达格列净二甲双胍片项目信息
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%
112.431575301575411575181573831574251574790.05
212.551595261593241594250.09
单位质量响应值RSD%判断
12669.2712703.190.19数据可信
供试品溶液-24110601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%
5min1133885-13388567.88175.5716.5667.8875.5716.56
2157297-15729779.75179.75
3138590-13859070.26670.27
4168515-16851585.43885.44
5181604-18160492.07592.07
6114418-11441858.01158.01
10min1156375-15637579.28385.579.4079.3985.689.41
2168170-16817085.26385.38
3158651-15865180.43780.54
4179382-17938290.94891.08
5195169-19516998.95299.09
6154899-15489978.53578.62
15min1163201-16320182.74488.008.0582.9688.248.06
2170382-17038286.38586.63
3164359-16435983.33183.56
4181485-18148592.01492.28
5198286-198286100.532100.82
6163641-16364182.96783.17
20min1166697-16669784.51789.207.5684.8689.587.57
2171850-17185087.12987.51
3167378-16737884.86285.21
4182765-18276592.66393.07
5200009-200009101.406101.84
6166919-16691984.62984.96
30min1171070-17107086.73490.596.8187.2191.106.82
2174178-17417888.31088.82
3171420-17142086.91187.39
4182838-18283892.70093.24
5201674-201674102.250102.84
6170833-17083386.61487.07
45min1174833-17483388.64291.866.3289.2492.506.33
2175382-17538288.92089.56
3175471-17547188.96589.57
4183893-18389393.23593.92
5203333-203333103.091103.83
6174154-17415488.29788.88
60min1177189-17718989.83692.565.9390.5793.355.95
2176314-17631489.39390.17
3178056-17805690.27691.02
4183720-18372093.14793.97
5203916-203916103.387104.28
6176229-17622989.34990.07
120min1179681-17968191.10093.315.5391.9794.235.55
2177328-17732889.90790.81
3181121-18112191.83092.71
4183427-18342792.99993.96
5204356-204356103.610104.66
6178380-17838090.44091.29
180min1180476-18047691.50393.615.5292.5194.675.53
2177412-17741289.94990.99
3181821-18182192.18593.20
4183555-18355593.06494.16
5204981-204981103.927105.13
6179598-17959891.05892.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1187314-18731494.97096.985.3696.1198.185.38
2183798-18379893.18794.36
3188770-18877095.70896.86
4189526-18952696.09197.33
5211792-211792107.380108.74
6186502-18650294.55895.68
360min1186779-18677994.69896.535.2595.9897.875.27
2183024-18302492.79594.11
3187713-18771395.17296.47
4188459-18845995.55096.93
5210414-210414106.681108.21
6185916-18591694.26195.53
480min1185887-18588794.24696.045.2895.6797.545.30
2181479-18147992.01193.47
3187121-18712194.87296.31
4187805-18780595.21996.75
5209307-209307106.120107.81
6184993-18499393.79395.20
600min1185348-18534893.97395.605.1395.5497.235.15
2181081-18108191.80993.40
3186483-18648394.54896.13
4186191-18619194.40096.07
5207861-207861105.387107.23
6184349-18434993.46695.02
720min1184562-18456293.57495.085.0995.2896.865.12
2179689-17968991.10492.84
3185435-18543594.01795.74
4185465-18546594.03295.84
5206513-206513104.704106.71
6183502-18350293.03794.73
960min1182920-18292092.74294.195.0894.5996.115.10
2178236-17823690.36792.24
3183551-18355193.06294.93
4183614-18361493.09495.05
5204576-204576103.722105.88
6181734-18173492.14093.97
1200min1181328-18132891.93593.495.1493.9295.555.16
2176643-17664389.55991.56
3182097-18209792.32594.33
4182290-18229092.42294.51
5203270-203270103.059105.37
6180715-18071591.62493.59
极限1180138-18013891.33193.105.1993.4695.305.21
2175892-17589289.17991.32
3181328-18132891.93594.08
4181502-18150292.02394.25
5202630-202630102.735105.20
6180281-18028191.40493.51
达格列净二甲双胍片项目信息
