达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
110.204058422406361940607684060965405639640600340.07
210.274070959406828640696220.05
单位质量响应值RSD%判断
398042.55396263.100.32数据可信
中间条件6月-供试品溶液-2025081521批-二甲双胍-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%
5min1158344-1583443.9874.144.223.994.144.17
2177305-1773054.4644.46
3162627-1626274.0954.09
4161884-1618844.0764.08
5166938-1669384.2034.20
6159676-1596764.0214.02
10min1340304-3403048.5698.682.658.598.702.63
2337011-3370118.4868.51
3359578-3595789.0549.07
4338929-3389298.5348.55
5352134-3521348.8678.89
6339409-3394098.5468.57
15min1477998-47799812.03612.454.5512.1012.524.55
2486656-48665612.25412.32
3536126-53612613.49913.57
4490648-49064812.35412.42
5501420-50142012.62512.69
6474594-47459411.95012.01
20min1610880-61088015.38215.652.5415.5015.772.57
2615649-61564915.50215.63
3647871-64787116.31316.45
4620689-62068915.62915.75
5629916-62991615.86115.99
6603319-60331915.19115.31
30min1812993-81299320.47120.832.2120.6721.032.22
2826776-82677620.81821.02
3852968-85296821.47721.69
4825413-82541320.78320.99
5842102-84210221.20421.41
6803170-80317020.22320.42
45min11071417-107141726.97827.402.2827.2827.712.28
21065332-106533226.82427.13
31129190-112919028.43228.75
41087135-108713527.37327.68
51105418-110541827.83428.15
61071655-107165526.98427.28
60min11286888-128688832.40333.012.3932.8433.462.39
21289042-128904232.45732.90
31352869-135286934.06434.53
41328058-132805833.44033.88
51333776-133377633.58434.04
61275283-127528332.11132.55
120min11940813-194081348.86849.831.9149.4750.441.91
21953984-195398449.20049.80
32037042-203704251.29151.93
41983338-198333849.93950.55
52008121-200812150.56351.18
61951361-195136149.13449.73
180min12412403-241240360.74362.051.4961.5962.911.49
22434474-243447461.29862.15
32515856-251585663.34864.24
42482998-248299862.52063.38
52466572-246657262.10762.98
62473524-247352462.28263.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12812934-281293470.82871.521.4071.9872.691.40
22799906-279990670.50071.66
32884987-288498772.64273.85
42889878-288987872.76573.94
52844895-284489571.63372.82
62809236-280923670.73571.89
360min13297216-329721683.02284.311.4184.5285.841.40
23284458-328445882.70184.21
33391941-339194185.40786.98
43351732-335173284.39485.93
53383949-338394985.20686.75
63381765-338176585.15186.66
480min13616536-361653691.06292.530.9392.9894.480.92
23662178-366217892.21194.13
33669488-366948892.39594.39
43710491-371049193.42895.39
53699990-369999093.16395.13
63690042-369004292.91394.84
600min13819403-381940396.17097.991.2498.54100.401.22
23885410-388541097.832100.22
33880076-388007697.698100.16
43949723-394972399.451101.88
53874643-387464397.561100.00
63941185-394118599.236101.63
720min13920345-392034598.712100.140.95101.56103.040.95
23943015-394301599.283102.16
33990630-3990630100.481103.43
44014366-4014366101.079104.00
53984585-3984585100.329103.25
64008858-4008858100.940103.83
极限13873152-387315297.52399.281.21100.87102.681.20
23908513-390851398.414101.78
33951670-395167099.500102.95
44008011-4008011100.919104.35
53942195-394219599.262102.69
63972951-3972951100.036103.43
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院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6250
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%
1 12.613360933606334373372033455335650.36
2 12.743383933826338320.03
单位质量响应值RSD%判断
2661.782655.570.17数据可信
中间条件6月-供试品溶液-2025081521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%
5min137039-3703989.60788.042.5089.6188.042.50
236368-3636887.98387.98
336184-3618487.53887.54
436057-3605787.23187.23
537679-3767991.15591.16
635018-3501884.71784.72
10min138195-3819592.40390.541.7992.8590.981.79
236805-3680589.04189.48
337649-3764991.08291.52
436474-3647488.24088.68
537976-3797691.87492.33
637456-3745690.61691.04
15min138189-3818992.38991.571.1993.3092.461.19
237336-3733690.32591.21
338289-3828992.63193.52
437357-3735790.37691.25
538246-3824692.52793.44
637684-3768491.16792.04
20min138672-3867293.55791.831.4794.9393.181.46
237582-3758290.92092.26
337229-3722990.06691.42
