恩格列净二甲双片项目信息
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对照品来源中检院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%
110.149406394488939409425694233941960.23
210.149374093978938590.18
单位质量响应值RSD%判断
9289.559256.310.26数据可信
长期6月-供试品溶液-2024112921批-恩格列净-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%
5min142267-4226741.02335.3510.5641.0235.3510.56
231674-3167430.74230.74
337610-3761036.50336.50
433185-3318532.20832.21
535331-3533134.29134.29
638447-3844737.31637.32
10min186102-8610283.56873.098.4383.6473.158.43
267822-6782265.82665.88
375306-7530673.09073.15
470509-7050968.43468.49
574510-7451072.31772.37
677568-7756875.28575.35
15min198359-9835995.46491.452.9595.6791.642.96
290174-9017487.52087.68
395645-9564592.83093.01
492562-9256289.83890.01
593946-9394691.18191.36
694682-9468291.89692.08
20min199294-9929496.37296.041.0396.7496.371.03
297277-9727794.41494.72
399781-9978196.84497.18
499664-9966496.73197.05
599549-9954996.61996.95
698145-9814595.25795.60
30min199302-9930296.38096.730.8996.9197.220.89
298433-9843395.53696.00
3100656-10065697.69498.19
4100628-10062897.66798.15
599850-9985096.91197.40
699089-9908996.17396.67
45min199463-9946396.53696.770.9897.2297.430.98
298355-9835595.46096.08
3100419-10041997.46498.13
4101105-10110598.13098.77
599830-9983096.89297.54
699071-9907196.15596.82
60min199577-9957796.64696.731.0197.5097.551.01
298294-9829495.40196.18
3100739-10073997.77498.60
4100891-10089197.92298.73
599467-9946796.54097.35
699021-9902196.10796.93
极限1100019-10001997.07597.270.7898.0998.250.77
2100129-10012997.18298.12
3101088-10108898.11399.10
4101041-10104198.06799.04
5100069-10006997.12498.10
698992-9899296.07997.06
恩格列净二甲双片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.999001289004058995219002219009549002460.06
210.069011679018349015000.06
单位质量响应值RSD%判断
90114.7189612.330.40数据可信
长期6月-供试品溶液-2024112921批-二甲双-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%
5min1468679-46867946.93941.379.1046.9441.379.10
2366966-36696636.75336.75
3425466-42546642.61242.61
4378099-37809937.86837.87
5405831-40583140.64540.65
6433126-43312643.37943.38
10min1858097-85809785.94176.777.1686.0276.847.16
2701377-70137770.24570.31
3767481-76748176.86576.94
4722126-72212672.32372.39
5763061-76306176.42376.49
6787009-78700978.82178.89
15min1954744-95474495.62092.482.5095.8492.682.51
2889550-88955089.09189.27
3938168-93816893.96094.16
4908003-90800390.93991.12
5919724-91972492.11392.31
6930376-93037693.18093.38
20min1962143-96214396.36196.010.7696.7496.360.77
2944861-94486194.63094.96
3965797-96579796.72797.08
4960798-96079896.22696.56
5960298-96029896.17696.53
6957905-95790595.93796.30
30min1961639-96163996.31196.500.6696.8597.010.66
2954079-95407995.55496.04
3972158-97215897.36497.88
4968890-96889097.03797.53
5962238-96223896.37196.88
6962338-96233896.38196.90
45min1961306-96130696.27796.470.7496.9897.140.74
2953514-95351495.49796.14
3972746-97274697.42398.10
4970115-97011597.16097.82
5961605-96160596.30796.98
6960133-96013396.16096.84
60min1959695-95969596.11696.350.7396.9897.180.73
2952993-95299395.44596.25
3971746-97174697.32398.16
4968752-96875297.02397.84
5960176-96017696.16496.99
6958549-95854996.00196.84
极限1957550-95755095.90196.330.5496.9297.320.53
2963265-96326596.47497.44
3969311-96931197.07998.08
4965796-96579696.72797.71
5957631-95763195.90996.90
6957154-95715495.86296.86
恩格列净二甲双片项目信息
