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 12.548258082505825138257382409825160.09
2 12.598324683231832380.02
单位质量响应值RSD%判断
6580.226611.440.34数据可信
供试品溶液-25042201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%
5min172840-7284071.03174.765.4171.0374.765.41
273020-7302071.20771.21
375073-7507373.20973.21
483248-8324881.18181.18
580009-8000978.02278.02
675768-7576873.88673.89
10min194187-9418791.84894.842.9291.9594.952.92
297249-9724994.83494.94
3101204-10120498.69198.80
499276-9927696.81196.93
597654-9765495.22995.35
693938-9393891.60591.72
15min196128-9612893.74196.682.5593.9996.932.55
298826-9882696.37296.62
3102691-102691100.141100.40
4100680-10068098.18098.45
5100017-10001797.53397.79
696491-9649194.09594.34
20min196874-9687494.46896.952.2294.8597.352.22
299596-9959697.12397.52
3102862-102862100.308100.72
4100188-10018897.70098.11
599825-9982597.34697.75
697163-9716394.75095.14
30min198267-9826795.82797.461.8596.3598.001.85
299992-9999297.50998.05
3102932-102932100.376100.93
4100346-10034697.85498.41
5100378-10037897.88598.44
697716-9771695.28995.82
45min198200-9820095.76197.661.7496.4398.351.74
2100194-10019497.70698.39
3102850-102850100.296101.01
4100305-10030597.81498.52
5100972-10097298.46599.16
698346-9834695.90496.58
60min198323-9832395.88197.421.7996.7098.261.79
299744-9974497.26798.10
3102953-102953100.396101.26
4100333-10033397.84198.70
5100123-10012397.63798.48
697945-9794595.51396.33
120min198301-9830195.86097.071.5096.8298.061.50
2100198-10019897.71098.69
3102041-10204199.507100.52
499349-9934996.88297.88
599529-9952997.05798.05
697861-9786195.43196.39
180min198779-9877996.32697.451.4697.4398.581.47
299771-9977197.29398.42
3102452-10245299.908101.07
499586-9958697.11398.26
5100594-10059498.09699.23
698390-9839095.94797.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1101843-10184399.314100.371.41100.56101.651.42
2103315-103315100.749102.02
3105430-105430102.812104.12
4102590-102590100.042101.33
5103121-103121100.560101.85
6101264-10126498.749100.00
360min1101580-10158099.057100.041.44100.45101.471.44
2102933-102933100.377101.80
3105191-105191102.579104.04
4102366-10236699.824101.27
5102573-102573100.026101.46
6100911-10091198.40599.80
480min1100390-10039097.89799.201.4099.44100.771.41
2101952-10195299.420100.99
3104204-104204101.616103.23
4101541-10154199.019100.61
5101978-10197899.446101.03
6100289-10028997.79999.34
600min1100210-10021097.72198.621.5499.41100.351.55
2100966-10096698.459100.18
3103947-103947101.366103.14
4100966-10096698.459100.20
5101389-10138998.871100.61
699337-9933796.87098.56
720min199643-9964397.16997.961.5799.0199.841.57
2100508-10050898.01299.88
3103301-103301100.736102.66
4100272-10027297.78299.67
5100451-10045197.95699.84
698572-9857296.12497.96
极限199266-9926696.80197.721.5498.7899.741.54
2100490-10049097.995100.01
3102913-102913100.357102.43
4100104-10010497.61899.65
5100145-10014597.65899.69
698337-9833795.89597.88
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%
1 9.981014191101354610148231015845101539210147590.10
2 10.081029381102939510293880.01
单位质量响应值RSD%判断
101679.26102121.830.31数据可信
供试品溶液-25042201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%
5min141956-419564.1174.033.814.124.043.82
242345-423454.1564.16
340122-401223.9373.94
439311-393113.8583.86
539723-397233.8983.90
643078-430784.2274.23
10min199620-996209.7769.921.859.789.921.84
2103285-10328510.13610.14
3102974-10297410.10510.11
498668-986689.6839.69
5101544-1015449.9659.97
6100170-1001709.8309.84
15min1145054-14505414.23514.642.0114.2614.662.00
2152030-15203014.92014.94
3151306-15130614.84814.87
4149356-14935614.65714.68
5151269-15126914.84514.87
6145896-14589614.31814.34
20min1183562-18356218.01418.331.9418.0618.371.93
2190630-19063018.70818.75
3191405-19140518.78418.83
4183607-18360718.01818.06
5187405-18740518.39118.43
6183970-18397018.05418.10
30min1245124-24512424.05524.442.2024.1224.502.20
2252918-25291824.82024.89
3258064-25806425.32525.40
