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%
110.204231054425950742309474243245424600042421510.29
210.244301370430062943010000.02
单位质量响应值RSD%判断
415897.16420019.530.70数据可信
供试品溶液-WK2170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%
15min1403994-4039949.6669.064.429.679.064.42
2368502-3685028.8178.82
3361966-3619668.6618.66
4391714-3917149.3729.37
5364704-3647048.7268.73
6381404-3814049.1269.13
30min1690370-69037016.51816.321.3116.5716.361.31
2671620-67162016.06916.11
3686159-68615916.41716.46
4692427-69242716.56716.61
5673001-67300116.10216.15
6678671-67867116.23816.28
45min1958720-95872022.93922.721.6423.0722.851.64
2932210-93221022.30422.43
3929211-92921122.23322.36
4959278-95927822.95223.08
5951755-95175522.77222.90
6967151-96715123.14023.27
60min11183933-118393328.32727.651.8928.5727.891.88
21128737-112873727.00727.24
31135623-113562327.17127.41
41149425-114942527.50227.75
51160259-116025927.76128.00
61175301-117530128.12128.36
75min11365889-136588932.68132.301.0333.0732.681.03
21328901-132890131.79632.17
31352888-135288832.37032.74
41337711-133771132.00732.39
51358137-135813732.49532.87
61356556-135655632.45832.84
90min11520458-152045836.37935.811.3636.9336.351.36
21477144-147714435.34335.87
31469392-146939235.15735.69
41515832-151583236.26836.81
51499518-149951835.87836.42
61497998-149799835.84236.39
105min11671809-167180940.00039.931.2540.7340.641.24
21643057-164305739.31240.02
31652480-165248039.53840.25
41670104-167010439.96040.68
51703755-170375540.76541.48
61670847-167084739.97740.70
120min11791403-179140342.86242.092.0643.7943.012.03
21714738-171473841.02841.93
31721655-172165541.19342.10
41750711-175071141.88842.81
51800408-180040843.07744.00
61777102-177710242.52043.44
极限11889643-188964345.21244.891.7646.3646.021.74
21840956-184095644.04745.16
31835685-183568543.92145.04
41871581-187158144.78045.91
51904392-190439245.56546.70
61915078-191507845.82146.96
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12500
标示量(mg)5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%
112.713150431600315603148731519315340.15
212.753176431952318580.42
单位质量响应值RSD%判断
2481.042498.670.51数据可信
供试品溶液-WK2170批-二甲双胍-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%
15min134889-3488990.12987.744.7090.1387.744.70
235691-3569192.20192.20
331099-3109980.33980.34
434695-3469589.62889.63
533803-3380387.32487.32
633605-3360586.81286.81
30min135312-3531291.22291.823.4991.6792.263.49
237360-3736096.51396.97
334106-3410688.10788.51
436104-3610493.26893.72
536113-3611393.29193.73
634277-3427788.54888.98
45min136735-3673594.89896.043.3795.8096.933.38
238696-3869699.964100.91
335144-3514490.78891.63
437818-3781897.69698.61
537940-3794098.01198.91
636720-3672094.85995.74
60min137341-3734196.46496.032.9597.8497.412.96
238657-3865799.863101.31
335548-3554891.83293.13
437104-3710495.85197.25
537942-3794298.01699.41
636445-3644594.14995.50
75min137605-3760597.14696.962.3999.0198.822.40
239084-39084100.966102.91
336783-3678395.02296.78
437269-3726996.27898.16
537844-3784497.76399.65
636606-3660694.56596.39
90min136758-3675894.95895.243.2597.3197.583.25
238730-38730100.052102.50
335414-3541491.48693.72
437313-3731396.39198.75
537227-3722796.16998.54
635750-3575092.35494.65
105min137303-3730396.36696.493.0099.1999.313.00
238918-38918100.538103.49
335935-3593592.83295.52
437484-3748496.83399.68
538165-3816598.592101.45
636303-3630393.78296.54
120min136262-3626293.67693.372.8096.9896.672.81
237234-3723496.18799.64
