非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.553143153135283145533142793139803141310.13
29.683246913249313248110.06
单位质量响应值RSD%判断
32893.3033554.861.41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%
5min118058-1805824.48536.2420.8624.4936.2420.86
232424-3242443.96543.96
325567-2556734.66734.67
422931-2293131.09331.09
530167-3016740.90440.90
631225-3122542.33942.34
10min125949-2594935.18544.6514.7235.4645.0514.77
238252-3825251.86752.36
331210-3121042.31942.70
429820-2982040.43440.78
534340-3434046.56347.02
637993-3799351.51651.99
15min129549-2954940.06648.9712.9740.7349.8713.04
240150-4015054.44155.51
335126-3512647.62848.48
433063-3306344.83145.63
536390-3639049.34250.31
642429-4242957.53158.57
20min132747-3274744.40351.0210.8145.5152.4610.92
241552-4155256.34258.01
336510-3651049.50550.89
434743-3474347.10948.40
536810-3681049.91251.43
643388-4338858.83160.51
30min136132-3613248.99254.938.4650.5956.948.65
243710-4371059.26861.56
338632-3863252.38254.32
438700-3870052.47454.29
540666-4066655.14057.21
645245-4524561.34963.68
45min140242-4024254.56558.846.1756.7161.466.43
245721-4572161.99464.95
342825-4282558.06860.58
441610-4161056.42058.82
542534-4253457.67360.36
647420-4742064.29867.32
60min141666-4166656.49660.474.7659.2563.745.07
245888-4588862.22165.86
344957-4495760.95864.12
443127-4312758.47761.50
544220-4422059.95963.29
647730-4773064.71868.45
极限149721-4972167.41866.891.2770.8070.840.81
248300-4830065.49169.83
349866-4986667.61571.45
449898-4989867.65871.33
549233-4923366.75670.75
648993-4899366.43170.88
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(%)80.4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%
114.055939395941845946995941625941645942300.05
214.246145726150936148320.06
单位质量响应值RSD%判断
42293.9543176.401.47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%
5min158764-5876449.75570.6719.4149.7670.6719.40
299335-9933584.10784.11
380427-8042768.09868.10
471673-7167360.68560.69
592054-9205477.94277.94
698525-9852583.42183.42
10min182647-8264769.97785.7612.8770.2586.1612.90
2115070-11507097.43097.90
397329-9732982.40882.79
492865-9286578.62978.97
5103738-10373887.83588.27
6116088-11608898.29298.76
15min192550-9255078.36292.8411.2779.0393.7111.30
2118734-118734100.532101.54
3107927-10792791.38292.22
4101329-10132985.79586.57
5109922-10992293.07193.99
6127412-127412107.880108.89
20min1101736-10173686.14097.029.6687.2498.419.71
2124198-124198105.158106.73
3112306-11230695.08996.43
4106502-10650290.17591.43
5111638-11163894.52495.96
6131165-131165111.057112.67
30min1111012-11101293.994103.326.9595.57105.247.06
2130573-130573110.556112.71
3117782-11778299.726101.60
4117518-11751899.502101.25
5121968-121968103.270105.23
6133282-133282112.850115.08
45min1123446-123446104.522109.524.60106.62112.024.74
2134424-134424113.817116.58
3127257-127257107.748110.17
4124987-124987105.826108.13
5127255-127255107.747110.28
6138751-138751117.480120.33
60min1126856-126856107.409112.043.11110.09115.153.29
2134748-134748114.091117.49
3132434-132434112.132115.16
4129238-129238109.426112.32
5132122-132122111.868115.00
6138562-138562117.320120.83
极限1138972-138972117.668117.770.89120.95121.500.82
2137180-137180116.150120.18
3138867-138867117.579121.23
4140921-140921119.318122.82
5138861-138861117.574121.33
6139773-139773118.346122.50
非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.553464873462303467663467683467273465960.07
29.683491613491373491490.01
单位质量响应值RSD%判断
36292.7736069.110.44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%
