恩格列净二甲双胍片项目信息
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对照品来源中检院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2000
标示量(mg)5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%
19.992317602319392325112323952322932321800.14
210.012324162309452316800.45
单位质量响应值RSD%判断
23241.2423144.860.30数据可信
供试品溶液-24012401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%
5min174846-7484628.75130.0612.8628.7530.0612.86
275615-7561529.04629.05
364289-6428924.69524.70
484594-8459432.49532.50
593997-9399736.10736.11
676234-7623429.28429.28
10min1157642-15764260.55563.8510.7860.6063.9010.78
2166591-16659163.99364.04
3142181-14218154.61654.66
4176252-17625267.70467.76
5194682-19468274.78374.84
6159894-15989461.42061.47
15min1219383-21938384.27286.446.6784.4286.606.68
2226678-22667887.07487.23
3200570-20057077.04577.18
4233811-23381189.81489.98
5245380-24538094.25894.44
6224335-22433586.17486.32
20min1241001-24100192.57693.772.1992.8694.072.21
2242083-24208392.99193.29
3236222-23622290.74091.00
4247058-24705894.90295.22
5250867-25086796.36596.71
6247492-24749295.06995.36
30min1250144-25014496.08896.100.9396.5396.560.93
2247367-24736795.02195.48
3248447-24844795.43695.85
4249903-24990395.99596.47
5251203-25120396.49597.00
6253992-25399297.56698.02
45min1250723-25072396.31096.140.8496.9196.760.85
2248006-24800695.26695.88
3248334-24833495.39295.96
4250097-25009796.07096.70
5250698-25069896.30196.96
6253845-25384597.50998.13
60min1250193-25019396.10796.130.8796.8796.910.87
2248234-24823495.35496.13
3248347-24834795.39796.13
4249826-24982695.96696.76
5250822-25082296.34897.17
6254138-25413897.62298.40
极限1253867-25386797.51896.920.9398.4497.860.93
2250161-25016196.09497.03
3250383-25038396.18097.07
4251203-25120396.49597.45
5251987-25198796.79697.78
6256238-25623898.42999.37
恩格列净二甲双胍片项目信息
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DA-11412209074对照品来源工作对照品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10
标示量(mg)850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%
19.919020178994159014049022189011659012440.13
29.908975838939418957620.29
单位质量响应值RSD%判断
90942.8990481.010.37数据可信
供试品溶液-24012401批-二甲双胍-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%
5min1400806-40080646.78447.5010.2146.7847.5010.22
2396821-39682146.31946.32
3347954-34795440.61540.61
4432935-43293550.53450.53
5471131-47113154.99354.99
6392223-39222345.78245.78
10min1711325-71132583.02986.608.8983.1186.688.89
2744344-74434486.88386.96
3654303-65430376.37376.44
4778199-77819990.83590.92
5847403-84740398.91399.00
6715872-71587283.56083.64
15min1928166-928166108.340110.165.37108.56110.385.38
2947375-947375110.582110.80
3861609-861609100.571100.77
4975901-975901113.912114.15
51012663-1012663118.203118.46
6936628-936628109.327109.54
20min1992705-992705115.873116.791.35116.27117.201.36
2993531-993531115.969116.38
3982174-982174114.644115.01
41009619-1009619117.847118.27
51018895-1018895118.930119.38
61006415-1006415117.473117.87
30min11017073-1017073118.717118.470.48119.31119.070.49
21008074-1008074117.667118.27
31010845-1010845117.990118.54
41014300-1014300118.394119.02
51019015-1019015118.944119.60
61020399-1020399119.106119.70
45min11016982-1016982118.707118.440.47119.49119.240.48
21007949-1007949117.652118.45
31010899-1010899117.997118.75
41014033-1014033118.362119.18
51017550-1017550118.773119.62
61020922-1020922119.167119.96
60min11014733-1014733118.444118.330.42119.43119.330.43
21008230-1008230117.685118.68
31011314-1011314118.045118.99
41011988-1011988118.124119.14
51015830-1015830118.572119.62
61020394-1020394119.105120.10
极限11015604-1015604118.546118.160.46119.73119.350.47
21006140-1006140117.441118.63
31008836-1008836117.756118.90
41011862-1011862118.109119.32