334635-3463589.47392.63
436283-3628393.73197.06
537110-3711095.86799.21
635326-3532691.25894.48
极限136765-3676594.97694.352.7498.7598.122.75
237873-3787397.838101.77
334842-3484290.00893.61
436454-3645494.17297.97
536967-3696795.49899.32
636229-3622993.59197.27
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%
110.204265973426938942662794265450426787542669930.04
210.244351354435026743508100.02
单位质量响应值RSD%判断
418332.65424883.791.10数据可信
供试品溶液-WK2170批-达格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1361099-3610998.5658.235.338.578.235.33
2365894-3658948.6798.68
3314396-3143967.4587.46
4342900-3429008.1348.13
5354510-3545108.4098.41
6343132-3431328.1398.14
30min1648748-64874815.38815.073.1415.4315.113.15
2651963-65196315.46515.51
3596735-59673514.15514.19
4640644-64064415.19615.24
5637181-63718115.11415.16
6636313-63631315.09315.13
45min1876008-87600820.77920.542.6720.9020.662.67
2893562-89356221.19521.32
3825774-82577419.58719.70
4860589-86058920.41320.53
5877490-87749020.81420.93
6861828-86182820.44320.56
60min11081088-108108825.64425.092.8525.8725.312.85
21071328-107132825.41225.64
3998574-99857423.68623.89
41057153-105715325.07625.29
51071364-107136425.41325.63
61068089-106808925.33525.55
75min11222922-122292229.00828.813.3829.3629.163.37
21256218-125621829.79830.15
31149322-114932227.26227.59
41226621-122662129.09629.44
51249678-124967829.64329.99
61183785-118378528.08028.42
90min11387521-138752132.91232.361.8633.4132.841.87
21383702-138370232.82233.32
31320325-132032531.31831.78
41378755-137875532.70433.19
51352866-135286632.09032.59
61361450-136145032.29432.78
105min11519399-151939936.04035.982.2336.7036.632.24
21544660-154466036.64037.31
31456317-145631734.54435.16
41523593-152359336.14036.79
51550127-155012736.76937.43
61506574-150657435.73636.38
120min11653995-165399539.23338.731.9140.0739.561.91
21647952-164795239.09039.94
31584667-158466737.58938.38
41638700-163870038.87039.70
51665940-166594039.51640.36
61606217-160621738.10038.93
极限11740665-174066541.28941.231.4842.3342.261.49
21751351-175135141.54242.59
31688519-168851940.05241.03
41741726-174172641.31442.34
51761397-176139741.78142.82
61746461-174646141.42642.44
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12500
标示量(mg)5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%
112.713314033153331203314233423331960.39
212.753352433584335540.13
单位质量响应值RSD%判断
2611.802631.690.54数据可信
供试品溶液-WK2170批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min135752-3575287.71389.063.3787.7189.063.37
235581-3558187.29387.29
336360-3636089.20489.20
437179-3717991.21491.21
538175-3817593.65793.66
634767-3476785.29685.30
30min137413-3741391.78893.063.6292.2393.513.61
236228-3622888.88089.32
338851-3885195.31695.76
439725-3972597.46097.92
538698-3869894.94095.41
636678-3667889.98490.41
45min137249-3724991.38593.333.1992.2894.243.19
236780-3678090.23591.12
339066-3906695.84396.77
439102-3910295.93196.87
539242-3924296.27597.22
636811-3681190.31191.19
60min137148-3714891.13892.993.1892.4994.373.18
236165-3616588.72690.06
338818-3881895.23596.64
439204-3920496.18297.60
538782-3878295.14696.57
637303-3730391.51892.85
75min136234-3623488.89591.674.2690.7193.524.24
236371-3637189.23191.01
337936-3793693.07194.95
439234-3923496.25598.16
539021-3902195.73397.63
635406-3540686.86488.65
90min136503-3650389.55591.213.2491.8193.513.24
235688-3568887.55689.78
338486-3848694.42096.76
438618-3861894.74497.13
537444-3744491.86494.24
636328-3632889.12691.35
