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%
110.107262767271817257457257197254617260760.10
210.117269767293667281710.24
单位质量响应值RSD%判断
71888.7172024.830.14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%
5min138554-3855424.13516.6253.1024.1316.6253.11
236406-3640622.79022.79
332308-3230820.22520.22
434298-3429821.47121.47
512942-129428.1028.10
64781-47812.9932.99
10min160281-6028137.73628.2941.1038.0028.4741.18
258200-5820036.43336.69
353482-5348233.48033.70
455914-5591435.00235.24
525582-2558216.01416.10
617648-1764811.04811.08
15min169150-6915043.28835.4436.0343.9835.9436.16
271798-7179844.94645.60
367813-6781342.45143.05
469899-6989943.75744.38
534322-3432221.48621.75
626717-2671716.72516.88
20min177101-7710148.26541.5633.7449.4342.4533.88
284758-8475853.05954.22
378521-7852149.15450.22
482280-8228051.50752.62
541435-4143525.93826.45
634248-3424821.43921.78
30min197927-9792761.30251.2830.2563.0152.6430.46
298696-9869661.78463.53
396430-9643060.36561.98
498396-9839661.59663.28
552700-5270032.99033.79
647348-4734829.64030.22
45min1118257-11825774.02962.6126.7576.4164.5427.03
2120233-12023375.26677.70
3115238-11523872.13974.42
4115221-11522172.12974.50
567174-6717442.05143.21
664011-6401140.07140.98
60min1128241-12824180.27969.2323.7383.4971.8524.09
2129252-12925280.91284.18
3123113-12311377.06980.16
4129242-12924280.90684.08
577964-7796448.80650.43
675745-7574547.41648.77
极限1142360-14236089.11892.723.4693.2296.113.30
2144325-14432590.34894.52
3151881-15188195.07899.02
4152425-15242595.41899.49
5143856-14385690.05492.23
6153834-15383496.30098.18
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%
113.823363523360463354093356013350033356820.16
213.903372133370903371520.03
单位质量响应值RSD%判断
24289.5824255.540.10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%
5min148232-4823271.89365.3619.5871.8965.3619.58
245807-4580768.27968.28
343403-4340364.69564.70
441753-4175362.23662.24
554874-5487481.79481.79
629039-2903943.28543.28
10min154252-5425280.86779.327.2781.2779.687.31
253160-5316079.23979.62
351451-5145176.69177.05
449991-4999174.51574.86
560318-6031889.90890.36
650103-5010374.68274.92
15min154253-5425380.86879.936.7181.7280.736.75
253179-5317979.26780.09
352270-5227077.91278.70
450415-5041575.14775.91
560405-6040590.03890.99
651204-5120476.32376.98
20min154568-5456881.33880.966.3382.6482.206.38
254468-5446881.18982.45
351801-5180177.21378.43
452306-5230677.96679.14
560846-6084690.69592.15
651889-5188977.34478.42
30min154850-5485081.75881.265.9883.5182.966.02
253367-5336779.54781.26
352330-5233078.00279.65
452056-5205677.59379.20
560852-6085290.70492.66
653661-5366179.98681.49
45min154814-5481481.70482.165.8683.9184.325.90
254425-5442581.12483.28
353325-5332579.48581.57
452290-5229077.94279.98
561429-6142991.56494.03
654456-5445681.17183.12
60min155285-5528582.40681.785.4985.0684.395.54
253995-5399580.48383.09
351780-5178077.18279.70
453606-5360679.90482.38
560564-6056490.27593.25
653978-5397880.45882.86
极限158643-5864387.41288.204.0090.5391.263.98
260160-6016089.67392.72
359865-5986589.23392.18
461053-6105391.00493.92
560652-6065290.40693.88
654649-5464981.45884.31
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%
110.107329637325897325187326157306567322680.13
210.117269827269647269730.01
单位质量响应值RSD%判断
72501.7871906.330.59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%
5min1133921-13392183.549109.6542.6483.55109.6542.64