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%
110.019070259096539091899107299107299094650.17
210.089201709192899197300.07
单位质量响应值RSD%判断
90855.6491243.060.31数据可信
供试品溶液-24110601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%
5min139779-397794.3694.607.034.374.607.04
246683-466835.1275.13
340850-408504.4874.49
443132-431324.7374.74
542633-426334.6824.68
638320-383204.2094.21
10min184901-849019.3259.807.309.339.817.29
299745-9974510.95510.96
386456-864569.4969.50
492774-9277410.18910.20
590122-901229.8989.91
681400-814008.9408.95
15min1123644-12364413.58014.026.1913.6014.056.20
2140696-14069615.45315.48
3124392-12439213.66213.68
4131470-13147014.43914.46
5128322-12832214.09414.12
6117641-11764112.92112.94
20min1156875-15687517.23017.835.7317.2717.875.73
2174669-17466919.18419.23
3167167-16716718.36018.40
4166653-16665318.30418.35
5160463-16046317.62417.67
6148053-14805316.26116.30
30min1209680-20968023.02923.394.8723.1023.464.88
2230634-23063425.33125.41
3210636-21063623.13423.20
4216436-21643623.77123.84
5211347-21134723.21223.28
6199028-19902821.85921.92
45min1274917-27491730.19430.434.0330.3030.544.04
2295294-29529432.43232.55
3278343-27834330.57130.67
4279120-27912030.65630.76
5274171-27417130.11230.22
6260595-26059528.62128.72
60min1335272-33527236.82336.213.7536.9736.363.76
2348260-34826038.25038.41
3330026-33002636.24736.40
4329497-32949736.18936.34
5324600-32460035.65135.80
6310688-31068834.12334.26
120min1481645-48164552.90052.552.6653.1052.752.67
2497294-49729454.61854.84
3482683-48268353.01453.22
4478130-47813052.51452.72
5471842-47184251.82352.03
6458955-45895550.40850.60
180min1590396-59039664.84464.382.2465.1264.662.25
2605321-60532166.48366.79
3589004-58900464.69164.97
4581782-58178263.89864.18
5585368-58536864.29264.57
6565097-56509762.06562.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1689621-68962175.74274.841.8376.1275.221.83
2695746-69574676.41576.82
3689846-68984675.76776.15
4678012-67801274.46774.85
5672250-67225073.83474.21
6663185-66318572.83873.20
360min1803417-80341788.24086.621.9588.7387.111.96
2804985-80498588.41288.93
3797623-79762387.60488.10
4781993-78199385.88786.38
5773888-77388884.99785.48
6769951-76995184.56585.03
480min1863568-86356894.84793.551.8295.4794.171.82
2865893-86589395.10295.75
3865914-86591495.10495.73
4846955-84695593.02293.64
5835409-83540991.75492.37
6832825-83282591.47092.07
600min1898337-89833798.66597.141.7699.4397.901.76
2896306-89630698.44299.23
3899576-89957698.80199.57
4878137-87813796.44797.21
5866311-86631195.14895.90
6868049-86804995.33996.07
720min1917622-917622100.78398.861.84101.7099.771.84
2912460-912460100.216101.16
3913622-913622100.344101.26
4892782-89278298.05598.96
5878835-87883596.52397.42
6885291-88529197.23298.11
960min1920391-920391101.08899.451.55102.15100.511.55
2912089-912089100.176101.27
3919954-919954101.040102.11
4899033-89903398.74299.80
5886610-88661097.37798.42
6895019-89501998.30199.32
1200min1918156-918156100.84299.291.43102.06100.501.43
2908997-90899799.836101.08
3917466-917466100.766101.98
4897611-89761198.58699.79
5886483-88648397.36398.55
6895516-89551698.35599.52
极限1913591-913591100.34198.981.36101.71100.331.36
2906088-90608899.517100.91
3914589-914589100.450101.82
4894294-89429498.22199.57
5884061-88406197.09798.43
6894470-89447098.24199.56
达格列净二甲双胍片项目信息
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%
