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%
110.05 9449094345943859432794004943100.20
210.019419394166941800.03
单位质量响应值RSD%判断
9384.089408.590.19数据可信
供试品溶液-F24707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%
5min143499-4349941.24346.4214.1441.2446.4214.14
254432-5443251.61051.61
356308-5630853.38853.39
438122-3812236.14536.15
549594-4959447.02247.02
651777-5177749.09249.09
10min180505-8050576.33176.1910.7676.4076.2610.76
282398-8239878.12578.21
376776-7677672.79572.88
473233-7323369.43669.50
572984-7298469.20069.28
696216-9621691.22791.31
15min1100570-10057095.35592.803.9695.5593.003.97
2100024-10002494.83895.05
396472-9647291.47091.68
494561-9456189.65889.83
592794-9279487.98288.18
6102802-10280297.47197.71
20min1102753-10275397.42598.262.5097.7898.622.48
2102244-10224496.94297.32
3102457-10245797.14497.51
4102842-10284297.50997.83
5108893-108893103.247103.59
6102597-10259797.27797.67
30min1103193-10319397.84297.580.3298.3698.100.32
2102452-10245297.14097.68
3102575-10257597.25697.78
4102938-10293897.60098.09
5103198-10319897.84798.36
6103126-10312697.77998.34
45min1103923-10392398.53497.760.5899.2198.450.57
2102314-10231497.00997.71
3102815-10281597.48498.17
4102963-10296397.62498.27
5103706-10370698.32999.00
6102941-10294197.60398.32
60min1103178-10317897.82897.430.4898.6798.280.46
2102172-10217296.87497.73
3102479-10247997.16598.01
4103140-10314097.79298.61
5103268-10326897.91398.75
6102314-10231497.00997.89
极限1102979-10297997.63997.500.7998.6598.510.76
2102251-10225196.94997.97
3102345-10234597.03898.05
4103915-10391598.52799.50
5103613-10361398.24099.24
6101880-10188096.59797.64
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%
110.05 4682504701164702834697274699044696560.18
29.984685794686524686160.02
单位质量响应值RSD%判断
46731.9446955.510.34数据可信
供试品溶液-F24707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%
5min1259417-25941749.84249.899.5449.8449.899.54
2266234-26623451.15151.15
3256274-25627449.23849.24
4235680-23568045.28145.28
5236938-23693845.52345.52
6303477-30347758.30758.31
10min1421624-42162481.00681.218.7981.0981.308.79
2433171-43317183.22583.31
3406208-40620878.04478.13
4393868-39386875.67475.75
5390558-39055875.03875.11
6490826-49082694.30294.40
15min1502075-50207596.46394.512.8996.6894.732.90
2503003-50300396.64296.87
3487811-48781193.72393.93
4481913-48191392.59092.79
5470436-47043690.38590.59
6506171-50617197.25097.50
20min1507249-50724997.45797.350.3597.8497.730.34
2508014-50801497.60497.99
3505695-50569597.15997.53
4509229-50922997.83898.19
5505424-50542497.10797.46
6504662-50466296.96097.38
30min1505881-50588197.19597.460.3097.7497.990.30
2505699-50569997.16097.71
3506557-50655797.32497.85
4508480-50848097.69498.21
5507367-50736797.48097.99
6509434-50943497.87798.46
45min1509672-50967297.92397.380.3298.6398.090.31
2505888-50588897.19697.91
3506684-50668497.34998.04
4507278-50727897.46398.14
5506849-50684997.38198.06
6504853-50485396.99797.74
60min1504214-50421496.87497.010.3997.7497.880.37
2504983-50498397.02297.89
3504454-50445496.92097.78
4508338-50833897.66798.51
5505323-50532397.08797.93
6502344-50234496.51597.42
极限1504004-50400496.83497.080.6297.8698.100.60
2503396-50339696.71797.75
3505208-50520897.06598.08
4511416-51141698.25899.26
5504595-50459596.94797.95
6503042-50304296.64997.71