5min1107523-107523133.867163.1116.29133.87163.1116.29
2157540-157540196.138196.14
3145210-145210180.787180.79
4147163-147163183.219183.22
5113811-113811141.695141.70
6114819-114819142.950142.95
10min1143928-143928179.191212.8710.21180.68214.6810.24
2185983-185983231.550233.73
3181279-181279225.693227.70
4182980-182980227.811229.85
5154368-154368192.189193.76
6177346-177346220.797222.38
15min1164719-164719205.076231.978.04208.55236.158.07
2197788-197788246.247251.00
3194257-194257241.851246.37
4189051-189051235.369239.94
5171020-171020212.921216.63
6201079-201079250.344254.39
20min1177632-177632221.153245.636.74226.91252.386.80
2203268-203268253.070260.56
3202366-202366251.947259.15
4204786-204786254.959262.14
5184095-184095229.199235.27
6211591-211591263.432270.25
30min1195161-195161242.976260.404.86251.19269.884.96
2211486-211486263.301273.60
3213548-213548265.868275.87
4213765-213765266.138276.15
5198843-198843247.560256.18
6222115-222115276.534286.28
45min1210664-210664262.278272.413.28273.19284.793.42
2218660-218660272.233285.46
3222556-222556277.083290.04
4221149-221149275.331288.30
5210727-210727262.356273.73
6229064-229064285.186298.01
60min1218554-218554272.101278.312.36285.93293.722.51
2222575-222575277.107293.36
3226069-226069281.457297.49
4224460-224460279.454295.49
5217655-217655270.981285.27
6231936-231936288.761304.75
极限1236401-236401294.320302.871.55311.17321.371.79
2245177-245177305.246324.58
3245837-245837306.068325.23
4244179-244179304.004323.14
5241634-241634300.835318.13
6246398-246398306.767325.97
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(%)80.4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%
114.056539156542456545586547056546916544230.06
214.246613236612356612790.01
单位质量响应值RSD%判断
46578.1546438.130.22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%
5min1166209-166209129.299151.9714.00129.30151.9814.00
2227269-227269176.799176.80
3213730-213730166.267166.27
4218645-218645170.091170.09
5171748-171748133.608133.61
6174542-174542135.781135.78
10min1273979-273979213.137252.0810.33213.85252.9210.34
2353665-353665275.127276.11
3347010-347010269.950270.87
4351210-351210273.217274.16
5293330-293330228.190228.93
6325029-325029252.850253.60
15min1340118-340118264.588301.068.07266.49303.308.08
2415973-415973323.598326.11
3411552-411552320.159322.58
4385868-385868300.178302.64
5359662-359662279.792281.80
6408845-408845318.053320.21
20min1383283-383283298.167338.137.52301.54342.047.53
2452084-452084351.690356.00
3449899-449899349.990354.19
4459351-459351357.343361.47
5403951-403951314.246317.81
6459319-459319357.318361.24
30min1445687-445687346.713379.375.59351.74385.175.62
2497118-497118386.723392.99
3500270-500270389.175395.32
4507958-507958395.156401.27
5462165-462165359.532364.84
6512802-512802398.924404.84
45min1499034-499034388.214412.523.95395.17420.424.00
2530296-530296412.533420.94
3539694-539694419.844428.15
4543785-543785423.027431.34
5513103-513103399.158406.47
6555773-555773432.353440.48
60min1532961-532961414.606432.272.87423.72442.462.94
2553285-553285430.417441.12
3561278-561278436.635447.28
4566397-566397440.617451.28
5543281-543281422.635432.16
6576782-576782448.696459.23
极限1580320-580320451.448471.622.34462.86484.222.41
2604416-604416470.193483.29
3614852-614852478.312491.38
4616042-616042479.238492.35
5603563-603563469.530481.40
6618302-618302480.996494.02
非奈利酮达格列净片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.553477573479573480603481463478503479540.05
29.683518783516013517400.06
