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%
112.691652951653161654711654561654651654010.06
212.681666271666061666160.01
单位质量响应值RSD%判断
13033.9613140.060.58数据可信
供试品溶液-2025070821批-达格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195290-19529095.98393.332.1095.9893.332.09
2184436-18443690.64890.65
3191721-19172194.22994.23
4192046-19204694.38894.39
5189401-18940193.08893.09
6186465-18646591.64591.65
10min1198802-19880297.70995.021.8397.8595.161.83
2190690-19069093.72293.86
3195051-19505195.86596.01
4194546-19454695.61795.76
5191948-19194894.34094.48
6188956-18895692.87093.01
15min1198776-19877697.69695.511.5197.9995.791.51
2193070-19307094.89295.17
3195666-19566696.16796.45
4195462-19546296.06796.35
5192557-19255794.63994.92
6190433-19043393.59593.87
20min1199260-19926097.93495.481.6898.3795.901.68
2193523-19352395.11495.53
3195370-19537096.02296.45
4195040-19504095.86096.29
5192977-19297794.84695.27
6189387-18938793.08193.50
30min1198763-19876397.69095.571.5798.2796.131.57
2194100-19410095.39895.96
3195727-19572796.19796.77
4195480-19548096.07696.65
5192853-19285394.78595.35
6189721-18972193.24693.80
45min1199419-19941998.01295.701.5698.7496.411.56
2194588-19458895.63896.34
3195381-19538196.02796.75
4195264-19526495.97096.69
5193503-19350395.10495.81
6190111-19011193.43794.13
60min1198497-19849797.55995.621.5798.4496.481.57
2194375-19437595.53396.38
3196213-19621396.43697.30
4195620-19562096.14597.01
5193034-19303494.87495.72
6189587-18958793.18094.02
120min1198937-19893797.77595.791.4598.8096.791.45
2195014-19501495.84796.84
3196109-19610996.38597.39
4195491-19549196.08197.09
5193309-19330995.00996.00
6190539-19053993.64894.62
180min1199065-19906597.83895.991.5699.0197.141.56
2195572-19557296.12197.26
3197025-19702596.83597.99
4196461-19646196.55897.71
5193267-19326794.98896.12
6190492-19049293.62494.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1199610-19961098.10696.071.5299.4297.361.52
2195984-19598496.32497.60
3196720-19672096.68597.98
4196042-19604296.35297.65
5193614-19361495.15996.44
6190846-19084693.79895.06
360min1199420-19942098.01295.881.5899.4897.311.58
2195905-19590596.28597.71
3195714-19571496.19197.63
4195789-19578996.22897.67
5193504-19350495.10596.53
6190122-19012293.44394.84
480min1202005-20200599.28397.001.74100.8998.571.74
2197740-19774097.18798.76
3198606-19860697.61299.20
4198366-19836697.49499.08
5195651-19565196.16097.72
6191756-19175694.24695.78
600min1201153-20115398.86496.571.66100.6298.291.65
2196178-19617896.41998.13
3197682-19768297.15898.89
4197166-19716696.90598.63
5195492-19549296.08297.79
6191208-19120893.97695.66
720min1199860-19986098.22996.091.68100.1497.951.68
2196297-19629796.47898.34
3196800-19680096.72598.60
4196289-19628996.47498.35
5193510-19351095.10896.96
6190238-19023893.50095.32
极限1199829-19982998.21395.931.69100.2797.941.68
2196017-19601796.34098.34
3196423-19642396.53998.56
4195848-19584896.25798.28
5192650-19265094.68596.68
6190366-19036693.56395.52
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%
110.131057907106012110612511060371106093210601160.13
210.131063958106513310645460.08
单位质量响应值RSD%判断
104651.14105088.450.30数据可信
供试品溶液-2025070821批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153092-530925.0635.229.255.065.229.29
249545-495454.7244.72
354173-541735.1665.17
451804-518044.9404.94
564144-641446.1176.12
655576-555765.3005.30
10min1110869-11086910.57210.512.3310.5810.522.35
2105992-10599210.10710.11
3112245-11224510.70310.71
4108488-10848810.34510.35
5112871-11287110.76310.77
6110956-11095610.58010.59
15min1154769-15476914.75814.691.2114.7814.711.21
2151064-15106414.40514.43
3155737-15573714.85114.87
4152583-15258314.55014.57
5155750-15575014.85214.88
6154218-15421814.70614.73
20min1191084-19108418.22118.101.2518.2718.141.25
2187592-18759217.88817.93
3192644-19264418.37018.42
4187093-18709317.84117.89
5191763-19176318.28618.33
6188388-18838817.96418.01
30min1250213-25021323.86023.690.9723.9323.760.96
2249341-24934123.77623.85
3250764-25076423.91223.99
