西格列净磷酸二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.898057380322803748047280309804100.14
213.968036880481804240.10
单位质量响应值RSD%判断
5789.065761.030.35数据可信
中间条件24月-供试品溶液-2024050521批-西格列净-1(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19978-997812.06912.9515.2912.0712.9515.30
210880-1088013.16013.16
39550-955011.55111.55
49462-946211.44511.44
513856-1385616.75916.76
610520-1052012.72412.72
10min130845-3084537.30840.656.8537.3340.676.85
235136-3513642.49842.52
331350-3135037.91937.94
432729-3272939.58739.61
536514-3651444.16544.19
635075-3507542.42442.45
15min148955-4895559.21263.044.2759.2963.134.28
253396-5339664.58464.68
350080-5008060.57360.66
451859-5185962.72562.81
553974-5397465.28365.38
654453-5445365.86265.95
20min161309-6130974.15577.092.4374.3477.282.42
263274-6327476.53176.73
363462-6346276.75976.94
465857-6585779.65679.85
563674-6367477.01577.23
664838-6483878.42378.62
30min173039-7303988.34289.911.3088.6590.231.30
274306-7430689.87590.20
374858-7485890.54390.85
475884-7588491.78492.11
574004-7400489.51089.85
673902-7390289.38689.72
45min180750-8075097.66996.370.9798.1296.840.95
278365-7836594.78495.26
379873-7987396.60897.07
479590-7959096.26696.74
579757-7975796.46896.96
679708-7970896.40996.89
60min181233-8123398.25396.751.2298.8797.381.20
278284-7828494.68695.32
380363-8036397.20197.82
479792-7979296.51097.15
580039-8003996.80997.46
680219-8021997.02797.67
极限182169-8216999.38597.191.52100.1697.991.50
278495-7849594.94295.74
381053-8105398.03698.82
479910-7991096.65397.45
580225-8022597.03497.84
680282-8028297.10397.91
西格列净磷酸二甲双胍片项目信息
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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
118.914033093403489840392794041324403529640367780.09
218.914054321405255540534380.04
单位质量响应值RSD%判断
213473.19214354.200.30数据可信
中间条件24月-供试品溶液-2024050521批-磷酸二甲双胍-1(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1753326-75332618.64419.8012.9318.6419.8012.94
2819251-81925120.27620.28
3726632-72663217.98317.98
4710732-71073217.59017.59
5993859-99385924.59724.60
6796497-79649719.71219.71
10min11900416-190041647.03350.615.9847.0650.645.98
22143510-214351053.05053.08
31912833-191283347.34147.37
42005579-200557949.63649.67
52178708-217870853.92153.96
62128814-212881452.68652.72
15min12754482-275448268.17171.973.8268.2872.093.82
22997005-299700574.17374.29
32789966-278996669.04969.16
42917474-291747472.20472.32
52972026-297202673.55573.69
63017483-301748374.68074.80
20min13283380-328338081.26084.232.2881.4884.472.28
23420450-342045084.65384.90
33366653-336665383.32183.55
43510184-351018486.87387.11
53388949-338894983.87384.13
63451771-345177185.42885.67
30min13751753-375175392.85294.461.3093.2194.841.29
23845811-384581195.18095.57
33817471-381747194.47894.84
43894524-389452496.38596.76
53788128-378812893.75294.15
63802564-380256494.10994.50
45min14027509-402750999.67799.180.44100.1999.720.43
23980723-398072398.51999.06
34004914-400491499.11799.64
44026659-402665999.656100.19
54000265-400026599.00299.55
64005106-400510699.12299.67
60min14054656-4054656100.34899.500.59101.03100.200.57
23985881-398588198.64699.36
34023323-402332399.573100.26
44033317-403331799.820100.52
54006561-400656199.15899.87
64019728-401972899.484100.19
极限14072769-4072769100.79799.590.72101.64100.460.70
23983806-398380698.59599.47
34023795-402379599.585100.44
44028578-402857899.703100.57
54017374-401737499.426100.31
64018380-401838099.451100.33
