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%
110.159287993124930779329892703930160.25
210.069136491492914280.10
单位质量响应值RSD%判断
9164.149088.270.59数据可信
供试品溶液-2024112921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%
5min134794-3479434.31337.1910.2234.3137.1910.23
238821-3882138.28538.28
343190-4319042.59342.59
434235-3423533.76233.76
534277-3427733.80433.80
640974-4097440.40840.41
10min170269-7026969.29876.019.7169.3676.079.71
281198-8119880.07780.14
388460-8846087.23887.31
472282-7228271.28471.34
569818-6981868.85468.91
680422-8042279.31179.38
15min194391-9439193.08794.625.1493.2694.815.14
2102681-102681101.263101.46
399279-9927997.90898.12
491050-9105089.79289.97
590147-9014788.90289.07
698138-9813896.78396.98
20min1101634-101634100.23098.682.64100.5699.032.65
2103926-103926102.491102.86
399470-9947098.09698.48
498093-9809396.73897.06
596503-9650395.17095.49
6100777-10077799.38599.75
30min1102561-102561101.14499.302.36101.6499.812.36
2104058-104058102.621103.16
399689-9968998.31298.86
499358-9935897.98698.47
597465-9746596.11996.60
6100989-10098999.594100.12
45min1103021-103021101.59899.482.37102.26100.152.38
2104128-104128102.690103.40
399893-9989398.51399.22
499509-9950998.13598.78
597633-9763396.28596.92
6101039-10103999.643100.34
60min1102563-102563101.14699.332.29101.98100.172.30
2103962-103962102.526103.41
399849-9984998.47099.34
499509-9950998.13598.95
597502-9750296.15596.95
6100919-10091999.525100.38
极限1102768-102768101.34999.502.30102.35100.512.30
2104082-104082102.644103.69
399856-9985698.47799.51
499851-9985198.47299.45
597599-9759996.25197.21
6101226-10122699.828100.85
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.079214049237099234339227369239259230410.12
29.989090999097179094080.05
单位质量响应值RSD%判断
91662.4691123.050.42数据可信
供试品溶液-2024112921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%
5min1382677-38267737.68540.408.5037.6840.408.51
2416657-41665741.03141.03
3461009-46100945.39945.40
4378678-37867837.29137.29
5382170-38217037.63537.63
6440539-44053943.38343.38
10min1689166-68916667.86773.768.1567.9373.838.15
2780491-78049176.86076.93
3841715-84171582.89082.97
4705595-70559569.48569.55
5697873-69787368.72468.79
6779443-77944376.75776.83
15min1881429-88142986.80088.303.8786.9888.493.87
2942767-94276792.84193.04
3920899-92089990.68790.90
4861235-86123584.81284.99
5858516-85851684.54484.72
6915099-91509990.11690.32
20min1934325-93432592.00991.301.7592.3391.641.76
2951361-95136193.68794.04
3924778-92477891.06991.43
4913224-91322489.93290.25
5906188-90618889.23989.56
6933036-93303691.88392.23
30min1941641-94164192.73091.681.5293.2092.171.52
2951563-95156393.70794.21
3925717-92571791.16291.68
4922513-92251390.84691.32
5912138-91213889.82590.29
6932123-93212391.79392.30
45min1942457-94245792.81091.711.5093.4492.351.50
2951112-95111293.66394.33
3925800-92580091.17091.84
4923502-92350290.94491.56
5912315-91231589.84290.46
6932457-93245791.82692.48
60min1939226-93922692.49291.501.4293.2892.301.42
2947626-94762693.31994.14
3924782-92478291.07091.89
4922008-92200890.79791.57
5910478-91047889.66190.43
6930936-93093691.67692.49
极限1938628-93862892.43391.551.4193.3792.501.41
2948408-94840893.39694.37
3924335-92433591.02692.00
4922398-92239890.83591.76
5911586-91158689.77090.69
6932730-93273091.85292.81
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%
