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%
19.844582814584014586814586634588924585840.06
29.894576764579554578160.05
单位质量响应值RSD%判断
46604.0746290.800.48数据可信
供试品溶液-3214157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%
5min1-0.0001.2182.670.001.2182.71
2-0.0000.00
38818-88181.7091.71
410355-103552.0062.01
56414-64141.2431.24
611865-118652.2992.30
10min194572-9457218.32517.0054.5618.3317.0054.55
2140620-14062027.24827.25
377310-7731014.98014.98
4-0.0000.00
5112668-11266821.83221.83
6101292-10129219.62719.63
15min1268330-26833051.99449.656.9752.0249.686.99
2278479-27847953.96154.01
3237695-23769546.05846.09
4232257-23225745.00445.01
5259684-25968450.31950.36
6260836-26083650.54250.58
20min1338332-33833265.55869.724.1865.6869.834.19
2376632-37663272.98073.12
3363896-36389670.51270.62
4344460-34446066.74666.82
5369614-36961471.62071.74
6365919-36591970.90471.02
30min1442970-44297085.83486.071.9486.0686.301.96
2449038-44903887.01087.27
3443217-44321785.88286.10
4428330-42833082.99783.19
5452339-45233987.65087.89
6449149-44914987.03187.27
45min1472459-47245991.54892.431.0591.9292.801.06
2480099-48009993.02993.43
3482510-48251093.49693.86
4472121-47212191.48391.81
5481765-48176593.35193.74
6472967-47296791.64792.03
60min1476960-47696092.42093.701.2192.9494.221.22
2488124-48812494.58495.14
3492213-49221395.37695.90
4481242-48124293.25093.73
5484238-48423893.83194.37
6478458-47845892.71193.25
120min1481388-48138893.27894.441.8993.9595.131.88
2498669-49866996.62797.34
3495872-49587296.08596.76
4488775-48877594.71095.35
5485857-48585794.14494.84
6473894-47389491.82692.52
240min1481850-48185093.36894.922.3994.2095.762.38
2505254-50525497.90398.78
3496237-49623796.15697.00
4488345-48834594.62695.42
5495167-49516795.94896.80
6472231-47223191.50492.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1475763-47576392.18895.122.2993.1896.122.28
2503994-50399497.65998.70
3495816-49581696.07497.07
4492258-49225895.38596.34
5498537-49853796.60197.62
6478852-47885292.78793.78
480min1491321-49132195.20397.392.6396.3498.542.62
2516567-516567100.095101.30
3509101-50910198.64899.81
4501750-50175097.22498.33
5513739-51373999.547100.72
6483034-48303493.59794.75
600min1490491-49049195.04297.323.0796.3498.643.06
2516279-516279100.039101.41
3506912-50691298.22499.55
4499540-49954096.79698.07
5520372-520372100.832102.18
6480027-48002793.01594.32
720min1486256-48625694.22296.913.1995.6898.393.17
2512546-51254699.316100.85
3504415-50441597.74099.23
4497743-49774396.44797.88
5521174-521174100.988102.50
6478718-47871892.76194.22
840min1482431-48243193.48095.743.4195.1097.393.39
2506697-50669798.18299.88
3499715-49971596.83098.48
4488783-48878394.71196.31
5516558-516558100.093101.77
6470488-47048891.16692.78
960min1476808-47680892.39194.493.7194.1696.293.69
2500929-50092997.06598.93
3496612-49661296.22898.04
4474156-47415691.87793.63
5511799-51179999.171101.02
6465392-46539290.17991.95
极限1473608-47360891.77193.553.7493.7095.513.71
2498271-49827196.55098.58
3496282-49628296.16498.14
4467109-46710990.51292.42
5501543-50154397.18499.20
6459951-45995189.12591.04
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%
19.919051439052739054959060029054999054820.04
29.969079489086069082770.06
单位质量响应值RSD%判断
91370.5391192.470.14数据可信
供试品溶液-3214157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%
5min1-0.0000.17110.970.000.18111.15
2-0.0000.00
31317-13170.1300.13
44878-48780.4810.48
51033-10330.1020.10
63398-33980.3350.34
10min12138-21380.2110.29121.250.210.29120.94
210065-100650.9920.99
31676-16760.1650.17
4-0.0000.00
52531-25310.2500.25
61336-13360.1320.13
15min1126249-12624912.4483.74114.8312.453.74114.78
219374-193741.9101.91
328280-282802.7882.79
412940-129401.2761.28
518567-185671.8311.83
622180-221802.1872.19
20min152633-526335.1896.2936.295.216.3036.24
257463-574635.6665.67
3109358-10935810.78210.79
463650-636506.2766.28
555163-551635.4395.44
644650-446504.4024.41
30min1125391-12539112.36311.355.7012.3911.365.74
2112476-11247611.09011.10
3119252-11925211.75811.78
4106116-10611610.46310.48
5113278-11327811.16911.18