51012196-1012196118.148119.39
61019133-1019133118.958120.15
恩格列净二甲双胍片项目信息
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对照品来源中检院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2000
标示量(mg)5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%
19.992335712333902336122336002338412336030.07
210.012334482317082325780.53
单位质量响应值RSD%判断
23383.6823234.570.46数据可信
供试品溶液-301166A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%
5min122396-223968.5608.8513.798.568.8513.78
222534-225348.6138.61
323226-232268.8778.88
419151-191517.3207.32
528968-2896811.07211.07
622717-227178.6838.68
10min142749-4274916.33916.8716.3516.3516.8816.33
245443-4544317.36917.38
345064-4506417.22417.24
434136-3413613.04713.06
556240-5624021.49621.51
641134-4113415.72215.74
15min161842-6184223.63724.9916.6823.6825.0416.68
267368-6736825.74925.79
367602-6760225.83925.88
450590-5059019.33619.37
583724-8372432.00132.06
661192-6119223.38923.43
20min179025-7902530.20532.8317.1430.2932.9217.14
288675-8867533.89333.98
389471-8947134.19834.28
467832-6783225.92725.99
5111274-11127442.53142.64
679157-7915730.25530.33
30min1114771-11477143.86845.2712.7844.0045.4112.74
2141178-14117853.96154.10
3131950-13195050.43450.58
4101664-10166438.85838.97
5106986-10698640.89241.07
6114112-11411243.61643.75
45min1178341-17834168.16568.8414.9268.3769.0614.91
2207517-20751779.31779.55
3189341-18934172.37072.60
4150821-15082157.64757.82
5208137-20813779.55479.80
6146536-14653656.00956.21
60min1219227-21922783.79383.5811.0884.1183.9111.07
2257754-25775498.51898.88
3214750-21475082.08282.43
4206105-20610578.77779.05
5229047-22904787.54687.93
6185141-18514170.76471.06
极限1256881-25688198.18597.410.9298.6497.880.93
2258115-25811598.65699.19
3253715-25371596.97597.46
4255213-25521397.54797.95
5253360-25336096.83997.36
6251902-25190296.28296.70
恩格列净二甲双胍片项目信息
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DA-11412209074对照品来源工作对照品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10
标示量(mg)850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%
19.918967578979628971548980708965028972890.08
29.908975268964888970070.09
单位质量响应值RSD%判断
90543.7990606.770.05数据可信
供试品溶液-301166A批-二甲双胍-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%
5min1193221-19322122.58822.666.8922.5922.666.89
2189272-18927222.12622.13
3193748-19374822.64922.65
4178313-17831320.84520.84
5218557-21855725.54925.55
6189717-18971722.17822.18
10min1304357-30435735.57936.308.1035.6236.348.10
2311106-31110636.36836.41
3313850-31385036.68936.73
4279529-27952932.67732.71
5355394-35539441.54641.59
6298881-29888134.93934.98
15min1390752-39075245.67947.228.8445.7847.328.84
2407284-40728447.61147.71
3411361-41136148.08848.19
4359379-35937942.01142.10
5466324-46632454.51354.63
6388356-38835645.39945.49
20min1463446-46344654.17756.899.7954.3557.079.78
2494636-49463657.82358.00
3497750-49775058.18758.37
4430255-43025550.29750.46
5569894-56989466.62166.82
6464067-46406754.24954.42
30min1592200-59220069.22870.907.2769.4971.177.25
2670457-67045778.37678.65
3648767-64876775.84176.12
4556893-55689365.10165.34
5573632-57363267.05767.37
6596938-59693869.78270.04
45min1785247-78524791.79593.839.1492.1794.229.13
2873833-873833102.151102.55
3829070-82907096.91897.32
4722481-72248184.45884.81
5887558-887558103.755104.18
6717900-71790083.92284.30
60min1911197-911197106.519106.857.03107.05107.407.02
21012008-1012008118.304118.88
3907839-907839106.126106.69
4871683-871683101.900102.39
5954335-954335111.562112.16
6827238-82723896.70497.22
极限11006254-1006254117.631117.210.74118.34117.930.77
21013812-1013812118.514119.29
31000275-1000275116.932117.67
4998707-998707116.749117.41
51004551-1004551117.432118.22
6992142-992142115.981116.66
