艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493744153743263743443745093747893744770.06
214.403736543735153735840.03
单位质量响应值RSD%判断
25843.8225943.330.28数据可信
供试品溶液-2026032321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%
5min1235858-23585862.90062.297.0462.9062.297.04
2243639-24363964.97564.97
3228719-22871960.99661.00
4235164-23516462.71562.71
5204787-20478754.61454.61
6253307-25330767.55367.55
10min1312772-31277283.41282.553.9483.5282.663.95
2310540-31054082.81782.92
3312718-31271883.39783.50
4307614-30761482.03682.14
5288098-28809876.83276.92
6325584-32558486.82986.94
15min1336079-33607989.62789.273.5289.8789.513.52
2331529-33152988.41488.66
3340564-34056490.82391.06
4332372-33237288.63988.88
5316042-31604284.28484.50
6351784-35178493.81694.07
20min1343959-34395991.72991.543.0192.1291.933.01
2340257-34025790.74291.14
3351002-35100293.60794.00
4343164-34316491.51791.91
5325574-32557486.82687.19
6355495-35549594.80595.22
30min1346331-34633192.36192.803.3092.9193.353.30
2342691-34269191.39191.94
3356546-35654695.08695.63
4345803-34580392.22192.76
5331749-33174988.47388.98
6364820-36482097.29297.86
45min1350592-35059293.49893.552.6694.2094.252.66
2345114-34511492.03792.73
3359549-35954995.88796.59
4351826-35182693.82794.52
5336283-33628389.68290.33
6361393-36139396.37897.11
60min1351256-35125693.67593.612.6694.5394.472.67
2345008-34500892.00992.86
3360840-36084096.23197.10
4350286-35028693.41694.27
5337216-33721689.93190.73
6361514-36151496.41197.31
极限1365234-36523497.40395.912.1698.4196.922.17
2352315-35231593.95794.96
3366321-36632197.69398.72
4358052-35805295.48796.49
5348965-34896593.06494.01
6366985-36698597.87098.92
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493734813733093734653731903731823733250.04
214.403734743735943735340.03
单位质量响应值RSD%判断
25764.3225939.860.49数据可信
供试品溶液-2026032321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%
5min1227206-22720660.69060.435.6860.6960.445.68
2237822-23782263.52663.53
3217700-21770058.15158.15
4245092-24509265.46865.47
5214093-21409357.18857.19
6215559-21555957.57957.58
10min1292387-29238778.10179.413.7978.2079.513.80
2308631-30863182.44082.55
3288439-28843977.04777.14
4313793-31379383.81983.93
5286302-28630276.47676.57
6294204-29420478.58678.68
15min1314956-31495684.13085.363.4284.3685.603.43
2330404-33040488.25688.50
3309857-30985782.76882.99
4335424-33542489.59789.85
5309136-30913682.57582.80
6317678-31767884.85785.08
20min1324094-32409486.57187.983.0786.9488.353.07
2340868-34086891.05191.44
3318572-31857285.09685.46
4343111-34311191.65092.05
5323882-32388286.51486.87
6325685-32568586.99687.36
30min1330970-33097088.40789.533.1688.9290.053.17
2348224-34822493.01693.56
3325906-32590687.05587.56
4348489-34848993.08793.64
5325202-32520286.86787.37
6332182-33218288.73189.24
45min1335492-33549289.61590.793.1090.2891.463.10
2353839-35383994.51695.21
3332104-33210488.71089.36
4352475-35247594.15294.86
5329668-32966888.05988.71
6335846-33584689.71090.37
60min1339837-33983790.77691.572.8991.5992.392.89
2356018-35601895.09895.95
3335369-33536989.58290.38
4354420-35442094.67195.53
5333313-33331389.03389.83
6337852-33785290.24691.06
极限1349961-34996193.48094.793.2494.4495.763.25
2368362-36836298.39599.41
3346081-34608192.44493.39
4370791-37079199.044100.06
5346966-34696692.68093.62
6347029-34702992.69793.66
