达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
1 12.608212982331821318231882199822220.12
2 12.618210982219821640.10
单位质量响应值RSD%判断
6525.566515.780.11数据可信
供试品溶液-WM0006批-达格列净-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%
5min146331-4633145.70144.097.6145.7044.097.62
241474-4147440.91040.91
350583-5058349.89549.90
441843-4184341.27441.27
544627-4462744.02044.02
643312-4331242.72342.72
10min190181-9018188.95583.705.9689.0283.765.96
279654-7965478.57178.63
385362-8536284.20184.28
478019-7801976.95877.02
589706-8970688.48688.55
686202-8620285.03085.09
15min199371-9937198.02092.304.7798.2292.494.76
288655-8865587.45087.63
391014-9101489.77689.98
489472-8947288.25588.43
597280-9728095.95796.16
695653-9565394.35294.54
20min1100030-10003098.67093.374.2999.0293.704.29
290338-9033889.11089.42
391669-9166990.42390.76
491269-9126990.02890.34
597590-9759096.26396.61
697052-9705295.73296.07
30min1100767-10076799.39793.943.9899.8994.413.97
292660-9266091.40091.84
392725-9272591.46491.94
491370-9137090.12890.57
595058-9505893.76594.25
698842-9884297.49897.97
45min1100004-10000498.64494.003.2399.2994.613.24
292641-9264191.38191.96
392473-9247391.21691.82
493007-9300791.74292.32
597107-9710795.78796.41
696542-9654295.22995.85
60min196822-9682295.50591.613.5896.3092.373.58
292151-9215190.89891.62
392171-9217190.91891.66
487376-8737686.18886.91
592962-9296291.69892.47
695774-9577494.47295.24
120min1100827-10082799.45693.185.30100.3994.075.26
297374-9737496.05096.90
392743-9274391.48292.36
488508-8850887.30588.15
589405-8940588.18989.10
697919-9791996.58897.50
180min199771-9977198.41491.026.4699.5092.056.41
296123-9612394.81695.81
390643-9064389.41090.43
487562-8756286.37187.35
583896-8389682.75583.80
695680-9568094.37995.43
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1100537-10053799.17090.997.17100.4092.167.11
297167-9716795.84696.99
389922-8992288.69989.85
487280-8728086.09387.20
583042-8304281.91383.08
695540-9554094.24195.43
360min196903-9690395.58588.557.1396.9789.857.06
294585-9458593.29994.58
389084-8908487.87389.16
485056-8505683.89985.14
579928-7992878.84180.13
693065-9306591.80093.13
480min196683-9668395.36887.497.8596.8988.937.78
295048-9504893.75695.18
386780-8678085.60087.02
483016-8301681.88783.25
579019-7901977.94579.35
691639-9163990.39391.87
600min194883-9488393.59386.307.6495.2687.867.56
292998-9299891.73393.30
385799-8579984.63286.18
482231-8223181.11382.60
577809-7780976.75178.27
691195-9119589.95591.56
720min193927-9392792.65085.537.8094.4687.237.72
292635-9263591.37593.08
384999-8499983.84385.52
481305-8130580.19981.81
576953-7695375.90777.55
690461-9046189.23190.97
960min193994-9399492.71684.628.0594.6686.447.97
289730-8973088.51090.35
386698-8669885.51987.32
480084-8008478.99580.72
575210-7521074.18775.94
688997-8899787.78789.66
1440min190810-9081089.57581.638.6891.6683.588.57
288816-8881687.60889.58
381456-8145680.34882.28
477856-7785676.79778.64
571766-7176670.79072.65
685832-8583284.66586.67
极限190873-9087389.63781.348.8891.8683.418.77
288630-8863087.42589.53
381112-8111280.00982.06
477310-7731076.25978.22
571412-7141270.44172.41
685425-8542584.26386.40
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.031110436111056311100061110606111021311103650.03
210.101098898109891210989050.01
单位质量响应值RSD%判断
110704.39108802.481.23数据可信
