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%
110.069135791425913259159791386914180.12
210.089164791490915680.13
单位质量响应值RSD%判断
9087.289084.130.03数据可信
加速3月-供试品溶液-24091002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%
5min148683-4868348.22446.4412.5448.2246.4412.54
244642-4464244.22144.22
354330-5433053.81853.82
452139-5213951.64751.65
542415-4241542.01542.01
639059-3905938.69138.69
10min183957-8395783.16582.966.6683.2583.046.66
281912-8191281.13981.21
388850-8885088.01288.10
491276-9127690.41590.50
580325-8032579.56779.64
676179-7617975.46075.52
15min196154-9615495.24796.412.1195.4796.622.12
295426-9542694.52694.73
399933-9993398.99099.23
499302-9930298.36598.60
598007-9800797.08397.29
695138-9513894.24194.43
20min199176-9917698.24199.041.0198.6299.421.01
298676-9867697.74598.11
3101506-101506100.549100.95
4100131-10013199.18799.59
5100522-10052299.57499.94
699902-9990298.96099.31
30min199535-9953598.59699.260.7399.1499.810.73
299637-9963798.69799.23
3101239-101239100.284100.85
499619-9961998.67999.25
5100857-10085799.906100.44
6100372-10037299.42599.94
45min199165-9916598.23099.120.8798.9499.830.87
299351-9935198.41499.11
3100838-10083899.887100.62
499709-9970998.76899.50
5101370-101370100.414101.11
699971-9997199.02899.71
60min199206-9920698.27098.960.8099.1499.830.80
299111-9911198.17699.03
3101187-101187100.233101.14
499555-9955598.61699.51
5100407-10040799.460100.32
699924-9992498.98199.82
极限1100081-10008199.13799.190.58100.17100.230.58
299348-9934898.41199.43
3100470-10047099.522100.59
499704-9970498.76499.82
5100980-100980100.028101.06
6100243-10024399.297100.31
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%
110.138527748535108548298548138561758544200.16
210.148574038573338573680.01
单位质量响应值RSD%判断
84345.5184553.060.18数据可信
加速3月-供试品溶液-24091002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%
5min1503544-50354453.66451.4010.6153.6651.4010.60
2459486-45948648.96948.97
3544367-54436758.01558.01
4529253-52925356.40456.40
5440911-44091146.98946.99
6416441-41644144.38144.38
10min1804356-80435685.72385.085.3685.8185.175.37
2785159-78515983.67783.76
3831725-83172588.63988.74
4858710-85871091.51591.61
5769945-76994582.05582.13
6740258-74025878.89278.97
15min1900405-90040595.95996.491.3496.1996.711.35
2889876-88987694.83795.06
3921602-92160298.21898.46
4917360-91736097.76698.01
5905351-90535196.48696.70
6897496-89749695.64995.85
20min1920405-92040598.09098.420.7798.4898.810.77
2911611-91161197.15397.53
3930910-93091099.21099.62
4924034-92403498.47798.89
5924056-92405698.47998.86
6930017-93001799.11599.48
30min1921721-92172198.23198.430.7598.7998.990.74
2913349-91334997.33897.88
3927876-92787698.88799.46
4921097-92109798.16498.74
5924020-92402098.47699.02
6933685-93368599.506100.04
45min1921360-92136098.19298.450.6798.9199.160.66
2914800-91480097.49398.20
3926986-92698698.79299.53
4921275-92127598.18398.92
5925174-92517498.59999.30
6933034-93303499.436100.13
60min1922021-92202198.26398.360.7299.1599.240.71
2913487-91348797.35398.22
3929405-92940599.04999.95
4918382-91838297.87598.78
5923520-92352098.42299.29
6930801-93080199.198100.06
极限1922350-92235098.29898.160.6099.3499.200.59
2913976-91397697.40598.43
3923796-92379698.45299.52
4916748-91674897.70198.76
5920085-92008598.05699.09
6929526-92952699.062100.09
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%
