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%
19.792267342265532267542267272267292266990.04
29.832287692289222288460.05
单位质量响应值RSD%判断
23156.1823280.370.38数据可信
供试品溶液-3216399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%
5min110454-104544.0521.11160.294.051.11160.26
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
66729-67292.6082.61
10min144353-4435317.19218.7126.4217.2018.7126.42
237168-3716814.40714.41
345876-4587617.78317.78
470291-7029127.24727.25
536656-3665614.20914.21
655232-5523221.40921.41
15min1120585-12058546.74248.4815.5446.7848.5115.54
2104495-10449540.50540.53
3120566-12056646.73546.76
4152846-15284659.24759.29
5107922-10792241.83441.86
6143964-14396455.80555.84
20min1177217-17721768.69470.506.6568.8170.616.66
2169434-16943465.67765.77
3174534-17453467.65467.76
4201728-20172878.19678.34
5177283-17728368.72068.81
6191021-19102174.04574.18
30min1233122-23312290.36588.603.2090.5988.833.22
2223064-22306486.46686.67
3222730-22273086.33686.56
4240771-24077193.33093.60
5222845-22284586.38186.59
6228926-22892688.73888.99
45min1249769-24976996.81893.872.3697.2094.252.37
2238198-23819892.33292.68
3236987-23698791.86392.23
4249015-24901596.52596.96
5239808-23980892.95693.31
6239148-23914892.70193.10
60min1251110-25111097.33794.582.4297.8895.122.44
2239365-23936592.78593.28
3239652-23965292.89693.41
4252027-25202797.69398.28
5241253-24125393.51794.02
6240640-24064093.27993.84
120min1260473-260473100.96795.963.65101.6796.663.65
2240033-24003393.04493.70
3242704-24270494.07994.75
4257707-25770799.895100.65
5242721-24272194.08694.75
6241759-24175993.71394.43
240min1256866-25686699.56995.642.71100.4496.502.72
2240828-24082893.35294.16
3243912-24391294.54795.38
4253410-25341098.22999.15
5243249-24324994.29095.11
6242165-24216593.87094.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1253873-25387398.40896.202.4299.4497.222.43
2240097-24009793.06894.03
3247853-24785396.07597.06
4254604-25460498.69299.78
5250469-25046997.08998.07
6242228-24222893.89494.92
480min1252769-25276997.98095.332.9399.1896.502.94
2239003-23900392.64493.76
3243408-24340894.35295.50
4256907-25690799.584100.83
5242481-24248193.99395.13
6240948-24094893.39894.58
600min1258254-258254100.10797.833.06101.4799.163.06
2244419-24441994.74496.02
3254557-25455798.67499.98
4263720-263720102.225103.64
5246820-24682095.67496.97
6246497-24649795.54996.89
720min1256126-25612699.28297.072.82100.8198.562.82
2242259-24225993.90695.34
3255621-25562199.086100.55
4258391-258391100.160101.74
5245543-24554395.17996.63
6244535-24453594.78996.29
840min1255352-25535298.98296.202.80100.6897.862.81
2240801-24080193.34194.93
3245719-24571995.24896.88
4258227-258227100.096101.85
5243773-24377394.49396.11
6245228-24522895.05796.71
960min1253917-25391798.42595.223.38100.2997.043.37
2239223-23922392.73094.47
3247071-24707195.77297.56
4256140-25614099.287101.21
5242414-24241493.96795.74
6235127-23512791.14292.96
极限1255050-25505098.86594.405.05100.8996.375.00
2237993-23799392.25394.15
3236889-23688991.82593.78
4260235-260235100.875102.96
5243808-24380894.50796.43
6227153-22715388.05190.02
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%
19.829209449231689257699272199279149250030.32
29.869395049399639397340.04
单位质量响应值RSD%判断
94195.8295307.710.83数据可信
供试品溶液-3216399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%
5min114342-143421.3620.35164.241.360.35164.35
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
67938-79380.7540.75
10min12174-21740.2070.2232.940.210.2233.69
23224-32240.3060.31
31703-17030.1620.16
43402-34020.3230.32
51819-18190.1730.17
61723-17230.1640.16
15min121732-217322.0642.1612.072.072.1612.05
224047-240472.2842.28
320467-204671.9441.94
421644-216442.0562.06
520785-207851.9741.97
627704-277042.6322.63
20min156294-562945.3475.619.775.355.629.72
259421-594215.6445.65
354134-541345.1425.15
456905-569055.4055.41
570330-703306.6816.68
657452-574525.4575.46
30min1127046-12704612.06812.333.4512.0812.343.45
2131645-13164512.50512.52
3124813-12481311.85611.87
4137620-13762013.07213.09
5128128-12812812.17112.19
6129574-12957412.30812.32