西格列净磷酸二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.898008080054802678020180109801420.12
213.968000980305801570.27
单位质量响应值RSD%判断
5769.765741.910.35数据可信
中间条件24月-供试品溶液-2024050521批-西格列净-2(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114173-1417317.20014.1514.0917.2014.1514.09
212321-1232114.95214.95
312232-1223214.84414.84
411474-1147413.92413.92
59756-975611.84011.84
610004-1000412.14012.14
10min137817-3781745.89344.296.8745.9244.316.87
239907-3990748.43048.45
336335-3633544.09544.12
436901-3690144.78244.80
532355-3235539.26539.28
635660-3566043.27643.30
15min155757-5575767.66569.345.4167.7769.445.41
260862-6086273.86073.97
356275-5627568.29368.39
457691-5769170.01270.11
552323-5232363.49763.58
659901-5990172.69472.79
20min166192-6619280.32883.774.6480.5583.994.64
274602-7460290.53490.76
367070-6707081.39481.61
469203-6920383.98284.20
566571-6657180.78880.98
670539-7053985.60385.82
30min176293-7629392.58693.141.5892.9493.491.59
279138-7913896.03996.42
376160-7616092.42592.77
476683-7668393.06093.41
575758-7575891.93792.26
676473-7647392.80593.16
45min179121-7912196.01896.060.9996.5296.570.99
279669-7966996.68397.22
379836-7983696.88697.39
479111-7911196.00696.52
579525-7952596.50896.99
677675-7767594.26394.77
60min179007-7900795.88096.241.1496.5596.911.14
279862-7986296.91797.62
380113-8011397.22297.89
479257-7925796.18396.85
579924-7992496.99397.63
677684-7768494.27494.94
极限179079-7907995.96796.481.3496.7997.311.33
279915-7991596.98297.84
380849-8084998.11598.94
479419-7941996.38097.21
580046-8004697.14197.94
677713-7771394.31095.13
西格列净磷酸二甲双胍片项目信息
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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
118.914029670402446240470354032021403808340342540.22
218.914048565404377140461680.09
单位质量响应值RSD%判断
213339.71213969.750.21数据可信
中间条件24月-供试品溶液-2024050521批-磷酸二甲双胍-2(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1979989-97998924.28321.1410.2724.2821.1410.26
2889635-88963522.04422.04
3887387-88738721.98821.99
4851539-85153921.10021.10
5740970-74097018.36018.36
6768674-76867419.04719.05
10min12224291-222429155.11554.075.1455.1654.105.14
22326574-232657457.65057.69
32167957-216795753.72053.76
42223191-222319155.08855.12
51987676-198767649.25249.28
62162492-216249253.58453.62
15min13030263-303026375.08777.364.3175.2277.494.31
23269755-326975581.02181.15
33077843-307784376.26676.39
43162094-316209478.35378.48
52930091-293009172.60472.72
63262647-326264780.84580.97
20min13484148-348414886.33389.793.6786.5990.043.66
23833610-383361094.99395.26
33534063-353406387.57087.82
43649107-364910790.42190.68
53531902-353190287.51787.75
63709188-370918891.91092.17
30min13887097-388709796.31897.170.9196.7297.580.92
23983291-398329198.70299.13
33892579-389257996.45496.85
43934873-393487397.50297.91
53905376-390537696.77197.15
63926136-392613697.28597.69
45min13972082-397208298.42499.180.7598.9999.750.73
23997401-399740199.05199.64
34017661-401766199.553100.11
44028011-402801199.810100.38
54036120-4036120100.011100.55
63964705-396470598.24198.81
60min13981912-398191298.66799.370.7699.39100.100.75
24003445-400344599.20199.96
34029099-402909999.837100.56
44033881-403388199.955100.69
54043593-4043593100.196100.90
63968729-396872998.34199.08
极限13971188-397118898.40299.280.8399.29100.180.82
23999903-399990399.113100.03
34037188-4037188100.037100.93
44026927-402692799.783100.69
54038960-4038960100.081100.96
63965114-396511498.25199.15