110.159293993255930649288292911930100.17
210.069164691637916420.01
单位质量响应值RSD%判断
9163.559109.540.42数据可信
供试品溶液-2024112921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%
5min133280-3328032.78334.0417.1532.7834.0417.14
244611-4461143.94543.94
326941-2694126.53926.54
432887-3288732.39632.40
537259-3725936.70236.70
632382-3238231.89831.90
10min168768-6876867.74171.0313.1767.8071.0913.17
289433-8943388.09788.17
361235-6123560.32060.36
469688-6968868.64768.70
574507-7450773.39473.46
669025-6902567.99468.05
15min189849-8984988.50791.375.4888.6791.545.50
2100729-10072999.22499.44
386827-8682785.53085.67
490450-9045089.09989.27
596726-9672695.28195.46
691931-9193190.55890.72
20min198232-9823296.76598.101.6997.0898.421.71
2101342-10134299.828100.21
398058-9805896.59396.88
498048-9804896.58496.90
5101628-101628100.110100.45
6100192-10019298.69699.01
30min199506-9950698.02098.911.2098.5099.401.21
2100975-10097599.467100.02
398606-9860697.13397.58
4100281-10028198.78399.26
5101786-101786100.266100.77
6101333-10133399.819100.30
45min199665-9966598.17699.091.0998.8299.741.11
2101253-10125399.741100.46
398868-9886897.39198.00
4100839-10083999.33399.98
5101724-101724100.205100.88
6101191-10119199.680100.33
60min199694-9969498.20599.181.2499.01100.001.26
2101361-10136199.847100.73
398667-9866797.19397.97
4100962-10096299.454100.26
5101942-101942100.419101.26
6101451-10145199.936100.75
极限1100644-10064499.14199.381.23100.11100.371.24
2101372-10137299.858100.91
398567-9856797.09598.03
4101574-101574100.057101.03
5102063-102063100.539101.55
6101121-10112199.611100.59
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.079253819295819251129250779255429261390.21
29.989099239099949099580.01
单位质量响应值RSD%判断
91970.1191178.160.62数据可信
供试品溶液-2024112921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%
5min1370595-37059536.42337.4214.3136.4237.4214.31
2473582-47358246.54546.54
3310523-31052330.51930.52
4366588-36658836.02936.03
5403821-40382139.68939.69
6359553-35955335.33835.34
10min1680154-68015466.84769.6310.7466.9169.7010.74
2847257-84725783.27183.35
3621672-62167261.10061.15
4689648-68964867.78167.84
5727757-72775771.52671.59
6684423-68442367.26767.33
15min1852372-85237283.77486.054.2083.9586.234.21
2934194-93419491.81592.03
3833655-83365581.93482.09
4860568-86056884.57984.75
5902831-90283188.73388.92
6869811-86981185.48885.66
20min1915157-91515789.94491.201.2290.2691.531.24
2939285-93928592.31692.69
3919370-91937090.35890.65
4919614-91961490.38290.70
5941155-94115592.49992.83
6933245-93324591.72292.04
30min1925383-92538390.94991.760.8691.4192.230.87
2938424-93842492.23192.75
3921916-92191690.60991.05
4936310-93631092.02392.49
5940968-94096892.48192.97
6938798-93879892.26892.73
45min1925758-92575890.98691.810.9591.6092.440.96
2939203-93920392.30892.98
3920411-92041190.46191.05
4940545-94054592.43993.06
5940953-94095392.48093.12
6938076-93807692.19792.82
60min1923371-92337190.75291.610.9591.5292.390.97
2937400-93740092.13092.96
3918600-91860090.28391.02
4938300-93830092.21992.99
5939564-93956492.34393.14
6935500-93550091.94492.72
极限1925481-92548190.95991.450.9291.8892.380.93
2933836-93383691.78092.76
3915635-91563589.99190.88
4937474-93747492.13893.06
5937738-93773892.16493.11
6932698-93269891.66892.60
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%