105min136133-3613388.64791.573.5291.3594.333.51
235909-3590988.09890.76
338356-3835694.10196.92
438554-3855494.58797.45
538620-3862094.74997.59
636371-3637189.23191.90
120min135914-3591488.11090.494.1691.2693.714.13
235041-3504185.96889.07
338228-3822893.78797.07
438135-3813593.55996.89
538416-3841694.24897.56
635579-3557987.28890.40
极限135850-3585087.95390.653.7091.5494.313.68
235037-3503785.95989.49
338115-3811593.51097.26
438112-3811293.50397.30
538160-3816093.62097.40
636414-3641489.33792.88
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%
110.204324756432493843240144325865432282843244800.03
210.244341201434156143413810.01
单位质量响应值RSD%判断
423968.63423962.990.01数据可信
供试品溶液-WK2170批-达格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1205658-2056584.8515.457.904.855.457.89
2241743-2417435.7025.70
3254587-2545876.0056.00
4236395-2363955.5765.58
5234061-2340615.5215.52
6213420-2134205.0345.03
30min1424203-42420310.00610.724.6810.0310.744.69
2455859-45585910.75210.78
3480774-48077411.34011.37
4468653-46865311.05411.08
5462250-46225010.90310.93
6434837-43483710.25610.28
45min1596571-59657114.07115.124.1414.1515.204.14
2654820-65482015.44515.53
3670944-67094415.82515.91
4654691-65469115.44215.53
5644634-64463415.20515.29
6625009-62500914.74214.82
60min1745584-74558417.58618.843.7617.7319.003.77
2801354-80135418.90119.06
3835181-83518119.69919.87
4804026-80402618.96419.12
5814750-81475019.21719.38
6791958-79195818.68018.83
75min1897348-89734821.16622.013.1021.4022.263.11
2931950-93195021.98222.24
3972764-97276422.94423.21
4944115-94411522.26922.52
5950556-95055622.42122.67
6903249-90324921.30521.55
90min11017709-101770924.00525.253.1524.3425.613.18
21069191-106919125.21925.58
31114859-111485926.29626.68
41086168-108616825.61925.99
51085748-108574825.60925.98
61049424-104942424.75325.10
105min11096830-109683025.87127.573.4526.3328.063.46
21181975-118197527.87928.37
31215054-121505428.65929.17
41177682-117768227.77828.27
51187826-118782628.01728.51
61154911-115491127.24127.71
120min11228490-122849028.97630.362.9129.5630.982.93
21293010-129301030.49831.13
31338933-133893331.58132.23
41295848-129584830.56531.20
51301608-130160830.70131.34
61263904-126390429.81130.42
极限11314748-131474831.01132.343.2831.7433.113.28
21329575-132957531.36032.14
31434504-143450433.83534.65
41390692-139069232.80233.59
51396768-139676832.94533.73
61359406-135940632.06432.82
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12500
标示量(mg)5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%
112.713333633371332703324533191332830.22
212.753363433751336920.25
单位质量响应值RSD%判断
2618.652642.510.65数据可信
供试品溶液-WK2170批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min131393-3139376.76084.535.1976.7684.535.19
236163-3616388.42488.42
335420-3542086.60786.61
435418-3541886.60286.60
535511-3551186.82986.83
633519-3351981.95981.96
30min134309-3430983.89088.333.2184.2788.753.22
236505-3650589.26089.70
335739-3573987.38787.82
437318-3731891.24891.68
537300-3730091.20491.64
635568-3556886.96987.38
45min134247-3424783.73989.233.6284.5490.093.62
238119-3811993.20694.09
336107-3610788.28789.16
437231-3723191.03591.92
537018-3701890.51491.40
636232-3623288.59289.44
60min134292-3429283.84989.223.3085.0790.533.31
237204-3720490.96992.32
335994-3599488.01089.32
436898-3689890.22191.57
537644-3764492.04593.39
636891-3689190.20491.49
75min134975-3497585.51988.522.5387.1690.282.55
236853-3685390.11191.92
335851-3585187.66189.41
436691-3669189.71591.51