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493752473752643751063750833750003751400.04
214.403755833756043755940.01
单位质量响应值RSD%判断
25889.5826082.920.53数据可信
供试品溶液-2026032321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%
5min1216763-21676357.60258.024.2957.6058.024.28
2207198-20719855.06055.06
3226780-22678060.26460.26
4215008-21500857.13657.14
5232090-23209061.67561.67
6212089-21208956.36056.36
10min1290051-29005177.07775.353.4677.1775.443.46
2266505-26650570.82070.91
3291437-29143777.44677.55
4284496-28449675.60175.70
5290851-29085177.29077.39
6277936-27793673.85873.95
15min1311702-31170282.83181.023.3883.0681.243.38
2285202-28520275.78976.00
3311616-31161682.80883.04
4307486-30748681.71081.93
5310857-31085782.60682.84
6302385-30238580.35580.57
20min1322228-32222885.62883.423.4985.9983.773.49
2293444-29344477.97978.32
3320568-32056885.18785.55
4316050-31605083.98684.34
5320856-32085685.26385.63
6310267-31026782.44982.80
30min1331570-33157088.11086.153.2588.6286.643.25
2304560-30456080.93381.40
3332208-33220888.28088.79
4326386-32638686.73387.23
5329729-32972987.62188.13
6320657-32065785.21085.70
45min1338437-33843789.93588.203.0790.5988.843.08
2312634-31263483.07883.68
3339379-33937990.18690.84
4333955-33395588.74489.39
5337990-33799089.81790.47
6329103-32910387.45588.09
60min1348114-34811492.50790.522.6193.3191.312.62
2324538-32453886.24286.98
3346584-34658492.10092.91
4339769-33976990.28991.08
5346690-34669092.12892.94
6338185-33818589.86890.64
极限1372370-37237098.95396.422.8599.9197.362.85
2348892-34889292.71493.60
3372379-37237998.95599.92
4352266-35226693.61094.55
5369522-36952298.19699.16
6361669-36166996.10997.03
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493757143759323756553758303757863757830.03
214.403751613752823752220.03
单位质量响应值RSD%判断
25933.9526057.080.34数据可信
供试品溶液-2026032321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%
5min1214483-21448356.97555.186.9056.9855.186.91
2225850-22585059.99559.99
3210496-21049655.91655.92
4212098-21209856.34256.34
5199380-19938052.96352.96
6184133-18413348.91348.91
10min1276447-27644773.43574.563.5273.5374.663.52
2293518-29351877.97078.07
3287871-28787176.47076.56
4284663-28466375.61875.71
5275411-27541173.16073.25
6266257-26625770.72970.81
15min1295748-29574878.56380.492.8978.7880.712.89
2314525-31452583.55083.78
3307542-30754281.69681.92
4308595-30859581.97582.20
5300338-30033879.78279.99
6291285-29128577.37777.58
20min1304259-30425980.82382.872.8581.1783.222.85
2323858-32385886.03086.40
3316708-31670884.13084.49
4317857-31785784.43684.79
5308209-30820981.87382.22
6300933-30093379.94080.27
30min1312559-31255983.02885.242.5383.5185.732.54
2332456-33245688.31488.83
3324461-32446186.19086.69
4325633-32563386.50187.00
5318651-31865184.64785.13
6311622-31162282.77983.24
45min1318202-31820284.52787.042.3885.1587.672.38
2339408-33940890.16090.82
3329479-32947987.52388.16
4331569-33156988.07888.72
5327230-32723086.92587.55
6320146-32014685.04485.64
60min1325788-32578886.54288.612.3287.3089.392.33
2344901-34490191.62092.43
3335042-33504289.00189.79
4338965-33896590.04390.83
5331897-33189788.16588.93
6324917-32491786.31187.05
极限1339083-33908390.07493.612.5090.9894.542.49
2364737-36473796.88997.85
3352107-35210793.53494.47
4350148-35014893.01393.95
5358963-35896395.35596.27
6349410-34941092.81793.70
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