110.159287893003928469290592929929120.07
210.069148491577915300.08
单位质量响应值RSD%判断
9153.899098.410.43数据可信
供试品溶液-2024120221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%
5min137811-3781137.28934.3316.9137.2934.3316.91
233602-3360233.13833.14
330687-3068730.26330.26
442630-4263042.04142.04
537957-3795737.43337.43
626173-2617325.81125.81
10min173808-7380872.78869.1310.0772.8569.1910.07
270626-7062669.65069.71
364473-6447363.58263.63
477778-7777876.70476.77
574845-7484573.81173.87
659069-5906958.25358.30
15min196414-9641495.08291.844.9495.2792.014.95
294340-9434093.03793.21
389956-8995688.71388.87
496753-9675395.41695.61
596018-9601894.69294.88
685263-8526384.08584.23
20min1100263-10026398.87899.421.3399.2299.751.35
2102617-102617101.199101.53
399718-9971898.34198.64
4101563-101563100.160100.52
5101626-101626100.222100.57
699104-9910497.73598.02
30min1100695-10069599.304100.521.1899.81101.011.18
2104065-104065102.627103.12
3101152-10115299.755100.22
4101699-101699100.294100.82
5102435-102435101.020101.53
6101510-101510100.108100.55
45min1100354-10035498.968100.741.4299.64101.401.41
2104406-104406102.964103.63
3101205-10120599.807100.44
4101518-101518100.116100.81
5102372-102372100.958101.64
6103067-103067101.643102.25
60min1101728-101728100.323100.511.19101.16101.331.19
2104225-104225102.785103.62
3101085-10108599.689100.49
4101131-10113199.734100.59
5102165-102165100.754101.60
6101144-10114499.747100.53
极限199856-9985698.477100.431.7499.48101.421.73
2105062-105062103.611104.62
3101496-101496100.094101.06
4101372-10137299.972101.00
5102251-102251100.839101.85
6100974-10097499.579100.52
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.079248369256699246509244859240489247380.07
29.989096459096739096590.01
单位质量响应值RSD%判断
91830.9891148.200.53数据可信
供试品溶液-2024120221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%
5min1416026-41602640.92637.9714.4940.9337.9814.49
2371399-37139936.53636.54
3348991-34899134.33134.33
4461390-46139045.38845.39
5414015-41401540.72840.73
6304246-30424629.93029.93
10min1729136-72913671.72768.598.5971.8068.658.60
2699942-69994268.85668.92
3649419-64941963.88563.94
4763524-76352475.11075.19
5736868-73686872.48872.56
6604350-60435059.45259.50
15min1905217-90521789.04986.603.9589.2486.783.96
2886724-88672487.23087.41
3855692-85569284.17784.34
4910834-91083489.60289.80
5901181-90118188.65288.84
6822112-82211280.87481.02
20min1934085-93408591.88992.081.0292.2392.401.03
2946652-94665293.12593.45
3926248-92624891.11891.42
4944179-94417992.88293.23
5940964-94096492.56692.90
6923945-92394590.89191.18
30min1935841-93584192.06292.840.9092.5593.310.90
2959003-95900394.34094.82
3937427-93742792.21892.67
4943458-94345892.81193.32
5946253-94625393.08693.58
6940277-94027792.49892.93
45min1934128-93412891.89393.001.0392.5493.631.02
2959107-95910794.35094.98
3936353-93635392.11292.72
4942637-94263792.73093.39
5946242-94624293.08593.73
6953599-95359993.80994.40
60min1943650-94365092.83092.690.8593.6393.480.86
2956674-95667494.11194.90
3935216-93521692.00092.76
4939697-93969792.44193.26
5942941-94294192.76093.56
6935151-93515191.99492.74
极限1927159-92715991.20892.341.4192.1693.281.40
2964125-96412594.84495.79
3932056-93205691.68992.61
4936317-93631792.10993.08
5939482-93948292.42093.38
6932848-93284891.76792.67
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%
