恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
19.792268272278072276862277892278682275950.20
29.832291662293172292420.05
单位质量响应值RSD%判断
23247.7023320.650.23数据可信
供试品溶液-3214147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%
5min13542-35421.3691.04135.191.371.04135.03
29300-93003.5953.59
3-0.0000.00
43354-33541.2961.30
5-0.0000.00
6-0.0000.00
10min133903-3390313.10519.3320.5913.1119.3320.58
252301-5230120.21620.22
342407-4240716.39216.39
451309-5130919.83219.83
561310-6131023.69823.70
658842-5884222.74422.74
15min1106053-10605340.99349.6310.9541.0249.6710.95
2136117-13611752.61352.65
3118773-11877345.90945.94
4127542-12754249.29949.33
5144070-14407055.68755.73
6137875-13787553.29353.33
20min1172206-17220666.56371.225.1366.6671.345.14
2187809-18780972.59472.72
3177053-17705368.43668.54
4179798-17979869.49769.61
5196887-19688776.10376.23
6191817-19181774.14374.27
30min1221771-22177185.72188.693.6585.9288.923.66
2236280-23628091.32991.58
3221465-22146585.60385.82
4223333-22333386.32586.56
5240839-24083993.09193.35
6232990-23299090.05890.31
45min1234992-23499290.83194.053.4691.1894.443.47
2247632-24763295.71796.12
3236710-23671091.49591.86
4237443-23744391.77992.16
5256613-25661399.18999.60
6246529-24652995.29195.69
60min1241636-24163693.39995.072.6893.9095.612.69
2250532-25053296.83897.40
3239252-23925292.47892.99
4239928-23992892.73993.27
5255127-25512798.61499.19
6249308-24930896.36596.92
120min1238127-23812792.04395.442.7592.7096.142.76
2251880-25188097.35998.08
3241781-24178193.45594.12
4243777-24377794.22794.91
5255962-25596298.93799.68
6249989-24998996.62897.35
240min1239024-23902492.39096.242.5093.2097.102.52
2252781-25278197.70798.59
3245860-24586095.03295.86
4247848-24784895.80196.64
5256868-25686899.287100.20
6251479-25147997.20498.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1239329-23932992.50896.472.3393.4797.492.34
2252807-25280797.71798.76
3248225-24822595.94696.93
4249210-24921096.32797.33
5256424-25642499.115100.19
6251496-25149697.21198.25
480min1237504-23750491.80296.282.4792.9297.462.48
2252429-25242997.57198.78
3248573-24857396.08197.22
4250037-25003796.64797.81
5255311-25531198.68599.92
6250737-25073796.91798.12
600min1247845-24784595.79999.201.8197.07100.541.82
2258767-258767100.021101.39
3255901-25590198.913100.21
4258857-258857100.056101.38
5260939-260939100.861102.26
6257568-25756899.558100.92
720min1241735-24173593.43898.282.4894.8799.782.48
2256185-25618599.023100.56
3257922-25792299.694101.16
4254547-25454798.39099.88
5258377-25837799.870101.44
6256796-25679699.259100.79
840min1239389-23938992.53197.962.8594.1199.622.85
2255047-25504798.583100.29
3254611-25461198.415100.05
4254534-25453498.385100.04
5256644-25664499.200100.94
6260308-260308100.617102.31
960min1238169-23816992.05996.922.4893.8098.762.48
2253273-25327397.89799.77
3253654-25365498.04599.84
4252037-25203797.42099.24
5253910-25391098.144100.05
6253491-25349197.98299.85
极限1236756-23675691.51396.722.7593.4098.722.74
2251354-25135497.15699.19
3256046-25604698.969100.93
4251667-25166797.27799.26
5251311-25131197.13999.21
6254258-25425898.278100.31
恩格列净二甲双胍片项目信息
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%
19.828786198772868767818776888783918777530.09
29.868861578864508863040.03
单位质量响应值RSD%判断
89384.2289888.840.40数据可信
供试品溶液-3214147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%
5min113371-133711.3430.59134.491.340.59134.36
23840-38400.3860.39
3-0.0000.00
418095-180951.8171.82
5-0.0000.00
6-0.0000.00
10min15451-54510.5470.5584.780.550.5584.48
24461-44610.4480.45
34195-41950.4210.42
41159-11590.1160.12
514358-143581.4421.44
63015-30150.3030.30
15min131737-317373.1872.2931.703.192.2931.64
214327-143271.4391.44
330896-308963.1023.10
416313-163131.6381.64
521460-214602.1552.16
622155-221552.2252.23
20min158272-582725.8515.5014.955.865.5014.92
242946-429464.3124.32
365193-651936.5466.55
447242-472424.7434.75
556224-562245.6455.65
658698-586985.8945.90
30min1128721-12872112.92412.066.0412.9412.086.07
2111487-11148711.19411.20
3120145-12014512.06312.08
4111446-11144611.19011.20
5125293-12529312.58012.60