4245250-24525023.38623.46
5249250-24925023.76823.84
6245575-24557523.41723.49
45min1320554-32055430.56730.381.0430.6830.491.04
2321699-32169930.67630.78
3320583-32058330.57030.68
4314571-31457129.99630.10
5319992-31999230.51330.62
6314246-31424629.96530.07
60min1376709-37670935.92235.841.1036.0835.991.10
2380698-38069836.30236.45
3380169-38016936.25236.41
4371690-37169035.44335.59
5374963-37496335.75535.91
6370911-37091135.36935.52
120min1546724-54672452.13451.890.9852.3452.100.98
2552332-55233252.66952.88
3546611-54661152.12352.33
4539870-53987051.48051.69
5541121-54112151.60051.81
6538325-53832551.33351.54
180min1666567-66656763.56263.571.0363.8563.861.03
2675930-67593064.45464.74
3669451-66945163.83764.12
4670576-67057663.94464.23
5659706-65970662.90763.19
6657841-65784162.73063.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1761954-76195472.65772.230.9073.0472.610.90
2767468-76746873.18373.57
3759133-75913372.38872.77
4755510-75551072.04372.42
5750644-75064471.57971.96
6750060-75006071.52371.90
360min1891892-89189285.04884.631.1485.5485.121.14
2905644-90564486.35986.85
3884576-88457684.35084.84
4884832-88483284.37584.86
5880092-88009283.92384.41
6877984-87798483.72284.21
480min1988084-98808494.22093.680.8094.8494.300.80
2993336-99333694.72195.34
3981516-98151693.59494.21
4983847-98384793.81694.43
5975070-97507092.98093.59
6972628-97262892.74793.36
600min11036463-103646398.83498.420.5999.5999.170.59
21039850-103985099.15799.92
31030389-103038998.25599.01
41034499-103449998.64699.40
51028219-102821998.04898.80
61023270-102327097.57698.32
720min11065261-1065261101.580100.950.82102.49101.850.82
21069597-1069597101.993102.91
31056648-1056648100.759101.67
41062308-1062308101.298102.20
51049230-1049230100.051100.95
61048595-104859599.991100.89
极限11066668-1066668101.714101.100.77102.77102.150.76
21071201-1071201102.146103.21
31055638-1055638100.662101.72
41063569-1063569101.418102.47
51051921-1051921100.308101.36
61052197-1052197100.334101.38
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%
112.691651461654501661281658531659441657040.25
212.681678581679441679010.04
单位质量响应值RSD%判断
13057.8413241.400.99数据可信
供试品溶液-2025070821批-达格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193002-19300294.41091.812.6794.4191.802.67
2186184-18618491.07491.07
3187406-18740691.67291.67
4181994-18199489.02589.02
5183291-18329189.65989.66
6194210-19421095.00095.00
10min1196271-19627196.00994.421.8296.1594.561.82
2193568-19356894.68694.82
3191464-19146493.65793.79
4190283-19028393.07993.21
5188798-18879892.35392.49
6197783-19778396.74896.89
15min1196236-19623695.99194.781.5896.2895.061.58
2193380-19338094.59494.87
3191667-19166793.75694.03
4192746-19274694.28494.56
5190086-19008692.98393.26
6198389-19838997.04597.33
20min1196014-19601495.88394.921.4096.3195.341.40
2192743-19274394.28394.70
3192901-19290194.36094.78
4193684-19368494.74395.16
5190618-19061893.24393.66
6198295-19829596.99997.43
30min1197363-19736396.54395.321.7597.1295.881.75
2193343-19334394.57695.14
3192313-19231394.07294.63
4194760-19476095.26995.83
5191159-19115993.50894.06
6200228-20022897.94498.52
45min1196882-19688296.30795.271.3297.0395.981.32
2193980-19398094.88895.59
3191997-19199793.91894.62
4195401-19540195.58396.28
5192077-19207793.95794.65
6198284-19828496.99397.72
60min1196471-19647196.10695.361.1796.9796.211.17
2194416-19441695.10195.95
3192482-19248294.15595.00
4195981-19598195.86796.71
5192302-19230294.06794.90
6197963-19796396.83697.71
120min1197644-19764496.68095.681.2297.6996.671.23
2194883-19488395.33096.32
3192612-19261294.21995.20
4196654-19665496.19697.18
5193307-19330794.55995.53
6198484-19848497.09198.11
180min1196633-19663396.18695.541.2697.3496.671.26
2194565-19456595.17496.31
3192401-19240194.11695.24
4196542-19654296.14197.27
5192936-19293694.37795.49
6198762-19876297.22798.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1196995-19699596.36396.061.0997.6697.351.09
2195219-19521995.49496.77
3193068-19306894.44295.71
4197608-19760896.66397.94