110.159310893137930739296793038930650.08
210.069157091455915120.09
单位质量响应值RSD%判断
9168.979096.620.57数据可信
供试品溶液-2024120221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%
5min134904-3490434.39733.759.7934.4033.759.78
234437-3443733.93733.94
338581-3858138.02138.02
428644-2864428.22828.23
532829-3282932.35232.35
636103-3610335.57935.58
10min172047-7204771.00169.839.0571.0669.889.05
271524-7152470.48570.54
381427-8142780.24480.31
461987-6198761.08761.13
567264-6726466.28766.34
670899-7089969.86969.93
15min195876-9587694.48392.754.2794.6692.924.28
292789-9278991.44191.62
3100724-10072499.26199.46
489336-8933688.03888.19
591173-9117389.84990.01
694802-9480293.42593.60
20min1101948-101948100.46799.101.55100.8099.431.56
299893-9989398.44298.77
3102598-102598101.108101.47
499164-9916497.72498.02
598726-9872697.29297.61
6101049-10104999.58199.91
30min1102409-102409100.92299.721.20101.42100.211.21
2100377-10037798.91999.41
3102337-102337100.851101.38
4100683-10068399.22199.68
599423-9942397.97998.46
6101908-101908100.428100.93
45min1101884-101884100.40499.991.67101.07100.651.68
2100556-10055699.09599.75
3103531-103531102.027102.73
4100475-10047599.01699.64
599183-9918397.74298.38
6103149-103149101.651102.32
60min1101421-10142199.948100.030.98100.78100.860.99
2100384-10038498.92699.75
3102262-102262100.777101.65
4101162-10116299.693100.48
5100752-10075299.289100.09
6103053-103053101.556102.39
极限1101535-101535100.06099.351.13101.06100.341.14
2100113-10011398.65999.64
3101781-101781100.303101.34
4100697-10069799.234100.19
598935-9893597.49898.47
6101806-101806100.327101.33
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.079250319258909252199250399251339252620.04
29.989075159080429077780.05
单位质量响应值RSD%判断
91883.0290959.720.72数据可信
供试品溶液-2024120221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%
5min1388838-38883838.28037.548.0238.2837.548.02
2382467-38246737.65337.65
3422418-42241841.58641.59
4330714-33071432.55832.56
5368343-36834336.26336.26
6395417-39541738.92838.93
10min1711866-71186670.08269.107.3970.1569.167.39
2708304-70830469.73169.79
3788895-78889577.66577.73
4632939-63293962.31162.37
5670735-67073566.03266.09
6698502-69850268.76668.83
15min1901735-90173588.77487.303.2888.9587.483.29
2878199-87819986.45786.64
3934350-93435091.98592.18
4852644-85264483.94184.10
5864541-86454185.11285.28
6889127-88912787.53387.71
20min1944725-94472593.00691.851.0793.3392.181.08
2928789-92878991.43791.76
3944989-94498993.03293.38
4926031-92603191.16691.46
5920740-92074090.64590.96
6932826-93282691.83592.16
30min1946987-94698793.22992.190.9093.7192.670.91
2930693-93069391.62592.10
3943369-94336992.87393.38
4932766-93276691.82992.28
5925042-92504291.06891.53
6939988-93998892.54093.02
45min1943320-94332092.86892.231.2893.5192.861.29
2927799-92779991.34091.97
3950445-95044593.56994.23
4931071-93107191.66292.26
5920915-92091590.66291.28
6947686-94768693.29893.93
60min1939852-93985292.52692.170.7893.3292.960.79
2927052-92705291.26692.05
3939055-93905592.44893.27
4931626-93162691.71692.47
5932531-93253191.80692.57
6947277-94727793.25794.05
极限1936886-93688692.23491.300.8993.1892.240.90
2922386-92238690.80791.74
3933623-93362391.91392.89
4924542-92454291.01991.93
5914991-91499190.07991.00
6931943-93194391.74892.69
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