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%
112.548269382715823708255481333823330.70
212.598454884271844100.24
单位质量响应值RSD%判断
6565.636704.531.49数据可信
供试品溶液-25042201批-达格列净-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%
5min187429-8742984.76289.863.9684.7689.863.97
289622-8962286.88886.89
394619-9461991.73391.73
496633-9663393.68693.69
591930-9193089.12689.13
695916-9591692.99192.99
10min195023-9502392.12596.082.9092.2596.222.90
2100924-10092497.84697.98
3102221-10222199.10399.24
4100269-10026997.21197.35
596090-9609093.15993.29
6100120-10012097.06697.21
15min195446-9544692.53596.642.9592.8096.922.95
2102157-10215799.04199.32
3102361-10236199.23999.53
4101220-10122098.13398.42
596652-9665293.70493.98
6100261-10026197.20397.49
20min195652-9565292.73597.073.3793.1497.493.36
2104573-104573101.383101.81
3102771-10277199.636100.07
4100820-10082097.74598.18
597083-9708394.12294.54
699816-9981696.77297.20
30min195221-9522192.31797.613.8092.8698.183.79
2101675-10167598.57499.15
3102609-10260999.479100.06
4106015-106015102.781103.36
597530-9753094.55595.11
6101042-10104297.96098.54
45min195574-9557492.65996.742.7293.3497.462.73
2101921-10192198.81299.54
3102602-10260299.473100.21
4100853-10085397.77798.51
597508-9750894.53495.23
6100264-10026497.20697.93
60min195407-9540792.49796.612.7193.3297.472.71
2101765-10176598.66199.53
3102464-10246499.339100.22
4100643-10064397.57398.45
597490-9749094.51695.36
6100111-10011197.05897.93
120min194556-9455691.67296.283.0292.6397.283.01
2100632-10063297.56398.58
3102549-10254999.421100.45
4101451-10145198.35799.38
597031-9703194.07195.05
699649-9964996.61097.62
180min194699-9469991.81196.212.7992.9197.362.79
2100726-10072697.65498.82
3102136-10213699.021100.20
4101040-10104097.95899.13
597348-9734894.37995.50
699490-9949096.45597.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min197721-9772194.74098.882.7095.98100.182.70
2103969-103969100.798102.11
3104800-104800101.604102.93
4103361-103361100.208101.53
599633-9963396.59497.86
6102490-10249099.364100.67
360min196644-9664493.69698.272.7695.0799.722.76
2103498-103498100.341101.81
3104157-104157100.980102.46
4102593-10259399.464100.94
599692-9969296.65198.06
6101607-10160798.50899.96
480min196222-9622293.28797.722.7694.8099.312.76
2102311-10231199.190100.81
3103548-103548100.390102.02
4102654-10265499.523101.14
598781-9878195.76897.32
6101243-10124398.15599.76
600min195946-9594693.02097.152.6294.6898.892.62
2101705-10170598.603100.37
3103010-10301099.868101.65
4101643-10164398.543100.31
598245-9824595.24896.95
6100707-10070797.63599.38
720min195084-9508492.18496.732.6793.9898.612.67
2101503-10150398.407100.32
3102430-10243099.306101.24
4100974-10097497.89499.81
598464-9846495.46197.30
6100182-10018297.12699.02
极限194315-9431591.43896.142.9193.3798.162.91
2100733-10073397.66199.72
3102335-10233599.214101.30
4100706-10070697.63499.70
597410-9741094.43996.42
699477-9947796.44398.48
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%
19.981106287110704311076471111259110408111072630.24
210.081144126113616511401460.50
单位质量响应值RSD%判断
110948.20113109.721.37数据可信
供试品溶液-25042201批-二甲双胍-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%
5min147158-471584.2104.414.894.214.414.90
245881-458814.0964.10
349297-492974.4014.40
451922-519224.6354.64
550367-503674.4964.50
651507-515074.5984.60
10min1117193-11719310.46210.602.0110.4710.602.02
2115254-11525410.28910.29
3121231-12123110.82210.83
4119407-11940710.66010.67
5121279-12127910.82710.83
6117900-11790010.52510.53
15min1170015-17001515.17715.220.9115.2015.240.93
2168017-16801714.99915.02
3170033-17003315.17915.20
4171770-17177015.33415.36
5172426-17242615.39315.42
6170632-17063215.23215.26
20min1211380-21138018.87018.970.8118.9119.010.82
2213206-21320619.03319.08
3211109-21110918.84618.89
4213427-21342719.05319.10
5215097-21509719.20219.25
6210694-21069418.80918.85
30min1280205-28020525.01425.775.6625.0925.855.64
2282109-28210925.18425.26
