西格列汀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%
114.13 7914879339792127925679214792340.09
214.147944079425794320.02
单位质量响应值RSD%判断
5607.505617.540.13数据可信
供试品溶液-2024050521批-西格列汀-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%
5min112664-1266415.76113.4018.5115.7613.4018.50
29569-956911.90911.91
313101-1310116.30516.30
411779-1177914.65914.66
58949-894911.13711.14
68525-852510.61010.61
10min138345-3834547.72241.9910.1447.7542.0110.14
233030-3303041.10741.13
336354-3635445.24445.27
434229-3422942.59942.62
528630-2863035.63135.65
631850-3185039.63939.66
15min159389-5938973.91266.857.5574.0266.947.55
253871-5387167.04567.13
356287-5628770.05270.15
452868-5286865.79765.89
547296-4729658.86258.94
652586-5258665.44665.53
20min170339-7033987.54083.554.4587.7783.764.46
267597-6759784.12784.33
369430-6943086.40986.63
466341-6634182.56482.77
561824-6182476.94377.12
667282-6728283.73583.93
30min177355-7735596.27295.770.4996.6596.110.50
277356-7735696.27396.61
376770-7677095.54495.91
476691-7669195.44595.79
576459-7645995.15795.46
677064-7706495.90996.24
45min177574-7757496.54496.360.3497.0896.860.33
277466-7746696.41096.91
376980-7698095.80596.33
477529-7752996.48896.99
577711-7771196.71597.18
677287-7728796.18796.68
60min177487-7748796.43696.230.3997.1396.900.38
277212-7721296.09496.76
376863-7686395.65996.34
477404-7740496.33397.00
577747-7774796.75997.38
677225-7722596.11096.76
极限177713-7771396.71796.540.5497.5797.360.53
277200-7720096.07996.90
377158-7715896.02696.87
477896-7789696.94597.77
578165-7816597.28098.07
677275-7727596.17296.98
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
119.974281514428369742945604288906429085242879060.13
219.944266575427437342704740.13
单位质量响应值RSD%判断
214717.38214166.200.19数据可信
供试品溶液-2024050521批-二甲双胍-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%
5min1876837-87683721.62619.2815.3921.6319.2815.40
2708452-70845217.47317.47
3940957-94095723.20723.21
4841545-84154520.75520.76
5667994-66799416.47516.47
6655108-65510816.15716.16
10min12232643-223264355.06449.858.2955.1049.888.30
22008019-200801949.52449.55
32171743-217174353.56253.60
42007590-200759049.51449.55
51762970-176297043.48143.51
61943971-194397147.94547.97
15min13184245-318424578.53472.376.3978.6672.486.40
22961526-296152673.04173.15
33065429-306542975.60375.73
42865696-286569670.67770.79
52636389-263638965.02265.12
62892689-289268971.34371.45
20min13611472-361147289.07185.903.7289.3386.143.73
23519438-351943886.80187.03
33588482-358848288.50488.76
43424115-342411584.45084.68
53256782-325678280.32380.53
63497979-349797986.27286.50
30min13881480-388148095.73095.410.7796.1495.790.78
23916125-391612596.58496.96
33873338-387333895.52995.93
43838325-383832594.66695.04
53836045-383604594.60994.95
63866064-386606495.35095.72
45min13898973-389897396.16195.950.5396.7396.490.53
23926030-392603096.82997.37
33885204-388520495.82296.38
43868946-386894695.42195.95
53888779-388877995.91096.41
63874851-387485195.56696.09
60min13887325-388732595.87495.850.3996.6096.540.39
23911456-391145696.46997.17
33889256-388925695.92296.64
43870833-387083395.46796.16
53888140-388814095.89496.55
63870757-387075795.46596.15
极限13895029-389502996.06495.860.4296.9596.720.43
23909270-390927096.41597.28
33887013-388701395.86696.75
43869415-386941595.43296.28
53893502-389350296.02696.85
63866894-386689495.37096.22