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对照品来源中检院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%
110.149400793677938309389693486937790.22
210.149542195221953210.15
单位质量响应值RSD%判断
9248.429400.491.16数据可信
长期6月-供试品溶液-2024112921批-恩格列净-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%
5min134752-3475233.54538.3017.7433.5438.3017.74
248514-4851446.82946.83
337074-3707435.78635.79
433148-3314831.99732.00
548711-4871147.01947.02
635899-3589934.65234.65
10min171192-7119268.71975.2611.2368.7875.3311.24
288938-8893885.84985.93
374002-7400271.43271.49
471193-7119368.72068.77
589425-8942586.31986.40
673084-7308470.54670.60
15min190671-9067187.52291.543.7487.6991.733.76
2100516-10051697.02597.25
394763-9476391.47291.65
492987-9298789.75789.93
597230-9723093.85394.08
692810-9281089.58789.76
20min194963-9496391.66594.422.2191.9894.762.22
2101352-10135297.83298.21
397757-9775794.36294.69
498279-9827994.86695.18
598210-9821094.79995.18
696336-9633692.99093.31
30min196300-9630092.95595.341.8893.4295.841.90
2101778-10177898.24398.79
399696-9969696.23396.72
498810-9881095.37895.85
598137-9813794.72895.27
697893-9789394.49394.97
45min196884-9688493.51995.241.4994.1495.901.51
2101174-10117497.66098.37
398693-9869395.26595.91
499053-9905395.61396.25
598603-9860395.17895.87
697613-9761394.22394.86
60min197186-9718693.81195.471.5994.5996.281.60
2101461-10146197.93798.81
398942-9894295.50696.31
499896-9989696.42697.22
598098-9809894.69195.54
697830-9783094.43295.23
极限197408-9740894.02595.541.5594.9696.521.56
2101815-10181598.27999.31
399229-9922995.78396.75
498916-9891695.48096.44
598436-9843695.01796.03
698070-9807094.66495.62
恩格列净二甲双片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.998989238983318987418978628987128985140.05
210.069072909076999074940.04
单位质量响应值RSD%判断
89941.3490208.150.21数据可信
长期6月-供试品溶液-2024112921批-二甲双-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%
5min1396385-39638539.60643.9415.1939.6143.9415.19
2522825-52282552.23952.24
3416364-41636441.60241.60
4374764-37476437.44537.45
5525656-52565652.52252.52
6402756-40275640.24240.24
10min1731848-73184873.12478.399.4273.1978.469.43
2876395-87639587.56787.65
3754078-75407875.34575.41
4720914-72091472.03272.09
5881252-88125288.05288.14
6742730-74273074.21274.28
15min1893687-89368789.29592.373.0089.4892.573.02
2966952-96695296.61596.85
3926979-92697992.62192.82
4906021-90602190.52790.71
5945565-94556594.47894.71
6907380-90738090.66390.85
20min1927037-92703792.62794.641.6792.9695.001.69
2973268-97326897.24697.64
3950714-95071494.99395.34
4948144-94814494.73695.07
5948914-94891494.81395.20
6935264-93526493.44993.79
30min1935258-93525893.44895.121.3993.9495.641.40
2971457-97145797.06597.62
3963051-96305196.22596.73
4950572-95057294.97995.47
5947865-94786594.70895.26
6943758-94375894.29894.80
45min1938509-93850993.77395.011.1594.4295.681.17
2969949-96994996.91597.63
3955501-95550195.47196.14
4950294-95029494.95195.60
5946594-94659494.58195.29
6944550-94455094.37795.03
60min1936500-93650093.57295.061.3094.3895.901.31
2971936-97193697.11397.99
3954835-95483595.40496.23
4955392-95539295.46096.27
5946427-94642794.56495.43
6943548-94354894.27795.09
极限1936267-93626793.54994.741.1794.5195.721.18
2966706-96670696.59197.63
3954773-95477395.39896.38
4946880-94688094.61095.58
5942970-94297094.21995.24
6941209-94120994.04395.01
恩格列净二甲双片项目信息
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对照品来源中检院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%