3279466-27946624.94825.02
4321800-32180028.72728.80
5283832-28383225.33825.41
6284950-28495025.43825.51
45min1359810-35981032.12132.240.7532.2332.360.75
2363082-36308232.41332.52
3357105-35710531.87931.99
4362236-36223632.33732.45
5364715-36471532.55832.67
6360213-36021332.15732.27
60min1424136-42413637.86338.010.6038.0238.170.60
2428930-42893038.29138.45
3422423-42242337.71037.87
4427569-42756938.16938.34
5427220-42722038.13838.30
6424226-42422637.87138.03
120min1605166-60516654.02454.290.5454.2454.510.54
2610527-61052754.50254.72
3603811-60381153.90354.12
4612524-61252454.68154.90
5608512-60851254.32254.54
6608285-60828554.30254.52
180min1730492-73049265.21265.580.5065.5165.880.51
2738332-73833265.91266.21
3731409-73140965.29465.59
4736662-73666265.76366.07
5738593-73859365.93566.24
6732146-73214665.35965.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1848160-84816075.71675.840.3776.1176.240.37
2850704-85070475.94376.34
3843911-84391175.33775.73
4850608-85060875.93576.34
5852611-85261176.11376.51
6851209-85120975.98876.38
360min1974191-97419186.96787.560.9887.4788.070.97
2979740-97974087.46287.97
3976458-97645887.16987.68
4977394-97739487.25387.77
5999940-99994089.26689.78
6977453-97745387.25887.77
480min11054513-105451394.13794.290.3994.7894.930.39
21054922-105492294.17494.82
31054341-105434194.12294.76
41051660-105166093.88394.53
51063356-106335694.92795.57
61058236-105823694.47095.11
600min11094446-109444697.70297.760.5398.4898.550.53
21090790-109079097.37698.16
31093941-109394197.65798.44
41089338-108933897.24698.04
51105600-110560098.69899.49
61096779-109677997.91098.69
720min11110502-111050299.13699.260.76100.06100.190.75
21107297-110729798.84999.78
31111365-111136599.213100.14
41102810-110281098.44999.38
51127538-1127538100.656101.59
61112047-111204799.273100.20
极限11104673-110467398.61599.170.8899.69100.250.88
21103123-110312398.47799.55
31117596-111759699.769100.84
41102177-110217798.39299.48
51126921-1126921100.601101.69
61110973-111097399.178100.26
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%
112.548334483584835748365083874836050.23
212.598331382877830950.38
单位质量响应值RSD%判断
6667.076600.080.72数据可信
供试品溶液-25042202批-达格列净-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%
5min178000-7800075.63281.747.4875.6381.747.48
288020-8802085.34885.35
383326-8332680.79680.80
483043-8304380.52280.52
594790-9479091.91291.91
678614-7861476.22776.23
10min191324-9132488.55192.353.1188.6692.473.12
296753-9675393.81593.94
394189-9418991.32991.45
495164-9516492.27592.40
5100069-10006997.03197.17
693952-9395291.09991.21
15min193512-9351290.67393.132.5090.9293.392.51
295970-9597093.05693.32
395062-9506292.17692.43
495640-9564092.73693.00
5100607-10060797.55297.84
695503-9550392.60392.85
20min194934-9493492.05293.712.1192.4394.112.12
296901-9690193.95994.37
395173-9517392.28392.68
496251-9625193.32993.73
5100518-10051897.46697.90
696074-9607493.15793.55
30min195397-9539792.50193.852.1493.0294.392.15
296276-9627693.35393.90
395645-9564592.74193.28
496231-9623193.30993.85
5100950-10095097.88598.46
696235-9623593.31393.84
45min196043-9604393.12793.791.8193.7994.471.82
295951-9595193.03893.73
395966-9596693.05293.73
495782-9578292.87493.55
5100273-10027397.22997.95
696339-9633993.41494.08
60min196123-9612393.20594.012.6094.0094.832.60
295902-9590292.99093.82
395319-9531992.42593.24
496254-9625493.33294.15
5102037-10203798.93999.81
696076-9607693.15993.97
120min196659-9665993.72494.101.7294.6695.071.72
296239-9623993.31794.29
395992-9599293.07794.03
495630-9563092.72693.68
5100137-10013797.09798.11
697646-9764694.68195.63
180min196814-9681493.87593.981.3394.9595.081.35
297049-9704994.10295.21
395984-9598493.07094.16
496177-9617793.25794.35
599396-9939696.37897.54
696093-9609393.17594.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min199008-9900896.00296.701.9997.2297.941.98
298478-9847895.48896.74
398987-9898795.98297.21
497547-9754794.58595.82
5102537-10253799.424100.73
