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%
114.493709083708553707863706513706963707790.03
214.403710313710393710350.01
单位质量响应值RSD%判断
25588.6125766.320.49数据可信
供试品溶液-2026032421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%
5min1245353-24535365.98362.355.7765.9862.355.77
2222083-22208359.72559.73
3217607-21760758.52258.52
4219975-21997559.15859.16
5239464-23946464.40064.40
6246494-24649466.29066.29
10min1319775-31977585.99881.883.1186.1181.993.12
2295389-29538979.44079.54
3297099-29709979.90080.00
4298494-29849480.27580.37
5305197-30519782.07782.18
6310876-31087683.60583.72
15min1344246-34424692.57988.102.7492.8388.342.74
2320356-32035686.15486.39
3322587-32258786.75486.98
4322403-32240386.70586.94
5324872-32487287.36987.61
6331108-33110889.04689.30
20min1346796-34679693.26590.042.2393.6790.422.24
2327779-32777988.15088.53
3330597-33059788.90889.28
4329856-32985688.70989.09
5332737-33273789.48489.87
6341034-34103491.71592.11
30min1351058-35105894.41191.321.9494.9791.861.94
2333228-33322889.61690.14
3337433-33743390.74791.27
4334541-33454189.96990.49
5338213-33821390.95691.50
6342925-34292592.22492.77
45min1353189-35318994.98492.211.6795.7092.901.68
2336553-33655390.51091.18
3340386-34038691.54192.22
4340942-34094291.69092.37
5341268-34126891.77892.47
6344971-34497192.77493.48
60min1353644-35364495.10692.531.9495.9893.381.94
2337478-33747890.75991.58
3341499-34149991.84092.67
4337006-33700690.63291.46
5349330-34933093.94694.79
6345481-34548192.91193.77
极限1356283-35628395.81693.901.6696.8594.901.65
2352220-35222094.72395.70
3351482-35148294.52595.51
4339724-33972491.36392.34
5349498-34949893.99194.99
6345735-34573592.97993.99
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%
114.493707343706893706633708203707333707280.02
214.403714463711603713030.06
单位质量响应值RSD%判断
25585.0925784.930.56数据可信
供试品溶液-2026032421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%
5min1212867-21286757.23059.914.9657.2359.914.95
2236492-23649263.58263.58
3221862-22186259.64959.65
4218081-21808158.63258.63
5236013-23601363.45363.45
6211623-21162356.89656.90
10min1293153-29315378.81579.821.7778.9179.921.77
2303821-30382181.68481.79
3296434-29643479.69879.80
4292107-29210778.53478.63
5302872-30287281.42881.53
6292862-29286278.73778.83
15min1314295-31429584.50085.521.4584.7385.761.46
2323721-32372187.03487.28
3320867-32086786.26686.50
4313101-31310184.17984.41
5322013-32201386.57586.82
6314642-31464284.59384.82
20min1324513-32451387.24787.971.6387.6188.341.64
2332863-33286389.49289.88
3333079-33307989.55089.93
4320605-32060586.19686.56
5329424-32942488.56788.95
6322746-32274686.77287.14
30min1335815-33581590.28590.351.7190.8090.871.70
2341778-34177891.88892.42
3343080-34308092.23892.76
4328533-32853388.32788.84
5336110-33611090.36590.90
6331082-33108289.01389.52
45min1343080-34308092.23891.961.8792.9092.631.87
2348852-34885293.79094.48
3349876-34987694.06694.74
4334092-33409289.82290.48
5339125-33912591.17591.86
6337173-33717390.65091.31
60min1347430-34743093.40892.742.0194.2393.572.00
2352232-35223294.69995.54
3352938-35293894.88995.72
4336374-33637490.43691.25
5341050-34105091.69392.53
6339656-33965691.31892.13
极限1355237-35523795.50794.201.7596.4895.181.75
2351977-35197794.63095.63
3359349-35934996.61297.61
4345860-34586092.98693.95
5344478-34447892.61493.60
6345285-34528592.83193.79