110.149408394033940479421694124941010.08
210.149474894579946640.13
单位质量响应值RSD%判断
9280.189335.700.43数据可信
长期6月-供试品溶液-2024120221批-恩格列净-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%
5min138613-3861337.33637.327.8537.3437.327.85
241393-4139340.02440.02
333217-3321732.11832.12
441552-4155240.17840.18
538829-3882937.54537.54
638002-3800236.74536.75
10min175881-7588173.37174.025.0673.4374.095.06
279713-7971377.07777.14
369191-6919166.90366.96
479239-7923976.61876.69
577082-7708274.53374.60
678228-7822875.64175.70
15min195109-9510991.96392.911.6592.1593.091.66
297882-9788294.64594.84
393485-9348590.39390.56
497110-9711093.89894.09
596150-9615092.97093.16
696770-9677093.56993.76
20min199737-9973796.43897.100.9496.7897.440.94
2100428-10042897.10697.46
3100583-10058397.25697.57
4102159-10215998.78099.13
5100066-10006696.75697.10
699545-9954596.25396.60
30min1100163-10016396.85097.890.9697.3598.390.95
2100800-10080097.46697.98
3102337-10233798.95299.43
4101649-10164998.28798.80
5102218-10221898.83799.34
6100234-10023496.91997.42
45min1101575-10157598.21597.970.5898.8898.640.58
2101384-10138498.03198.71
3101564-10156498.20598.85
4101946-10194698.57499.25
5101227-10122797.87998.55
6100233-10023396.91897.58
60min1100477-10047797.15497.890.5197.9898.720.51
2101699-10169998.33599.18
3101252-10125297.90398.71
4101761-10176198.39599.24
5100805-10080597.47198.30
6101465-10146598.10998.94
极限1100886-10088697.54997.990.5398.5398.980.53
2101429-10142998.07499.08
3101461-10146198.10599.07
4102129-10212998.75199.76
5101511-10151198.15499.15
6100623-10062397.29598.29
恩格列净二甲双片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.998989628995178987738987908987978989680.04
210.069008499013959011220.05
单位质量响应值RSD%判断
89986.7989574.750.33数据可信
长期6月-供试品溶液-2024120221批-二甲双-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%
5min1433147-43314743.42143.396.6143.4243.396.61
2461686-46168646.28246.28
3380359-38035938.12938.13
4454165-45416545.52845.53
5438277-43827743.93543.93
6429446-42944643.05043.05
10min1768758-76875877.06477.544.2177.1477.624.22
2804035-80403580.60080.68
3711529-71152971.32771.39
4790690-79069079.26279.34
5779883-77988378.17978.25
6786329-78632978.82578.90
15min1925806-92580692.80793.461.3893.0193.671.38
2949291-94929195.16195.37
3912149-91214991.43891.62
4935085-93508593.73793.95
5931190-93119093.34793.55
6940696-94069694.30094.50
20min1961841-96184196.41996.740.7396.7797.100.72
2962405-96240596.47696.85
3966532-96653296.89097.22
4978396-97839698.07998.44
5962462-96246296.48296.84
6958818-95881896.11696.48
30min1964715-96471596.70897.320.8497.2297.840.84
2965740-96574096.81097.34
3978622-97862298.10298.60
4971862-97186297.42497.95
5982172-98217298.45898.98
6962082-96208296.44496.96
45min1967763-96776397.01397.050.3397.6997.730.32
2967784-96778497.01597.71
3970341-97034197.27297.93
4971425-97142597.38098.07
5968747-96874797.11297.80
6962478-96247896.48397.16
60min1962403-96240396.47696.990.2997.3197.840.30
2970139-97013997.25198.11
3968103-96810397.04797.87
4969595-96959597.19798.05
5966972-96697296.93497.78
6968183-96818397.05597.90
极限1961864-96186496.42296.600.3297.4297.600.32
2963084-96308496.54497.56
3964359-96435996.67297.66
4967773-96777397.01498.03
5965558-96555896.79297.80
6959033-95903396.13897.14
恩格列净二甲双片项目信息
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对照品来源中检院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%