112.431579011578861578541579371579881579130.04
212.551578331584811581570.29
单位质量响应值RSD%判断
12704.1812602.150.58数据可信
供试品溶液-TL3535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%
5min174191-7419137.71447.2716.0237.7147.2716.02
273830-7383037.53137.53
3106912-10691254.34854.35
4100804-10080451.24351.24
5100157-10015750.91450.91
6102055-10205551.87951.88
10min1141274-14127471.81586.1411.4971.8786.2111.50
2148167-14816775.31975.38
3184945-18494594.01594.10
4177419-17741990.18990.27
5184100-18410093.58593.66
6180837-18083791.92792.00
15min1158070-15807080.35393.268.9780.5293.478.98
2167364-16736485.07885.25
3195682-19568299.47399.70
4190990-19099097.08897.30
5195950-19595099.60999.83
6192751-19275197.98398.20
20min1165637-16563784.20095.327.3184.4895.667.33
2175220-17522089.07189.37
3198025-198025100.664101.04
4193145-19314598.18398.54
5197953-197953100.627100.99
6195113-19511399.18499.55
30min1174505-17450588.70897.515.4489.1297.995.47
2183738-18373893.40193.83
3200627-200627101.987102.51
4195246-19524699.25199.76
5199636-199636101.483102.00
6197162-197162100.225100.74
45min1181348-18134892.18699.104.0192.7399.724.04
2190396-19039696.78697.36
3201948-201948102.658103.33
4196354-19635499.814100.47
5200601-200601101.973102.64
6199007-199007101.163101.82
60min1185681-18568194.38999.873.1295.07100.643.15
2194007-19400798.62199.34
3202949-202949103.167104.00
4196854-196854100.069100.87
5200770-200770102.059102.88
6198469-198469100.890101.70
120min1190927-19092797.056100.852.2397.88101.782.26
2199096-199096101.208102.07
3203983-203983103.693104.68
4196659-19665999.970100.92
5201029-201029102.191103.17
6198650-198650100.982101.95
180min1192649-19264997.931101.212.0198.90102.292.03
2201109-201109102.232103.25
3203900-203900103.650104.79
4196376-19637699.826100.93
5200709-200709102.028103.16
6199899-199899101.617102.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1199836-199836101.585104.781.92102.70106.021.94
2208300-208300105.887107.06
3210846-210846107.181108.48
4203289-203289103.340104.59
5207707-207707105.586106.87
6206792-206792105.121106.39
360min1199790-199790101.561104.621.92102.83106.011.94
2208920-208920106.202107.53
3210287-210287106.897108.35
4202560-202560102.969104.38
5206608-206608105.027106.47
6206691-206691105.069106.50
480min1199321-199321101.323104.061.85102.74105.601.86
2208718-208718106.100107.59
3208634-208634106.057107.67
4201502-201502102.431103.99
5205573-205573104.501106.10
6204496-204496103.953105.54
600min1198240-198240100.773103.591.96102.35105.291.97
2208056-208056105.763107.41
3208059-208059105.765107.54
4200325-200325101.833103.55
5204280-204280103.844105.60
6203751-203751103.575105.31
720min1197031-197031100.159102.952.01101.88104.812.02
2206936-206936105.194107.00
3206957-206957105.204107.14
4198875-198875101.096102.97
5202933-202933103.159105.07
6202442-202442102.909104.80
960min1195962-19596299.615102.021.88101.49104.031.89
2204748-204748104.081106.04
3204951-204951104.185106.28
4196929-196929100.107102.13
5200928-200928102.140104.20
6200669-200669102.008104.06
1200min1194471-19447198.857101.261.77100.88103.431.78
2203036-203036103.211105.33
3202789-202789103.086105.33
4195853-19585399.560101.73
5199843-199843101.588103.81
6199228-199228101.275103.48
极限1194051-19405198.644101.071.91100.82103.381.92
2202684-202684103.032105.31
3203043-203043103.215105.62
4194865-19486599.058101.38
5199692-199692101.511103.88
