恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.983057683055293054563050873053223054320.09
210.933062543061763062150.02
单位质量响应值RSD%判断
27817.1228016.010.51数据可信
供试品溶液-6032401批-恩格列净-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%
5min131801-3180151.26262.3322.1551.2662.3422.15
236723-3672359.19659.20
348318-4831877.88777.89
434388-3438855.43255.43
530433-3043349.05749.06
650352-5035281.16681.17
10min158399-5839994.13794.285.0494.7194.985.09
253272-5327285.87386.53
361786-6178699.597100.46
457858-5785893.26593.88
558983-5898395.07995.62
660642-6064297.75398.65
15min160459-6045997.45896.904.1299.0798.644.09
255332-5533289.19390.81
361141-6114198.557100.53
460619-6061997.71699.37
562594-62594100.899102.50
660520-6052097.55699.54
20min161300-6130098.81496.321.77101.5199.131.71
259090-5909095.25197.85
360285-6028597.177100.24
458536-5853694.35897.10
560321-6032197.23599.96
658969-5896995.05698.13
30min158844-5884494.85595.601.2098.6599.481.24
259373-5937395.70799.37
360420-6042097.395101.54
458471-5847194.25398.04
559776-5977696.357100.16
658942-5894295.01399.14
45min158440-5844094.20394.441.3199.0599.381.40
257613-5761392.87097.59
359920-5992096.589101.82
458386-5838694.11698.95
558852-5885294.86799.74
658301-5830193.97999.16
60min158700-5870094.62293.721.48100.5299.721.42
258366-5836694.08499.84
358851-5885194.866101.17
456831-5683191.61097.49
558780-5878094.751100.68
657301-5730192.36798.60
90min157963-5796393.43492.752.09100.3899.791.93
257904-5790493.339100.14
358822-5882294.819102.18
457102-5710292.04798.94
558073-5807393.612100.59
655364-5536489.24596.50
120min157347-5734792.44192.751.59100.43100.821.61
257557-5755792.780100.62
358984-5898495.080103.49
456234-5623490.64798.57
557981-5798193.463101.48
657139-5713992.106100.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限157457-5745792.61992.622.61101.63101.722.56
256760-5676091.495100.37
360357-6035797.293106.76
456052-5605290.35499.28
557080-5708092.011101.07
657055-5705591.971101.24
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.284102524101824095324101384098814099970.08
211.354099474104744102100.10
单位质量响应值RSD%判断
36347.2536141.850.41数据可信
供试品溶液-6032401批-非奈利酮-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%
5min18021-80219.94923.0862.589.9523.0862.58
211411-1141114.15314.15
336459-3645945.22145.22
424203-2420330.02030.02
57173-71738.8978.90
624397-2439730.26030.26
10min151695-5169564.11975.1618.2464.2375.4118.36
247748-4774859.22359.38
378729-7872997.65098.15
466444-6644482.41382.75
558904-5890473.06173.16
660042-6004274.47274.81
15min172735-7273590.21688.858.6591.0489.948.70
262944-6294478.07278.89
377757-7775796.44598.03
474428-7442892.31693.56
576854-7685495.32596.24
665099-6509980.74581.91
20min177396-7739695.99791.465.8397.8293.545.84
268233-6823384.63286.31
375959-7595994.21596.87
475374-7537493.48995.76
577142-7714295.68297.65
668325-6832584.74686.81
30min174670-7467092.61693.841.9895.5196.932.22
273132-7313290.70893.33
376608-7660895.02098.73
476731-7673195.17298.49
576963-7696395.46098.49
675817-7581794.03897.04
45min174240-7424092.08293.051.9296.0097.182.11
272808-7280890.30693.94
375041-7504193.07697.84
477135-7713595.673100.04
575568-7556893.73097.82
675320-7532093.42297.47
60min174405-7440592.28792.400.7497.2397.570.54
274682-7468292.63197.27
373472-7347291.13096.93
474721-7472192.67998.11
575066-7506693.10798.24
674620-7462092.55497.64
90min172887-7288790.40491.091.5096.3797.291.58
273556-7355691.23496.90
373514-7351491.18297.99
474999-7499993.02499.49
573995-7399591.77997.95
671709-7170988.94395.06
120min172693-7269390.16490.560.8197.1497.770.88
272371-7237189.76496.44
372422-7242289.82797.65
473450-7345091.10398.60
573459-7345991.11498.30
673694-7369491.40598.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限172326-7232689.70889.760.6797.6897.980.89
271559-7155988.75796.43
372206-7220689.56098.38
472885-7288590.40298.91
572404-7240489.80598.01
672837-7283790.34298.46
