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%
114.138558085520855088545785436855000.07
213.548191781724818200.17
单位质量响应值RSD%判断
6050.966042.840.10数据可信
长期6月-供试品溶液-X022139批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120343-2034323.49921.8112.4823.5021.8212.48
221258-2125824.55624.56
321337-2133724.64724.65
416532-1653219.09719.10
516324-1632418.85718.86
617505-1750520.22120.22
10min143780-4378050.57248.886.3350.6148.926.34
244040-4404050.87250.91
345133-4513352.13552.18
441850-4185048.34348.37
537652-3765243.49343.52
641441-4144147.87047.90
15min163107-6310772.89871.054.6573.0271.174.65
262457-6245772.14772.27
364372-6437274.35974.49
461702-6170271.27571.39
556124-5612464.83164.94
661296-6129670.80670.92
20min174220-7422085.73584.393.8185.9884.623.82
273350-7335084.73084.98
375721-7572187.46887.72
473755-7375585.19785.43
567646-6764678.14178.35
673630-7363085.05385.28
30min182278-8227895.04393.971.9495.4394.351.95
280677-8067793.19393.58
381967-8196794.68395.08
482920-8292095.78496.16
578503-7850390.68291.02
681754-8175494.43794.81
45min184653-8465397.78697.560.8898.3398.090.89
284752-8475297.90198.44
384843-8484398.00698.56
485101-8510198.30498.84
583040-8304095.92396.42
684330-8433097.41397.94
60min184779-8477997.93297.950.7498.6498.650.75
284916-8491698.09098.80
384800-8480097.95698.67
485155-8515598.36699.06
583655-8365596.63397.29
685487-8548798.75099.44
极限184460-8446097.56397.560.7798.4498.420.78
284792-8479297.94798.82
384584-8458497.70698.59
485365-8536598.60999.47
583449-8344996.39597.21
684097-8409797.14498.00
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%
118.973882177388546938870733889549389204238872620.10
218.543770883377405337724680.06
单位质量响应值RSD%判断
204916.29203477.240.50数据可信
长期6月-供试品溶液-X022139批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11209881-120988131.33729.2910.2331.3429.2910.23
21242387-124238732.17932.18
31247053-124705332.30032.30
41016266-101626626.32226.32
5996829-99682925.81925.82
61071591-107159127.75527.76
10min12337785-233778560.55158.345.4760.6058.395.47
22329733-232973360.34260.40
32367699-236769961.32661.38
42237481-223748157.95358.00
52036258-203625852.74152.78
62205642-220564257.12857.17
15min13138798-313879881.29879.193.7081.4579.343.71
23087676-308767679.97480.13
33164875-316487581.97382.13
43070028-307002879.51779.66
52847039-284703973.74173.87
63036334-303633478.64478.79
20min13570037-357003792.46790.832.9792.7691.112.98
23511617-351161790.95491.24
33597357-359735793.17593.47
43532743-353274391.50191.77
53304311-330431185.58585.84
63525063-352506391.30291.58
30min13866791-3866791100.15498.931.58100.6099.361.59
23792078-379207898.21898.66
33838317-383831799.41699.86
43883804-3883804100.594101.02
53716624-371662496.26496.66
63820229-382022998.94899.37
45min13939680-3939680102.041101.360.65102.65101.960.66
23917918-3917918101.478102.08
33920144-3920144101.535102.15
43934975-3934975101.920102.51
53873350-3873350100.323100.88
63894468-3894468100.870101.46
60min13932540-3932540101.857101.450.54102.64102.220.55
23913463-3913463101.362102.13
33912896-3912896101.348102.13
43935664-3935664101.937102.70
53879102-3879102100.472101.20
63928544-3928544101.753102.51
极限13927742-3927742101.732101.170.65102.68102.100.66
23910439-3910439101.284102.22
33905834-3905834101.165102.12
43936890-3936890101.969102.90
53873181-3873181100.319101.21
63881096-3881096100.524101.45