6123649-12364912.41512.43
45min1203705-20370520.45319.425.2020.4919.465.20
2184988-18498818.57418.60
3188168-18816818.89318.93
4181664-18166418.24018.27
5205815-20581520.66520.70
6196247-19624719.70419.74
60min1256273-25627325.73124.593.7125.8124.663.72
2240039-24003924.10124.16
3237627-23762723.85923.93
4233407-23340723.43623.50
5251823-25182325.28525.36
6250040-25004025.10625.17
120min1397318-39731839.89338.973.0340.0139.083.03
2384114-38411438.56738.67
3375028-37502837.65537.76
4374927-37492737.64537.75
5401955-40195540.35940.47
6395251-39525139.68639.80
240min1579364-57936458.17257.251.4158.3657.421.42
2565830-56583056.81356.98
3558701-55870156.09756.27
4566097-56609756.84057.00
5578052-57805258.04058.22
6573002-57300257.53357.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1712223-71222371.51270.261.1471.7970.531.15
2693434-69343469.62569.88
3689373-68937369.21769.48
4701886-70188670.47470.73
5702707-70270770.55670.83
6699015-69901570.18670.46
480min1794468-79446879.77078.780.8780.1779.170.88
2778623-77862378.17978.55
3779445-77944578.26178.64
4778784-77878478.19578.57
5790433-79043379.36479.76
6786064-78606478.92679.31
600min1878386-87838688.19587.140.8688.7387.660.86
2859441-85944186.29386.80
3860404-86040486.39086.90
4870882-87088287.44287.95
5872537-87253787.60888.14
6865358-86535886.88787.41
720min1921154-92115492.49091.351.3893.1792.021.38
2893949-89394989.75890.41
3901614-90161490.52891.18
4901188-90118890.48591.14
5924114-92411492.78793.46
6917057-91705792.07892.74
840min1932781-93278193.65792.930.6694.4993.740.66
2918136-91813692.18792.99
3918332-91833292.20693.01
4926349-92634993.01193.82
5927544-92754493.13193.96
6929867-92986793.36494.18
960min1942789-94278994.66293.570.7195.6594.540.71
2923362-92336292.71193.66
3927754-92775493.15294.11
4933696-93369693.74994.71
5931176-93117693.49694.48
6932543-93254393.63394.61
极限1941383-94138394.52193.500.8795.6794.620.87
2920042-92004292.37893.49
3928400-92840093.21794.33
4933361-93336193.71594.83
5925360-92536092.91294.05
6938473-93847394.22995.36
恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
19.792306052305082303602305832305382305190.05
29.832294132294462294300.02
单位质量响应值RSD%判断
23546.3723339.780.63数据可信
供试品溶液-3214147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%
5min1-0.0000.34244.950.000.34244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
55328-53282.0462.05
6-0.0000.00
10min147595-4759518.27221.9613.7818.2721.9613.78
247799-4779918.35118.35
363386-6338624.33524.33
458629-5862922.50922.51
559446-5944622.82222.83
666406-6640625.49425.49
15min1128959-12895949.50953.068.2849.5453.108.28
2122449-12244947.01047.04
3145196-14519655.74355.78
4134089-13408951.47951.52
5147225-14722556.52256.56
6151383-15138358.11858.16
20min1185550-18555071.23672.654.0871.3572.784.09
2180009-18000969.10869.22
3192670-19267073.96974.10
4185357-18535771.16271.28
5189469-18946972.74072.88
6202338-20233877.68177.82
30min1235659-23565990.47388.664.1490.7088.914.14
2226008-22600886.76886.99
3229868-22986888.25088.51
4224024-22402486.00686.25
5222290-22229085.34185.60
6247837-24783795.14995.42
45min1246214-24621494.52692.484.2694.9192.884.25
2239572-23957291.97692.34
3238768-23876891.66792.07
4232396-23239689.22189.61
5230122-23012288.34888.75
6258289-25828999.16199.59
60min1248677-24867795.47193.444.2096.0193.994.19
2245691-24569194.32594.85
3239322-23932291.88092.44
4233194-23319489.52790.06
5233572-23357289.67290.22
6259851-25985199.761100.35
120min1252618-25261896.98493.914.5197.6894.614.49
2243726-24372693.57094.25
3241479-24147992.70893.42
4235039-23503990.23590.92
5232796-23279689.37490.07
6261932-261932100.560101.32
240min1252779-25277997.04694.274.7197.9195.134.70
2244471-24447193.85694.69
3244767-24476793.97094.83
4234561-23456190.05290.89
5232922-23292289.42390.27
6263828-263828101.288102.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1252610-25261096.98194.454.7398.0095.464.72
2245475-24547594.24295.23
3246014-24601494.44995.47
4234556-23455690.05091.03
5233084-23308489.48590.48
6264293-264293101.466102.56
480min1251775-25177596.66094.064.7497.8495.244.73
