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%
110.103363523360463354093356013350033356820.16
210.113372133370903371520.03
单位质量响应值RSD%判断
33235.8433348.370.24数据可信
供试品溶液-25102801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%
5min148232-4823265.25959.3319.5865.2659.3319.58
245807-4580761.97861.98
343403-4340358.72558.73
441753-4175356.49356.49
554874-5487474.24674.25
629039-2903939.29139.29
10min154252-5425273.40472.007.2774.1372.667.35
253160-5316071.92772.62
351451-5145169.61570.27
449991-4999167.63968.27
560318-6031881.61282.44
650103-5010367.79168.23
15min154253-5425373.40672.556.7174.9574.016.79
253179-5317971.95373.44
352270-5227070.72372.15
450415-5041568.21369.59
560405-6040581.73083.46
651204-5120469.28070.47
20min154568-5456873.83273.496.3376.1975.756.42
254468-5446873.69775.98
351801-5180170.08872.30
452306-5230670.77172.91
560846-6084682.32684.97
651889-5188970.20772.17
30min154850-5485074.21473.775.9877.3976.856.06
253367-5336772.20775.31
352330-5233070.80473.79
452056-5205670.43373.36
560852-6085282.33485.89
653661-5366172.60575.34
45min154814-5481474.16574.585.8678.1778.495.93
254425-5442573.63977.55
353325-5332572.15075.93
452290-5229070.75074.46
561429-6142983.11587.58
654456-5445673.68077.23
60min155285-5528574.80274.245.4979.6378.975.58
253995-5399573.05777.78
351780-5178070.06074.64
453606-5360672.53077.02
560564-6056481.94587.34
653978-5397873.03477.40
极限158643-5864379.34680.064.0085.0085.623.97
260160-6016081.39886.94
359865-5986580.99986.36
461053-6105382.60687.90
560652-6065282.06488.37
654649-5464973.94279.12
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%
113.826517206519626507496502396505226510380.12
213.906515786534616525200.21
单位质量响应值RSD%判断
47108.3946943.880.25数据可信
供试品溶液-25102801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%
5min133908-3390826.08817.8054.4426.0917.8054.44
232004-3200424.62324.62
328271-2827121.75121.75
429902-2990223.00523.01
511140-111408.5718.57
63584-35842.7572.76
10min153265-5326540.98030.6341.4641.1230.7341.50
251467-5146739.59739.73
347253-4725336.35536.48
449176-4917637.83437.96
522237-2223717.10817.16
615456-1545611.89111.91
15min161241-6124147.11638.4936.2947.4938.7636.36
263385-6338548.76649.12
360085-6008546.22746.55
461860-6186047.59347.93
530109-3010923.16523.31
623463-2346318.05218.13
20min168265-6826552.52045.1534.0253.1545.6334.10
275043-7504357.73558.36
369330-6933053.34053.92
472985-7298556.15256.75
536379-3637927.98928.26
630085-3008523.14623.33
30min187162-8716267.05955.8930.3867.9956.6330.49
287500-8750067.31968.27
385566-8556665.83166.71
487193-8719367.08368.00
546465-4646535.74836.18
641993-4199332.30832.62
45min1104987-10498780.77368.2827.0282.0769.3227.15
2106801-10680182.16983.49
3102487-10248778.85080.09
4102434-10243478.80980.10
559232-5923245.57146.20
656552-5655243.50944.00
60min1113949-11394987.66875.5423.9089.4276.9624.08
2114958-11495888.44490.22
3109246-10924684.05085.73
4114901-11490188.40090.13
568926-6892653.02953.91
667129-6712951.64652.38
极限1126688-12668897.469101.493.4999.70103.333.36
2128645-12864598.975101.24
3135168-135168103.993106.14
4135774-135774104.459106.68
5128078-12807898.53899.71
6137132-137132105.504106.52
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%
110.103404243398963399933399213393943399260.11
210.113380113381163380640.03
单位质量响应值RSD%判断
33656.0433438.580.46数据可信
供试品溶液-25102801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%
5min1153937-153937206.698232.8217.44206.70232.8217.44
