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%
110.039328793441933239346293258933540.10
210.129610495822959630.21
单位质量响应值RSD%判断
9307.489482.511.32数据可信
供试品溶液-2024092521批-恩格列净-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133162-3316231.45037.289.3831.4537.289.38
242234-4223440.05340.05
339408-3940837.37337.37
437625-3762535.68235.68
539836-3983637.77937.78
643600-4360041.34941.35
10min169092-6909265.52473.257.9165.5873.317.91
281919-8191977.68977.76
376932-7693272.96073.02
473168-7316869.39069.45
576122-7612272.19172.25
686203-8620381.75281.82
15min192846-9284688.05290.082.2188.2190.262.22
296915-9691591.91192.11
393588-9358888.75588.94
494153-9415389.29189.47
594191-9419189.32789.51
698192-9819293.12293.33
20min197554-9755492.51793.271.3292.8393.611.31
298706-9870693.60993.96
396117-9611791.15491.49
499589-9958994.44794.77
599079-9907993.96394.30
699049-9904993.93494.29
30min199079-9907993.96393.881.2294.4394.371.22
298825-9882593.72294.23
396733-9673391.73892.22
499740-9974094.59095.07
5100177-10017795.00495.49
699405-9940594.27294.79
45min198857-9885793.75294.041.4094.3794.691.39
298036-9803692.97493.64
397136-9713692.12092.76
4100434-10043495.24895.89
5100453-10045395.26695.91
6100039-10003994.87395.55
60min199174-9917494.05394.361.2094.8395.171.20
299510-9951094.37295.19
397456-9745692.42493.21
499829-9982994.67495.47
5101086-10108695.86696.67
699956-9995694.79595.63
极限1101011-10101195.79595.961.4896.7396.921.46
299638-9963894.49395.47
3100016-10001694.85295.80
4101236-10123696.00996.96
5103883-10388398.51999.48
6101309-10130996.07897.07
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%
110.12 1079357108493110884391087323108438410848870.33
210.171112514111351211130130.07
单位质量响应值RSD%判断
107202.27109440.811.47数据可信
供试品溶液-2024092521批-二甲双胍-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1484243-48424340.23846.187.9140.2446.187.91
2591677-59167749.16549.17
3556782-55678246.26646.27
4533215-53321544.30744.31
5560588-56058846.58246.58
6607878-60787850.51250.51
10min1878068-87806872.96380.396.9573.0380.476.95
21014286-101428684.28284.36
3964921-96492180.18080.26
4921372-92137276.56176.64
5957761-95776179.58579.66
61068341-106834188.77488.86
15min11113346-111334692.51394.231.7992.7094.441.81
21152347-115234795.75495.98
31128818-112881893.79994.01
41121156-112115693.16293.36
51123268-112326893.33893.55
61165359-116535996.83597.07
20min11157171-115717196.15596.610.7796.5096.980.77
21162760-116276096.61997.00
31148201-114820195.41095.78
41168757-116875797.11897.47
51166302-116630296.91497.28
61172895-117289597.46297.86
30min11160602-116060296.44096.930.6996.9497.460.69
21159743-115974396.36996.91
31158738-115873896.28596.81
41168346-116834697.08497.60
51176827-117682797.78898.32
61174727-117472797.61498.17
45min11161551-116155196.51996.920.7997.1897.610.79
21157801-115780196.20796.91
31156237-115623796.07796.76
41169106-116910697.14797.83
51176083-117608397.72698.42
61177221-117722197.82198.54
60min11159920-115992096.38396.880.5997.2197.730.60
21163107-116310796.64897.51
31158012-115801296.22597.07
41166370-116637096.91997.76
51173007-117300797.47198.32
61174832-117483297.62298.50
极限11159219-115921996.32596.860.8797.3197.880.87
21157734-115773496.20297.23
31160150-116015096.40297.41
41160929-116092996.46797.47
51182911-118291198.29499.31
61173284-117328497.49498.54
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%