2244850-24485094.00295.15
3242812-24281293.21994.40
4233890-23389089.79490.93
5232905-23290589.41690.56
6263800-263800101.277102.54
600min1257741-25774198.95196.244.81100.3097.574.80
2250326-25032696.10497.41
3248311-24831195.33196.66
4238976-23897691.74793.03
5238425-23842591.53592.83
6270222-270222103.743105.18
720min1255461-25546198.07695.564.8599.5997.064.83
2249375-24937595.73997.20
3246773-24677394.74096.23
4236668-23666890.86192.30
5236790-23679090.90892.35
6268457-268457103.065104.67
840min1254098-25409897.55295.514.4899.2397.164.47
2249350-24935095.72997.35
3245580-24558094.28295.93
4235808-23580890.53092.12
5240506-24050692.33493.93
6267311-267311102.625104.40
960min1253018-25301897.13894.484.8498.9796.294.82
2246628-24662894.68496.47
3244163-24416393.73895.55
4233795-23379589.75891.50
5233938-23393889.81391.56
6264961-264961101.723103.67
极限1252489-25248996.93594.474.9098.9396.444.88
2249711-24971195.86897.81
3242892-24289293.25095.21
4233689-23368989.71791.61
5233123-23312389.50091.40
6264525-264525101.555103.67
恩格列净二甲双胍片项目信息
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%
19.828852088849598852178852548847758850830.03
29.868806998808098807540.01
单位质量响应值RSD%判断
90130.6589325.960.64数据可信
供试品溶液-3214147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%
5min1-0.0000.05244.950.000.05244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
52956-29560.2970.30
6-0.0000.00
10min11826-18260.1830.4864.190.180.4864.73
24326-43260.4340.43
35013-50130.5030.50
49945-99450.9981.00
56110-61100.6130.61
61609-16090.1610.16
15min120959-209592.1023.0735.662.103.0735.65
229727-297272.9822.98
331639-316393.1743.17
431682-316823.1783.18
550168-501685.0325.03
619725-197251.9791.98
20min151047-510475.1206.4615.925.126.4615.92
266304-663046.6516.66
368777-687776.8996.90
475637-756377.5877.59
571994-719947.2217.23
652556-525565.2725.28
30min1118459-11845911.88212.966.5011.8912.986.53
2131942-13194213.23413.25
3133214-13321413.36213.38
4135242-13524213.56513.59
5137565-13756513.79813.82
6118875-11887511.92411.94
45min1191482-19148219.20720.286.2019.2420.326.22
2198667-19866719.92719.97
3201598-20159820.22120.26
4225644-22564422.63322.68
5203834-20383420.44620.49
6191918-19191819.25019.28
60min1245566-24556624.63125.142.0024.7025.212.02
2250243-25024325.10125.17
3252040-25204025.28125.35
4255942-25594225.67225.75
5255708-25570825.64925.73
6244056-24405624.48024.54
120min1390811-39081139.20039.240.8639.3139.350.88
2388678-38867838.98639.10
3393153-39315339.43539.55
4396429-39642939.76439.89
5391165-39116539.23639.36
6386863-38686338.80438.91
240min1571344-57134457.30957.300.5557.4857.480.55
2568722-56872257.04657.22
3574523-57452357.62757.81
4574441-57444157.61957.81
5566749-56674956.84857.03
6571711-57171157.34557.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1716383-71638371.85770.161.2572.1270.441.24
2694339-69433969.64669.92
3699982-69998270.21270.49
4697501-69750169.96370.25
5692072-69207269.41869.70
6696624-69662469.87570.14
480min1782711-78271178.51078.630.3878.9079.020.37
2786745-78674578.91479.30
3786426-78642678.88279.28
4782851-78285178.52478.93
5779010-77901078.13878.54
6785601-78560178.80079.18
600min1868771-86877187.14286.840.3987.6687.360.38
2863710-86371086.63487.16
3867398-86739887.00487.53
4868376-86837687.10287.63
5860160-86016086.27886.81
6866024-86602486.86687.38
720min1914127-91412791.69190.440.7992.3591.110.78
2898054-89805490.07990.75
3904433-90443390.71991.39
4898886-89888690.16390.84
5893694-89369489.64290.31
6900944-90094490.36991.03
840min1924475-92447592.72992.610.6493.5493.430.63
2918330-91833092.11392.93
3926415-92641592.92493.75
4920394-92039492.32093.15
5917207-91720792.00092.82
6932844-93284493.56994.38
960min1934364-93436493.72193.270.4594.6994.240.44
2928463-92846393.12994.10
3935177-93517793.80394.78
4926966-92696692.97993.96
5924803-92480392.76293.74
6929163-92916393.20094.16
极限1935997-93599793.88593.610.9895.0194.740.96
2928941-92894193.17794.30
3932313-93231393.51594.65
4929480-92948093.23194.37
5923005-92300592.58293.71
6949625-94962595.25296.37
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