恩格列净二甲双胍片项目信息
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对照品来源中检院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2000
标示量(mg)5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%
19.992339902339972339072343592346272341760.14
210.012339722330302335010.29
单位质量响应值RSD%判断
23441.0423326.770.35数据可信
供试品溶液-202799B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%
5min129028-2902811.06012.3820.9011.0612.3820.92
234562-3456213.16813.17
324999-249999.5249.52
434096-3409612.99012.99
544167-4416716.82716.83
628110-2811010.71010.71
10min164157-6415724.44427.2422.3024.4627.2722.30
278910-7891030.06430.09
352113-5211319.85519.87
471508-7150827.24427.27
598489-9848937.52437.55
663880-6388024.33824.36
15min197785-9778537.25642.0822.2137.3142.1522.21
2122013-12201346.48646.56
380591-8059130.70530.75
4110220-11022041.99342.06
5151887-15188757.86857.96
6100209-10020938.17938.24
20min1126707-12670748.27555.2721.3848.4055.4121.38
2160242-16024261.05161.20
3107179-10717940.83540.93
4144659-14465955.11455.25
5196991-19699175.05375.24
6134669-13466951.30851.43
30min1188715-18871571.89973.8411.3272.1074.0711.32
2223240-22324085.05385.30
3156289-15628959.54559.71
4200065-20006576.22476.45
5192804-19280473.45773.77
6201730-20173076.85877.07
45min1240159-24015991.49990.835.4791.8291.185.50
2245634-24563493.58593.98
3213858-21385881.47981.75
4244602-24460293.19293.55
5250470-25047095.42895.86
6235743-23574389.81790.15
60min1243632-24363292.82394.602.8293.3095.112.85
2247804-24780494.41294.96
3237180-23718090.36490.77
4255762-25576297.44497.96
5251368-25136895.77096.36
6254089-25408996.80797.29
极限1246598-24659893.95396.242.0594.5896.902.01
2248855-24885594.81395.52
3254518-25451896.97097.52
4257149-25714997.97298.65
5249117-24911794.91295.67
6259430-25943098.84299.49
恩格列净二甲双胍片项目信息
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DA-11412209074对照品来源工作对照品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10
标示量(mg)850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%
19.919017819036039023959042229033079030620.11
29.909048809041619045200.06
单位质量响应值RSD%判断
91126.3491365.660.19数据可信
供试品溶液-202799B批-二甲双胍-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%
5min1190517-19051722.10823.3411.8722.1123.3411.86
2210196-21019624.39124.39
3173442-17344220.12620.13
4205726-20572623.87323.87
5241456-24145628.01928.02
6185680-18568021.54621.55
10min1330534-33053438.35540.8913.4938.3940.9313.49
2379594-37959444.04844.09
3294503-29450334.17434.21
4348744-34874440.46940.51
5431063-43106350.02150.07
6329729-32972938.26238.30
15min1447114-44711451.88355.7214.5951.9855.8314.59
2521071-52107160.46560.58
3394014-39401445.72245.81
4472507-47250754.83054.94
5596009-59600969.16169.29
6450611-45061152.28952.39
20min1540707-54070762.74468.0314.4962.9368.2314.48
2639246-63924674.17974.39
3480750-48075055.78755.95
4576073-57607366.84867.05
5724210-72421084.03884.28
6556550-55655064.58264.77
30min1712123-71212382.63583.378.6282.9383.688.60
2810160-81016094.01294.35
3630290-63029073.13973.40
4735681-73568185.36985.68
5675662-67566278.40478.79
6746682-74668286.64686.94
45min1851026-85102698.75497.043.7399.1897.493.75
2858767-85876799.652100.15
3775346-77534689.97290.35
4848013-84801398.40498.86
5852398-85239898.91399.43
6831906-83190696.53596.97
60min1854719-85471999.18299.321.6499.7899.941.65
2855575-85557599.28299.94
3831664-83166496.50797.04
4869961-869961100.951101.57
5853963-85396399.09599.78
6869619-869619100.911101.51
极限1854253-85425399.12899.851.3399.89100.631.29
2853092-85309298.99399.82
3862726-862726100.111100.80
4870951-870951101.066101.85
5846148-84614898.18899.03
6875741-875741101.622102.39
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