110.039488795006950199500794998949830.06
210.129406293666938640.30
单位质量响应值RSD%判断
9469.899275.101.47数据可信
供试品溶液-2024092521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%
5min129607-2960728.14634.3012.3128.1534.3012.30
237202-3720235.36635.37
335617-3561733.86033.86
436595-3659534.78934.79
543247-4324741.11341.11
634216-3421632.52832.53
10min162934-6293459.82969.3710.2159.8869.4310.21
277233-7723373.42273.48
371013-7101367.50967.57
472366-7236668.79668.85
584875-8487580.68780.76
669432-6943266.00666.06
15min186538-8653882.26887.255.2482.4187.435.25
295168-9516890.47290.65
391392-9139286.88387.05
489608-8960885.18785.36
599545-9954594.63494.84
688445-8844584.08184.25
20min195759-9575991.03492.122.4391.3292.442.44
297635-9763592.81893.15
398257-9825793.40993.72
495049-9504990.35990.67
5100523-10052395.56395.92
694202-9420289.55489.86
30min198231-9823193.38493.451.8893.8293.921.89
297818-9781892.99293.48
3100375-10037595.42395.89
496411-9641191.65492.12
5100585-10058595.62296.14
696378-9637891.62392.08
45min198630-9863093.76493.911.7294.3594.541.73
298448-9844893.59194.23
3100696-10069695.72896.36
497080-9708092.29092.91
5100887-10088795.90996.59
696976-9697692.19192.80
60min198907-9890794.02793.901.5594.7794.681.56
298112-9811293.27194.07
3100739-10073995.76996.56
497578-9757892.76493.54
5100364-10036495.41296.25
696941-9694192.15892.92
极限1100471-10047195.51495.261.2896.4296.201.29
299646-9964694.73095.68
3101440-10144096.43597.38
498936-9893694.05594.98
5101884-10188496.85797.86
698876-9887693.99894.91
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%
110.12 1109775110902111116791108735110752211093460.14
210.171091268109248210918750.08
单位质量响应值RSD%判断
109619.17107362.341.48数据可信
供试品溶液-2024092521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%
5min1457413-45741337.94944.489.7837.9544.489.78
2551550-55155045.76045.76
3528877-52887743.87843.88
4541604-54160444.93444.93
5619047-61904751.35951.36
6518072-51807242.98242.98
10min1833436-83343669.14678.678.6969.2178.748.69
2994678-99467882.52482.60
3924323-92432376.68776.76
4945761-94576178.46578.54
51077718-107771889.41389.50
6913147-91314775.76075.83
15min11089061-108906190.35494.363.7790.5394.563.78
21172124-117212497.24697.46
31125898-112589893.41193.61
41122241-112224193.10793.31
51204698-120469899.948100.18
61110039-111003992.09592.29
20min11175107-117510797.49398.241.2297.8298.601.24
21187358-118735898.51098.89
31191055-119105598.81699.17
41173264-117326497.34097.70
51208034-1208034100.225100.63
61169841-116984197.05697.41
30min11190721-119072198.78998.781.0699.2899.301.07
21186147-118614798.40998.95
31206289-1206289100.080100.60
41179156-117915697.82998.35
51204688-120468899.947100.52
61176615-117661597.61898.13
45min11192466-119246698.93398.910.9499.5999.600.95
21179234-117923497.83698.54
31204042-120404299.894100.58
41184443-118444398.26898.95
51206850-1206850100.127100.86
61185820-118582098.38299.06
60min11188889-118888998.63798.700.8499.4699.560.84
21178399-117839997.76698.63
31204319-120431999.917100.77
41183356-118335698.17899.03
51198747-119874799.454100.36
61184267-118426798.25399.09
极限11188338-118833898.59198.670.7699.5899.690.77
21181289-118128998.00699.04
31199005-119900599.476100.50
41180526-118052697.94398.96
51201519-120151999.684100.75
61185163-118516398.32799.33
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