110.149445594283944629455394418944340.11
210.149589195612957520.21
单位质量响应值RSD%判断
9313.029443.000.99数据可信
长期6月-供试品溶液-2024120221批-恩格列净-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%
5min137456-3745635.94840.5117.1335.9540.5117.13
234829-3482933.42733.43
340412-4041238.78538.78
439859-3985938.25438.25
545719-4571943.87843.88
654979-5497952.76552.77
10min174581-7458171.57877.179.9371.6477.249.94
270829-7082967.97768.03
377487-7748774.36774.43
479802-7980276.58976.65
591416-9141687.73587.81
688335-8833584.77884.87
15min195873-9587392.01393.673.9292.1993.873.94
291496-9149687.81287.98
397762-9776293.82694.01
497374-9737493.45493.64
5100692-10069296.63896.86
6102419-10241998.29598.52
20min1100632-10063296.58096.571.3896.9196.921.39
298206-9820694.25294.57
3100407-10040796.36496.71
4101069-10106997.00097.35
5100941-10094196.87797.26
6102446-10244698.32198.71
30min1101010-10101096.94397.091.3397.4497.601.35
298861-9886194.88195.35
3102103-10210397.99298.50
4101175-10117597.10297.61
5100980-10098096.91497.46
6102836-10283698.69699.25
45min1101249-10124997.17397.101.1597.8397.771.17
299043-9904395.05595.69
3101681-10168197.58798.26
4101354-10135497.27397.94
5101152-10115297.07997.78
6102546-10254698.41799.14
60min1101083-10108397.01396.840.9997.8397.681.00
299045-9904595.05795.85
3101670-10167097.57798.41
4101041-10104196.97397.81
5100781-10078196.72397.59
6101797-10179797.69898.58
极限1101343-10134397.26397.031.2598.2498.031.27
299039-9903995.05296.00
3101398-10139897.31698.31
4101077-10107797.00798.00
5100787-10078796.72997.76
6102958-10295898.81399.86
恩格列净二甲双片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.999006029005739007979005979008009006740.02
210.069114679120769117720.05
单位质量响应值RSD%判断
90157.5690633.400.38数据可信
长期6月-供试品溶液-2024120221批-二甲双-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%
5min1423545-42354542.16946.1714.6542.1746.1714.65
2391319-39131938.96138.96
3445713-44571344.37744.38
4441803-44180343.98743.99
5496666-49666649.45049.45
6583318-58331858.07758.08
10min1757849-75784975.45480.148.0175.5280.218.02
2732576-73257672.93873.00
3775829-77582977.24477.32
4797575-79757579.40979.48
5895052-89505289.11489.20
6870412-87041286.66186.76
15min1932383-93238392.83193.962.8293.0394.172.84
2903283-90328389.93490.12
3940713-94071393.66093.86
4939706-93970693.56093.77
5968982-96898296.47596.71
6976972-97697297.27097.51
20min1970189-97018996.59596.320.8696.9596.690.88
2954466-95446695.03095.37
3964105-96410595.98996.35
4967118-96711896.28996.65
5969019-96901996.47996.87
6979938-97993897.56697.97
30min1969443-96944396.52196.530.8097.0397.060.82
2957977-95797795.37995.87
3976070-97607097.18197.70
4966181-96618196.19696.72
5967641-96764196.34196.89
6979977-97997797.57098.14
45min1972520-97252096.82796.500.7597.5097.180.76
2957514-95751495.33395.99
3970314-97031496.60897.29
4967777-96777796.35597.04
5967564-96756496.33497.05
6979421-97942197.51498.24
60min1968737-96873796.45196.250.6997.2897.100.70
2955301-95530195.11395.93
3968796-96879696.45697.30
4966342-96634296.21297.06
5965468-96546896.12597.00
6975485-97548597.12298.01
极限1965665-96566596.14596.120.9397.1497.130.95
2954039-95403994.98795.96
3965470-96547096.12597.13
4963067-96306795.88696.89
5962870-96287095.86696.90
6981483-98148397.72098.77
恩格列净二甲双片项目信息
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对照品来源中检院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%