437756-3775691.34192.67
538518-3851893.18594.56
638002-3800291.93693.27
30min137949-3794991.80890.780.8393.6592.590.84
237225-3722590.05791.85
337440-3744090.57792.38
437222-3722290.04991.84
537848-3784891.56493.41
637458-3745890.62092.41
45min137755-3775591.33991.151.1893.6493.411.17
236978-3697889.45991.70
337684-3768491.16793.43
437401-3740190.48392.72
538209-3820992.43794.74
638028-3802891.99994.24
60min137921-3792191.74191.031.1394.5093.751.13
237056-3705689.64892.34
337391-3739190.45893.17
437575-3757590.90393.59
538272-3827292.59095.35
637544-3754490.82893.53
120min137720-3772091.25491.331.4194.4794.501.40
237275-3727590.17893.31
337733-3773391.28694.45
437110-3711089.77992.92
538557-3855793.27996.51
638103-3810392.18195.34
180min137818-3781891.49191.191.1595.1694.821.13
237212-3721290.02593.61
337617-3761791.00594.63
437234-3723490.07893.67
537948-3794891.80695.50
638322-3832292.71196.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138119-3811992.22091.211.4596.3595.291.43
236729-3672988.85792.89
337410-3741090.50494.58
437797-3779791.44195.48
538115-3811592.21096.36
638031-3803192.00796.09
360min137638-3763891.05690.092.2095.6494.642.14
236273-3627387.75492.24
337064-3706489.66794.20
436346-3634687.93092.43
537869-3786991.61596.23
638250-3825092.53697.08
480min137084-3708489.71689.391.4494.7694.381.41
236612-3661288.57493.49
336244-3624487.68392.66
436683-3668388.74593.68
537493-3749390.70595.78
637589-3758990.93795.94
600min137257-3725790.13489.851.3395.6395.291.29
236676-3667688.72994.09
336578-3657888.49193.91
437131-3713189.82995.21
537250-3725090.11795.64
637951-3795191.81397.27
720min137147-3714789.86889.201.6595.8195.091.61
236295-3629587.80793.61
336393-3639388.04493.90
436398-3639888.05693.89
537190-3719089.97295.95
637807-3780791.46597.39
极限136565-3656588.46088.411.1194.8594.741.09
235992-3599287.07493.32
336250-3625087.69894.00
436558-3655888.44394.72
536725-3672588.84795.27
637165-3716589.91296.29
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106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50
标示量(mg)1000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%
110.204112739411060741129334109778411177041115650.04
210.274061136406406240625990.06
单位质量响应值RSD%判断
403094.61395579.261.34数据可信
中间条件6月-供试品溶液-2025081521批-二甲双胍-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%
5min1160161-1601614.0114.243.714.014.243.69
2168679-1686794.2244.22
3173147-1731474.3364.34
4171257-1712574.2894.29
5177859-1778594.4544.45
6164722-1647224.1254.13
10min1343248-3432488.5969.164.218.629.184.17
2382197-3821979.5729.59
3366627-3666279.1829.20
4357264-3572648.9478.97
5361183-3611839.0459.07
6383366-3833669.6019.62
15min1484570-48457012.13512.522.6612.2012.592.64
2488388-48838812.23112.30
3520555-52055513.03713.10
4497265-49726512.45312.52
5508766-50876612.74112.81
6500378-50037812.53112.60
20min1613092-61309215.35415.571.9115.4815.701.88
2605949-60594915.17515.31
3628288-62828815.73515.87
4633945-63394515.87616.00
5633385-63338515.86215.99
6614693-61469315.39415.53
30min1809944-80994420.28420.892.7620.4821.102.76
2810326-81032620.29420.50
3861143-86114321.56621.78
4857777-85777721.48221.69
5843260-84326021.11821.33
6823202-82320220.61620.82
45min11061782-106178226.59127.152.0126.8927.462.01
21073164-107316426.87627.18
31102116-110211627.60127.92
41078065-107806526.99927.31
51118935-111893528.02228.34
61071251-107125126.82827.14
60min11268449-126844931.76732.492.3032.2032.942.29
21282419-128241932.11732.56
31343193-134319333.63934.10
41273780-127378031.90032.35
51323567-132356733.14733.60
61293698-129369832.39932.84
120min11918942-191894248.05749.101.3648.6549.711.37
21953331-195333148.91949.52
31984664-198466449.70350.33
41966944-196694449.26049.87
51991762-199176249.88150.50
61947836-194783648.78149.39
180min12400119-240011960.10860.951.0660.9461.801.07
22424701-242470160.72461.57
32478921-247892162.08162.96
42426711-242671160.77461.63
52436105-243610561.00961.88
62434743-243474360.97561.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12785869-278586969.76970.922.2970.9072.082.27