4244403-24440323.98524.05
5248357-24835724.37324.44
6245147-24514724.05824.13
45min1317397-31739731.14831.491.3331.2531.601.33
2324540-32454031.84931.96
3325741-32574131.96732.08
4316338-31633831.04431.15
5323853-32385331.78131.89
6317536-31753631.16231.27
60min1376586-37658636.95637.221.1137.1137.381.12
2383281-38328137.61337.77
3385769-38576937.85838.02
4375479-37547936.84837.00
5377746-37774637.07037.23
6376809-37680936.97837.13
120min1544707-54470753.45553.731.0453.6653.941.04
2553238-55323854.29254.51
3555889-55588954.55254.77
4541640-54164053.15453.36
5545068-54506853.49053.70
6544649-54464953.44953.66
180min1666783-66678365.43565.610.7965.7265.900.80
2672213-67221365.96866.26
3676464-67646466.38566.68
4661038-66103864.87165.16
5667855-66785565.54065.83
6666770-66677065.43465.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1785278-78527877.06476.740.8677.4577.130.85
2786525-78652577.18677.58
3790021-79002177.52977.92
4771810-77181075.74276.13
5777601-77760176.31076.70
6780450-78045076.59076.98
360min1909086-90908689.21389.320.7789.7189.820.77
2918045-91804590.09390.60
3919140-91914090.20090.71
4902038-90203888.52289.02
5905358-90535888.84889.35
6907231-90723189.03189.53
480min1983289-98328996.49596.610.6197.1397.250.61
2990410-99041097.19497.84
3993099-99309997.45898.11
4978984-97898496.07396.70
5979070-97907096.08196.72
6981991-98199196.36897.00
600min11020596-1020596100.157100.100.60100.94100.890.60
21023951-1023951100.486101.28
31030066-1030066101.086101.88
41015350-101535099.642100.42
51014872-101487299.595100.38
61015396-101539699.646100.43
720min11036291-1036291101.697101.390.73102.63102.320.73
21038825-1038825101.945102.89
31043780-1043780102.432103.38
41027488-1027488100.833101.76
51025551-1025551100.643101.57
61027021-1027021100.787101.72
极限11035135-1035135101.583101.400.66102.67102.480.66
21039120-1039120101.974103.07
31042678-1042678102.324103.42
41027083-1027083100.793101.87
51026892-1026892100.774101.86
61028605-1028605100.943102.02
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 12.548360083545835388360083342835250.13
2 12.598379483643837180.13
单位质量响应值RSD%判断
6660.696649.560.12数据可信
供试品溶液-25042202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%
5min187653-8765384.71474.6717.1384.7174.6617.13
254756-5475652.92052.92
382381-8238179.61979.62
477500-7750074.90274.90
590918-9091887.87087.87
670332-7033267.97467.97
10min197557-9755794.28692.013.5894.4192.123.59
292016-9201688.93189.01
397088-9708893.83393.95
496095-9609592.87392.99
598470-9847095.16995.30
689992-8999286.97587.08
15min197778-9777894.50093.492.5694.7793.742.57
295061-9506191.87492.09
398634-9863495.32795.59
497497-9749794.22894.48
598881-9888195.56695.84
692519-9251989.41789.65
20min196890-9689093.64293.802.4894.0594.192.49
295335-9533592.13992.49
398792-9879295.48095.88
498874-9887495.55995.95
599229-9922995.90296.32
693215-9321590.09090.46
30min195433-9543392.23493.822.5892.7894.352.59
296109-9610992.88793.38
398943-9894395.62696.17
499248-9924895.92196.46
599388-9938896.05696.62
693328-9332890.19990.70
45min193755-9375590.61294.103.1691.3094.773.16
296561-9656193.32493.95
399735-9973596.39197.08
499862-9986296.51497.19
5100417-10041797.05097.76
693849-9384990.70391.34
60min192926-9292689.81193.823.2490.6494.633.23
296488-9648893.25394.02
399233-9923395.90696.74
499848-9984896.50097.33
5100086-10008696.73197.58
693856-9385690.70991.48
120min184078-8407881.25992.176.3382.2293.126.27
296349-9634993.11994.03
398673-9867395.36596.34
499758-9975896.41497.38
599801-9980196.45597.45
693529-9352990.39391.30
180min180896-8089678.18491.457.6979.2792.547.62
295483-9548392.28293.33
398993-9899395.67496.80
499907-9990796.55897.67
599626-9962696.28697.43
692800-9280089.68990.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min177503-7750374.90593.8110.1876.1095.0410.08
299358-9935896.02797.21
3102480-10248099.044100.31
4103439-10343999.971101.23
5102560-10256099.122100.41
