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%
19.844580554581084580014584384580224581250.04
29.894513304518484515890.09
单位质量响应值RSD%判断
46557.4245661.171.38数据可信
供试品溶液-3215076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%
5min16762-67621.3200.39156.811.320.39156.82
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
65228-52281.0211.02
10min1108410-10841021.16217.6534.9521.1617.6534.94
271971-7197114.04914.05
3127477-12747724.88424.88
448503-485039.4689.47
5117469-11746922.93122.93
668778-6877813.42613.43
15min1252711-25271149.33145.8518.5849.3745.8818.58
2205266-20526640.06940.09
3282791-28279155.20355.24
4191254-19125437.33437.35
5283926-28392655.42455.46
6193447-19344737.76237.79
20min1352929-35292968.89467.2110.8769.0167.3110.89
2308874-30887460.29460.38
3377725-37772573.73573.87
4318776-31877662.22762.31
5396831-39683177.46477.59
6310560-31056060.62360.71
30min1424244-42424482.81586.443.9583.0586.663.97
2440465-44046585.98286.17
3456432-45643289.09989.36
4429883-42988383.91684.10
5470519-47051991.84992.11
6435275-43527584.96985.16
45min1446523-44652387.16492.763.3287.5493.123.31
2480244-48024493.74794.08
3477827-47782793.27593.68
4469619-46961991.67391.99
5490535-49053595.75696.17
6486278-48627894.92595.25
60min1448429-44842987.53693.113.2588.0593.623.25
2483519-48351994.38694.88
3481473-48147393.98794.55
4471181-47118191.97892.45
5491766-49176695.99696.57
6485392-48539294.75295.24
120min1452810-45281088.39294.373.4389.0695.043.41
2484845-48484594.64595.29
3483716-48371694.42595.14
4484006-48400694.48195.11
5493715-49371596.37797.11
6501416-50141697.88098.53
240min1463579-46357990.49494.372.2891.3095.202.28
2487012-48701295.06895.87
3484229-48422994.52595.40
4479834-47983493.66794.45
5493738-49373896.38197.27
6492180-49218096.07796.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1448560-44856087.56294.043.4588.5295.033.43
2483987-48398794.47895.44
3485427-48542794.75995.79
4489206-48920695.49696.44
5493283-49328396.29297.35
6490041-49004195.65996.63
480min1462109-46210990.20795.803.1391.3196.943.13
2487930-48793095.24796.37
3496276-49627696.87698.07
4491812-49181296.00597.11
5505177-50517798.61499.83
6501289-50128997.85598.98
600min1459774-45977489.75195.493.2091.0196.803.20
2486543-48654394.97796.26
3497158-49715897.04998.40
4489884-48988495.62996.89
5503518-50351898.29099.67
6498280-49828097.26898.56
720min1454882-45488288.79694.833.2890.2096.293.27
2484215-48421594.52295.96
3493031-49303196.24397.76
4488916-48891695.44096.86
5497959-49795997.20598.75
6495663-49566396.75798.21
840min1446273-44627387.11693.913.7588.6795.533.73
2478054-47805493.31994.92
3491735-49173595.99097.66
4486047-48604794.88096.46
5494877-49487796.60398.31
6489542-48954295.56297.18
960min1433863-43386384.69392.164.1286.3993.944.09
2471892-47189292.11793.87
3483864-48386494.45496.29
4478395-47839593.38695.12
5486613-48661394.99096.86
6478024-47802493.31495.09
极限1427644-42764483.47991.294.4485.3293.224.41
2470948-47094891.93293.84
3480320-48032093.76295.75
4475444-47544492.81094.70
5485393-48539394.75296.78
6466093-46609390.98592.91
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%
19.919471699502059536189554909565239526010.41
29.969568779583969576360.12
单位质量响应值RSD%判断
96125.2396148.190.02数据可信
供试品溶液-3215076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%
5min14103-41030.3840.15156.820.380.15157.07
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
65314-53140.4970.50
10min17445-74450.6970.9685.370.700.9685.42
24769-47690.4460.45
326123-261232.4462.45
44419-44190.4140.41
514401-144011.3481.35
64067-40670.3810.38
15min144108-441084.1293.4971.824.133.5071.69
286103-861038.0618.06
335295-352953.3043.31
419532-195321.8291.83
529516-295162.7632.77
69341-93410.8740.88
20min172106-721066.7505.6347.706.765.6447.67
241858-418583.9193.93
346281-462814.3334.34
455858-558585.2295.23
5111876-11187610.47310.48
632787-327873.0693.07
30min1131220-13122012.28411.3313.2212.3011.3513.19
2111245-11124510.41410.44
3113930-11393010.66610.68
4141342-14134213.23213.24
5130412-13041212.20912.23
698061-980619.1809.19