22772134-277213469.42570.58
32849971-284997171.37472.56
42819414-281941470.60971.77
52951778-295177873.92475.10
62810942-281094270.39671.55
360min13286973-328697382.31883.471.0983.8084.981.09
23362049-336204984.19885.70
33380583-338058384.66286.20
43302951-330295182.71884.23
53347181-334718183.82685.37
63317164-331716483.07484.58
480min13846587-384658796.33392.822.1698.2394.762.10
23615397-361539790.54392.46
33661560-366156091.69993.66
43704253-370425392.76894.69
53673225-367322591.99193.96
63737880-373788093.61095.53
600min13786212-378621294.82196.370.9197.2098.770.90
23862364-386236496.72899.10
33892124-389212497.47399.90
43847423-384742396.35498.74
53846099-384609996.32198.75
63854035-385403596.51998.91
720min13882200-388220097.22598.621.06100.08101.501.05
23929002-392900298.397101.25
34004096-4004096100.277103.19
43932822-393282298.493101.36
53961720-396172099.216102.12
63916862-391686298.093100.97
极限13922780-392278098.24199.041.41101.58102.411.36
23935699-393569998.565101.91
33997730-3997730100.118103.53
43929003-392900398.397101.76
53897748-389774897.614101.02
64045327-4045327101.310104.67
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院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6250
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%
1 12.613395133950339783403033988339790.10
2 12.743369933675336870.06
单位质量响应值RSD%判断
2694.612644.191.34数据可信
中间条件6月-供试品溶液-2025081521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%
5min136764-3676488.59287.921.3488.5987.921.34
235840-3584086.36586.37
335891-3589186.48886.49
436873-3687388.85588.85
536655-3665588.32988.33
636891-3689188.89888.90
10min138090-3809091.78790.501.2492.2390.941.25
237129-3712989.47189.90
336929-3692988.98989.42
437492-3749290.34690.79
537711-3771190.87491.32
637997-3799791.56392.01
15min137863-3786391.24090.530.6692.1491.420.64
237570-3757090.53491.41
337697-3769790.84091.72
437667-3766790.76891.66
537461-3746190.27191.17
637151-3715189.52490.43
20min138016-3801691.60990.780.7992.9792.130.79
237494-3749490.35191.68
337258-3725889.78291.11
437999-3799991.56892.92
537682-3768290.80492.15
637594-3759490.59291.94
30min137584-3758490.56889.830.9292.3891.630.92
237197-3719789.63591.42
336819-3681988.72490.50
436957-3695789.05790.86
537642-3764290.70892.51
637480-3748090.31792.12
45min137467-3746790.28690.100.6492.5592.340.63
237280-3728089.83592.07
337332-3733289.96192.18
437372-3737290.05792.31
537799-3779991.08693.34
637083-3708389.36191.62
60min137273-3727389.81889.680.5592.5492.380.54
237249-3724989.76192.44
337276-3727689.82692.50
436863-3686388.83091.53
537477-3747790.31093.02
637149-3714989.52092.22
120min137388-3738890.09689.990.9893.2793.130.95
237661-3766190.75393.88
336822-3682288.73291.85
437436-3743690.21193.36
537748-3774890.96394.12
637004-3700489.17092.32
180min137469-3746990.29189.430.5793.9193.030.56
237209-3720989.66493.25
337021-3702189.21192.78
437115-3711589.43893.04
536862-3686288.82892.44
636995-3699589.14992.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137391-3739190.10390.162.0694.1794.211.99
237043-3704389.26493.30
336822-3682288.73292.74
437328-3732889.95194.00
538926-3892693.80297.86
636988-3698889.13293.17
360min136973-3697389.09688.881.2393.6293.371.17
237585-3758590.57095.05
336839-3683988.77393.23
436641-3664188.29592.79
537034-3703489.24393.77
636224-3622487.29191.78
480min138616-3861693.05589.252.3598.0294.192.24
236484-3648487.91792.85
336069-3606986.91791.82
437076-3707689.34494.28
536898-3689888.91593.89
637087-3708789.37094.29
600min136641-3664188.29587.940.7993.7393.330.75
237019-3701989.20694.58
336369-3636987.64092.97
436324-3632487.53292.92
536323-3632387.52992.95
636296-3629687.46492.83
720min136367-3636787.63587.471.0593.5193.300.99
236669-3666988.36394.18
336448-3644887.83093.60
436160-3616087.13692.96
536550-3655088.07693.93
635609-3560985.80991.62
极限136587-3658788.16587.380.8194.4893.640.77
236649-3664988.31594.57
336122-3612287.04593.26
435921-3592186.56092.82
536079-3607986.94193.24
636197-3619787.22693.46
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