西格列净磷酸二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.898002880098799768007279960800270.08
213.967999479854799240.13
单位质量响应值RSD%判断
5761.485725.210.45数据可信
中间条件24月-供试品溶液-2024050621批-西格列净-1(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110996-1099613.37316.6014.8713.3716.6014.87
213617-1361716.56116.56
315552-1555218.91418.91
414258-1425817.34117.34
515923-1592319.36619.37
611558-1155814.05714.06
10min135247-3524742.86846.898.0442.8946.928.04
239985-3998548.63048.66
341440-4144050.40050.43
438842-3884247.24047.27
541489-4148950.45950.49
634316-3431641.73541.76
15min155346-5534667.31270.235.1167.4170.345.12
258353-5835370.96971.08
360397-6039773.45573.57
457549-5754969.99170.10
561290-6129074.54174.66
653540-5354065.11665.21
20min166029-6602980.30583.375.2380.5183.595.24
267388-6738881.95882.18
370310-7031085.51185.75
469534-6953484.56884.79
574116-7411690.14090.38
663921-6392177.74177.94
30min174570-7457090.69292.302.8691.0392.672.87
273928-7392889.91290.28
377119-7711993.79294.17
478499-7849995.47195.84
577804-7780494.62695.02
673448-7344889.32889.66
45min178571-7857195.55896.030.5596.0596.540.56
278357-7835795.29895.81
379050-7905096.14196.68
479556-7955696.75697.28
579187-7918796.30896.86
679022-7902296.10796.59
60min179738-7973896.97896.810.8097.6397.490.79
278678-7867895.68996.36
379196-7919696.31997.02
479679-7967996.90697.59
579727-7972796.96497.67
680587-8058798.01098.65
极限180785-8078598.25197.071.0499.0697.911.02
278930-7893095.99596.83
378962-7896296.03496.89
479452-7945296.63097.48
580063-8006397.37398.24
680699-8069998.14698.95
西格列净磷酸二甲双胍片项目信息
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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
118.914036060403128340338634034465403640340344150.06
218.914050259404653740483980.07
单位质量响应值RSD%判断
213348.23214087.680.25数据可信
中间条件24月-供试品溶液-2024050621批-磷酸二甲双胍-1(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1819512-81951220.30124.1411.8020.3024.1411.80
2966715-96671523.94723.95
31080091-108009126.75626.76
41008890-100889024.99224.99
51107103-110710327.42527.42
6864868-86486821.42421.42
10min12115842-211584252.41356.586.2552.4556.626.26
22348102-234810258.16658.21
32427372-242737260.13060.17
42298340-229834056.93456.98
52410831-241083159.72059.77
62103305-210330552.10252.14
15min13034171-303417175.16178.013.9175.2878.143.92
23156522-315652278.19278.33
33268911-326891180.97681.12
43143802-314380277.87778.01
53300262-330026281.75381.90
62990287-299028774.07474.20
20min13487243-348724386.38589.363.8586.6389.633.86
23543468-354346887.77788.04
33681623-368162391.20091.48
43654709-365470990.53390.80
53823331-382333194.71094.99
63454346-345434685.57085.82
30min13822331-382233194.68596.301.9695.0896.721.96
23805112-380511294.25994.67
33939428-393942897.58698.02
43987120-398712098.76799.18
53936516-393651697.51497.95
63835239-383523995.00595.39
45min13973536-397353698.43199.150.8698.9899.720.85
23959330-395933098.07998.65
34005312-400531299.21899.81
44024753-402475399.700100.28
53999482-399948299.07499.68
64053309-4053309100.407100.95
60min14015180-401518099.46299.621.01100.17100.361.00
23978317-397831798.54999.28
34008325-400832599.293100.05
44011907-401190799.381100.13
54015960-401596099.482100.25
64099268-4099268101.545102.26
极限14035701-403570199.97199.481.12100.85100.391.09
23965094-396509498.22299.12
33986668-398666898.75699.68
44007953-400795399.283100.20
54007396-400739699.270100.20
64093334-4093334101.398102.28