45min1207022-20702219.38118.952.3219.4218.992.35
2201653-20165318.87818.92
3203346-20334619.03719.07
4197709-19770918.50918.54
5208117-20811719.48319.53
6196734-19673418.41818.44
60min1260468-26046824.38423.714.1324.4623.784.15
2261810-26181024.51024.58
3247428-24742823.16323.23
4243406-24340622.78722.85
5265303-26530324.83724.91
6241217-24121722.58222.64
120min1405780-40578037.98838.554.5838.1038.664.54
2406003-40600338.00938.12
3395896-39589637.06237.17
4405778-40577837.98838.09
5407952-40795238.19138.31
6449190-44919042.05242.14
240min1599856-59985656.15755.901.8556.3356.071.85
2616525-61652557.71757.89
3591902-59190255.41255.58
4586035-58603554.86355.03
5599403-59940356.11456.30
6588765-58876555.11855.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1719364-71936467.34468.381.0967.6168.641.09
2736826-73682668.97969.25
3732338-73233868.55968.82
4739423-73942369.22269.48
5732013-73201368.52968.80
6722328-72232867.62267.88
480min1839246-83924678.56778.700.6178.9579.080.61
2835409-83540978.20878.59
3846320-84632079.23079.60
4835747-83574778.24078.61
5847272-84727279.31979.71
6840077-84007778.64579.01
600min1901757-90175784.42084.830.7484.9385.340.74
2900142-90014284.26884.78
3913545-91354585.52386.03
4902303-90230384.47184.97
5915547-91554785.71086.23
6903524-90352484.58585.08
720min1936157-93615787.64088.490.6388.2989.140.62
2940847-94084788.07988.73
3950652-95065288.99789.64
4946799-94679988.63689.28
5951535-95153589.08089.74
6945396-94539688.50589.14
840min1947564-94756488.70890.251.1289.5191.051.11
2956376-95637689.53390.34
3975391-97539191.31392.11
4970274-97027490.83491.63
5972906-97290691.08091.89
6961774-96177490.03890.82
960min1938094-93809487.82190.181.5188.7791.131.50
2961860-96186090.04691.00
3976788-97678891.44492.39
4973575-97357591.14392.09
5972565-97256591.04892.01
6957040-95704089.59590.53
极限1930240-93024087.08689.741.9688.1890.841.94
2961911-96191190.05191.15
3973822-97382291.16692.27
4971000-97100090.90292.00
5973842-97384291.16892.28
6940561-94056188.05289.14
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%
19.844521044523594522434522564521294522180.03
29.894524924521024522970.07
单位质量响应值RSD%判断
45957.1145732.760.35数据可信
供试品溶液-3215076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%
5min17247-72471.4230.73168.901.420.74169.01
215209-152092.9862.99
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min165890-6589012.93520.0123.4612.9420.0123.45
2123958-12395824.33524.34
378118-7811815.33615.34
4109973-10997321.58921.59
5117094-11709422.98722.99
6116411-11641122.85322.85
15min1219537-21953743.09848.1711.6643.1248.2011.67
2283670-28367055.68955.73
3204562-20456240.15940.18
4254307-25430749.92449.96
5258352-25835250.71850.76
6251858-25185849.44449.48
20min1334129-33412965.59568.925.0565.6969.035.06
2366246-36624671.90072.04
3326297-32629764.05764.15
4356697-35669770.02570.14
5371156-37115672.86472.99
6351732-35173269.05069.17
30min1448644-44864488.07687.381.7788.2887.611.75
2439921-43992186.36386.62
3455352-45535289.39289.59
4448822-44882288.11188.35
5445099-44509987.38087.62
6432803-43280384.96685.20
45min1480885-48088594.40591.932.3994.7692.302.37
2461204-46120490.54190.94
3478237-47823793.88594.23
4463032-46303290.90091.28
5474032-47403293.06093.45
6452279-45227988.78989.17
60min1484550-48455095.12492.162.3195.6392.692.28
2460088-46008890.32290.88
3479416-47941694.11794.62
4465790-46579091.44291.98
5470030-47003092.27492.82
6456882-45688289.69390.22
120min1489717-48971796.13993.221.9296.8193.901.90
2465728-46572891.42992.13
3479973-47997394.22694.89
4469254-46925492.12292.81
5476475-47647593.53994.24
6467863-46786391.84992.52
240min1492255-49225596.63793.691.9297.4794.521.89
2466247-46624791.53192.39
3480783-48078394.38595.20
4469865-46986592.24293.08
5475685-47568593.38494.24
6478481-47848193.93394.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1491315-49131596.45393.631.9097.4494.621.87
2465222-46522291.33092.34
3482132-48213294.65095.63
4470955-47095592.45693.45
5475340-47534093.31694.33
6476509-47650993.54694.53
480min1501593-50159398.47095.751.9299.6296.901.89