供试品溶液-WM0006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%
5min139326-393263.5833.406.333.583.406.33
237509-375093.4183.42
335252-352523.2123.21
440368-403683.6783.68
537286-372863.3983.40
634116-341163.1093.11
10min189965-899658.1988.022.118.208.022.09
284637-846377.7127.72
387993-879938.0188.02
489357-893578.1428.15
587816-878168.0028.01
688341-883418.0508.05
15min1140788-14078812.82912.412.2712.8512.432.28
2131644-13164411.99512.01
3135569-13556912.35312.37
4134676-13467612.27212.29
5137727-13772712.55012.57
6137035-13703512.48712.50
20min1181034-18103416.49616.022.1316.5316.062.12
2170648-17064815.54915.58
3174835-17483515.93115.97
4173279-17327915.78915.83
5178496-17849616.26516.30
6176881-17688116.11716.15
30min1251007-25100722.87222.002.2022.9322.062.19
2236623-23662321.56121.62
3239323-23932321.80721.87
4237017-23701721.59721.66
5242568-24256822.10322.16
6241786-24178622.03222.09
45min1317723-31772328.95128.671.1629.0528.761.16
2310590-31059028.30128.39
3313415-31341528.55828.65
4310550-31055028.29728.39
5318571-31857129.02829.12
6317125-31712528.89628.99
60min1377051-37705134.35734.271.2734.5034.411.28
2370515-37051533.76133.89
3373350-37335034.02034.15
4372877-37287733.97734.11
5383213-38321334.91835.06
6379623-37962334.59134.73
120min1586102-58610253.40653.501.1753.6053.691.16
2581137-58113752.95353.14
3582096-58209653.04153.23
4583679-58367953.18553.37
5599160-59916054.59654.78
6590748-59074853.82954.02
180min1722274-72227465.81466.050.6466.0866.320.64
2720639-72063965.66565.93
3727131-72713166.25666.52
4719740-71974065.58365.85
5730714-73071466.58366.85
6728695-72869566.39966.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1825673-82567375.23575.580.5875.6175.950.58
2827197-82719775.37475.74
3825887-82588775.25575.62
4827289-82728975.38375.75
5837209-83720976.28776.66
6833513-83351375.95076.32
360min1969937-96993788.38188.930.5188.8689.410.51
2975973-97597388.93189.41
3971255-97125588.50188.98
4975535-97553588.89189.37
5982484-98248489.52490.01
6980562-98056289.34989.83
480min11058393-105839396.44197.110.5197.0697.720.51
21071755-107175597.65898.27
31061382-106138296.71397.32
41063577-106357796.91397.52
51069563-106956397.45998.08
61069732-106973297.47498.09
600min11102834-1102834100.490101.100.36101.25101.860.36
21113104-1113104101.426102.18
31107361-1107361100.903101.66
41109562-1109562101.103101.86
51112651-1112651101.385102.15
61111925-1111925101.319102.08
720min11117057-1117057101.786102.490.48102.70103.400.48
21129460-1129460102.917103.82
31120246-1120246102.077102.98
41126679-1126679102.663103.57
51124207-1124207102.438103.36
61130972-1130972103.054103.97
960min11123799-1123799102.401102.640.28103.46103.700.28
21129989-1129989102.965104.03
31124309-1124309102.447103.51
41125650-1125650102.569103.63
51124056-1124056102.424103.50
61130636-1130636103.024104.09
1440min11110355-1110355101.176101.760.46102.39102.970.46
21123011-1123011102.329103.54
31112165-1112165101.341102.55
41116912-1116912101.773102.99
51115880-1115880101.679102.90
61122055-1122055102.242103.47
极限11106816-1106816100.853101.280.65102.22102.650.64
21120265-1120265102.079103.45
31109506-1109506101.098102.46
41112364-1112364101.359102.73
51101459-1101459100.365101.74
61118634-1118634101.930103.31
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