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%
114.138729687286871538726487204872410.07
213.548188981841818650.05
单位质量响应值RSD%判断
6174.176046.161.49数据可信
中间条件6月-供试品溶液-X022139批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120672-2067223.63426.8018.5323.6326.8018.55
229343-2934333.54833.55
321107-2110724.13224.13
428703-2870332.81632.82
520729-2072923.70023.70
620076-2007622.95322.95
10min148479-4847955.42655.789.6155.4755.839.62
252604-5260460.14260.20
347149-4714953.90653.95
455928-5592863.94364.00
543593-4359349.84049.88
644985-4498551.43251.47
15min169145-6914579.05476.856.5379.1976.996.53
267693-6769377.39477.55
369881-6988179.89580.03
472518-7251882.91083.07
560722-6072269.42469.55
663355-6335572.43472.56
20min177478-7747888.58187.274.4688.8487.544.47
275813-7581386.67786.96
379222-7922290.57590.84
480249-8024991.74992.05
571032-7103281.21181.45
674219-7421984.85585.10
30min182240-8224094.02593.171.7194.4493.581.72
280590-8059092.13992.57
383197-8319795.12095.53
482464-8246494.28294.73
579436-7943690.82091.19
681030-8103092.64293.03
45min183216-8321695.14195.040.5195.7195.600.51
282348-8234894.14994.73
383565-8356595.54096.11
483348-8334895.29295.90
583045-8304594.94695.47
683231-8323195.15895.70
60min183854-8385495.87195.640.2796.6096.370.28
283302-8330295.24095.98
383639-8363995.62596.36
483917-8391795.94396.71
583614-8361495.59696.28
683590-8359095.56996.27
极限184912-8491297.08096.690.3897.9797.580.40
284776-8477696.92597.82
384625-8462596.75297.64
484735-8473596.87897.81
584309-8430996.39197.23
684078-8407896.12796.99
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%
118.973890209388948338915283889983389033338903070.02
218.543774032377514337745880.03
单位质量响应值RSD%判断
205076.81203591.590.52数据可信
中间条件6月-供试品溶液-X022139批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11241339-124133932.13035.1715.1232.1335.1715.12
21630592-163059242.20642.21
31242310-124231032.15532.16
41614518-161451841.78941.79
51235778-123577831.98631.99
61188008-118800830.75030.75
10min12496084-249608464.60865.207.5264.6665.267.52
22675103-267510369.24169.31
32445533-244553363.29963.35
42810590-281059072.74872.82
52310539-231053959.80559.86
62376389-237638961.50961.56
15min13331322-333132286.22684.535.0486.3984.695.05
23281136-328113684.92785.11
33366237-336623787.13087.29
43467148-346714889.74289.93
53016118-301611878.06878.22
63132098-313209881.07081.22
20min13640513-364051394.22993.493.3194.5393.803.31
23591434-359143492.95993.29
33720518-372051896.30096.60
43746645-374664596.97697.32
53420939-342093988.54688.83
63552025-355202591.93992.23
30min13818753-381875398.84398.511.0799.3098.971.07
23775491-377549197.72398.21
33856851-385685199.829100.29
43834128-383412899.24199.74
53745155-374515596.93897.37
63804657-380465798.47898.92
45min13861089-386108999.939100.160.39100.57100.790.36
23848547-384854799.614100.26
33872847-3872847100.243100.87
43866712-3866712100.084100.75
53891474-3891474100.725101.32
63878278-3878278100.384100.99
60min13872219-3872219100.227100.510.21101.02101.300.20
23878893-3878893100.400101.21
33878717-3878717100.395101.19
43886289-3886289100.591101.43
53892873-3892873100.761101.52
63889538-3889538100.675101.45
极限13896096-3896096100.845100.910.11101.81101.870.11
23903832-3903832101.045102.02
33892651-3892651100.756101.72
43898044-3898044100.895101.90
53903221-3903221101.029101.96
63897579-3897579100.883101.82
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