2476466-47646693.53794.70
3491209-49120996.43297.57
4478739-47873993.98495.13
5486013-48601395.41296.58
6492337-49233796.65397.79
600min1500888-50088898.33295.801.8499.6597.111.81
2479586-47958694.15095.47
3489799-48979996.15597.45
4477571-47757193.75495.06
5485448-48544895.30196.63
6494631-49463197.10498.40
720min1498327-49832797.82995.201.8799.3196.671.84
2476657-47665793.57595.05
3487753-48775395.75397.21
4474318-47431893.11694.58
5482123-48212394.64896.13
6490463-49046396.28597.75
840min1495599-49559997.29494.761.8798.9396.381.84
2476025-47602593.45195.08
3483900-48390094.99796.61
4471408-47140892.54594.16
5479106-47910694.05695.70
6489980-48998096.19097.81
960min1492318-49231896.64993.971.9298.4595.761.89
2473312-47331292.91894.70
3478584-47858493.95395.73
4466772-46677291.63493.40
5475385-47538593.32595.12
6485801-48580195.37097.15
极限1491673-49167396.52393.412.1098.4995.352.07
2470593-47059392.38594.32
3474516-47451693.15595.08
4463765-46376591.04492.97
5471221-47122192.50894.46
6482979-48297994.81696.76
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%
19.919577739585409578859585419585569582590.05
29.969582119585299583700.03
单位质量响应值RSD%判断
96696.1796221.890.35数据可信
供试品溶液-3215076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%
5min112306-123061.1480.33157.631.150.33157.72
29036-90360.8430.84
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11103-11030.1031.41138.060.101.42137.93
21016-10160.0950.10
36208-62080.5790.58
48053-80530.7510.75
555739-557395.2015.20
618814-188141.7551.76
15min129158-291582.7212.2332.552.722.2332.35
232156-321563.0003.00
331320-313202.9222.92
415186-151861.4171.42
518760-187601.7501.76
616872-168721.5741.58
20min153922-539225.0315.7456.335.045.7556.31
249163-491634.5874.59
343753-437534.0824.09
441609-416093.8823.89
5131758-13175812.29412.31
649128-491284.5844.59
30min1124283-12428311.59611.223.9311.6111.243.92
2118563-11856311.06211.08
3113960-11396010.63310.65
4126868-12686811.83711.85
5120714-12071411.26311.30
6117257-11725710.94110.95
45min1199583-19958318.62218.757.1918.6618.797.21
2207675-20767519.37719.41
3192930-19293018.00118.03
4193212-19321218.02818.06
5226472-22647221.13121.18
6186128-18612817.36717.40
60min1254733-25473323.76823.202.0623.8323.272.08
2246905-24690523.03723.10
3249180-24918023.25023.31
4248472-24847223.18423.24
5252728-25272823.58123.67
6240067-24006722.39922.46
120min1403559-40355937.65437.181.7037.7637.291.71
2397142-39714237.05537.16
3396946-39694637.03737.14
4401858-40185837.49537.59
5405136-40513637.80137.93
6386564-38656436.06836.17
240min1593294-59329455.35755.050.7155.5255.220.73
2587612-58761254.82754.99
3588025-58802554.86555.03
4592171-59217155.25255.41
5595080-59508055.52455.71
6583955-58395554.48654.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1725028-72502867.64867.591.0967.9167.851.09
2720784-72078467.25267.51
3725131-72513167.65867.91
4736430-73643068.71268.97
5726540-72654067.78968.07
6712346-71234666.46566.71
480min1841587-84158778.52478.010.5778.9078.380.57
2833638-83363877.78278.15
3833609-83360977.77978.14
4838967-83896778.27978.65
5839431-83943178.32378.72
6829182-82918277.36677.73
600min1909542-90954284.86484.680.5585.3785.180.56
2911640-91164085.06085.56
3900683-90068384.03884.53
4905912-90591284.52685.02
5913620-91362085.24585.77
6903743-90374384.32384.81
720min1952454-95245488.86888.490.5589.5189.130.56
2950433-95043388.68089.32
3943217-94321788.00688.64
4948416-94841688.49189.13
5954443-95444389.05489.72
6941338-94133887.83188.46
840min1976650-97665091.12690.620.5991.9291.400.60
2977102-97710291.16891.96
3962808-96280889.83490.62
4969817-96981790.48891.27
5973891-97389190.86891.68
6966813-96681390.20890.98
960min1986951-98695192.08791.320.7493.0392.260.74
2985232-98523291.92792.87
3967631-96763190.28491.22
4976216-97621691.08592.02
5981445-98144591.57392.54
6975017-97501790.97391.90
极限1987665-98766592.15491.120.9093.2592.210.90
2984113-98411391.82292.92
3962817-96281789.83590.92
4973811-97381190.86191.95
5976950-97695091.15492.27
6973983-97398390.87791.95
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