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%
110.081404682140180214036021402461140185614028810.09
210.111392736139646613946010.19
单位质量响应值RSD%判断
139174.70137942.730.63数据可信
中间条件12月-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%
5min1842298-84229854.71259.686.3254.7159.696.32
21002631-100263165.12765.13
3895151-89515158.14558.15
4930819-93081960.46260.46
5881006-88100657.22657.23
6961239-96123962.43862.44
10min11163934-116393475.60477.422.8975.7077.522.90
21242191-124219180.68780.80
31169462-116946275.96376.06
41215405-121540578.94779.05
51154827-115482775.01375.11
61205626-120562678.31278.42
15min11251680-125168081.30481.871.9781.5282.101.97
21295948-129594884.17984.42
31243544-124354480.77581.00
41279635-127963583.12083.35
51228002-122800279.76679.99
61263819-126381982.09282.33
20min11276873-127687382.94083.281.8083.2983.641.81
21314072-131407285.35685.74
31268229-126822982.37982.74
41302242-130224284.58884.96
51250415-125041581.22281.57
61280351-128035183.16683.54
30min11300182-130018284.45484.581.7684.9585.081.76
21335247-133524786.73287.26
31288518-128851883.69784.19
41318123-131812385.62086.13
51269558-126955882.46582.95
61300939-130093984.50385.01
45min11315461-131546185.44785.451.3286.0886.091.33
21339759-133975987.02587.70
31303066-130306684.64285.28
41327350-132735086.21986.87
51290597-129059783.83284.46
61316593-131659385.52086.17
60min11330672-133067286.43586.261.1687.2187.041.16
21350110-135011087.69788.51
31313441-131344185.31586.09
41337931-133793186.90687.70
51308972-130897285.02585.79
61326721-132672186.17886.97
极限11446576-144657693.96395.671.9394.8896.601.92
21504853-150485397.74998.71
31506003-150600397.82398.74
41471426-147142695.57896.52
51470283-147028395.50396.41
61438284-143828493.42594.36
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%
110.081398129140012014005201402163140144714004760.11
210.111407142140837214077570.07
单位质量响应值RSD%判断
138936.11139244.020.16数据可信
中间条件12月-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%
5min1786562-78656250.89653.345.8850.9053.345.88
2859672-85967255.62655.63
3782417-78241750.62750.63
4904451-90445158.52458.52
5795789-79578951.49351.49
6816747-81674752.84952.85
10min11188769-118876976.92175.142.7777.0175.232.77
21193989-119398977.25977.35
31106729-110672971.61271.70
41173013-117301375.90176.00
51157677-115767774.90974.99
61147135-114713574.22774.32
15min11306919-130691984.56681.113.0684.7881.333.06
21283219-128321983.03283.25
31197005-119700577.45477.66
41254116-125411681.14981.37
51245270-124527080.57780.79
61234734-123473479.89580.11
20min11368847-136884788.57383.493.6288.9383.843.61
21310391-131039184.79185.15
31232479-123247979.74980.08
41292715-129271583.64784.01
51268278-126827882.06682.41
61268760-126876082.09782.44
30min11431026-143102692.59685.764.3993.1086.254.38
21332641-133264186.23086.73
31265295-126529581.87382.34
41334595-133459586.35786.86
51290481-129048183.50283.98
61298131-129813183.99784.48
45min11466015-146601594.86087.584.5895.5288.214.57
21353752-135375287.59688.24
31297340-129734083.94684.55
41371618-137161888.75289.40
51305381-130538184.46685.09
61326630-132663085.84186.46
60min11469115-146911595.06188.564.1195.8889.344.10
21364544-136454488.29589.09
31321320-132132085.49886.24
41392646-139264690.11390.90
51322816-132281685.59586.36
61341282-134128286.78987.55
极限11478294-147829495.65595.450.7496.6396.380.74
21483963-148396396.02296.96
31459471-145947194.43795.32
41464377-146437794.75495.70
51478648-147864895.67896.58
61486049-148604996.15797.07
