二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.942320752318252323602321202315622319880.14
29.992312832304402308620.26
单位质量响应值RSD%判断
23338.8323109.310.70数据可信
供试品溶液-301166A批-恩格列净-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%
5min124908-249089.5559.6521.559.569.6421.56
219533-195337.4937.49
318597-185977.1347.13
430092-3009211.54411.54
532041-3204112.29212.29
625700-257009.8599.86
10min147252-4725218.12718.7324.6118.1418.7424.61
237064-3706414.21914.23
333766-3376612.95312.97
457678-5767822.12722.15
565115-6511524.98025.00
652047-5204719.96619.98
15min169808-6980826.78027.6526.6226.8327.7026.63
252519-5251920.14820.18
348617-4861718.65118.68
484826-8482632.54132.60
598604-9860437.82737.89
678074-7807429.95130.00
20min190315-9031534.64736.5127.1734.7436.6027.16
269754-6975426.75926.83
364057-6405724.57424.64
4111816-11181642.89543.01
5132128-13212850.68850.81
6102906-10290639.47739.58
30min1129233-12923349.57753.4828.0749.7353.6428.06
2102793-10279339.43439.55
393793-9379335.98136.09
4164667-16466763.17063.35
5197859-19785975.90476.11
6148137-14813756.82956.99
45min1197130-19713075.62475.1620.9975.8575.4021.00
2165483-16548363.48363.66
3133856-13385651.35051.52
4227502-22750287.27587.56
5246860-24686094.70195.04
6204651-20465178.50978.77
60min1232222-23222289.08687.4311.7889.4487.8011.83
2206898-20689879.37179.66
3187762-18776272.03072.28
4254276-25427697.54697.98
5256755-25675598.49798.99
6229471-22947188.03188.42
极限1256005-25600598.21098.400.4498.7298.910.44
2256116-25611698.25298.67
3258018-25801898.98299.35
4256758-25675898.49999.09
5257293-25729398.70499.36
6254799-25479997.74798.28
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.341089579109023710894231090216108931610897540.05
210.28 1087924108242910851760.36
单位质量响应值RSD%判断
105392.07105561.870.12数据可信
供试品溶液-301166A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%
5min1256917-25691721.90021.4712.1721.9021.4712.16
2218657-21865718.63918.64
3214078-21407818.24818.25
4281477-28147723.99323.99
5287355-28735524.49524.49
6253031-25303121.56921.57
10min1398937-39893734.00634.0013.1634.0434.0413.16
2343965-34396529.32029.35
3333879-33387928.46028.49
4441996-44199637.67637.72
5466602-46660239.77439.81
6407860-40786034.76734.80
15min1511433-51143343.59543.8614.6043.6943.9514.59
2437061-43706137.25637.34
3422047-42204735.97636.05
4570857-57085748.66148.76
5615563-61556352.47152.58
6530038-53003845.18145.28
20min1608177-60817751.84252.4815.5552.0152.6515.54
2520089-52008944.33344.48
3498131-49813142.46142.60
4684141-68414158.31758.50
5748822-74882263.83164.03
6634536-63453654.08954.26
30min1771918-77191865.79967.4216.7566.0567.6816.74
2664604-66460456.65256.87
3629853-62985353.69053.90
4883902-88390275.34575.63
5981468-98146883.66283.96
6814012-81401269.38869.65
45min1994623-99462384.78384.1213.1985.1484.4813.19
2883833-88383375.33975.65
3793681-79368167.65467.95
41085812-108581292.55692.96
51148318-114831897.88498.32
61014818-101481886.50586.88
60min11109357-110935794.56392.977.0895.0793.477.12
21027724-102772487.60588.04
3970989-97098982.76883.18
41163640-116364099.19099.75
51165089-116508999.31499.92
61106891-110689194.35394.87
极限11167811-116781199.54699.380.37100.21100.040.43
21160955-116095598.96199.54
31161163-116116398.97999.53
41166045-116604599.395100.12
51167426-116742699.513100.28
61172065-117206599.908100.58