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.983060313061553061783063663054773060410.12
210.933059283064953062120.14
单位质量响应值RSD%判断
27872.5928015.740.37数据可信
供试品溶液-6032401素片批-恩格列净-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%
5min158871-5887194.80491.786.8394.8091.786.83
249366-4936679.49779.50
356480-5648090.95390.95
458602-5860294.37194.37
559608-5960895.99195.99
659051-5905195.09495.09
10min161297-6129798.71198.933.6999.7699.953.71
258029-5802993.44894.33
360187-6018796.92397.93
461403-6140398.88199.93
563199-63199101.773102.84
664479-64479103.835104.89
15min161332-6133298.76798.102.28100.92100.222.30
259908-5990896.47498.40
359081-5908195.14297.23
460573-6057397.54599.69
563021-63021101.487103.68
661599-6159999.197101.41
20min160002-6000296.62596.731.5999.8799.941.60
259773-5977396.25699.25
359773-5977396.25699.40
458615-5861594.39297.62
561181-6118198.524101.85
661074-6107498.351101.66
30min160363-6036397.20696.561.32101.53100.841.35
259169-5916995.28499.35
360371-6037197.219101.43
458784-5878494.66498.94
560344-6034497.176101.60
660738-6073897.810102.22
45min158742-5874294.59694.502.08100.0099.852.06
258571-5857194.32199.44
357218-5721892.14297.44
457458-5745892.52897.86
560231-6023196.994102.49
659861-5986196.398101.89
60min158291-5829193.87094.802.91100.32101.212.78
257656-5765692.84799.02
361239-6123998.617104.94
456764-5676491.41197.77
560523-6052397.464104.04
658734-5873494.583101.15
90min157258-5725892.20692.311.6599.7099.771.64
257371-5737192.38899.59
356399-5639990.82398.24
456150-5615090.42297.80
558293-5829393.873101.53
658453-5845394.131101.74
120min157440-5744092.49992.111.85101.02100.601.80
257595-5759592.749100.98
355973-5597390.13798.56
455815-5581589.88398.26
558270-5827093.836102.54
658101-5810193.564102.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限156569-5656991.09791.542.00100.64101.051.97
256088-5608890.32299.58
355496-5549689.36998.79
456470-5647090.937100.32
558097-5809793.557103.30
658338-5833893.945103.65
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.284106884101764105934107354107514105890.06
211.354099484110474104980.19
单位质量响应值RSD%判断
36399.7336167.220.46数据可信
供试品溶液-6032401素片批-非奈利酮-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%
5min169168-6916885.70056.2538.6885.7056.2538.67
222668-2266828.08628.09
329158-2915836.12736.13
450233-5023362.23962.24
542891-4289153.14253.14
658286-5828672.21772.22
10min179122-7912298.03388.3714.7098.9889.0014.84
253523-5352366.31566.63
365519-6551981.17881.58
480740-80740100.037100.73
570700-7070087.59888.19
678331-7833197.05397.86
15min179128-7912898.04092.488.39100.0894.098.62
263751-6375178.98880.04
371502-7150288.59189.89
480513-8051399.756101.56
574754-7475492.62194.18
678210-7821096.90398.78
20min176993-7699395.39593.744.6498.5396.384.92
269078-6907885.58887.51
376661-7666194.98397.27
478164-7816496.84699.76
574561-7456192.38294.97
678491-7849197.251100.21
30min177454-7745495.96695.762.78100.1699.442.84
275079-7507993.02395.90
380613-8061399.880103.22
478113-7811396.783100.77
574802-7480292.68096.30
677676-7767696.241100.28
45min175462-7546293.49894.081.2098.7598.821.42
275133-7513393.09097.00
376640-7664094.95799.41
476658-7665894.980100.04
574800-7480092.67897.33
676904-7690495.285100.39
60min174616-7461692.45094.333.2098.75100.113.13
273877-7387791.53496.48
379229-7922998.165103.67
479238-7923898.176104.29
575086-7508693.03298.71
674738-7473892.60198.77
90min173588-7358891.17691.421.6398.5098.251.73
273202-7320290.69896.66
375138-7513893.09699.70
474103-7410391.81499.02
571843-7184389.01495.73
674824-7482492.70799.90
120min172969-7296990.40990.741.2198.7598.591.29
273161-7316190.64797.62
374211-7421191.94899.58
473526-7352691.09999.33
571693-7169388.82896.53
673846-7384691.49699.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限171820-7182088.98590.162.0298.3399.022.14
271223-7122388.24696.22
374264-7426492.014100.67
474047-7404791.745100.99
571311-7131188.35597.04
673962-7396291.639100.88
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