697073-9707393.81995.00
360min173182-7318270.72892.6411.9072.0494.0111.77
298350-9835095.05396.38
3101748-10174898.33799.75
4102953-10295399.501100.91
5102531-10253199.094100.53
696338-9633893.10894.43
480min171256-7125668.86790.3412.2270.2891.8512.07
297874-9787494.59396.07
3100992-10099297.60699.17
4102243-10224398.815100.37
592867-9286789.75491.34
695628-9562892.42293.88
600min169806-6980667.46690.6812.7768.9992.3212.62
297484-9748494.21695.83
3100271-10027196.90998.62
4101516-10151698.11399.82
598791-9879195.47997.20
695057-9505791.87093.47
720min169304-6930466.98189.9312.7368.6091.7112.58
296914-9691493.66595.42
399467-9946796.13297.98
4100855-10085597.47499.33
597333-9733394.07095.93
694447-9444791.28193.02
极限168876-6887666.56790.1313.0768.2992.0512.91
296189-9618992.96494.86
399408-9940896.07598.07
4100544-10054497.17399.17
5100061-10006196.70698.71
694485-9448591.31793.19
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%
1 9.981030647103160810321191030224102807610305350.16
2 10.081029284102804110286620.09
单位质量响应值RSD%判断
103260.02102049.800.84数据可信
供试品溶液-25042202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%
5min140685-406853.9634.157.833.964.157.80
240982-409823.9923.99
338788-387883.7793.78
441927-419274.0844.08
546856-468564.5654.56
646633-466334.5434.54
10min1100672-1006729.8079.954.079.819.964.08
299150-991509.6599.66
3101007-1010079.8409.85
4101244-1012449.8639.87
5110499-11049910.76410.77
6100367-1003679.7779.78
15min1146741-14674114.29514.602.2314.3214.632.23
2150439-15043914.65514.68
3150451-15045114.65714.68
4149357-14935714.55014.57
5155756-15575615.17315.20
6146636-14663614.28514.31
20min1186782-18678218.19618.371.5618.2418.411.55
2190297-19029718.53818.58
3187473-18747318.26318.31
4184133-18413317.93817.98
5191426-19142618.64818.69
6191349-19134918.64118.68
30min1246008-24600823.96524.281.6824.0324.351.68
2255286-25528624.86924.94
3249104-24910424.26724.34
4245763-24576323.94224.01
5253309-25330924.67724.75
6245817-24581723.94724.02
45min1318473-31847331.02531.411.8031.1331.521.80
2328945-32894532.04532.15
3322808-32280831.44731.55
4316960-31696030.87730.98
5329889-32988932.13732.25
6317589-31758930.93931.05
60min1377689-37768936.79337.131.3836.9537.281.38
2388300-38830037.82737.98
3382259-38225937.23937.39
4376716-37671636.69936.85
5386021-38602137.60537.76
6375619-37561936.59236.74
120min1545163-54516353.10853.681.3053.3253.891.29
2563450-56345054.89055.10
3551339-55133953.71053.92
4547252-54725253.31253.52
5554106-55410653.97954.19
6544701-54470153.06353.27
180min1665928-66592864.87365.331.3765.1665.621.37
2682392-68239266.47766.77
3675203-67520365.77666.07
4668527-66852765.12665.41
5675445-67544565.80066.10
6656117-65611763.91764.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1777112-77711275.70476.621.1576.0977.011.15
2800462-80046277.97978.37
3793152-79315277.26777.66
4782500-78250076.22976.61
5787354-78735476.70277.10
6778553-77855375.84476.23
360min1902819-90281987.95089.001.0388.4589.501.02
2927660-92766090.37090.88
3913406-91340688.98189.49
4916095-91609589.24389.74
5917747-91774789.40489.91
6903726-90372688.03888.54
480min1976662-97666295.14495.980.9895.7796.620.98
21002811-100281197.69198.34
3987003-98700396.15196.79
4985533-98553396.00896.64
5982408-98240895.70396.35
6977092-97709295.18695.81
600min11010756-101075698.46599.521.0099.24100.300.99
21040635-1040635101.376102.17
31019393-101939399.306100.09
41022426-102242699.602100.38
51017061-101706199.07999.87
61019084-101908499.276100.05
720min11024933-102493399.846100.870.92100.77101.800.92
21053254-1053254102.605103.55
31033695-1033695100.700101.63
41034382-1034382100.767101.69
51034450-1034450100.773101.71
61031694-1031694100.505101.43
极限11020166-102016699.382100.900.94100.45101.980.95
21050516-1050516102.338103.44
31036255-1036255100.949102.03
41034778-1034778100.805101.88
51038655-1038655101.183102.27
61033939-1033939100.723101.80
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