110.069166092023918649131991980917690.32
210.089125691358913070.08
单位质量响应值RSD%判断
9122.179058.230.50数据可信
中间条件3月-供试品溶液-24091002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%
5min144714-4471444.27144.577.9944.2744.577.99
250639-5063950.13750.14
345815-4581545.36145.36
446555-4655546.09446.09
540633-4063340.23040.23
641749-4174941.33541.34
10min181919-8191981.10781.084.1081.1881.154.10
285675-8567584.82684.91
384910-8491084.06884.14
482892-8289282.07082.15
578642-7864277.86377.93
677297-7729776.53176.60
15min198104-9810497.13297.281.7297.3497.491.73
2100629-10062999.63299.86
399533-9953398.54798.76
498480-9848097.50497.72
596295-9629595.34195.54
696497-9649795.54195.74
20min1100671-10067199.673100.161.37100.04100.531.38
2102955-102955101.935102.33
3101588-101588100.581100.96
4101722-101722100.714101.09
598798-9879897.81998.17
6101252-101252100.249100.60
30min1100219-10021999.226100.171.4899.76100.711.48
2103250-103250102.227102.79
3101823-101823100.814101.36
4101498-101498100.492101.04
598870-9887097.89098.41
6101403-101403100.398100.92
45min1100280-10028099.28699.961.5299.99100.671.53
2103349-103349102.325103.06
3101169-101169100.166100.88
4101484-101484100.478101.19
598682-9868297.70498.39
6100794-10079499.795100.49
60min199677-9967798.68999.701.5499.56100.571.54
2102953-102953101.933102.83
3101128-101128100.126101.01
4101135-101135100.133101.01
598387-9838797.41298.26
6100908-10090899.908100.76
极限199731-9973198.743100.192.0699.77101.232.06
2103121-103121102.099103.17
3104063-104063103.032104.08
4101199-101199100.196101.24
598536-9853697.55998.57
6100509-10050999.513100.54
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%
110.138572558582028570628582928557268573070.13
210.148542148546878544500.04
单位质量响应值RSD%判断
84630.5084265.290.31数据可信
中间条件3月-供试品溶液-24091002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%
5min1468035-46803549.88150.166.4549.8850.166.45
2515674-51567454.95854.96
3475611-47561150.68850.69
4489510-48951052.17052.17
5436565-43656546.52746.53
6438699-43869946.75446.75
10min1783014-78301483.45083.473.2383.5383.553.23
2808774-80877486.19586.29
3799664-79966485.22485.31
4798408-79840885.09085.18
5768633-76863381.91781.99
6740622-74062278.93279.01
15min1914880-91488097.50397.261.3797.7397.481.38
2923150-92315098.38598.62
3916578-91657897.68497.91
4922844-92284498.35298.58
5908453-90845396.81897.03
6889731-88973194.82395.03
20min1927061-92706198.80299.431.0599.1999.821.05
2945072-945072100.721101.12
3928433-92843398.94899.34
4945769-945769100.795101.19
5925225-92522598.60698.98
6926188-92618898.70999.08
30min1926717-92671798.76599.361.0899.3199.911.09
2945701-945701100.788101.36
3927640-92764098.86399.42
4944676-944676100.679101.24
5924262-92426298.50399.04
6924790-92479098.56099.09
45min1924454-92445498.52499.211.1799.2499.931.18
2946097-946097100.830101.57
3926261-92626198.71699.44
4943532-943532100.557101.29
5923095-92309598.37999.08
6922135-92213598.27798.97
60min1922347-92234798.29998.941.1699.1899.821.16
2942261-942261100.422101.32
3923442-92344298.41699.30
4941794-941794100.372101.27
5919640-91964098.01198.88
6920430-92043098.09598.96
极限1922632-92263298.33099.181.3599.37100.231.35
2941636-941636100.355101.43
3946400-946400100.863101.91
4936932-93693299.854100.92
5918380-91838097.87698.91
6917771-91777197.81298.84
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