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%
114.493722793718083716093716513716203717930.08
214.403741963742943742450.02
单位质量响应值RSD%判断
25658.5925989.240.91数据可信
供试品溶液-2026032421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%
5min1208140-20814055.66056.094.5955.6656.094.59
2218232-21823258.35858.36
3220035-22003558.84158.84
4214917-21491757.47257.47
5196689-19668952.59852.60
6200490-20049053.61453.61
10min1276252-27625273.87475.233.3373.9775.323.33
2290976-29097677.81177.91
3278375-27837574.44274.54
4284239-28423976.01076.11
5266966-26696671.39171.48
6291065-29106577.83577.92
15min1300236-30023680.28881.013.1480.5081.233.13
2314471-31447184.09484.32
3298024-29802479.69679.92
4307114-30711482.12782.35
5288070-28807077.03477.24
6309777-30977782.83983.06
20min1308619-30861982.52983.382.8682.8883.742.86
2322560-32256086.25786.62
3308241-30824182.42882.78
4316658-31665884.67985.04
5297496-29749679.55579.89
6317308-31730884.85385.21
30min1316551-31655184.65086.901.8585.1487.401.85
2331472-33147288.64189.15
3322274-32227486.18186.67
4331131-33113188.54989.05
5321001-32100185.84086.31
6327438-32743887.56288.06
45min1322327-32232786.19589.621.9186.8290.261.90
2336253-33625389.91990.58
3337791-33779190.33090.97
4336969-33696990.11190.76
5339726-33972690.84891.46
6337709-33770990.30890.95
60min1327803-32780387.65990.341.7988.4391.121.78
2332958-33295889.03889.85
3343051-34305191.73792.52
4340724-34072491.11591.91
5341321-34132191.27492.04
6341020-34102091.19491.99
极限1357658-35765895.64394.181.4496.5695.111.43
2349554-34955493.47694.43
3355106-35510694.96195.90
4356811-35681195.41796.37
5345234-34523492.32193.23
6348641-34864193.23294.18
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%
114.493732723732503734873732663730973732740.04
214.403746463741693744080.10
单位质量响应值RSD%判断
25760.8026000.560.66数据可信
供试品溶液-2026032421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%
5min1250051-25005166.71964.154.7666.7264.154.77
2242338-24233864.66164.66
3254577-25457767.92767.93
4239966-23996664.02864.03
5223303-22330359.58259.58
6232374-23237462.00362.00
10min1318256-31825684.91885.321.6685.0385.421.66
2317877-31787784.81784.92
3324665-32466586.62886.74
4327387-32738787.35487.46
5312931-31293183.49783.60
6317413-31741384.69384.80
15min1342001-34200191.25492.001.3891.5192.251.38
2342510-34251091.39091.64
3347201-34720192.64192.90
4352779-35277994.13094.38
5339359-33935990.54990.79
6344977-34497792.04892.29
20min1351120-35112093.68793.730.7694.0994.130.76
2350531-35053193.53093.93
3352708-35270894.11194.52
4353919-35391994.43494.84
5346484-34648492.45092.84
6352943-35294394.17394.57
30min1352785-35278594.13194.740.4794.6995.300.47
2353559-35355994.33894.90
3356952-35695295.24395.81
4355605-35560594.88495.45
5354887-35488794.69295.24
6356551-35655195.13695.69
45min1354752-35475294.65694.810.8395.3795.520.83
2356590-35659095.14695.86
3356278-35627895.06395.79
4356770-35677095.19595.92
5349697-34969793.30794.01
6357801-35780195.47096.18
60min1353270-35327094.26194.900.8195.1495.780.81
2357535-35753595.39996.27
3355781-35578194.93195.82
4355877-35587794.95695.84
5351817-35181793.87394.73
6359790-35979096.00096.87
极限1352745-35274594.12194.960.6595.1595.990.64
2359419-35941995.90196.93
3355517-35551794.86095.90
4356130-35613095.02496.07
5354397-35439794.56195.57
6357068-35706895.27496.31
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