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%
110.081381888138259413827021383887138312513828390.06
210.111391592139190713917500.02
单位质量响应值RSD%判断
137186.41137660.730.25数据可信
中间条件12月-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%
5min1856727-85672756.10858.346.5656.1158.346.56
2813786-81378653.29653.30
3980778-98077864.23264.23
4914651-91465159.90259.90
5914632-91463259.90059.90
6863957-86395756.58256.58
10min11226377-122637780.31780.572.4780.4180.672.47
21186195-118619577.68577.77
31235198-123519880.89581.00
41273285-127328583.38983.49
51249689-124968981.84481.94
61210922-121092279.30579.40
15min11361802-136180289.18686.842.6889.4187.082.68
21290704-129070484.53084.75
31303440-130344085.36485.61
41365780-136578089.44689.69
51344752-134475288.06988.31
61289702-128970284.46484.69
20min11436022-143602294.04789.773.2994.4290.153.28
21329835-132983587.09287.45
31341808-134180887.87788.26
41397534-139753491.52691.91
51394221-139422191.30991.69
61325073-132507386.78187.15
30min11473580-147358096.50692.173.4797.0492.693.46
21368255-136825589.60990.11
31388467-138846790.93291.46
41426385-142638593.41693.96
51443028-144302894.50695.04
61344312-134431288.04188.55
45min11491819-149181997.70193.773.2898.3994.453.27
21399630-139963091.66392.32
31422604-142260493.16893.85
41441158-144115894.38395.08
51471701-147170196.38397.08
61364231-136423189.34590.00
60min11491470-149147097.67894.433.0698.5395.263.06
21412920-141292092.53493.34
31438952-143895294.23995.08
41455541-145554195.32596.18
51479506-147950696.89597.75
61372623-137262389.89590.70
极限11498174-149817498.11797.561.1099.1498.561.09
21508353-150835398.78499.74
31482337-148233797.08098.07
41463739-146373995.86296.87
51502146-150214698.37799.39
61483562-148356297.16098.12
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%
110.081381399137974613790561378710137812313794070.10
210.111378086137894513785160.05
单位质量响应值RSD%判断
136845.93136351.730.26数据可信
中间条件12月-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%
5min1865993-86599357.05755.384.3557.0655.384.35
2890551-89055158.67558.68
3858402-85840256.55756.56
4811782-81178253.48653.49
5820397-82039754.05354.05
6796244-79624452.46252.46
10min11244651-124465182.00679.752.3282.1079.842.32
21243573-124357381.93582.03
31184161-118416178.02078.11
41205033-120503379.39579.48
51205083-120508379.39979.49
61180052-118005277.75077.84
15min11338864-133886488.21386.722.2988.4486.942.28
21339545-133954588.25888.49
31274805-127480583.99384.22
41344618-134461888.59288.81
51313812-131381286.56386.78
61285702-128570284.71184.93
20min11378194-137819490.80489.662.5691.1890.032.56
21374148-137414890.53890.92
31315106-131510686.64887.01
41404943-140494392.56792.94
51369947-136994790.26190.63
61322656-132265687.14587.50
30min11400668-140066892.28592.082.8492.8292.602.83
21405942-140594292.63393.17
31363162-136316289.81490.32
41448403-144840395.43095.95
51425825-142582593.94394.46
61341097-134109788.36088.86
45min11423863-142386393.81394.043.0094.5094.712.99
21442745-144274595.05895.74
31416222-141622293.31093.97
41479341-147934197.46998.15
51449057-144905795.47396.15
61352414-135241489.10689.76
60min11429701-142970194.19895.083.2595.0495.913.24
21460971-146097196.25897.10
31456696-145669695.97796.79
41491684-149168498.28299.13
51463515-146351596.42697.26
61356352-135635289.36590.16
极限11511061-151106199.55998.730.60100.5699.720.60
21486280-148628097.92698.93
31505235-150523599.175100.15
41500166-150016698.84199.85
51495339-149533998.52399.52
61492909-149290998.36399.31
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