2243762-243762152.075152.08
3208202-208202129.890129.89
442564-4256426.55426.55
5220969-220969137.855137.86
6205134-205134127.976127.98
10min1446683-446683278.671223.4333.00279.60224.6432.99
2418398-418398261.025262.71
3419716-419716261.847263.29
4137851-13785186.00186.30
5417678-417678260.576262.11
6308459-308459192.438193.86
15min1559665-559665349.157269.7230.80353.18273.4230.80
2479686-479686299.261303.85
3511230-511230318.940323.29
4199292-199292124.332125.58
5490758-490758306.168310.59
6353424-353424220.490224.05
20min1612971-612971382.413294.5429.99390.32301.2430.00
2511897-511897319.356327.27
3563746-563746351.703359.60
4231050-231050144.145146.78
5533316-533316332.719340.55
6379773-379773236.928242.94
30min1666664-666664415.910320.4329.55428.06330.4029.57
2551292-551292343.933355.40
3616370-616370384.533396.34
4259642-259642161.982166.22
5578948-578948361.187372.71
6408751-408751255.006263.65
45min1704131-704131439.284340.1129.43456.06353.6429.45
2580551-580551362.187377.47
3656160-656160409.357425.43
4277979-277979173.422179.46
5620278-620278386.971402.51
6431880-431880269.436280.91
60min1730165-730165455.526350.6729.70477.18367.9829.71
2596309-596309372.018391.33
3677946-677946422.948443.57
4286752-286752178.895186.86
5640135-640135399.359419.20
6441270-441270275.294289.76
极限1755046-755046471.049404.5513.40497.77425.7614.15
2633246-633246395.062418.50
3706717-706717440.898466.22
4524540-524540327.243337.19
5694957-694957433.561457.84
6576210-576210359.479377.01
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%
113.823404243398963399933399213393943399260.11
213.903380113381163380640.03
单位质量响应值RSD%判断
24596.6724321.150.80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%
5min1153937-153937227.713256.4917.44227.71256.4917.44
2213245-213245315.445315.45
3144970-144970214.449214.45
4159371-159371235.752235.75
5158393-158393234.305234.30
6210424-210424311.272311.27
10min1249526-249526369.114327.9715.02370.38329.3915.01
2250404-250404370.413372.17
3174690-174690258.412259.60
4215185-215185318.315319.62
5191192-191192282.823284.12
6249269-249269368.734370.46
15min1258348-258348382.164339.0814.81385.48342.3314.80
2257172-257172380.425384.24
3179444-179444265.445268.07
4227786-227786336.955340.03
5197727-197727292.490295.36
6254860-254860377.005380.78
20min1264207-264207390.831345.5914.46396.27350.7214.45
2260436-260436385.253391.18
3183561-183561271.535275.64
4234771-234771347.288352.24
5201921-201921298.694303.19
6256827-256827379.915385.79
30min1271006-271006400.889354.0214.34408.50361.0714.33
2267095-267095395.104403.17
3188411-188411278.709284.32
4241969-241969357.936364.82
5206816-206816305.935312.09
6260629-260629385.539393.52
45min1275383-275383407.364362.9213.85417.20371.9413.85
2273640-273640404.785415.04
3194370-194370287.524294.68
4250069-250069369.918378.79
5213112-213112315.249323.11
6265454-265454392.676402.80
60min1280057-280057414.278369.0013.46426.38380.0413.48
2278155-278155411.464423.97
3199211-199211294.685303.44
4255185-255185377.486388.41
5217463-217463321.685331.29
6266635-266635394.423406.73
极限1291011-291011430.482431.147.47444.88444.227.56
2309012-309012457.110471.90
3269986-269986399.380409.77
4315631-315631466.901479.92
5261365-261365386.627398.02
6301741-301741446.354460.85
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%
110.107207987218297202217219907201257209930.13
210.117241717256607249160.15
单位质量响应值RSD%判断