西格列汀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%
114.13 7880679023789747900078894789390.12
214.147939079290793400.09
单位质量响应值RSD%判断
5586.625611.030.31数据可信
供试品溶液-2024050521批-西格列汀-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%
5min112256-1225615.29015.4611.5915.2915.4611.57
214246-1424617.77317.77
312400-1240015.47015.47
412239-1223915.26915.27
513285-1328516.57416.57
69936-993612.39612.40
10min133983-3398342.39744.137.7042.4244.167.70
238931-3893148.57048.60
334453-3445342.98343.01
432639-3263940.72040.75
538669-3866948.24348.27
633555-3355541.86341.88
15min153958-5395867.31868.895.2367.4168.995.24
257264-5726471.44271.55
354635-5463568.16268.26
451336-5133664.04664.14
559681-5968174.45874.57
654457-5445767.94068.03
20min167228-6722883.87385.264.4484.0885.474.44
268548-6854885.52085.75
368266-6826685.16885.38
464566-6456680.55280.75
573804-7380492.07792.31
667605-6760584.34384.55
30min177020-7702096.09095.910.9196.4496.260.92
276242-7624295.11995.49
377007-7700796.07396.43
475978-7597894.79095.12
577940-7794097.23797.62
677060-7706096.13996.48
45min178256-7825697.63296.920.9698.1497.440.94
276642-7664295.61896.15
377304-7730496.44496.96
478724-7872498.21598.71
577784-7778497.04397.59
677406-7740696.57197.08
60min178336-7833697.73196.901.0198.4097.580.99
276568-7656895.52696.22
377148-7714896.24996.92
478704-7870498.19098.85
577726-7772696.97097.68
677522-7752296.71697.38
极限179071-7907198.64897.361.3699.4898.201.34
276937-7693795.98696.84
377188-7718896.29997.13
479588-7958899.293100.11
577696-7769696.93397.80
677745-7774596.99497.82
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
119.974271071427152742878274282150427936942783890.17
219.944262688427088642667870.14
单位质量响应值RSD%判断
214240.81213981.290.09数据可信
供试品溶液-2024050521批-二甲双胍-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%
5min1857626-85762621.18421.759.6221.1821.759.62
2978005-97800524.15824.16
3900312-90031222.23922.24
4878259-87825921.69421.69
5936666-93666623.13723.14
6731363-73136318.06618.07
10min12033402-203340250.22852.186.4750.2652.216.48
22291652-229165256.60756.65
32066642-206664251.04951.09
41967847-196784748.60848.64
52275523-227552356.20856.25
62038817-203881750.36150.39
15min12947877-294787772.81674.374.6272.9474.504.62
23114233-311423376.92677.06
32985189-298518973.73873.86
42815723-281572369.55269.67
53216956-321695679.46379.60
62984556-298455673.72273.84
20min13490121-349012186.21187.693.7286.4587.943.72
23567227-356722788.11588.38
33551221-355122187.72087.96
43375861-337586183.38883.62
53778854-377885493.34393.61
63536595-353659587.35987.60
30min13874063-387406395.69495.800.8196.0896.190.81
23847420-384742095.03695.45
33883107-388310795.91896.31
43842006-384200694.90395.27
53923393-392339396.91397.33
63900023-390002396.33696.72
45min13915686-391568696.72396.560.6797.2797.110.66
23867034-386703495.52196.09
33894023-389402396.18896.74
43943869-394386997.41997.95
53921758-392175896.87397.45
63911018-391101896.60797.15
60min13917447-391744796.76696.540.7397.4797.250.71
23864546-386454695.45996.19
33887016-388701696.01496.73
43945441-394544197.45898.15
53913590-391359096.67197.41
63921248-392124896.86097.56
极限13933766-393376697.16996.480.8898.0497.360.86
23862520-386252095.40996.30
33878186-387818695.79696.67
43954863-395486397.69098.55
53899335-389933596.31997.22
63906634-390663496.49997.36
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