1 12.608218882004820718208382213821120.11
2 12.618327283225832480.04
单位质量响应值RSD%判断
6516.836601.740.92数据可信
供试品溶液-WM0006批-达格列净-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%
5min146238-4623845.34346.175.5745.3446.175.57
248398-4839847.46147.46
344438-4443843.57743.58
444596-4459643.73243.73
547436-4743646.51746.52
651392-5139250.39750.40
10min187445-8744585.75284.204.0685.8284.264.06
288260-8826086.55186.62
389910-8991088.16988.23
485760-8576084.09984.16
583410-8341081.79581.86
680382-8038278.82578.90
15min194992-9499293.15391.602.7493.3591.802.74
295677-9567793.82494.03
396233-9623394.37094.57
492346-9234690.55890.75
590958-9095889.19789.39
690270-9027088.52288.72
20min195545-9554593.69593.542.0294.0393.872.02
296883-9688395.00795.35
398286-9828696.38396.72
494401-9440192.57392.90
594045-9404592.22492.55
693158-9315891.35491.68
30min195760-9576093.90694.331.4294.3894.801.42
297251-9725195.36895.85
398426-9842696.52097.00
495151-9515193.30893.77
594970-9497093.13193.60
695587-9558793.73694.20
45min196185-9618594.32294.691.6694.9495.301.66
297690-9769095.79896.43
399157-9915797.23797.87
494928-9492893.09093.70
595256-9525693.41194.02
696124-9612494.26394.87
60min196601-9660194.73094.691.4295.4995.441.42
297539-9753995.65096.42
398769-9876996.85697.63
495493-9549393.64494.39
595521-9552193.67194.42
695410-9541093.56294.31
120min1101643-10164399.675100.091.35100.58100.991.35
2103651-103651101.644102.56
3103908-103908101.896102.82
4101460-10146099.495100.38
5100800-10080098.84899.73
6100919-10091998.96599.85
180min1102622-102622100.63599.791.65101.69100.841.65
2102997-102997101.003102.07
3103859-103859101.848102.92
4100982-10098299.027100.06
599410-9941097.48598.52
6100674-10067498.72599.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1101411-10141199.44799.551.41100.65100.751.41
2102527-102527100.542101.76
3103848-103848101.837103.06
4100807-10080798.855100.04
5100220-10022098.27999.46
6100306-10030698.36499.55
360min1101292-10129299.33199.562.00100.68100.912.00
2101977-101977100.002101.37
3105368-105368103.328104.71
4100002-10000298.06699.40
5100206-10020698.26699.59
6100326-10032698.38399.71
480min1100289-10028998.34798.701.1699.85100.201.16
2101401-10140199.437100.96
3102672-102672100.684102.22
499822-9982297.88999.37
599811-9981197.87899.35
699908-9990897.97399.45
600min199438-9943897.51297.741.4199.1699.391.41
2100640-10064098.691100.36
3102030-102030100.054101.74
498768-9876896.85598.48
598569-9856996.66098.28
698594-9859496.68598.31
720min199092-9909297.17397.191.3598.9798.981.35
2100154-10015498.215100.03
3101215-10121599.255101.09
498110-9811096.21097.98
598139-9813996.23998.00
697923-9792396.02797.80
960min197946-9794696.04995.941.2797.9997.881.28
298555-9855596.64798.61
399907-9990797.97299.96
496870-9687094.99496.91
596844-9684494.96996.88
696880-9688095.00496.92
1440min196710-9671094.83795.020.8996.9297.100.90
297305-9730595.42197.53
398419-9841996.51398.64
496391-9639194.52496.58
596084-9608494.22396.28
696441-9644194.57396.63
极限196057-9605794.19794.391.4696.4296.611.46
296796-9679694.92297.17
398694-9869496.78399.06
495784-9578493.92996.13
595649-9564993.79795.99
694544-9454492.71394.91
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.031098442109567310969651095809109751310968800.11
210.101112379111040111113900.13