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%
110.05 9434894201941909427893888941810.19
210.019527995007951430.21
单位质量响应值RSD%判断
9371.249504.801.01数据可信
供试品溶液-F24707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%
5min150841-5084147.99437.9719.8947.9937.9819.89
245230-4523042.69742.70
338630-3863036.46736.47
426936-2693625.42825.43
541066-4106638.76738.77
638661-3866136.49636.50
10min195910-9591090.54076.0115.7190.6276.0715.72
287580-8758082.67682.75
377848-7784873.48973.55
458375-5837555.10655.15
584232-8423279.51679.58
679152-7915274.72074.78
15min1103677-10367797.87293.017.5298.1093.207.54
2102359-10235996.62796.84
397890-9789092.40992.59
484163-8416379.45079.58
5103510-10351097.71497.91
699555-9955593.98194.17
20min1103444-10344497.65297.192.1798.0597.532.20
2102853-10285397.09497.46
3103992-10399298.16998.51
498745-9874593.21693.48
5105345-10534599.44699.81
6103332-10333297.54697.89
30min1103441-10344197.64997.830.8098.2198.340.81
2102411-10241196.67797.21
3104098-10409898.26998.77
4103023-10302397.25497.68
5104612-10461298.75499.28
6104217-10421798.38198.89
45min1103468-10346897.67497.670.8898.3998.340.89
2102347-10234796.61697.31
3104196-10419698.36299.03
4102473-10247396.73597.32
5104589-10458998.73399.42
6103694-10369497.88898.56
60min1103267-10326797.48597.641.0598.3798.481.05
2102007-10200796.29597.15
3104789-10478998.92199.75
4102389-10238996.65697.40
5104079-10407998.25199.11
6104078-10407898.25099.08
极限1103960-10396098.13997.690.6099.1898.680.61
2102722-10272296.97097.98
3102917-10291797.15498.15
4103516-10351697.72098.63
5104370-10437098.52699.54
6103409-10340997.61998.61
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%
110.05 4689674693984696894677344682614688100.18
29.984714704712894713800.03
单位质量响应值RSD%判断
46647.7647232.460.89数据可信
供试品溶液-F24707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%
5min1313108-31310860.03648.8617.5860.0448.8617.59
2284020-28402054.45854.46
3246903-24690347.34147.34
4180300-18030034.57134.57
5261193-26119350.08150.08
6243562-24356246.70146.70
10min1488445-48844593.65581.6112.3293.7681.6912.33
2458570-45857087.92788.02
3411317-41131778.86678.95
4334959-33495964.22564.28
5440946-44094684.54784.63
6419377-41937780.41280.49
15min1508322-50832297.46694.435.8497.7294.645.86
2506518-50651897.12097.36
3494596-49459694.83495.04
4435423-43542383.48883.65
5512413-51241398.25198.48
6497554-49755495.40295.61
20min1506986-50698697.21097.121.4597.6397.491.47
2507191-50719197.24997.65
3510966-51096697.97398.34
4492287-49228794.39294.70
5512768-51276898.31998.71
6508770-50877097.55297.92
30min1504955-50495596.82197.280.6897.4097.810.69
2505912-50591297.00497.57
3510711-51071197.92498.46
4502340-50234096.31996.78
5510418-51041897.86898.42
6509613-50961397.71498.25
45min1504334-50433496.70297.030.5597.4497.730.57
2504703-50470396.77297.50
3507715-50771597.35098.04
4502223-50222396.29796.92
5509802-50980297.75098.47
6507460-50746097.30198.00
60min1502265-50226596.30597.070.9097.2197.930.90
2503886-50388696.61697.50
3511446-51144698.06598.92
4500820-50082096.02896.81
5508633-50863397.52698.40
6510583-51058397.90098.76
极限1510814-51081497.94496.890.8599.0197.910.87
2501319-50131996.12397.17
3506408-50640897.09998.12
4499938-49993895.85996.80
5508943-50894397.58598.63
6504414-50441496.71797.74
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%