6198565-198565100.938103.29
达格列净二甲双胍片项目信息
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%
110.019086179091089094929092449080829089090.07
210.089155299142929149100.10
单位质量响应值RSD%判断
90800.1090764.880.03数据可信
供试品溶液-TL3535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%
5min137990-379904.1853.2615.374.183.2615.33
229995-299953.3043.30
326262-262622.8932.89
429030-290303.1983.20
524962-249622.7502.75
629489-294893.2483.25
10min165517-655177.2177.384.047.227.384.05
264456-644567.1007.11
368938-689387.5947.60
468297-682977.5237.53
564001-640017.0507.05
670670-706707.7857.79
15min196765-9676510.65911.305.4310.6811.325.42
296260-9626010.60310.62
3107318-10731811.82111.84
4105392-10539211.60911.63
5100581-10058111.07911.09
6109434-10943412.05512.07
20min1124994-12499413.76914.534.5713.8014.564.56
2124457-12445713.70913.74
3136502-13650215.03615.07
4136086-13608614.99015.02
5131239-13123914.45614.49
6138159-13815915.21915.25
30min1173835-17383519.14920.023.7219.2020.073.71
2173470-17347019.10819.16
3187332-18733220.63520.69
4186457-18645720.53920.59
5180920-18092019.92919.98
6188255-18825520.73720.79
45min1232613-23261325.62326.673.0925.7126.753.09
2233794-23379425.75325.83
3248389-24838927.36127.45
4247326-24732627.24427.33
5241150-24115026.56326.65
6249321-24932127.46427.55
60min1282803-28280331.15232.362.4531.2732.492.45
2291431-29143132.10232.22
3303498-30349833.43133.56
4297844-29784432.80932.94
5290426-29042631.99132.11
6296804-29680432.69432.82
120min1426539-42653946.98548.001.6347.1548.181.63
2429096-42909647.26647.43
3444317-44431748.94349.12
4439890-43989048.45548.63
5433964-43396447.80347.97
6440905-44090548.56748.75
180min1529812-52981258.36159.481.6958.6059.731.70
2530178-53017858.40158.64
3547286-54728660.28560.54
4542364-54236459.74359.99
5538102-53810259.27459.52
6552370-55237060.84561.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1627303-62730369.10070.161.2169.4370.491.22
2628200-62820069.19869.52
3644689-64468971.01571.36
4639490-63949070.44270.78
5637061-63706170.17470.51
6644597-64459771.00571.35
360min1742254-74225481.76282.960.8882.1983.400.88
2753636-75363683.01683.45
3758556-75855683.55884.01
4752659-75265982.90883.35
5750571-75057182.67883.11
6760878-76087883.81384.26
480min1819805-81980590.30491.060.6990.8691.620.69
2822829-82282990.63791.19
3831487-83148791.59192.16
4826585-82658591.05191.62
5824295-82429590.79991.36
6834940-83494091.97192.55
600min1862061-86206194.95995.730.6295.6596.430.63
2866913-86691395.49396.18
3874093-87409396.28497.00
4867853-86785395.59796.30
5866865-86686595.48896.18
6876752-87675296.57797.29
720min1878930-87893096.81797.930.7197.6598.780.71
2890082-89008298.04698.88
3893548-89354898.42799.28
4884228-88422897.40198.25
5891907-89190798.24799.09
6895460-89546098.63899.50
960min1891908-89190898.24799.070.5699.22100.060.56
2897765-89776598.89299.87
3903587-90358799.533100.54
4899447-89944799.077100.07
5897702-89770298.88599.87
6905990-90599099.798100.80
1200min1891899-89189998.24698.990.5799.37100.130.58
2897672-89767298.882100.01
3901930-90193099.351100.50
4895654-89565498.65999.80
5898107-89810798.930100.07
6906625-90662599.868101.02
极限1897322-89732298.84398.940.47100.11100.230.47
2896165-89616598.71699.99
3902197-90219799.380100.68
4892944-89294498.36199.65
5896560-89656098.759100.04
6904241-90424199.605100.91
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