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%
110.18 2377162379882374892383842387442380640.22
210.19 2382362379152380760.10
单位质量响应值RSD%判断
23385.4623363.690.07数据可信
供试品溶液-24052201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%
5min1109684-10968441.80638.878.5941.8138.878.60
297019-9701936.97836.98
390860-9086034.63134.63
4112287-11228742.79842.80
595196-9519636.28336.28
6106823-10682340.71540.72
10min1205345-20534578.26673.215.9378.3473.285.94
2183387-18338769.89769.96
3177981-17798167.83767.89
4202431-20243177.15677.23
5184948-18494870.49270.55
6198387-19838775.61475.68
15min1238782-23878291.01188.502.7191.2188.692.72
2225364-22536485.89686.07
3225035-22503585.77185.94
4239545-23954591.30191.50
5233280-23328088.91389.09
6231209-23120988.12488.32
20min1244467-24446793.17792.231.4793.5392.571.48
2240087-24008791.50891.83
3237583-23758390.55490.87
4245394-24539493.53193.88
5245533-24553393.58493.91
6238851-23885191.03791.38
30min1244478-24447893.18292.901.3793.6993.391.38
2242441-24244192.40592.88
3239333-23933391.22191.69
4247183-24718394.21394.72
5247764-24776494.43494.92
6241287-24128791.96592.46
45min1245333-24533393.50793.151.4094.1793.791.40
2244106-24410693.04093.67
3239998-23999891.47492.09
4248183-24818394.59495.26
5247785-24778594.44295.08
6240929-24092991.82992.47
60min1244470-24447093.17992.841.0294.0093.641.03
2243703-24370392.88693.67
3239771-23977191.38892.16
4245079-24507993.41194.23
5246738-24673894.04394.84
6241782-24178292.15492.95
极限1247024-24702494.15294.121.1495.1395.071.14
2247587-24758794.36795.30
3242431-24243192.40193.32
4247375-24737594.28695.26
5251152-25115295.72596.68
6246004-24600493.76394.72
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%
110.431086778109111710885081091453109244510900600.22
210.361093099109059510918470.17
单位质量响应值RSD%判断
104511.98105390.640.60数据可信
供试品溶液-24052201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%
5min1631225-63122554.13150.627.3554.1350.627.35
2567605-56760548.67548.68
3538476-53847646.17746.18
4638491-63849154.75454.75
5550466-55046647.20647.21
6615178-61517852.75552.75
10min11032026-103202688.50283.904.6188.5983.984.61
2944636-94463681.00881.09
3921128-92112878.99279.07
41015471-101547187.08287.17
5950962-95096281.55081.63
61005622-100562286.23886.33
15min11154225-115422598.98196.582.0799.2296.802.08
21105301-110530194.78695.00
31095263-109526393.92594.13
41147639-114763998.41698.65
51132963-113296397.15897.37
61121867-112186796.20696.44
20min11163131-116313199.74599.250.89100.1599.640.89
21161025-116102599.56499.94
31142749-114274997.99798.36
41161038-116103899.56599.97
51169194-1169194100.265100.64
61147112-114711298.37198.76
30min11165741-116574199.96999.510.85100.54100.060.85
21162099-116209999.656100.20
31145224-114522498.20998.74
41159618-115961899.444100.01
51174338-1174338100.706101.25
61155090-115509099.05599.61
45min11163439-116343999.77199.561.02100.51100.271.03
21162987-116298799.733100.44
31141620-114162097.90098.59
41173703-1173703100.652101.38
51170482-1170482100.375101.09
61153303-115330398.90299.62
60min11158495-115849599.34799.141.04100.25100.021.04
21159770-115977099.457100.33
31137954-113795497.58698.44
41156367-115636799.165100.06
51174014-1174014100.678101.56
61149757-114975798.59899.48
极限11158014-115801499.30698.970.84100.37100.020.84
21159253-115925399.412100.45
31137392-113739297.53898.56
41153949-115394998.958100.02
51165424-116542499.942100.99
61150662-115066298.67699.73