5196125-19612595.93797.20
6199294-19929497.48798.80
360min1196501-19650196.12195.691.0397.5697.121.03
2195559-19555995.66097.08
3192655-19265594.24095.65
4196877-19687796.30597.73
5194021-19402194.90896.31
6198115-19811596.91198.36
480min1197674-19767496.69596.601.1198.2898.161.11
2197441-19744196.58198.14
3194485-19448595.13596.68
4199062-19906297.37498.94
5195697-19569795.72897.27
6200475-20047598.06599.66
600min1197589-19758996.65396.221.1398.3897.931.13
2196138-19613895.94497.65
3193588-19358894.69696.39
4198252-19825296.97898.69
5195021-19502195.39797.09
6199642-19964297.65899.40
720min1196668-19666896.20395.731.2498.0897.591.24
2195678-19567895.71997.57
3192547-19254794.18796.02
4197457-19745796.58998.44
5193185-19318594.49996.33
6198711-19871197.20299.10
极限1196753-19675396.24495.751.1698.2697.751.16
2194911-19491195.34397.34
3192770-19277094.29696.27
4196835-19683596.28498.29
5194083-19408394.93896.91
6199071-19907197.37899.42
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%
110.131058467106023710625941061929106041010607270.16
210.131065860106798010669200.15
单位质量响应值RSD%判断
104711.45105322.800.42数据可信
供试品溶液-2025070821批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154013-540135.1434.843.635.144.843.61
250335-503354.7934.79
351172-511724.8734.87
448549-485494.6234.62
549737-497374.7364.74
651068-510684.8634.86
10min1114714-11471410.92310.304.2610.9310.304.27
2109159-10915910.39410.40
3109349-10934910.41310.42
4102455-1024559.7569.76
5103205-1032059.8289.83
6109992-10999210.47410.48
15min1157910-15791015.03714.463.0815.0614.483.08
2153989-15398914.66314.69
3153132-15313214.58214.60
4145685-14568513.87313.89
5146762-14676213.97514.00
6153323-15332314.60014.62
20min1194576-19457618.52817.932.8918.5717.972.90
2190851-19085118.17318.22
3191430-19143018.22918.27
4181143-18114317.24917.29
5182007-18200717.33117.37
6189455-18945518.04118.09
30min1292607-29260727.86324.437.9227.9424.507.91
2251128-25112823.91323.99
3247890-24789023.60523.68
4239500-23950022.80622.87
5240811-24081122.93123.00
6267426-26742625.46525.54
45min1325286-32528630.97530.232.0231.0930.332.03
2323387-32338730.79430.90
3317739-31773930.25630.36
4308814-30881429.40629.51
5311689-31168929.68029.78
6317712-31771230.25430.36
60min1382103-38210336.38535.721.7836.5535.871.79
2382326-38232636.40636.56
3376471-37647135.84936.00
4366041-36604134.85635.00
5368999-36899935.13735.29
6374736-37473635.68435.84
120min1555113-55511352.86051.941.4353.0852.141.43
2553364-55336452.69352.90
3545896-54589651.98252.19
4534802-53480250.92651.12
5540497-54049751.46851.67
6542929-54292951.70051.91
180min1671694-67169463.96163.331.1464.2663.621.15
2673655-67365564.14864.44
3666440-66644063.46163.75
4652754-65275462.15762.43
5661626-66162663.00263.28
6664335-66433563.26063.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1766886-76688673.02572.481.0473.4272.861.04
2768621-76862173.19173.57
3760242-76024272.39372.77
4747686-74768671.19771.57
5765996-76599672.94173.31
6757323-75732372.11572.50
360min1893013-89301385.03684.680.9985.5485.170.99
2902618-90261885.95086.44
3889288-88928884.68185.17
4876557-87655783.46983.94
5890395-89039584.78685.27
6883720-88372084.15184.64
480min1985953-98595393.88693.770.8094.5294.380.80
2996814-99681494.92095.54
3985417-98541793.83594.45
4974359-97435992.78293.38
5987431-98743194.02794.64
6978282-97828293.15593.77
600min11036330-103633098.68398.610.7199.4599.360.71
21046549-104654999.656100.42
31033369-103336998.40199.16
41027018-102701897.79698.54
51040798-104079899.10899.86
61029149-102914997.99998.75
720min11062603-1062603101.185101.070.72102.10101.970.72
21074894-1074894102.355103.27
31058583-1058583100.802101.71
41054187-1054187100.383101.27
51062973-1062973101.220102.12
61054905-1054905100.452101.35
极限11063976-1063976101.315101.290.63102.39102.340.63
21073315-1073315102.205103.27
31062744-1062744101.198102.25
41055653-1055653100.523101.56
51068855-1068855101.780102.83
61057522-1057522100.701101.75
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