2213245-213245286.334286.33
3144970-144970194.658194.66
4159371-159371213.995213.99
5158393-158393212.681212.68
6210424-210424282.546282.55
10min1249526-249526335.050297.7015.02337.35300.2915.00
2250404-250404336.229339.41
3174690-174690234.564236.73
4215185-215185288.939291.32
5191192-191192256.722259.09
6249269-249269334.705337.84
15min1258348-258348346.895307.7914.81352.91313.6814.79
2257172-257172345.316352.23
3179444-179444240.947245.72
4227786-227786305.858311.45
5197727-197727265.497270.71
6254860-254860342.212349.07
20min1264207-264207354.763313.6914.46364.64323.0014.45
2260436-260436349.699360.45
3183561-183561246.476253.92
4234771-234771315.238324.22
5201921-201921271.128279.29
6256827-256827344.853355.51
30min1271006-271006363.892321.3514.34377.71334.1514.32
2267095-267095358.640373.28
3188411-188411252.988263.17
4241969-241969324.903337.39
5206816-206816277.701288.88
6260629-260629349.958364.45
45min1275383-275383369.769329.4313.85387.63345.8013.85
2273640-273640367.429386.05
3194370-194370260.989273.99
4250069-250069335.779351.88
5213112-213112286.155300.42
6265454-265454356.437374.82
60min1280057-280057376.045334.9513.46398.01354.9813.49
2278155-278155373.491396.20
3199211-199211267.490283.39
4255185-255185342.648362.48
5217463-217463291.997309.44
6266635-266635358.023380.36
极限1291011-291011390.754391.357.47416.90415.107.67
2309012-309012414.924441.78
3269986-269986362.522381.39
4315631-315631423.812447.45
5261365-261365350.946371.63
6301741-301741405.161431.48
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%
113.826571476564636566106562836548476562700.14
213.906514356516516515430.03
单位质量响应值RSD%判断
47486.9846873.600.92数据可信
供试品溶液-25102801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%
5min1119008-11900891.265120.2242.8891.26120.2242.88
2217753-217753166.990166.99
3186053-186053142.680142.68
437425-3742528.70028.70
5197455-197455151.424151.42
6182898-182898140.260140.26
10min1399795-399795306.594245.5833.08307.10246.2533.08
2374111-374111286.898287.83
3375788-375788288.184288.98
4122888-12288894.24094.40
5373459-373459286.398287.24
6275391-275391211.191211.97
15min1501704-501704384.746296.8830.91386.96298.9130.91
2429258-429258329.189331.71
3458258-458258351.428353.82
4177871-177871136.405137.09
5439605-439605337.123339.56
6316034-316034242.360244.31
20min1549773-549773421.609324.2630.10425.96327.9530.11
2458453-458453351.578355.93
3504935-504935387.224391.57
4206330-206330158.230159.67
5477960-477960366.537370.84
6339569-339569260.408263.71
30min1598078-598078458.653352.9529.71465.34358.4329.72
2493831-493831378.708385.01
3552859-552859423.975430.47
4231514-231514177.543179.86
5519449-519449398.354404.70
6365704-365704280.450285.20
45min1631960-631960484.636374.6929.59493.87382.1429.60
2520579-520579399.221407.63
3588460-588460451.277460.13
4248096-248096190.259193.57
5556361-556361426.661435.22
6386090-386090296.084302.39
60min1655213-655213502.469386.3829.86514.40395.9029.86
2534416-534416409.832420.46
3608445-608445466.603477.96
4255885-255885196.233200.60
5574265-574265440.391451.32
6394747-394747302.723310.67
极限1677797-677797519.788445.8813.51534.51457.5513.89
2568183-568183435.727448.63
3633930-633930486.147500.10
4469484-469484360.037365.49
5623453-623453478.112491.48
6515702-515702395.481405.11
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%
110.103345213353733345523351683351543349540.12
210.113372973376203374580.07
单位质量响应值RSD%判断
