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%
110.051396164139710313975441397265139692013969990.04
210.081388067138901213885400.05
单位质量响应值RSD%判断
139004.88137751.980.65数据可信
供试品溶液-2024040911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%
5min1955535-95553561.52155.8411.8761.5255.8411.87
2822605-82260552.96252.96
3852061-85206154.85954.86
4881580-88158056.75956.76
5990314-99031463.76063.76
6701322-70132245.15445.15
10min11307462-130746284.17981.304.2184.2881.394.22
21264663-126466381.42381.51
31233714-123371479.43179.52
41314493-131449384.63284.73
51283662-128366282.64782.75
61172391-117239175.48375.56
15min11408828-140882890.70589.222.1290.9589.452.12
21403666-140366690.37390.60
31340893-134089386.33186.56
41416843-141684391.22191.46
51364954-136495487.88088.12
61379707-137970788.83089.03
20min11454445-145444593.64292.232.0294.0492.612.02
21452490-145249093.51693.89
31388157-138815789.37489.74
41453950-145395093.61094.00
51404351-140435190.41790.81
61441518-144151892.81093.16
30min11506760-150676097.01094.851.6597.5695.381.65
21481536-148153695.38695.92
31438932-143893292.64393.16
41484882-148488295.60296.15
51452214-145221493.49994.04
61474886-147488694.95895.46
45min11538181-153818199.03396.481.4999.7597.171.49
21503235-150323596.78397.47
31476811-147681195.08295.75
41503134-150313496.77797.48
51482000-148200095.41696.11
61488040-148804095.80596.47
60min11549182-154918299.74297.201.50100.6298.051.50
21519628-151962897.83998.69
31494771-149477196.23997.07
41511104-151110497.29098.15
51488425-148842595.83096.69
61495049-149504996.25697.08
极限11564132-1564132100.70499.100.86101.75100.110.87
21542247-154224799.295100.31
31531141-153114198.58099.57
41530312-153031298.52799.55
51537740-153774099.005100.02
61529298-152929898.46299.44
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%
110.051391386139119413920051389775139249613913710.08
210.081395469139573113956000.02
单位质量响应值RSD%判断
138444.88138452.380.01数据可信
供试品溶液-2024040911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%
5min1823544-82354452.99557.406.3752.9957.396.37
2930727-93072759.89259.89
3964618-96461862.07362.07
4907743-90774358.41358.41
5826087-82608753.15853.16
6898863-89886357.84157.84
10min11257238-125723880.90383.571.9080.9983.671.90
21299429-129942983.61883.72
31312685-131268584.47184.57
41331228-133122885.66485.76
51300496-130049683.68683.77
61291219-129121983.08983.19
15min11336925-133692586.03089.402.4286.2589.642.42
21378046-137804688.67788.92
31389904-138990489.44089.68
41428382-142838291.91692.16
51423017-142301791.57091.80
61379538-137953888.77389.01
20min11365829-136582987.89091.472.6288.2691.862.61
21407351-140735190.56290.95
31424497-142449791.66692.06
41465127-146512794.28094.67
51459860-145986093.94194.32
61406352-140635290.49890.88
30min11381530-138153088.90192.752.7989.4193.282.78
21425340-142534091.72092.26
31447034-144703493.11693.66
41485582-148558295.59696.15
51484971-148497195.55796.09
61423593-142359391.60792.14
45min11396269-139626989.84994.023.0790.5194.713.07
21439771-143977192.64993.34
31469137-146913794.53895.24
41503734-150373496.76597.47
51516897-151689797.61298.31
61440988-144098892.72793.41
60min11400197-140019790.10294.493.1090.9195.343.09
21443970-144397092.91993.76
31478240-147824095.12495.98
41507928-150792897.03497.91
51525071-152507198.13899.00
61455162-145516293.63994.48
极限11509294-150929497.12298.120.7198.0899.130.72
21529141-152914198.39999.40
31521755-152175597.92498.94
41530915-153091598.51499.55
51539803-153980399.086100.11
61518133-151813397.69198.69