110.05 9462294436942269396794522943550.28
210.019484994386946180.35
单位质量响应值RSD%判断
9388.569452.350.48数据可信
供试品溶液-F24707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%
5min129808-2980828.19036.5917.7228.1936.6017.72
245255-4525542.79942.80
339036-3903636.91836.92
432215-3221530.46730.47
538747-3874736.64436.64
647104-4710444.54844.55
10min163254-6325459.82173.3912.9159.8773.4512.91
289438-8943884.58484.66
379308-7930875.00475.07
469849-6984966.05866.11
576594-7659472.43772.50
687152-8715282.42282.50
15min186412-8641281.72291.345.8481.8791.525.85
2100956-10095695.47795.69
399326-9932693.93694.12
494374-9437489.25289.41
596978-9697891.71591.90
6101421-10142195.91796.13
20min198153-9815392.82695.211.3793.1195.541.40
2101504-10150495.99596.37
3101477-10147795.97096.31
4101105-10110595.61895.93
5100020-10002094.59294.93
6101769-10176996.24696.62
30min1101360-10136095.85995.590.5996.3096.090.59
2101203-10120395.71196.24
3101302-10130295.80496.31
4101172-10117295.68196.15
599895-9989594.47494.97
6101532-10153296.02296.55
45min1101474-10147495.96795.650.7696.5696.310.76
2101004-10100495.52296.21
3101388-10138895.88696.55
4101566-10156696.05496.68
599669-9966994.26094.91
6101757-10175796.23596.93
60min1101539-10153996.02895.670.7996.7996.480.78
2100850-10085095.37796.23
3102135-10213596.59297.41
4101284-10128495.78796.58
599783-9978394.36895.17
6101344-10134495.84496.70
极限1101605-10160596.09195.640.5797.0196.610.57
2101102-10110295.61596.62
3101084-10108495.59896.58
4101453-10145395.94796.90
5100040-10004094.61195.57
6101499-10149995.99197.00
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%
110.05 4679224685914695864690484697654689820.17
29.984690094700684695380.16
单位质量响应值RSD%判断
46664.8847047.900.58数据可信
供试品溶液-F24707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%
5min1192548-19254836.98545.0914.1836.9845.0914.18
2268100-26810051.49751.50
3236951-23695145.51345.51
4202892-20289238.97138.97
5232949-23294944.74544.74
6274989-27498952.82052.82
10min1334467-33446764.24476.0810.6964.3176.1610.69
2446769-44676985.81585.90
3404109-40410977.62177.70
4364671-36467170.04670.11
5391505-39150575.20075.27
6435085-43508583.57183.66
15min1426830-42683081.98588.984.2082.1589.184.21
2478511-47851191.91292.14
3473305-47330590.91291.12
4457802-45780287.93488.12
5465930-46593089.49689.70
6477030-47703091.62891.85
20min1467865-46786589.86791.210.9290.1791.560.94
2479136-47913692.03292.41
3475855-47585591.40291.76
4476737-47673791.57191.90
5471401-47140190.54690.90
6478143-47814391.84192.22
30min1477594-47759491.73691.310.5292.1991.820.52
2476846-47684691.59292.13
3474852-47485291.20991.72
4475102-47510291.25791.74
5470935-47093590.45790.96
6476991-47699191.62092.15
45min1478316-47831691.87591.270.5192.4891.920.50
2475938-47593891.41892.11
3474160-47416091.07691.74
4474635-47463591.16891.80
5471297-47129790.52691.18
6476554-47655491.53692.22
60min1477358-47735891.69191.450.9392.4592.250.92
2475547-47554791.34392.18
3482449-48244992.66993.48
4475727-47572791.37792.16
5468755-46875590.03890.84
6476693-47669391.56392.40
极限1476680-47668091.56091.240.9792.4792.200.97
2482535-48253592.68593.68
3472612-47261290.77991.75
4474471-47447191.13692.07
5468762-46876290.04090.99
6475056-47505691.24992.24
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