6114106-11410611.25011.26
45min1190471-19047118.78018.232.7218.8318.262.75
2179963-17996317.74417.78
3190810-19081018.81318.86
4179064-17906417.65517.69
5183629-18362918.10518.14
6185146-18514618.25518.29
60min1244251-24425124.08223.682.7924.1623.742.81
2236153-23615323.28423.35
3248302-24830224.48224.56
4231795-23179522.85422.91
5234996-23499623.17023.23
6245370-24537024.19324.25
120min1387749-38774938.23137.491.5338.3537.591.54
2377626-37762637.23237.33
3386979-38697938.15538.27
4376005-37600537.07337.17
5374011-37401136.87636.98
6378859-37885937.35437.46
240min1570704-57070456.26955.810.9656.4555.980.96
2565887-56588755.79455.96
3570088-57008856.20956.39
4557505-55750554.96855.13
5570036-57003656.20356.36
6561827-56182755.39455.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1691096-69109668.13968.751.3768.4269.011.36
2687711-68771167.80668.06
3698165-69816568.83669.11
4690548-69054868.08568.34
5703598-70359869.37269.63
6712579-71257970.25870.51
480min1807534-80753479.62079.381.0580.0179.751.05
2803821-80382179.25479.62
3807144-80714479.58179.97
4794105-79410578.29678.66
5818703-81870380.72181.09
6799033-79903378.78279.15
600min1872168-87216885.99285.521.1186.5286.021.11
2866302-86630285.41485.92
3871266-87126685.90486.42
4851360-85136083.94184.44
5879555-87955586.72187.23
6863326-86332685.12185.62
720min1909325-90932589.65689.471.0890.3290.121.08
2907249-90724989.45190.09
3908772-90877289.60190.26
4893672-89367288.11388.75
5923343-92334391.03891.69
6902380-90238088.97189.62
840min1926902-92690291.38990.921.3192.2191.721.31
2923102-92310291.01491.81
3925984-92598491.29892.11
4904575-90457589.18889.97
5939273-93927392.60993.41
6912874-91287490.00690.80
960min1931523-93152391.84591.241.7692.8292.191.75
2928545-92854591.55192.50
3934327-93432792.12193.09
4897015-89701588.44289.37
5943278-94327893.00493.96
6917428-91742890.45591.40
极限1926762-92676291.37590.651.8892.5091.751.88
2926429-92642991.34292.44
3934533-93453392.14193.26
4888023-88802387.55688.63
5929644-92964491.65992.77
6911050-91105089.82690.92
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%
19.844568214568344572254568404570804569600.05
29.894586524587674587100.02
单位质量响应值RSD%判断
46439.0246381.190.09数据可信
供试品溶液-3214157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%
5min1-0.0000.95157.850.000.95157.87
2-0.0000.00
3-0.0000.00
412331-123312.3912.39
5-0.0000.00
617009-170093.2983.30
10min1123202-12320223.89216.4451.3623.8916.4451.36
2-0.0000.00
386983-8698316.86816.87
489219-8921917.30217.31
5105709-10570920.49920.50
6103477-10347720.06720.07
15min1273983-27398353.13246.358.6053.1746.388.61
2218571-21857142.38642.39
3219779-21977942.62042.65
4238222-23822246.19746.23
5235326-23532645.63545.67
6248087-24808748.11048.15
20min1366174-36617471.01066.293.7771.1466.403.78
2331983-33198364.37964.45
3339889-33988965.91266.01
4330676-33067664.12664.24
5339162-33916265.77165.88
6343125-34312566.54066.66
30min1445067-44506786.30985.683.0586.5685.893.05
2426334-42633482.67682.85
3463345-46334589.85390.06
4432370-43237083.84784.06
5448923-44892387.05787.28
6434747-43474784.30884.54
45min1471772-47177291.48892.463.8291.8892.823.80
2474660-47466092.04892.36
3508988-50898898.70599.06
4457546-45754688.72989.09
5484003-48400393.85994.22
6463880-46388089.95790.33
60min1477155-47715592.53193.333.7193.0793.853.70
2467707-46770790.69991.17
3511628-51162899.21799.74
4467532-46753290.66591.17
5493617-49361795.72496.25
6470137-47013791.17191.69
120min1486522-48652294.34894.373.1695.0595.043.15
2478033-47803392.70293.32
3510796-51079699.05599.74
4471963-47196391.52592.18
5498521-49852196.67597.36
6473926-47392691.90592.58
240min1494830-49483095.95995.193.0696.8196.023.05
2489557-48955794.93795.71
3511030-51103099.10199.95
4476288-47628892.36393.17
5501794-50179497.31098.15
6471706-47170691.47592.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1493604-49360495.72195.293.1296.7496.273.11
2491452-49145295.30496.24
3513131-51313199.508100.53
4475967-47596792.30193.26
5501410-50141097.23598.24
6472566-47256691.64292.62
480min1507631-50763198.44297.943.0099.6299.092.99