33163.7633378.640.46数据可信
供试品溶液-25102801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%
5min1247856-247856335.569255.6127.15335.57255.6127.15
2161248-161248218.312218.31
3234730-234730317.798317.80
4176564-176564239.048239.05
5108749-108749147.234147.23
6203643-203643275.710275.71
10min1298140-298140403.648333.0715.64407.38335.9215.73
2216922-216922293.688296.11
3281576-281576381.222384.75
4241810-241810327.384330.04
5195707-195707264.965266.60
6241927-241927327.542330.61
15min1301768-301768408.560343.3114.05416.77349.8614.16
2224051-224051303.340309.03
3286788-286788388.279396.05
4248800-248800336.847343.14
5208671-208671282.517287.10
6251375-251375340.334347.04
20min1304147-304147411.781349.4013.55424.53359.7513.68
2228117-228117308.845317.90
3291097-291097394.113406.19
4253745-253745343.542353.58
5213539-213539289.108296.83
6257764-257764348.984359.47
30min1306295-306295414.689355.4512.62432.02369.6812.78
2233624-233624316.301328.79
3294230-294230398.354414.81
4260238-260238352.333366.19
5221135-221135299.392310.32
6259713-259713351.622365.98
45min1309688-309688419.283362.6612.05441.22380.8512.23
2237933-237933322.135338.14
3298548-298548404.200425.09
4267853-267853362.643380.41
5227714-227714308.299322.56
6265463-265463359.407377.68
60min1310934-310934420.970366.6411.53447.56388.8611.74
2241760-241760327.316346.90
3300762-300762407.198432.58
4270501-270501366.228388.03
5231844-231844313.891331.57
6269037-269037364.246386.51
极限1316818-316818428.936405.455.66460.21431.746.09
2288110-288110390.069413.29
3316106-316106427.972457.87
4282324-282324382.235408.10
5282237-282237382.117403.29
6311214-311214421.349447.66
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%
113.826461546468106455186468536450836460840.13
213.906488716505826497260.19
单位质量响应值RSD%判断
46749.9346742.880.02数据可信
供试品溶液-25102801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%
5min172150-7215055.84162.1035.1955.8462.1035.19
2113168-11316887.58887.59
364093-6409349.60649.61
452478-5247840.61640.62
561272-6127247.42247.42
6118222-11822291.49991.50
10min1222355-222355172.095166.688.17172.40167.028.12
2221816-221816171.677172.16
3190623-190623147.535147.81
4232063-232063179.608179.83
5229208-229208177.399177.66
6196066-196066151.748152.26
15min1289191-289191223.823216.099.68225.09217.369.62
2274452-274452212.416213.86
3259486-259486200.833201.93
4312682-312682242.004243.23
5300014-300014232.200233.45
6239388-239388185.278186.63
20min1327749-327749253.666245.519.83256.18247.989.77
2308080-308080238.443241.06
3301399-301399233.272235.48
4355812-355812275.385277.95
5341389-341389264.223266.76
6268842-268842208.074210.45
30min1370441-370441286.708279.1510.50290.63282.9910.43
2351009-351009271.668275.61
3349337-349337270.374273.88
4405209-405209313.617317.71
5390443-390443302.189306.20
6297633-297633230.357233.89
45min1409659-409659317.061310.0610.33322.57315.4410.27
2390552-390552302.273307.73
3390833-390833302.490307.50
4448192-448192346.884352.72
5433866-433866335.796341.48
6330555-330555255.837260.65
60min1433267-433267335.333328.3910.27342.61335.5010.21
2416894-416894322.661329.79
3415238-415238321.379328.07
4470871-470871364.437372.20
5461059-461059356.843364.39
6348479-348479269.710275.95
极限1450357-450357348.560350.436.95357.70359.376.98
2458846-458846355.130364.06
3438330-438330339.251347.73
4486069-486069376.200385.99
5482317-482317373.296382.83
6400734-400734310.153317.89
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