51350532-135053285.92186.30
61292702-129270282.24182.59
30min11312333-131233383.49084.222.3883.9584.712.39
21282623-128262381.60082.06
31357805-135780586.38386.87
41305162-130516283.03483.52
51363888-136388886.77087.30
61321337-132133784.06384.54
45min11352530-135253086.04886.142.8986.6586.762.89
21297127-129712782.52383.12
31393745-139374588.67089.30
41319007-131900783.91584.54
51370943-137094387.21987.89
61390271-139027188.44989.07
60min11396311-139631188.83387.643.6189.5888.413.59
21313556-131355683.56884.30
31414494-141449489.99090.77
41329714-132971484.59685.36
51369137-136913787.10487.92
61442013-144201391.74192.51
极限11508392-150839295.96495.650.7396.8696.560.74
21487023-148702394.60495.47
31517419-151741996.53897.47
41496632-149663295.21596.12
51500288-150028895.44896.41
61510649-151064996.10797.03
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%
110.281424939142466014254011424660142461514248550.03
210.211435092143549614352940.02
单位质量响应值RSD%判断
138604.57140577.281.00数据可信
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%
5min1911788-91178858.19658.448.4058.2058.448.40
2805427-80542751.40751.41
31036703-103670366.16966.17
4924125-92412558.98358.98
5871910-87191055.65155.65
6943375-94337560.21260.21
10min11242550-124255079.30779.592.6379.4079.682.63
21211455-121145577.32277.41
31302816-130281683.15483.26
41240596-124059679.18279.28
51221431-122143177.95978.05
61262657-126265780.59080.69
15min11359793-135979386.79086.361.3687.0286.591.36
21368377-136837787.33887.55
31365806-136580687.17487.42
41324486-132448684.53784.77
51335578-133557885.24585.47
61363924-136392487.05487.29
20min11428510-142851091.17689.881.7191.5590.261.69
21434939-143493991.58791.95
31395382-139538289.06289.46
41368659-136865987.35687.73
51409650-140965089.97290.34
61412136-141213690.13190.51
30min11458047-145804793.06192.461.6093.5992.991.59
21479738-147973894.44694.96
31428787-142878791.19491.74
41415982-141598290.37790.89
51461483-146148393.28193.80
61448165-144816592.43192.96
45min11473088-147308894.02194.081.0994.7094.761.08
21489864-148986495.09295.76
31451815-145181592.66493.36
41460718-146071893.23293.90
51475587-147558794.18194.85
61492968-149296895.29095.97
60min11482436-148243694.61894.711.0095.4695.550.98
21503483-150348395.96196.79
31460471-146047193.21694.07
41480038-148003894.46595.29
51481373-148137394.55095.38
61495352-149535295.44296.29
极限11495266-149526695.43795.760.4896.4396.760.48
21508817-150881796.30297.29
31503330-150333095.95296.96
41504795-150479596.04597.03
51489187-148918795.04996.03
61500979-150097995.80296.80
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%
110.281431718143157114325011432722143319214323410.05
210.211436486143650714364960.01
单位质量响应值RSD%判断
139332.78140695.000.69数据可信
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%
5min1864054-86405454.98156.345.9154.9856.345.92
2879428-87942855.95955.96
3952751-95275160.62560.63
4814597-81459751.83451.83
5940625-94062559.85359.85
6860989-86098954.78654.79
10min11163400-116340074.02976.645.1874.1276.745.18
21211403-121140377.08477.18
31288727-128872782.00482.10
41159302-115930273.76873.85
51267540-126754080.65680.76
61136642-113664272.32672.42
15min11234575-123457578.55882.245.6678.7782.465.66
21295592-129559282.44182.66
31384747-138474788.11488.35
41243335-124333579.11579.32
51377067-137706787.62587.86
61219667-121966777.60977.82
20min11266732-126673280.60484.535.9880.9584.895.97
21333001-133300184.82185.18
31430109-143010991.00091.38
41267880-126788080.67781.02
51418590-141859090.26790.65
61254178-125417879.80580.15
30min11289279-128927982.03986.536.2982.5287.036.29
21370336-137033687.19787.70
31464744-146474493.20493.74
41293873-129387382.33182.81
51459544-145954492.87393.40
61281255-128125581.52882.00
45min11297614-129761482.56988.016.6883.1988.656.67
21410839-141083989.77490.42
31487464-148746494.65095.34
41329546-132954684.60185.21
51488385-148838594.70895.39
61284401-128440181.72982.34
60min11307570-130757083.20389.006.4883.9689.796.47
21428943-142894390.92691.72
31493745-149374595.04995.90
41368532-136853287.08287.84
51501023-150102395.51396.36
61292006-129200682.21282.96
极限11526709-152670997.14796.700.8198.0497.640.82
21538128-153812897.87498.82
31511071-151107196.15297.16
41514438-151443896.36697.27
51523859-152385996.96697.97
61504093-150409395.70896.59
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