单位质量响应值RSD%判断
36434.9736336.780.20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%
5min1110444-110444136.728165.4414.41136.73165.4414.41
2136322-136322168.764168.76
3118319-118319146.477146.48
4132475-132475164.002164.00
5166036-166036205.550205.55
6138222-138222171.116171.12
10min1149682-149682185.304203.629.97186.82205.4610.00
2162996-162996201.786203.66
3150522-150522186.344187.97
4154796-154796191.635193.46
5188798-188798233.729236.01
6180081-180081222.937224.84
15min1165975-165975205.474220.369.04209.05224.469.07
2175977-175977217.856221.97
3164978-164978204.240207.94
4165152-165152204.455208.41
5200479-200479248.190253.07
6195436-195436241.946246.32
20min1176907-176907219.008232.267.77224.87238.817.83
2183434-183434227.088233.63
3178292-178292220.722226.69
4175097-175097216.767222.99
5208285-208285257.853265.49
6203651-203651252.116259.18
30min1191907-191907237.578248.305.96245.87257.436.08
2197423-197423244.406253.47
3195042-195042241.459249.88
4188162-188162232.941241.57
5216578-216578268.120278.62
6214305-214305265.306275.17
45min1205699-205699254.652263.864.48265.59275.744.64
2209684-209684259.585271.36
3210064-210064260.056271.16
4203354-203354251.749262.97
5225456-225456279.111292.59
6224549-224549277.988290.80
60min1215586-215586266.892274.093.20280.66288.923.41
2218737-218737270.793285.45
3220507-220507272.984286.98
4213635-213635264.476278.49
5230501-230501285.356301.94
6229455-229455284.061299.97
极限1247888-247888306.881306.030.60323.61323.900.59
2247561-247561306.476324.15
3245977-245977304.515321.54
4248898-248898308.131325.09
5248004-248004307.025326.78
6244891-244891303.171322.23
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(%)80.4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%
114.056567766570586576506579866566726572280.09
214.246659036662606660820.04
单位质量响应值RSD%判断
46777.7946775.420.01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%
5min195617-9561773.95696.8918.9373.9696.8918.93
2124062-12406295.95795.96
3112450-11245086.97686.98
4128674-12867499.52599.52
5167127-167127129.267129.27
6123662-12366295.64895.65
10min1194993-194993150.820173.4012.74151.23173.9412.76
2217650-217650168.344168.88
3201553-201553155.894156.38
4222980-222980172.467173.02
5275099-275099212.779213.50
6232844-232844180.096180.63
15min1252975-252975195.667217.3111.61196.92218.8111.63
2271585-271585210.061211.53
3251880-251880194.820196.17
4275579-275579213.150214.66
5339141-339141262.313264.21
6294575-294575227.843229.37
20min1292503-292503226.240247.4910.13228.58250.2010.16
2308936-308936238.951241.59
3293269-293269226.833229.26
4312779-312779241.923244.62
5378336-378336292.629295.99
6334020-334020258.352261.15
30min1349131-349131270.040289.198.19273.63293.288.24
2361513-361513279.617283.58
3350427-350427271.043274.73
4365468-365468282.676286.72
5429745-429745332.392337.38
6387069-387069299.384303.62
45min1405233-405233313.433329.046.33318.53334.736.41
2411079-411079317.955323.47
3405440-405440313.593318.79
4421172-421172325.761331.37
5475626-475626367.879374.71
6433880-433880335.590341.49
60min1440283-440283340.543355.725.21347.38363.245.31
2447096-447096345.812353.10
3446183-446183345.106352.05
4458547-458547354.669362.09
5506045-506045391.407400.28
6461245-461245356.756364.52
极限1483669-483669374.100384.104.34382.83393.594.43
2486972-486972376.655385.86
3481970-481970372.786381.64
4504040-504040389.857399.25
5537448-537448415.696426.74
6485448-485448375.476385.22
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