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对照品来源分装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200
标示量(mg)50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%
110.212832501283539028365392840629283844328367000.11
210.292840392284000728402000.01
单位质量响应值RSD%判断
277835.46276015.550.47数据可信
供试品溶液-2024052511批-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%
5min11856126-185612659.71557.543.5559.7157.543.54
21859646-185964659.82859.83
31739316-173931655.95755.96
41774697-177469757.09557.10
51799980-179998057.90957.91
61700843-170084354.71954.72
10min12455440-245544078.99677.622.6079.1077.722.60
22427785-242778578.10678.21
32380765-238076576.59476.69
42457456-245745679.06179.16
52454296-245429678.95979.06
62299665-229966573.98474.08
15min12608627-260862783.92484.281.9484.1684.501.94
22631774-263177484.66984.90
32625286-262528684.46084.68
42605560-260556083.82684.05
52701473-270147386.91187.14
62544688-254468881.86782.08
20min12669611-266961185.88687.292.1786.2687.662.17
22726487-272648787.71688.09
32724336-272433687.64788.01
42665947-266594785.76886.13
52819727-281972790.71691.09
62673911-267391186.02586.38
30min12746291-274629188.35390.842.3388.8791.352.32
22855571-285557191.86992.39
32848714-284871491.64892.16
42755083-275508388.63689.15
52919492-291949293.92594.45
62816068-281606890.59891.09
45min12817665-281766590.64993.971.9391.3194.631.92
22948014-294801494.84395.51
32959372-295937295.20895.87
42917599-291759993.86494.52
52973346-297334695.65896.34
62908826-290882693.58294.23
60min12854384-285438491.83195.171.8192.6495.991.80
22974477-297447795.69496.52
32997881-299788196.44797.27
42978141-297814195.81296.63
52993088-299308896.29397.13
62951742-295174294.96395.76
极限13015050-301505097.00097.320.3897.9798.300.37
23017333-301733397.07398.06
33037514-303751497.72298.70
43035521-303552197.65898.63
53012254-301225496.91097.91
63033238-303323897.58598.54
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对照品来源分装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200
标示量(mg)50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%
110.212826017282884228302202839954283250228315070.19
210.292838605283409428363500.12
单位质量响应值RSD%判断
277326.84275641.400.44数据可信
供试品溶液-2024052511批-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%
5min11670113-167011353.81655.845.8553.8255.845.85
21674384-167438453.95453.95
31898180-189818061.16561.17
41697759-169775954.70754.71
51816304-181630458.52758.53
61641193-164119352.88452.88
10min12304120-230412074.24677.113.7974.3477.203.79
22320406-232040674.77174.86
32550394-255039482.18282.28
42379346-237934676.67076.76
52438479-243847978.57578.67
62364915-236491576.20576.29
15min12513293-251329380.98683.183.3181.2083.403.31
22514732-251473281.03381.25
32737900-273790088.22488.46
42544970-254497082.00782.23
52614289-261428984.24184.47
62562945-256294582.58682.80
20min12607908-260790884.03585.693.4884.3886.053.49
22575938-257593883.00583.35
32814118-281411890.68091.07
42604154-260415483.91484.27
52729025-272902587.93888.31
62623823-262382384.54884.90
30min12730023-273002387.97087.834.2788.4688.334.26
22607562-260756284.02484.51
32897684-289768493.37293.91
42630362-263036284.75885.25
52828197-282819791.13391.65
62660147-266014785.71886.21
45min12780606-278060689.60089.245.2190.2389.895.20
22627312-262731284.66085.29
32983787-298378796.14796.84
42647520-264752085.31185.95
52893975-289397593.25393.92
62683418-268341886.46887.10
60min12806003-280600390.41889.905.5891.2090.695.56
22635884-263588484.93685.71
33012015-301201597.05797.91
42652843-265284385.48386.26
52933017-293301794.51195.33
62698839-269883986.96587.75
极限13038843-303884397.92197.780.5698.8698.730.59
23019969-301996997.31398.22
33064907-306490798.76199.78
43019138-301913897.28698.21
53028809-302880997.59898.58
63035160-303516097.80298.73