110.149371193582937309381793463936610.15
210.149382593838938320.01
单位质量响应值RSD%判断
9236.799253.650.13数据可信
长期6月-供试品溶液-2024120321批-恩格列净-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%
5min130479-3047929.67137.5516.6629.6737.5516.66
237294-3729436.30536.30
343900-4390042.73642.74
445828-4582844.61344.61
542136-4213641.01841.02
631828-3182830.98430.98
10min165612-6561263.87275.5511.6763.9275.6111.68
273369-7336971.42371.48
386585-8658584.28984.36
485416-8541683.15183.22
584625-8462582.38182.45
670039-7003968.18168.23
15min189958-8995887.57293.243.8687.7393.433.88
295421-9542192.89093.07
397528-9752894.94195.15
499967-9996797.31697.53
598505-9850595.89296.10
693299-9329990.82490.99
20min198406-9840695.79697.541.5796.1097.881.58
2100434-10043497.77098.10
398874-9887496.25296.62
4102327-10232799.61399.99
5101672-10167298.97599.34
699486-9948696.84797.16
30min199851-9985197.20398.011.5097.6698.521.50
2101206-10120698.52299.02
398362-9836295.75396.28
4102429-10242999.712100.25
5101987-10198799.28299.81
6100262-10026297.60398.08
45min1100081-10008197.42798.291.3698.0598.961.36
2101818-10181899.11799.78
398926-9892696.30296.99
4102378-10237899.663100.37
5102152-10215299.443100.14
6100473-10047397.80898.45
60min199959-9995997.30897.951.4398.0998.781.43
2101245-10124598.56099.39
398306-9830695.69996.55
4102290-10229099.577100.45
5101691-10169198.99499.86
6100219-10021997.56198.36
极限1100382-10038297.72098.221.1998.6799.211.20
2101425-10142598.73599.73
398896-9889696.27397.28
4102303-10230399.590100.63
5101681-10168198.984100.01
6100666-10066697.99698.96
恩格列净二甲双片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.999413199413549408999407929407219410170.04
210.069413779398449406100.12
单位质量响应值RSD%判断
94195.9093500.000.53数据可信
长期6月-供试品溶液-2024120321批-二甲双-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%
5min1372789-37278935.75143.4914.2335.7543.4914.23
2440491-44049142.24442.24
3509623-50962348.87348.87
4522658-52265850.12350.12
5491020-49102047.08947.09
6384266-38426636.85236.85
10min1717574-71757468.81678.879.8168.8878.959.81
2783045-78304575.09575.17
3903664-90366486.66286.74
4890859-89085985.43485.52
5885476-88547684.91885.00
6753957-75395772.30572.37
15min1933314-93331489.50693.642.8989.6893.842.90
2967833-96783392.81693.01
3994923-99492395.41495.64
41004527-100452796.33596.56
51000030-100003095.90496.12
6958035-95803591.87792.06
20min11003495-100349596.23697.101.0196.5697.461.02
21007436-100743696.61496.96
31004067-100406796.29196.68
41025494-102549498.34698.73
51025098-102509898.30898.69
61009548-100954896.81797.15
30min11015410-101541097.37997.340.9097.8697.860.90
21010056-101005696.86697.38
31001787-100178796.07296.62
41025119-102511998.31098.86
51025138-102513898.31298.86
61012534-101253497.10397.60
45min11012356-101235697.08697.240.8697.7397.920.86
21009280-100928096.79197.46
31000670-100067095.96596.67
41023614-102361498.16698.88
51022738-102273898.08298.79
61014942-101494297.33497.99
60min11012680-101268097.11797.120.8497.9397.970.84
21008786-100878696.74497.58
3998992-99899295.80496.67
41022062-102206298.01798.89
51020731-102073197.88998.76
61013135-101313597.16197.98
极限11011130-101113096.96996.910.7997.9497.920.79
21006681-100668196.54297.54
3997219-99721995.63496.66
41018219-101821997.64898.69
51018453-101845397.67198.70
61011236-101123696.97997.96
恩格列净二甲双片项目信息