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%
110.051389201138922913897521390706139047913898730.06
210.081404131140448114043060.02
单位质量响应值RSD%判断
138295.82139316.070.52数据可信
供试品溶液-2024040911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%
5min1967469-96746962.09760.193.3662.1060.193.36
2899315-89931557.72257.72
3972366-97236662.41162.41
4926591-92659159.47359.47
5906513-90651358.18458.18
6954427-95442761.26061.26
10min11423294-142329491.35486.323.3091.4686.423.30
21294361-129436183.07883.17
31336387-133638785.77685.88
41355654-135565487.01287.11
51314427-131442784.36684.46
61345176-134517686.34086.44
15min11485200-148520095.32792.352.1795.5892.592.17
21399631-139963189.83590.07
31420987-142098791.20691.45
41462215-146221593.85294.10
51422072-142207291.27591.51
61442648-144264892.59692.84
20min11512328-151232897.06894.921.7197.4895.321.71
21445156-144515692.75793.14
31455156-145515693.39993.80
41496306-149630696.04096.44
51478872-147887294.92195.31
61485207-148520795.32895.73
30min11525363-152536397.90596.751.3198.4897.301.32
21476592-147659294.77595.31
31489216-148921695.58596.14
41520027-152002797.56398.12
51513059-151305997.11597.66
61519512-151951297.52998.09
45min11535619-153561998.56397.761.1899.3098.481.18
21497601-149760196.12396.82
31503562-150356296.50697.22
41533972-153397298.45899.18
51528975-152897598.13798.85
61539185-153918598.79299.51
60min11535580-153558098.56197.991.1199.4698.871.11
21503112-150311296.47797.33
31507712-150771296.77297.65
41536661-153666198.63099.52
51533650-153365098.43799.31
61543412-154341299.06399.95
极限11541813-154181398.96198.710.85100.0399.760.86
21524938-152493897.87898.90
31518715-151871597.47898.51
41545670-154567099.208100.26
51544383-154438399.126100.16
61552008-155200899.615100.67
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%
110.051393209139329913920001392769139416913930890.06
210.081396442139672313965820.02
单位质量响应值RSD%判断
138615.82138549.800.04数据可信
供试品溶液-2024040911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%
5min1770589-77058949.53955.868.0749.5455.868.07
2878196-87819656.45756.46
3885676-88567656.93856.94
4939241-93924160.38160.38
5800675-80067551.47351.47
6939046-93904660.36960.37
10min11199697-119969777.12578.921.8877.2179.021.89
21243823-124382379.96280.06
31235715-123571579.44179.54
41255333-125533380.70280.80
51200034-120003477.14777.23
61231403-123140379.16379.26
15min11335295-133529585.84285.321.6286.0585.541.62
21361095-136109587.50187.73
31319521-131952184.82885.06
41321854-132185484.97885.21
51295905-129590583.31083.52
61329268-132926885.45585.69
20min11394792-139479289.66788.112.3590.0288.482.34
21422568-142256891.45391.83
31368933-136893388.00588.37
41345036-134503686.46986.85
51344490-134449086.43386.79
61347794-134779486.64687.02
30min11448153-144815393.09890.752.9093.6091.272.88
21474255-147425594.77695.30
31407031-140703190.45490.97
41372238-137223888.21788.74
51387178-138717889.17889.68
61381285-138128588.79989.32
45min11477986-147798695.01692.472.8795.6793.132.85
21498369-149836996.32697.01
31435152-143515292.26292.93
41395972-139597289.74390.41
51407940-140794090.51391.16
61414729-141472990.94991.62
60min11492180-149218095.92893.402.5896.7594.222.56
21505127-150512796.76097.60
31450211-145021193.23094.05
41416094-141609491.03791.85
51427781-142778191.78892.58
61426204-142620491.68792.51
极限11529556-152955698.33197.900.8299.3198.880.82
21524447-152444798.00299.01
31538765-153876598.92399.90
41501075-150107596.50097.47
51522958-152295897.90798.86
61520764-152076497.76698.74
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