2509970-50997098.89599.99
3522873-522873101.397102.58
4491232-49123295.26196.38
5515795-515795100.025101.19
6482851-48285193.63694.77
600min1506169-50616998.15897.742.7899.5099.052.76
2510062-51006298.913100.17
3519947-519947100.830102.18
4491169-49116995.24996.52
5513471-51347199.574100.91
6483361-48336193.73595.02
720min1503798-50379897.69897.043.0999.2098.513.07
2509110-50911098.728100.15
3515685-515685100.003101.53
4487974-48797494.63096.06
5510241-51024198.948100.45
6475583-47558392.22793.67
840min1496098-49609896.20596.013.0697.8797.643.04
2502519-50251997.45099.04
3510021-51002198.905100.59
4482047-48204793.48095.07
5507795-50779598.473100.14
6471993-47199391.53093.13
960min1485893-48589394.22694.502.9996.0596.292.96
2493771-49377195.75497.50
3498711-49871196.71298.56
4479058-47905892.90194.65
5502980-50298097.54099.37
6463497-46349789.88391.63
极限1481385-48138593.35293.753.1095.3395.703.08
2486423-48642394.32996.24
3495032-49503295.99898.01
4476804-47680492.46394.37
5501896-50189697.32999.32
6459176-45917689.04590.94
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%
19.919057299056509059349055139059709057590.03
29.969059179061059060110.02
单位质量响应值RSD%判断
91398.4990964.960.34数据可信
供试品溶液-3214157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%
5min1-0.0000.52197.490.000.52197.45
2-0.0000.00
3-0.0000.00
45566-55660.5490.55
5-0.0000.00
625810-258102.5482.55
10min15815-58150.5740.54125.790.570.54126.14
2-0.0000.00
33071-30710.3030.30
42537-25370.2500.25
519020-190201.8771.88
62418-24180.2390.24
15min121434-214342.1161.7228.052.121.7228.15
211590-115901.1441.14
314382-143821.4201.42
421900-219002.1622.16
513086-130861.2921.29
621980-219802.1702.17
20min153372-533725.2685.5831.855.275.5831.83
243744-437444.3184.32
390433-904338.9268.93
449762-497624.9124.92
541210-412104.0684.07
660650-606505.9865.99
30min1117567-11756711.60411.0310.6511.6211.0410.65
2106448-10644810.50710.52
3101712-10171210.03910.06
4113721-11372111.22511.24
599503-995039.8219.83
6131520-13152012.98213.00
45min1184582-18458218.21918.405.7818.2518.435.77
2204082-20408220.14420.17
3181400-18140017.90517.94
4183642-18364218.12618.16
5172339-17233917.01117.04
6192146-19214618.96619.01
60min1236488-23648823.34223.653.5323.4123.713.52
2227452-22745222.45122.51
3237026-23702623.39623.46
4240850-24085023.77323.84
5253151-25315124.98725.04
6242539-24253923.94024.01
120min1375400-37540037.05437.363.1337.1637.463.13
2370483-37048336.56836.67
3382401-38240137.74537.85
4371936-37193636.71236.81
5369818-36981836.50336.60
6400695-40069539.55039.66
240min1562366-56236655.50855.290.8955.6755.450.89
2558278-55827855.10555.26
3568215-56821556.08556.25
4554459-55445954.72854.89
5556244-55624454.90455.06
6561222-56122255.39555.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1685312-68531267.64367.741.2167.9068.001.21
2681444-68144467.26267.51
3696311-69631168.72968.99
4675233-67523366.64966.90
5683728-68372867.48767.74
6695620-69562068.66168.93
480min1792570-79257078.23078.470.5578.6078.840.55
2795979-79597978.56778.93
3801760-80176079.13779.51
4788716-78871677.85078.22
5794663-79466378.43778.80
6796535-79653578.62279.01
600min1855362-85536284.42884.920.5284.9385.420.53
2858207-85820784.70985.20
3866239-86623985.50286.01
4856064-85606484.49784.99
5862545-86254585.13785.63
6863806-86380685.26285.78
720min1892353-89235388.07988.500.5888.7289.140.57
2895699-89569988.41089.04
3905830-90583089.41090.06
4892504-89250488.09488.73
5898923-89892388.72889.36
6894444-89444488.28688.94
840min1904914-90491489.31990.150.8190.1190.940.80
2910599-91059989.88090.66
3924257-92425791.22892.03
4908564-90856489.67990.46
5920121-92012190.82091.60
6911795-91179589.99890.80
960min1901711-90171189.00390.320.9389.9491.260.92
2910991-91099189.91990.85
3921623-92162390.96891.92
4919662-91966290.77591.71
5924419-92441991.24492.18
6911750-91175089.99490.95
极限1898327-89832788.66989.991.1889.7591.081.17
2902342-90234289.06590.15
3919084-91908490.71891.82
4918687-91868790.67991.76
5925050-92505091.30792.39
6906606-90660689.48690.59
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