非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241101对照品来源原料对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.556578046576226583396579516580846579600.05
29.686806156812166809160.07
单位质量响应值RSD%判断
68896.3470342.561.47数据可信
供试品溶液-25091501批-非奈利酮-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%
5min166609-6660943.10260.5719.0243.1060.5619.03
2110887-11088771.75471.75
390260-9026058.40658.41
480394-8039452.02252.02
5103000-10300066.65066.65
6110432-11043271.45971.46
10min192256-9225659.69873.2312.9359.9473.5612.96
2128407-12840783.09183.49
3108963-10896370.50970.83
4103514-10351466.98367.27
5115884-11588474.98775.36
6129974-12997484.10584.50
15min1103760-10376067.14279.3711.1667.7180.1111.19
2133008-13300886.06886.93
3120930-12093078.25278.97
4113056-11305673.15773.82
5123145-12314579.68680.47
6142043-14204391.91492.78
20min1113589-11358973.50282.909.4574.4584.089.50
2139147-13914790.04091.38
3125735-12573581.36282.51
4119247-11924777.16378.23
5125328-12532881.09882.33
6145632-14563294.23795.61
30min1124098-12409880.30288.166.7781.6589.806.87
2145342-14534294.04995.89
3131967-13196785.39487.00
4131409-13140985.03386.53
5136043-13604388.03289.71
6148579-14857996.14498.04
45min1138165-13816589.40593.404.6391.2095.534.76
2149528-14952896.75899.12
3141906-14190691.82693.90
4139261-13926190.11492.08
5141836-14183691.78093.95
6155291-155291100.487102.92
60min1141704-14170491.69595.373.0493.9998.033.22
2149945-14994597.02899.93
3147269-14726995.29697.88
4144384-14438493.42995.90
5146472-14647294.78097.46
6154546-154546100.005103.00
极限1154489-15448999.968100.360.77102.77103.550.74
2153382-15338299.252102.69
3155201-155201100.429103.55
4156874-156874101.511104.50
5154880-154880100.221103.43
6155788-155788100.808104.35
非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241201对照品来源原料对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053143153135283145533142793139803141310.13
214.243246913249313248110.06
单位质量响应值RSD%判断
22358.0822809.761.42数据可信
供试品溶液-25091501批-达格列净-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%
5min118058-1805836.02153.3220.8636.0253.3220.87
232424-3242464.67864.68
325567-2556751.00051.00
422931-2293145.74245.74
530167-3016760.17660.18
631225-3122562.28662.29
10min125949-2594951.76265.6814.7251.9665.9814.74
238252-3825276.30476.66
331210-3121062.25662.54
429820-2982059.48459.74
534340-3434068.50068.83
637993-3799375.78776.13
15min129549-2954958.94372.0512.9759.4372.7113.00
240150-4015080.09080.87
335126-3512670.06870.70
433063-3306365.95366.54
536390-3639072.58973.30
642429-4242984.63685.40
20min132747-3274765.32275.0510.8166.1476.1210.87
241552-4155282.88684.11
336510-3651072.82973.85
434743-3474369.30470.25
536810-3681073.42774.55
643388-4338886.54987.79
30min136132-3613272.07580.828.4673.2582.298.56
243710-4371087.19188.88
338632-3863277.06278.48
438700-3870077.19778.53
540666-4066681.11982.64
645245-4524590.25391.97
45min140242-4024280.27386.566.1781.8588.486.30
245721-4572191.20293.38
342825-4282585.42687.28
441610-4161083.00284.77
542534-4253484.84586.82
647420-4742094.59296.81
60min141666-4166683.11488.964.7685.1491.374.92
245888-4588891.53694.22
344957-4495789.67892.00
443127-4312786.02888.25
544220-4422088.20890.66
647730-4773095.21097.95
极限149721-4972199.18198.411.27101.67101.321.01
248300-4830096.34799.54
349866-4986699.471102.29
449898-4989899.535102.24
549233-4923398.208101.15
648993-4899397.729101.00
非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241101对照品来源原料对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.557243037245487245217243177243127244000.02
29.687311677314407313040.03
单位质量响应值RSD%判断