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.942318872310732309392305622314902311900.23
29.992323892312112318000.36
单位质量响应值RSD%判断
23258.5523203.200.17数据可信
供试品溶液-301166A批-恩格列净-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%
5min129511-2951111.3189.4419.7711.329.4419.78
218413-184137.0617.06
324540-245409.4119.41
420758-207587.9617.96
523512-235129.0179.02
630918-3091811.85711.86
10min158828-5882822.56119.3521.2022.5819.3721.20
237787-3778714.49114.50
350834-5083419.49519.51
442419-4241916.26816.28
546354-4635417.77717.79
666584-6658425.53525.55
15min187283-8728333.47329.4419.8533.5329.4919.85
259702-5970222.89622.93
376134-7613429.19829.25
464406-6440624.70024.74
572148-7214827.66927.71
6100942-10094238.71238.77
20min1114801-11480144.02739.0918.9544.1439.1918.95
280707-8070730.95131.03
3100931-10093138.70738.80
486057-8605733.00333.08
596162-9616236.87836.97
6132949-13294950.98651.11
30min1161408-16140861.90056.7518.5462.0956.9118.54
2118012-11801245.25845.38
3146994-14699456.37356.53
4128231-12823149.17749.31
5138327-13832753.04953.20
6194857-19485774.72874.94
45min1218261-21826183.70479.0613.8283.9979.3213.84
2169841-16984165.13565.34
3206384-20638479.14979.40
4204057-20405778.25678.48
5185675-18567571.20771.45
6252720-25272096.91997.26
60min1242830-24283093.12690.457.6293.5590.847.64
2224871-22487186.23986.55
3232648-23264889.22189.61
4250503-25050396.06996.42
5207704-20770479.65580.01
6256536-25653698.38298.88
极限1254803-25480397.71897.200.7898.3097.740.84
2252708-25270896.91497.37
3253660-25366097.27997.82
4250715-25071596.15096.66
5252543-25254396.85197.34
6256351-25635198.31198.97
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.341085231108444210833181082570108440310839930.10
210.28 1097243109308910951660.27
单位质量响应值RSD%判断
104834.91106533.661.14数据可信
供试品溶液-301166A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%
5min1258069-25806921.95619.5811.7321.9619.5811.74
2193812-19381216.48916.49
3231131-23113119.66519.66
4206967-20696717.60917.61
5229280-22928019.50719.51
6261828-26182822.27622.28
10min1412075-41207535.05931.8512.1335.1031.8812.13
2318582-31858227.10527.13
3377257-37725732.09732.13
4337791-33779128.73928.77
5361034-36103430.71730.75
6439500-43950037.39337.43
15min1538654-53865445.82842.1612.0145.9242.2412.01
2426835-42683536.31536.39
3495264-49526442.13742.22
4446805-44680538.01438.09
5478126-47812640.67940.76
6587416-58741649.97750.08
20min1654032-65403255.64551.1911.9955.8251.3512.00
2518661-51866144.12744.26
3600755-60075551.11251.27
4542676-54267646.17146.31
5580641-58064149.40149.55
6713319-71331960.68960.87
30min1827368-82736870.39266.1711.9370.6666.4111.93
2674493-67449357.38657.59
3776953-77695366.10366.34
4707764-70776460.21660.43
5747171-74717163.56963.80
6932731-93273179.35679.64
45min11020396-102039686.81583.069.0287.2083.419.03
2868983-86898373.93374.24
3975714-97571483.01383.37
4962780-96278081.91382.23
5909591-90959177.38877.73
61120058-112005895.29495.71
60min11095546-109554693.20990.964.8593.7391.454.86
21039863-103986388.47188.90
31056052-105605289.84990.34
41107513-110751394.22794.68
5987136-98713683.98584.45
61128401-112840196.00496.58
极限11121732-112173295.43794.890.5996.1295.530.63
21114381-111438194.81195.38
31111843-111184394.59595.24
41106364-110636494.12994.74
51113546-111354694.74095.35
61123809-112380995.61396.35
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.942305622312732310512307372304152308080.16