45min1206314-20631419.59719.601.0219.6319.631.02
2208408-20840819.79619.83
3204653-20465319.44019.47
4203245-20324519.30619.34
5206968-20696819.66019.69
6208514-20851419.80619.84
60min1263844-26384425.06225.020.4925.1325.090.49
2264223-26422325.09825.17
3263119-26311924.99325.06
4261473-26147324.83724.90
5262652-26265224.94925.02
6265111-26511125.18225.25
120min1431436-43143640.98139.671.7441.0939.781.73
2414324-41432439.35639.47
3418431-41843139.74639.85
4410764-41076439.01839.13
5413987-41398739.32439.43
6416874-41687439.59839.71
240min1618133-61813358.71557.921.2258.8958.101.21
2604973-60497357.46557.64
3618546-61854658.75558.93
4600845-60084557.07357.25
5605051-60505157.47357.65
6611181-61118158.05558.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1746306-74630670.89071.011.1271.1771.281.12
2734271-73427169.74770.02
3759210-75921072.11672.39
4743967-74396770.66870.94
5751503-75150371.38471.65
6749928-74992871.23471.51
480min1835085-83508579.32379.200.8379.7279.590.83
2823896-82389678.26078.65
3844300-84430080.19980.59
4832959-83295979.12179.51
5829481-82948178.79179.18
6836860-83686079.49279.88
600min1921947-92194787.57487.741.2488.1088.261.24
2910108-91010886.45086.97
3943532-94353289.62590.15
4925772-92577287.93888.46
5915620-91562086.97387.49
6925306-92530687.89388.42
720min1961410-96141091.32391.471.4091.9992.131.40
2948426-94842690.08990.75
3988234-98823493.87194.54
4959454-95945491.13791.80
5956583-95658390.86491.53
6963490-96349091.52092.19
840min1986757-98675793.73093.570.8794.5594.390.87
2972244-97224492.35293.16
3997156-99715694.71895.55
4986379-98637993.69494.51
5979156-97915693.00893.83
6988573-98857393.90394.73
960min1996699-99669994.67594.111.2995.6695.091.28
2983118-98311893.38594.35
31009546-100954695.89596.88
4993727-99372794.39295.37
5989498-98949893.99194.96
6971989-97198992.32893.31
极限1997375-99737594.73993.401.8795.8894.531.85
2980130-98013093.10194.22
3985197-98519793.58294.73
4996211-99621194.62895.76
5992317-99231794.25995.39
6948256-94825690.07391.21
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%
19.792263162261572260952261672261182261710.04
29.832260032260262260140.01
单位质量响应值RSD%判断
23102.2522992.270.34数据可信
供试品溶液-3216399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%
5min14834-48341.8880.31244.951.890.32244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min177047-7704730.08731.2318.1830.0931.2318.18
262732-6273224.49724.50
383402-8340232.56932.57
490188-9018835.21935.22
5100706-10070639.32639.33
665697-6569725.65525.65
15min1161378-16137863.01962.959.6263.0763.019.62
2140226-14022654.75954.80
3171211-17121166.85966.91
4170883-17088366.73166.79
5178607-17860769.74769.81
6144977-14497756.61456.66
20min1202580-20258079.10881.003.7379.2781.163.74
2197932-19793277.29377.43
3215485-21548584.14884.31
4210719-21071982.28782.46
5216149-21614984.40784.59
6201682-20168278.75878.89
30min1233768-23376891.28792.842.3691.5893.142.37
2231274-23127490.31390.57
3247286-24728696.56696.87
4237029-23702992.56192.87
5240320-24032093.84694.17
6236860-23686092.49592.76
45min1238416-23841693.10295.142.0793.5495.592.07
2239240-23924093.42493.84
3252470-25247098.59199.06
4243058-24305894.91595.38
5243723-24372395.17595.65
6244881-24488195.62796.05
60min1239293-23929393.44595.282.1494.0495.892.15
2238331-23833193.06993.64
3252841-25284198.73599.37
4244494-24449495.47696.10
5245549-24554995.88896.53
6243481-24348195.08095.66
120min1241152-24115294.17195.362.3194.9296.122.32
2238208-23820893.02193.74
3254610-25461099.426100.22
4243854-24385495.22696.00
5245078-24507895.70496.50
6242217-24221794.58795.33
240min1242643-24264394.75395.292.2295.6696.222.23
2237159-23715992.61293.49
3253593-25359399.02999.99
4244477-24447795.46996.41
5244408-24440895.44296.40
6241846-24184694.44295.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1240411-24041193.88295.422.4594.9596.512.45
2236705-23670592.43493.47
3254369-25436999.332100.46
4245495-24549595.86796.96
5245595-24559595.90697.02
6243584-24358495.12196.18
480min1241864-24186494.44995.432.6295.6796.672.62
2236383-23638392.30993.49