75853.4075547.930.29数据可信
供试品溶液-25091501批-非奈利酮-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%
5min1183969-183969109.470128.8514.00109.47128.8514.00
2251957-251957149.925149.93
3237152-237152141.116141.12
4242070-242070144.042144.04
5190703-190703113.477113.48
6193397-193397115.080115.08
10min1302923-302923180.252213.5910.45180.86214.3110.46
2392645-392645233.641234.47
3384987-384987229.084229.87
4388956-388956231.446232.25
5324701-324701193.211193.84
6359487-359487213.910214.55
15min1377194-377194224.447255.048.08226.06256.948.09
2460889-460889274.249276.38
3455505-455505271.045273.10
4426890-426890254.018256.10
5397659-397659236.624238.33
6453540-453540269.876271.70
20min1424566-424566252.635286.207.36255.49289.527.37
2499349-499349297.134300.79
3497352-497352295.946299.51
4505880-505880301.021304.52
5449017-449017267.185270.20
6509699-509699303.293306.62
30min1493892-493892293.887320.565.35298.15325.475.39
2548488-548488326.374331.68
3551228-551228328.005333.21
4560197-560197333.342338.51
5512611-512611305.026309.53
6565893-565893336.731341.74
45min1555962-555962330.822349.483.78336.71356.173.83
2586824-586824349.186356.30
3597545-597545355.565362.59
4602955-602955358.784365.81
5566828-566828337.287343.48
6613842-613842365.263372.15
60min1588288-588288350.057365.142.89357.79373.772.95
2610840-610840363.476372.53
3619003-619003368.334377.34
4624426-624426371.561380.58
5600925-600925357.576365.65
6638331-638331379.835388.75
极限1641908-641908381.963398.282.23391.64408.942.31
2668209-668209397.613408.69
3677246-677246402.991414.04
4680412-680412404.875415.95
5666135-666135396.379406.44
6682093-682093405.875416.90
非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241201对照品来源原料对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053464873462303467663467683467273465960.07
214.243491613491373491490.01
单位质量响应值RSD%判断
24668.7524518.890.44数据可信
供试品溶液-25091501批-达格列净-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%
5min1107523-107523196.936239.9616.29196.94239.9616.29
2157540-157540288.546288.55
3145210-145210265.963265.96
4147163-147163269.540269.54
5113811-113811208.453208.45
6114819-114819210.300210.30
10min1143928-143928263.615313.1610.21264.71314.5010.23
2185983-185983340.642342.24
3181279-181279332.026333.50
4182980-182980335.142336.64
5154368-154368282.736283.89
6177346-177346324.822325.99
15min1164719-164719301.695341.268.04304.25344.338.06
2197788-197788362.263365.76
3194257-194257355.796359.12
4189051-189051346.261349.62
5171020-171020313.236315.96
6201079-201079368.291371.26
20min1177632-177632325.346361.356.74329.58366.326.77
2203268-203268372.300377.81
3202366-202366370.648375.95
4204786-204786375.081380.36
5184095-184095337.184341.65
6211591-211591387.545392.56
30min1195161-195161357.452383.084.86363.49390.064.91
2211486-211486387.352394.93
3213548-213548391.129398.49
4213765-213765391.527398.89
5198843-198843364.196370.54
6222115-222115406.820413.99
45min1210664-210664385.847400.753.28393.87409.863.35
2218660-218660400.492410.22
3222556-222556407.628417.16
4221149-221149405.051414.59
5210727-210727385.962394.33
6229064-229064419.548428.98
60min1218554-218554400.298409.432.36410.47420.762.43
2222575-222575407.663419.62
3226069-226069414.062425.86
4224460-224460411.115422.91
5217655-217655398.651409.16
6231936-231936424.808436.57
极限1236401-236401432.986445.571.55445.38459.181.67
2245177-245177449.060463.28
3245837-245837450.269464.36
4244179-244179447.232461.31
5241634-241634442.571455.30
6246398-246398451.296465.42
非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241101对照品来源原料对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.557264667269377270577275247265097268990.06