71385.4571702.870.32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%
5min181081-8108151.05056.8534.8251.0556.8534.82
2126997-12699779.95979.96
372336-7233645.54445.54
459475-5947537.44637.45
569237-6923743.59343.59
6132637-13263783.51083.51
10min1249266-249266156.941151.968.17157.51152.598.09
2248404-248404156.399157.29
3213525-213525134.438134.94
4260281-260281163.877164.29
5256747-256747161.652162.14
6219893-219893138.448139.38
15min1323729-323729203.824196.799.61206.14199.119.48
2307141-307141193.380196.01
3290832-290832183.112185.11
4349675-349675220.160222.40
5335688-335688211.354213.63
6268230-268230168.881171.35
20min1366532-366532230.774223.409.85235.35227.909.72
2344653-344653216.998221.77
3337134-337134212.264216.30
4398075-398075250.634255.32
5381910-381910240.456245.08
6300596-300596189.260193.60
30min1414113-414113260.731253.8110.40267.87260.8010.27
2392407-392407247.065254.25
3390529-390529245.883252.28
4452446-452446284.866292.33
5435963-435963274.489281.79
6333270-333270209.832216.28
45min1457600-457600288.111281.8210.30298.15291.6310.18
2436275-436275274.685284.62
3436674-436674274.936284.06
4500757-500757315.284325.92
5484646-484646305.140315.49
6369660-369660232.743241.52
60min1483809-483809304.613298.2810.22317.85311.2210.11
2465426-465426293.039306.02
3463504-463504291.829304.01
4525597-525597330.923345.06
5514522-514522323.950337.69
6389652-389652245.330256.69
极限1502341-502341316.281318.336.91332.90334.586.97
2512410-512410322.621338.86
3489803-489803308.387323.81
4542553-542553341.599359.41
5538560-538560339.085356.43
6447896-447896282.002296.09
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%
113.823345213353733345523351683351543349540.12
213.903372973376203374580.07
单位质量响应值RSD%判断
24236.9024277.550.12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%
5min1247856-247856369.681281.6027.15369.68281.6027.15
2161248-161248240.504240.50
3234730-234730350.103350.10
4176564-176564263.348263.35
5108749-108749162.201162.20
6203643-203643303.737303.74
10min1298140-298140444.680366.9315.64446.73368.5015.68
2216922-216922323.542324.88
3281576-281576419.975421.92
4241810-241810360.663362.13
5195707-195707291.900292.80
6241927-241927360.838362.53
15min1301768-301768450.092378.2114.05454.62381.8214.11
2224051-224051334.175337.31
3286788-286788427.749432.03
4248800-248800371.089374.56
5208671-208671311.236313.76
6251375-251375374.930378.62
20min1304147-304147453.640384.9113.55460.66390.6213.62
2228117-228117340.240345.23
3291097-291097434.176440.83
4253745-253745378.465383.99
5213539-213539318.497322.75
6257764-257764384.459390.23
30min1306295-306295456.844391.5812.62466.39399.4212.70
2233624-233624348.454355.33
3294230-294230438.849447.92
4260238-260238388.149395.78
5221135-221135329.826335.85
6259713-259713387.366395.28
45min1309688-309688461.904399.5312.05473.99409.5412.14
2237933-237933354.881363.70
3298548-298548445.289456.79
4267853-267853399.507409.29
5227714-227714339.639347.49
6265463-265463395.942406.01
60min1310934-310934463.763403.9111.53478.41416.1511.64
2241760-241760360.589371.38
3300762-300762448.591462.57
4270501-270501403.456415.46
5231844-231844345.799355.54
6269037-269037401.273413.54
极限1316818-316818472.539446.665.66489.76461.145.88
2288110-288110429.720442.51
3316106-316106471.477487.95
4282324-282324421.091435.34
5282237-282237420.961432.62
6311214-311214464.180478.67
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