单位质量响应值RSD%判断
109359.92110038.610.44数据可信
供试品溶液-WM0006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%
5min133766-337663.0783.264.603.083.264.53
235988-359883.2813.28
334615-346153.1553.16
434773-347733.1703.17
537650-376503.4323.43
637645-376453.4323.43
10min187247-872477.9538.122.667.968.122.66
288208-882088.0418.05
386417-864177.8787.88
489346-893468.1458.15
593075-930758.4858.49
689889-898898.1948.20
15min1129487-12948711.80412.251.7911.8212.261.79
2135587-13558712.36012.38
3135092-13509212.31512.33
4135675-13567512.36812.38
5135051-13505112.31112.33
6135168-13516812.32212.34
20min1166285-16628515.15815.742.0015.1915.782.01
2175670-17567016.01416.05
3174761-17476115.93115.97
4174495-17449515.90715.94
5173374-17337415.80515.84
6171410-17141015.62615.66
30min1226164-22616420.61721.251.5120.6721.311.53
2236137-23613721.52621.59
3234290-23429021.35821.42
4234686-23468621.39421.45
5233327-23332721.27021.33
6233830-23383021.31621.38
45min1297736-29773627.14127.891.4327.2327.991.43
2309494-30949428.21328.31
3309323-30932328.19828.29
4305195-30519527.82127.91
5306841-30684127.97128.06
6307434-30743428.02528.12
60min1358060-35806032.64033.251.1232.7733.381.12
2369741-36974133.70533.84
3367454-36745433.49733.63
4366225-36622533.38533.52
5363483-36348333.13533.27
6363273-36327333.11633.25
120min1565694-56569451.56851.760.9451.7551.940.94
2575597-57559752.47152.66
3570730-57073052.02752.21
4570010-57001051.96252.14
5562002-56200251.23251.42
6562434-56243451.27151.45
180min1691983-69198363.08163.710.7163.3463.970.71
2704483-70448364.22064.48
3701197-70119763.92164.18
4702148-70214864.00764.27
5699879-69987963.80064.06
6693872-69387263.25363.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1790757-79075772.08572.880.7872.4373.230.78
2806745-80674573.54273.90
3804387-80438773.32773.68
4801435-80143573.05873.42
5799834-79983472.91273.27
6793607-79360772.34572.70
360min1938901-93890185.58986.090.6986.0586.560.69
2950466-95046686.64487.11
3953704-95370486.93987.41
4944917-94491786.13886.60
5940555-94055585.74086.21
6938007-93800785.50885.97
480min11024715-102471593.41293.950.5994.0094.540.58
21036303-103630394.46995.07
31029973-102997393.89194.49
41039353-103935394.74795.34
51027826-102782693.69694.29
61025387-102538793.47394.07
600min11066766-106676697.24697.750.5397.9798.490.53
21081076-108107698.55099.29
31074497-107449797.95098.69
41075529-107552998.04498.78
51067719-106771997.33298.07
61068292-106829297.38598.12
720min11085572-108557298.96099.350.4499.83100.240.44
21097394-1097394100.038100.93
31089988-108998899.362100.25
41091377-109137799.489100.37
51090942-109094299.449100.33
61084006-108400698.81799.70
960min11086042-108604299.00399.390.44100.02100.420.44
21097584-1097584100.055101.09
31090170-109017099.379100.41
41092524-109252499.594100.63
51090724-109072499.430100.46
61084444-108444498.85799.88
1440min11078308-107830898.29898.830.4999.47100.010.49
21090759-109075999.433100.62
31079449-107944998.40299.59
41090059-109005999.369100.55
51084000-108400098.817100.00
61082071-108207198.64199.82
极限11070936-107093697.62698.490.6498.9499.820.63
21088771-108877199.251100.59
31082220-108222098.65499.99
41085256-108525698.931100.26
51081751-108175198.61299.94
61073808-107380897.88799.21
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