西格列净磷酸二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.898002880065800847998280008800330.06
213.968010180216801580.11
单位质量响应值RSD%判断
5761.925741.980.25数据可信
中间条件24月-供试品溶液-2024050621批-西格列净-2(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112891-1289115.65515.5610.2915.6515.5610.28
212391-1239115.04715.05
312923-1292315.69315.69
415269-1526918.54218.54
511726-1172614.24014.24
611682-1168214.18614.19
10min135706-3570643.36144.298.5943.3944.318.58
235696-3569643.34843.37
335149-3514942.68442.71
442245-4224551.30151.33
532957-3295740.02240.05
637053-3705344.99645.02
15min153513-5351364.98567.276.1965.0867.376.19
255796-5579667.75767.85
352494-5249463.74863.84
460624-6062473.62073.74
551912-5191263.04163.13
658052-5805270.49770.60
20min165777-6577779.87880.413.3480.0880.623.34
267003-6700381.36781.58
364307-6430778.09378.30
467350-6735081.78882.03
563385-6338576.97377.17
669469-6946984.36284.58
30min174882-7488290.93591.101.9391.2791.441.93
276202-7620292.53892.88
374713-7471390.73091.06
474859-7485990.90791.28
572645-7264588.21988.54
676816-7681693.28493.64
45min179014-7901495.95395.900.8696.4496.400.85
278719-7871995.59596.09
380288-8028897.50097.98
478696-7869695.56796.09
578393-7839395.19995.67
678715-7871595.59096.10
60min179632-7963296.70396.481.0997.3597.141.07
278995-7899595.93096.59
380972-8097298.33198.98
479328-7932896.33497.02
579397-7939796.41897.05
678386-7838695.19095.86
极限179649-7964996.72496.520.9897.5497.340.96
279198-7919896.17697.00
380673-8067397.96898.78
479369-7936996.38497.23
579691-7969196.77597.57
678295-7829595.08095.91
西格列净磷酸二甲双胍片项目信息
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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
118.914033065402996640340044032411403342840325750.04
218.914055290406424640597680.16
单位质量响应值RSD%判断
213250.93214688.950.48数据可信
中间条件24月-供试品溶液-2024050621批-磷酸二甲双胍-2(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1944570-94457023.37122.908.1123.3722.908.12
2911058-91105822.54222.54
3926967-92696722.93622.94
41058296-105829626.18526.19
5865523-86552321.41521.42
6845918-84591820.93020.93
10min12133458-213345852.78754.036.9352.8354.076.92
22166704-216670453.61053.65
32100360-210036051.96852.01
42464958-246495860.99061.03
52026583-202658350.14350.18
62211079-221107954.70854.74
15min12951914-295191473.03875.524.9473.1775.654.94
23088479-308847976.41776.54
32906572-290657271.91672.04
43273914-327391481.00581.15
52920456-292045672.26072.38
63172123-317212378.48778.61
20min13463180-346318085.68886.882.8785.9487.142.87
23573251-357325188.41288.67
33415361-341536184.50584.75
43564805-356480588.20388.48
53399774-339977484.11984.36
63652355-365235590.36990.63
30min13841353-384135395.04595.631.5695.4496.021.57
23930154-393015497.24297.64
33849492-384949295.24795.63
43859287-385928795.48995.92
53774239-377423993.38593.76
63934221-393422197.34397.75
45min13985903-398590398.62299.190.6899.1799.750.67
24021953-402195399.514100.08
34058065-4058065100.407100.95
43993689-399368998.81499.40
53992776-399277698.79299.33
64000502-400050298.98399.55
60min13997741-399774198.91599.670.8599.63100.400.84
24041315-404131599.993100.72
34084587-4084587101.063101.78
44026255-402625599.620100.37
54030720-403072099.731100.43
63989414-398941498.70999.44
极限13991060-399106098.74999.480.7899.63100.370.77
24021936-402193699.513100.41
34063400-4063400100.539101.42
44021870-402187099.512100.43
54044216-4044216100.065100.93
63980849-398084998.49799.40
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