6101791-10179198.70099.93
360min198412-9841295.42495.721.8196.7997.111.81
297693-9769394.72796.12
398671-9867195.67597.05
497523-9752394.56295.94
5102241-10224199.137100.59
697770-9777094.80296.18
480min198560-9856095.56895.441.3697.0796.981.37
297904-9790494.93196.47
397644-9764494.67996.20
497212-9721294.26095.78
5100967-10096797.90199.51
698306-9830695.32196.84
600min197440-9744094.48294.551.6796.1396.231.67
296146-9614693.22794.90
397180-9718094.22995.89
496209-9620993.28894.95
5100587-10058797.53399.28
697524-9752494.56396.23
720min196646-9664693.71293.871.4295.5095.691.43
295803-9580392.89494.71
396405-9640593.47895.28
495718-9571892.81294.61
599443-9944396.42498.32
696846-9684693.90695.71
极限196855-9685593.91493.691.3795.8595.651.38
295599-9559992.69694.65
396617-9661793.68495.63
495367-9536792.47194.41
599057-9905796.04998.09
696236-9623693.31495.26
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%
19.981123361112948411242541122783112449411248750.24
210.081128318112996811291430.11
单位质量响应值RSD%判断
112712.93112018.150.44数据可信
供试品溶液-25042202批-二甲双胍-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%
5min147018-470184.1844.288.314.184.288.32
245477-454774.0474.05
348400-484004.3074.31
443035-430353.8303.83
550396-503964.4854.49
654498-544984.8504.85
10min1110768-1107689.85810.6411.519.8610.6411.53
2146964-14696413.07913.09
3118978-11897810.58910.60
4111322-1113229.9079.91
5114984-11498410.23310.24
6114188-11418810.16210.17
15min1174639-17463915.54215.063.1515.5615.093.14
2164133-16413314.60714.63
3171256-17125615.24115.26
4163803-16380314.57814.60
5166053-16605314.77814.80
6175770-17577015.64315.67
20min1206833-20683318.40718.741.6818.4518.781.69
2212166-21216618.88218.93
3216090-21609019.23119.28
4207675-20767518.48218.52
5208522-20852218.55818.60
6212155-21215518.88118.93
30min1274329-27432924.41424.831.8124.4924.901.80
2271275-27127524.14224.22
3283450-28345025.22625.30
4280154-28015424.93325.00
5283305-28330525.21325.29
6281290-28129025.03425.11
45min1355817-35581731.66631.721.5031.7731.831.51
2350134-35013431.16131.27
3364669-36466932.45432.57
4352753-35275331.39431.50
5354361-35436131.53731.65
6360592-36059232.09132.20
60min1420872-42087237.45638.323.9837.6138.483.96
2415352-41535236.96537.12
3428914-42891438.17238.33
4422525-42252537.60337.76
5463219-46321941.22541.38
6432822-43282238.51938.68
120min1604191-60419153.77154.212.6653.9854.422.66
2597664-59766453.19053.40
3615079-61507954.74054.96
4599116-59911653.31953.53
5599043-59904353.31253.53
6639423-63942356.90657.12
180min1732236-73223665.16665.230.7365.4665.530.73
2729696-72969664.94065.23
3739474-73947465.81066.11
4731211-73121165.07565.37
5726075-72607564.61864.92
6739080-73908065.77566.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1850617-85061775.70275.581.4976.0975.981.48
2838987-83898774.66775.06
3855640-85564076.14976.55
4837261-83726174.51374.90
5842624-84262474.99075.39
6870627-87062777.48277.88
360min1980599-98059987.26986.951.0187.7787.461.01
2966547-96654786.01986.52
3991826-99182688.26988.78
4975143-97514386.78487.28
5966207-96620785.98986.50
6981890-98189087.38487.90
480min11060149-106014994.34993.990.9694.9894.630.96
21049292-104929293.38394.02
31063459-106345994.64495.29
41053665-105366593.77294.40
51041359-104135992.67793.31
61068976-106897695.13595.78
600min11099337-109933797.83797.380.9098.6198.160.89
21084800-108480096.54397.32
31103906-110390698.24399.03
41092124-109212497.19597.97
51081274-108127496.22997.01
61103934-110393498.24699.04
720min11112618-111261899.01998.921.0199.9499.851.01
21104394-110439498.28799.20
31121803-112180399.836100.77
41107657-110765798.57799.49
51096280-109628097.56598.49
61126452-1126452100.250101.19
极限11116720-111672099.38498.890.95100.4699.960.95
21105242-110524298.36299.43
31120481-112048199.718100.80
41108258-110825898.63199.70
51094479-109447997.40498.47
61121829-112182999.838100.93
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