3255207-25520799.659100.95
4244773-24477395.58596.84
5246841-24684196.39297.67
6241221-24122194.19895.41
600min1243799-24379995.20597.312.9396.5998.712.93
2239533-23953393.53994.88
3259481-259481101.328102.79
4254992-25499299.575100.99
5250032-25003297.63999.07
6247243-24724396.54997.92
720min1243202-24320294.97196.683.1396.5198.253.12
2237042-23704292.56694.06
3258386-258386100.901102.53
4253717-25371799.078100.66
5249020-24902097.24398.84
6244155-24415595.34496.88
840min1241293-24129394.22695.933.0295.9297.653.02
2236154-23615492.21993.87
3256551-256551100.184101.98
4251636-25163698.265100.01
5245918-24591896.03297.79
6242374-24237494.64896.34
960min1234039-23403991.39394.682.9793.2596.562.96
2235797-23579792.08093.88
3251302-25130298.134100.10
4250350-25035097.76399.67
5242220-24222094.58896.51
6241061-24106194.13595.98
极限1234491-23449191.57094.703.2693.5896.743.25
2233632-23363291.23493.19
3253782-25378299.103101.23
4248670-24867097.10799.18
5243355-24335595.03197.11
6241094-24109494.14896.15
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%
19.829293929288599284459287509287659288420.04
29.869292489289069290770.03
单位质量响应值RSD%判断
94586.7694226.880.27数据可信
供试品溶液-3216399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%
5min11356-13560.1290.02244.950.130.02244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min14786-47860.4560.4717.500.460.4717.13
25800-58000.5530.55
33731-37310.3560.36
45625-56250.5360.54
55443-54430.5190.52
64069-40690.3880.39
15min132922-329223.1393.2711.213.143.2611.24
238993-389933.7173.72
331931-319313.0443.04
437129-371293.5403.54
535995-359953.4313.43
628532-285322.7202.72
20min172590-725906.9207.105.966.937.105.98
276713-767137.3137.32
373771-737717.0337.04
479223-792237.5537.56
577544-775447.3927.40
666903-669036.3786.38
30min1147859-14785914.09614.082.6514.1114.102.66
2150942-15094214.39014.41
3147371-14737114.04914.07
4150418-15041814.34014.36
5149548-14954814.25714.28
6140312-14031213.37613.39
45min1222619-22261921.22321.381.4221.2621.421.43
2229971-22997121.92421.97
3223817-22381721.33721.38
4224979-22497921.44821.49
5223816-22381621.33721.38
6220473-22047321.01821.06
60min1279778-27977826.67226.791.3326.7526.871.33
2287342-28734227.39327.47
3279702-27970226.66526.74
4281857-28185726.87026.95
5281442-28144226.83126.91
6276023-27602326.31426.39
120min1438426-43842641.79641.610.9641.9241.730.97
2441493-44149342.08942.21
3437020-43702041.66241.78
4436922-43692241.65341.78
5435921-43592141.55741.68
6428865-42886540.88541.00
240min1642719-64271961.27261.151.1461.4661.341.13
2643294-64329461.32761.52
3639408-63940860.95661.15
4652466-65246662.20162.39
5640841-64084161.09361.29
6629963-62996360.05660.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1785755-78575574.90874.591.4875.2074.891.48
2791510-79151075.45775.75
3783361-78336174.68074.97
4788925-78892575.21075.51
5785510-78551074.88575.18
6759704-75970472.42472.71
480min1889081-88908184.75884.230.8185.1884.640.81
2887625-88762584.61985.04
3883285-88328584.20684.62
4881699-88169984.05584.48
5889056-88905684.75685.17
6870330-87033082.97183.38
600min1972004-97200492.66492.690.7193.2293.240.71
2979396-97939693.36893.93
3974497-97449792.90193.46
4967935-96793592.27692.84
5978411-97841193.27493.83
6961251-96125191.63892.18
720min11012051-101205196.48196.230.8597.1996.940.84
21015745-101574596.83397.55
31009658-100965896.25396.96
41011882-101188296.46597.18
51014378-101437896.70397.42
6992615-99261594.62895.33
840min11027035-102703597.91097.590.8398.7898.460.83
21031243-103124398.31199.19
31026627-102662797.87198.74
41027325-102732597.93798.81
51022444-102244497.47298.35
61007524-100752496.05096.90
960min11032429-103242998.42497.660.6499.4698.690.65
21023120-102312097.53798.58
31020701-102070197.30698.34
41031175-103117598.30499.34
51023896-102389697.61198.65
61014961-101496196.75997.77
极限11009509-100950996.23997.621.0097.4498.811.00
21034462-103446298.61899.83
31031193-103119398.30699.50
41029132-102913298.11099.31
51026285-102628597.83899.04
61013161-101316196.58797.76
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