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%
110.18 2369622370472370082368392367712369250.05
210.19 2377052376952377000.01
单位质量响应值RSD%判断
23273.5823326.790.17数据可信
供试品溶液-24052202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%
5min197518-9751837.28737.758.9337.2937.758.93
288083-8808333.68033.68
393303-9330335.67635.68
4108052-10805241.31541.32
594792-9479236.24536.24
6110635-11063542.30342.30
10min1180987-18098769.20372.538.3069.2672.608.30
2176725-17672567.57367.63
3178287-17828768.17068.23
4206707-20670779.03779.11
5182842-18284269.91269.97
6212632-21263281.30281.37
15min1222681-22268185.14587.353.9185.3287.533.92
2218802-21880283.66283.83
3220411-22041184.27784.45
4238065-23806591.02791.23
5232238-23223888.79988.98
6238440-23844091.17091.38
20min1237770-23777090.91491.270.8291.2391.600.84
2235710-23571090.12790.43
3237729-23772990.89991.21
4240676-24067692.02592.38
5240305-24030591.88492.21
6240051-24005191.78692.14
30min1240618-24061892.00392.090.2192.4792.570.20
2241360-24136092.28792.75
3240700-24070092.03592.50
4240039-24003991.78292.29
5241248-24124892.24492.72
6241060-24106092.17292.68
45min1241060-24106092.17293.723.7392.8094.363.70
2241551-24155192.36092.97
3242142-24214292.58693.20
4240104-24010491.80792.47
5263687-263687100.824101.46
6242177-24217792.59993.26
60min1241361-24136192.28792.250.4093.0793.040.38
2242255-24225592.62993.40
3241676-24167692.40893.18
4239713-23971391.65792.47
5241953-24195392.51493.31
6240549-24054991.97792.80
极限1244927-24492793.65193.660.7394.5894.610.71
2247116-24711694.48895.41
3245808-24580893.98894.91
4242685-24268592.79493.76
5246202-24620294.13895.09
6243002-24300292.91593.89
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%
110.431087611108723710896571090364108864310887020.13
210.361094334109459310944640.02
单位质量响应值RSD%判断
104381.78105643.240.85数据可信
供试品溶液-24052202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%
5min1569813-56981348.83749.427.2548.8449.427.25
2528603-52860345.30545.31
3550745-55074547.20347.20
4620177-62017753.15453.15
5555830-55583047.63947.64
6634681-63468154.39754.40
10min1933065-93306579.97083.056.2980.0583.146.29
2922128-92212879.03379.11
3922772-92277279.08879.17
41034921-103492188.70088.79
5943210-94321080.84080.92
61058069-105806990.68490.77
15min11091455-109145593.54695.372.5593.7695.602.56
21087542-108754293.21093.42
31082535-108253592.78192.99
41140548-114054897.75397.99
51133647-113364797.16297.38
61140996-114099697.79298.03
20min11142905-114290597.95598.230.4898.3398.610.47
21144403-114440398.08498.45
31147325-114732598.33498.70
41144507-114450798.09298.49
51156271-115627199.10199.48
61141129-114112997.80398.21
30min11149357-114935798.50898.650.4199.0499.190.40
21157928-115792899.24399.77
31150611-115061198.61699.14
41146956-114695698.30298.87
51155172-115517299.00799.55
61145838-114583898.20798.77
45min11150305-115030598.58998.560.6899.2999.270.66
21159588-115958899.385100.08
31153456-115345698.85999.55
41140100-114010097.71598.44
51155243-115524399.01399.72
61141402-114140297.82698.56
60min11147243-114724398.32798.290.7099.1999.160.68
21157594-115759499.214100.07
31148203-114820398.40999.27
41138187-113818797.55198.44
51152566-115256698.78399.65
61137016-113701697.45098.34
极限11145890-114589098.21198.260.8899.2499.300.86
21155014-115501498.993100.02
31154349-115434998.93699.96
41133245-113324597.12798.18
51155099-115509999.000100.04
61135502-113550297.32198.38