29.687351527359867355690.09
单位质量响应值RSD%判断
76115.0875988.530.12数据可信
供试品溶液-25091501批-非奈利酮-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%
5min1106646-10664663.16682.5018.7763.1782.5018.77
2138663-13866382.12982.13
3125024-12502474.05174.05
4142661-14266184.49784.50
5185463-185463109.849109.85
6137240-13724081.28681.29
10min1215891-215891127.871147.2212.82128.22147.6712.84
2241954-241954143.308143.76
3223403-223403132.320132.73
4246101-246101145.764146.23
5305324-305324180.842181.45
6258635-258635153.188153.64
15min1280379-280379166.067184.4411.54167.13185.7211.56
2300897-300897178.219179.47
3280323-280323166.034167.18
4305387-305387180.879182.16
5376038-376038222.725224.34
6325416-325416192.742194.04
20min1323542-323542191.632210.1110.14193.62212.4110.17
2341363-341363202.187204.43
3326511-326511193.391195.46
4346807-346807205.412207.70
5419493-419493248.463251.32
6370674-370674219.548221.92
30min1386421-386421228.875245.148.17231.92248.608.22
2399969-399969236.899240.27
3388107-388107229.873233.02
4404947-404947239.848243.27
5475599-475599281.694285.93
6428203-428203253.622257.22
45min1448143-448143265.432279.116.31269.75283.946.39
2455807-455807269.972274.65
3449899-449899266.472270.89
4466509-466509276.310281.07
5526802-526802312.022317.82
6480214-480214284.428289.43
60min1488448-488448289.305301.645.11295.10308.025.20
2496412-496412294.022300.20
3492688-492688291.816297.72
4508913-508913301.426307.72
5559322-559322331.283338.81
6509906-509906302.014308.60
极限1535111-535111316.943325.324.22324.34333.374.31
2538985-538985319.238327.05
3533250-533250315.841323.36
4557749-557749330.351338.32
5592899-592899351.171360.54
6537480-537480318.346326.61
非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号241201对照品来源原料对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053477573479573480603481463478503479540.05
214.243518783516013517400.06
单位质量响应值RSD%判断
24765.4124700.840.19数据可信
供试品溶液-25091501批-达格列净-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%
5min1110444-110444201.146243.3814.41201.15243.3914.41
2136322-136322248.276248.28
3118319-118319215.488215.49
4132475-132475241.269241.27
5166036-166036302.392302.39
6138222-138222251.736251.74
10min1149682-149682272.608299.569.97273.73300.919.99
2162996-162996296.856298.23
3150522-150522274.137275.33
4154796-154796281.921283.26
5188798-188798343.847345.53
6180081-180081327.972329.37
15min1165975-165975302.281324.189.04304.91327.209.05
2175977-175977320.497323.53
3164978-164978300.465303.19
4165152-165152300.782303.69
5200479-200479365.121368.71
6195436-195436355.937359.16
20min1176907-176907322.191341.697.77326.50346.507.80
2183434-183434334.078338.89
3178292-178292324.713329.10
4175097-175097318.894323.47
5208285-208285379.338384.96
6203651-203651370.898376.10
30min1191907-191907349.510365.295.96355.61372.006.02
2197423-197423359.556366.22
3195042-195042355.219361.41
4188162-188162342.689349.04
5216578-216578394.442402.17
6214305-214305390.302397.56
45min1205699-205699374.628388.174.48382.67396.924.56
2209684-209684381.886390.55
3210064-210064382.578390.74
4203354-203354370.357378.61
5225456-225456410.611420.53
6224549-224549408.959418.39
60min1215586-215586392.635403.233.20402.76414.133.31
2218737-218737398.374409.16
3220507-220507401.597411.89
4213635-213635389.082399.39
5230501-230501419.799432.00
6229455-229455417.894429.59
极限1247888-247888451.465450.220.60463.77463.360.56
2247561-247561450.869463.87
3245977-245977447.984460.51
4248898-248898453.304465.78
5248004-248004451.676466.21
6244891-244891446.006460.03
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