29.992313952318392316170.14
单位质量响应值RSD%判断
23220.1223184.880.11数据可信
供试品溶液-301166A批-恩格列净-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%
5min160072-6007223.06620.5219.9023.0720.5219.90
260633-6063323.28123.28
367459-6745925.90225.90
444128-4412816.94416.94
541496-4149615.93315.93
646857-4685717.99217.99
10min1132565-13256550.90145.6219.1550.9445.6519.16
2132690-13269050.94950.99
3148774-14877457.12557.17
4102323-10232339.28939.32
588484-8848433.97534.00
6108003-10800341.47041.50
15min1189802-18980272.87966.8616.4973.0066.9716.49
2194276-19427674.59674.72
3210723-21072380.91281.05
4153398-15339858.90058.99
5134863-13486351.78451.87
6161645-16164562.06762.17
20min1223377-22337785.77081.6611.7486.0281.8811.76
2237188-23718891.07391.32
3241232-24123292.62692.90
4194445-19444574.66174.85
5179506-17950668.92569.09
6200292-20029276.90677.11
30min1249394-24939495.76094.344.6196.1594.704.65
2258345-25834599.19799.60
3257157-25715798.74199.17
4237015-23701591.00791.32
5230004-23000488.31588.60
6242201-24220192.99893.33
45min1252226-25222696.84897.321.7497.3997.841.79
2259272-25927299.553100.12
3258663-25866399.31999.91
4248969-24896995.59796.07
5250677-25067796.25396.68
6250942-25094296.35596.84
60min1251563-25156396.59397.391.2897.3098.061.32
2258078-25807899.09599.83
3256627-25662798.53899.30
4249491-24949195.79796.42
5253841-25384197.46898.06
6252155-25215596.82097.47
极限1250799-25079996.30097.421.3697.1798.261.37
2258438-25843899.233100.13
3255772-25577298.20999.13
4249488-24948895.79696.58
5255592-25559298.14098.89
6252181-25218196.83097.64
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.341089159108586410860611087418108576710868540.14
210.28 1089633109076310901980.08
单位质量响应值RSD%判断
105111.61106050.390.63数据可信
供试品溶液-301166A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%
5min1400532-40053234.10931.2514.0734.1131.2514.07
2398338-39833833.92233.92
3436572-43657237.17837.18
4320069-32006927.25727.26
5310945-31094526.48026.48
6334966-33496628.52528.53
10min1715128-71512860.90055.9113.7060.9655.9613.70
2707977-70797760.29160.35
3774953-77495365.99466.06
4588020-58802050.07550.12
5539231-53923145.92045.96
6613687-61368752.26152.31
15min1931294-93129479.30874.0712.1579.4774.2212.16
2944024-94402480.39280.55
31002436-100243685.36785.54
4791715-79171567.42267.55
5725825-72582561.81161.93
6823674-82367470.14370.28
20min11052235-105223589.60785.758.6489.9086.028.65
21089271-108927192.76193.05
31101604-110160493.81294.13
4947349-94734980.67580.92
5885437-88543775.40375.63
6965552-96555282.22582.48
30min11130069-113006996.23694.893.0096.6895.303.04
21148251-114825197.78498.23
31143046-114304697.34197.81
41093309-109330993.10593.48
51060417-106041790.30490.65
61110669-111066994.58494.97
45min11134910-113491096.64896.790.6397.2597.360.66
21148156-114815697.77698.38
31140725-114072597.14397.78
41130241-113024196.25096.78
51129182-112918296.16096.66
61136095-113609596.74997.30
60min11133534-113353496.53196.650.7097.2997.380.73
21146740-114674097.65598.43
31138758-113875896.97697.77
41122982-112298295.63296.32
51131538-113153896.36197.02
61135889-113588996.73197.44
极限11130323-113032396.25796.340.7497.1897.240.76
21143646-114364697.39298.33
31134584-113458496.62097.58
41118089-111808995.21596.07
51129586-112958696.19497.02
61131550-113155096.36297.23
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