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%
110.18 2393262399622392942393282398032395430.14
210.19 2374102373632373860.02
单位质量响应值RSD%判断
23530.7523295.980.71数据可信
供试品溶液-24052203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%
5min175157-7515728.59933.8212.7928.6033.8212.79
295450-9545036.32136.32
385234-8523432.43432.43
479019-7901930.06930.07
592490-9249035.19535.19
6105921-10592140.30540.31
10min1164344-16434462.53769.528.4162.5869.588.41
2189308-18930872.03672.10
3182637-18263769.49869.55
4165276-16527662.89162.94
5191520-19152072.87872.94
6203108-20310877.28777.35
15min1217915-21791582.92285.763.2383.0785.933.25
2228277-22827786.86587.05
3230334-23033487.64787.82
4215456-21545681.98682.14
5226062-22606286.02286.20
6234158-23415889.10389.30
20min1232403-23240388.43589.001.5388.7289.321.55
2233883-23388388.99889.32
3236833-23683390.12090.44
4227779-22777986.67586.97
5234677-23467789.30089.62
6237778-23777890.48090.82
30min1234368-23436889.18289.511.2489.6289.981.26
2234364-23436489.18189.65
3237624-23762490.42190.89
4230458-23045887.69588.13
5235926-23592689.77590.25
6238657-23865790.81491.31
45min1235370-23537089.56489.910.9290.1590.520.94
2236012-23601289.80890.43
3238738-23873890.84591.46
4232596-23259688.50889.09
5237035-23703590.19790.82
6237863-23786390.51291.16
60min1234702-23470289.31090.231.5390.0490.991.54
2235779-23577989.71990.49
3237611-23761190.41691.18
4233145-23314588.71789.45
5243553-24355392.67893.45
6237948-23794890.54591.34
极限1238478-23847890.74691.721.4991.6392.631.50
2240234-24023491.41592.34
3239800-23980091.24992.17
4238086-23808690.59791.47
5247839-24783994.30895.24
6241734-24173491.98592.93
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%
110.431100592109965710994531099619110100111000640.07
210.361092443109083910916410.11
单位质量响应值RSD%判断
105471.14105370.750.07数据可信
供试品溶液-24052203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%
5min1466414-46641439.81945.2810.0339.8245.2810.03
2562170-56217047.99447.99
3513727-51372743.85843.86
4483212-48321241.25341.25
5547726-54772646.76046.76
6609345-60934552.02152.02
10min1866352-86635273.96280.406.6074.0380.486.60
2971292-97129282.92183.00
3941721-94172180.39780.47
4871177-87117774.37474.44
5978159-97815983.50783.59
61021747-102174787.22987.32
15min11070989-107098991.43394.082.1691.6294.292.17
21114649-111464995.16095.38
31119121-111912195.54295.75
41074754-107475491.75491.95
51104590-110459094.30194.52
61127578-112757896.26496.50
20min11119589-111958995.58296.200.7295.9296.570.74
21127732-112773296.27796.65
31132737-113273796.70497.07
41114971-111497195.18795.53
51130368-113036896.50296.88
61135883-113588396.97397.37
30min11120281-112028195.64196.420.7496.1496.940.75
21128350-112835096.33096.87
31133276-113327696.75097.28
41119660-111966095.58896.09
51134015-113401596.81397.35
61140594-114059497.37597.93
45min11123970-112397095.95696.440.4996.6297.120.50
21132804-113280496.71097.41
31135911-113591196.97597.66
41121875-112187595.77796.44
51131225-113122596.57597.27
61131788-113178896.62397.34
60min11122999-112299995.87396.270.3896.6997.120.40
21129654-112965496.44197.30
31130017-113001796.47297.32
41122173-112217395.80296.63
51128345-112834596.32997.19
61132980-113298096.72597.60
极限11119583-111958395.58195.980.4696.5696.990.48
21126066-112606696.13597.15
31128327-112832796.32897.34
41116279-111627995.29996.28
51126578-112657896.17897.20
61129038-112903896.38897.43
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