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对照品来源分装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200
标示量(mg)50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%
110.212835292283483228349072832905283410028344070.04
210.292839862284076428403130.03
单位质量响应值RSD%判断
277610.87276026.530.41数据可信
供试品溶液-2024052611批-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%
5min12025677-202567765.19560.298.3565.1960.288.35
22063884-206388466.42466.42
31884018-188401860.63660.64
41867376-186737660.10060.10
51727049-172704955.58455.58
61670747-167074753.77253.77
10min12658153-265815385.55081.945.0085.6682.045.00
22651883-265188385.34985.46
32576496-257649682.92283.02
42615343-261534384.17384.27
52372066-237206676.34376.44
62400989-240098977.27477.36
15min12848177-284817791.66689.013.4591.9289.243.45
22837478-283747891.32291.57
32798131-279813190.05590.29
42819117-281911790.73190.97
52629523-262952384.62984.85
62661221-266122185.64985.87
20min12903325-290332593.44191.982.3193.8592.372.32
22914989-291498993.81694.22
32881697-288169792.74593.13
42897147-289714793.24293.63
52757328-275732888.74289.10
62793902-279390289.91990.28
30min12935068-293506894.46394.711.4495.0295.251.45
22994663-299466396.38196.94
32966873-296687395.48696.03
42970571-297057195.60596.15
52905576-290557693.51394.02
62884670-288467092.84193.35
45min12970386-297038695.59996.110.8796.3296.810.88
22997184-299718496.46297.18
33006021-300602196.74697.45
43014383-301438397.01597.72
52985580-298558096.08896.75
62944073-294407394.75295.42
60min12980599-298059995.92896.661.0396.8097.511.03
23001762-300176296.60997.49
33019099-301909997.16798.03
43040823-304082397.86698.73
53021080-302108097.23198.06
62955985-295598595.13695.96
极限13016455-301645597.08297.660.9898.1298.680.99
23060618-306061898.50399.55
33043286-304328697.94698.97
43061789-306178998.54199.57
53040921-304092197.86998.86
62984334-298433496.04897.03
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对照品来源分装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200
标示量(mg)50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%
110.212839364283758728385892838917283314128375200.09
210.292852675285002328513490.07
单位质量响应值RSD%判断
277915.77277099.030.21数据可信
供试品溶液-2024052611批-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%
5min11842255-184225559.14457.884.0959.1457.884.09
21812649-181264958.19358.19
31843648-184364859.18959.19
41857088-185708859.62059.62
51658463-165846353.24353.24
61803836-180383657.91057.91
10min12476791-247679179.51579.733.2479.6179.833.24
22451741-245174178.71178.81
32486599-248659979.83079.93
42550219-255021981.87281.97
52353229-235322975.54875.64
62582667-258266782.91483.01
15min12729731-272973187.63587.462.7787.8787.702.77
22712062-271206287.06887.30
32700523-270052386.69886.93
42802041-280204189.95790.19
52599833-259983383.46583.68
62802213-280221389.96290.20
20min12811408-281140890.25890.252.3590.6390.632.35
22790002-279000289.57089.94
32790321-279032189.58189.96
42900387-290038793.11493.50
52711242-271124287.04287.40
62864389-286438991.95992.34
30min12868251-286825192.08393.411.9092.6193.941.90
22941037-294103794.41994.94
32874713-287471392.29092.82
42988635-298863595.94796.49
52845568-284556891.35491.85
62939775-293977594.37994.92
45min12911590-291159093.47495.141.3894.1595.821.38
22995160-299516096.15796.84
32940746-294074694.41095.09
43025574-302557497.13397.83
52951765-295176594.76495.41
62955358-295535894.87995.57
60min12935123-293512394.22995.971.1495.0796.811.13
23015385-301538596.80697.65
32991842-299184296.05096.89
43032305-303230597.34998.21
52987393-298739395.90796.72
62973978-297397895.47796.33
极限13033854-303385497.39997.620.7498.3998.620.72
23073869-307386998.68499.69
33051403-305140397.96298.96
43029101-302910197.24698.27
53047129-304712997.82598.79
63008607-300860796.58997.60
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