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对照品来源中检院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%
110.149397893880938789353493788938120.19
210.149369993963938310.20
单位质量响应值RSD%判断
9251.689253.550.02数据可信
长期6月-供试品溶液-2024120321批-恩格列净-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%
5min150267-5026748.89537.8820.6748.8937.8820.66
241271-4127140.14440.14
345179-4517943.94643.95
432244-3224431.36431.36
529254-2925428.45528.46
635432-3543234.46534.46
10min187131-8713184.75274.5912.8784.8374.6512.88
280694-8069478.49178.56
387914-8791485.51485.59
467890-6789066.03666.09
565498-6549863.71063.76
670954-7095469.01769.07
15min196665-9666594.02691.184.6394.2591.364.65
296171-9617193.54593.74
399610-9961096.89097.11
490046-9004687.58887.75
588792-8879286.36886.52
691122-9112288.63488.81
20min197655-9765594.98995.661.4295.3796.001.43
299746-9974697.02397.38
3100136-10013697.40297.78
498251-9825195.56995.88
597922-9792295.24995.55
696383-9638393.75294.07
30min196931-9693194.28596.551.6594.8297.041.63
2100100-10010097.36797.88
3100221-10022197.48598.02
4100829-10082998.07698.54
5100015-10001597.28497.74
697450-9745094.78995.27
45min196753-9675394.11196.801.7794.8197.461.75
2100161-10016197.42698.10
3100504-10050497.76098.46
4100271-10027197.53398.16
5101423-10142398.65499.27
698012-9801295.33695.97
60min196470-9647093.83696.501.6394.6997.321.61
2100029-10002997.29898.14
3100012-10001297.28198.15
4100333-10033397.59498.39
5100415-10041597.67398.46
697974-9797495.29996.09
极限196905-9690594.25996.891.5895.2797.871.56
2100312-10031297.57398.58
3100478-10047897.73598.76
4100670-10067097.92298.88
5100791-10079198.03998.98
698495-9849595.80696.76
恩格列净二甲双片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.999407469406239398969390059394469399430.08
210.069373429370799372100.02
单位质量响应值RSD%判断
94088.3993162.030.70数据可信
长期6月-供试品溶液-2024120321批-二甲双-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%
5min1567018-56701854.50843.6417.8854.5143.6417.88
2479914-47991446.13446.13
3516481-51648149.64949.65
4379265-37926536.45936.46
5359316-35931634.54134.54
6421939-42193940.56140.56
10min1898024-89802486.32777.6610.6786.4277.7410.68
2843417-84341781.07881.15
3905462-90546287.04287.13
4724428-72442869.63969.70
5710403-71040368.29168.35
6765737-76573773.61173.68
15min1975080-97508093.73591.763.5193.9791.963.53
2973090-97309093.54393.76
3999207-99920796.05496.28
4922645-92264588.69488.87
5913328-91332887.79987.97
6943596-94359690.70890.90
20min1981453-98145394.34795.360.9994.7495.721.00
21003253-100325396.44396.81
31004362-100436296.55096.94
4990170-99017095.18595.51
5989607-98960795.13195.45
6982982-98298294.49494.84
30min1977916-97791694.00795.961.1094.5696.481.08
21003953-100395396.51097.04
31001988-100198896.32196.87
41007712-100771296.87297.35
51004004-100400496.51596.99
6994074-99407495.56196.06
45min1976049-97604993.82895.921.2294.5396.591.19
21002523-100252396.37397.06
31001907-100190796.31497.02
41002899-100289996.40997.05
51010694-101069497.15897.80
6992569-99256995.41696.07
60min1974191-97419193.64995.811.2294.5196.641.19
21000825-100082596.21097.06
31002469-100246996.36897.24
41004119-100411996.52697.33
51006284-100628496.73497.53
6991817-99181795.34496.16
极限1973848-97384893.61695.671.2094.6396.661.18
21000959-100095996.22297.23
31000489-100048996.17797.21
41002291-100229196.35197.32
51004891-100489196.60097.56
6988639-98863995.03896.01
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