537369-3736991.37293.18
635481-3548186.75688.49
90min134794-3479485.07688.912.6187.1491.102.63
237285-3728591.16793.43
335986-3598687.99190.18
436992-3699290.45192.69
537091-3709190.69392.95
636019-3601988.07290.24
105min133374-3337481.60486.993.5284.1089.633.50
236964-3696490.38293.10
335355-3535586.44889.08
435740-3574087.38990.09
536545-3654589.35892.07
635479-3547986.75189.36
120min134349-3434983.98887.572.4286.8990.652.45
236688-3668889.70792.87
335468-3546886.72489.79
436242-3624288.61791.75
536516-3651689.28792.45
635613-3561387.07990.13
极限134236-3423683.71286.902.1687.0390.422.17
235231-3523186.14589.76
335597-3559787.04090.54
436021-3602188.07691.65
536473-3647389.18292.79
635681-3568187.24590.73
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%
110.204360416436096643579374360243436005443599230.03
210.244337261433859943379300.03
单位质量响应值RSD%判断
427443.43423625.980.64数据可信
供试品溶液-WK2170批-达格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1156050-1560503.6673.577.313.673.577.24
2157339-1573393.6983.70
3129999-1299993.0553.06
4153191-1531913.6003.60
5161056-1610563.7853.78
6153416-1534163.6053.61
30min1331904-3319047.8007.665.217.827.685.23
2339483-3394837.9788.00
3292259-2922596.8686.88
4331357-3313577.7877.80
5332941-3329417.8247.84
6328127-3281277.7117.73
45min1467111-46711110.97711.014.6011.0311.064.62
2490102-49010211.51811.58
3427387-42738710.04410.09
4478747-47874711.25111.31
5473958-47395811.13811.20
6472650-47265011.10711.16
60min1575390-57539013.52214.264.4213.6314.374.43
2627145-62714514.73814.85
3570756-57075613.41313.51
4611936-61193614.38114.49
5630170-63017014.80914.92
6624812-62481214.68314.80
75min1648686-64868615.24416.806.1215.4216.986.08
2766972-76697218.02418.21
3686298-68629816.12816.30
4702588-70258816.51116.70
5740594-74059417.40417.59
6743431-74343117.47117.66
90min1850097-85009719.97819.923.2320.2320.183.24
2870410-87041020.45520.73
3794318-79431818.66718.91
4850040-85004019.97620.24
5855927-85592720.11520.39
6864545-86454520.31720.59
105min1932535-93253521.91522.202.7922.2722.572.81
2965244-96524422.68423.07
3896349-89634921.06421.41
4956744-95674422.48422.85
5960120-96012022.56322.94
6957624-95762422.50422.88
120min11040203-104020324.44524.344.1524.9124.824.15
21070422-107042225.15525.65
3952216-95221622.37722.82
41035710-103571024.34024.82
51060462-106046224.92125.41
61056200-105620024.82125.31
极限1986892-98689223.19222.872.6523.7823.462.66
21007588-100758823.67924.30
3929441-92944121.84222.40
4968903-96890322.77023.37
5974096-97409622.89223.50
6970894-97089422.81623.43
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12500
标示量(mg)5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%
112.713374233689336093362533854337040.30
212.753331633405333600.19
单位质量响应值RSD%判断
2651.772616.470.95数据可信
供试品溶液-WK2170批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min133205-3320581.08479.1711.8681.0879.1711.86
235789-3578987.39487.39
325209-2520961.55861.56
434404-3440484.01284.01
531310-3131076.45676.46
634608-3460884.51084.51
30min134729-3472984.80584.478.9785.2184.878.98
237974-3797492.72993.17
329331-2933171.62471.93
436585-3658589.33789.76
532902-3290280.34480.73
636038-3603888.00288.42
45min133510-3351081.82884.127.5182.6684.937.52
237390-3739091.30392.20
330784-3078475.17275.84
436662-3666289.52590.39
532530-3253079.43580.22
635804-3580487.43088.29
60min132271-3227178.80385.646.9680.0486.886.97
237807-3780792.32193.68
332543-3254379.46780.51
436931-3693190.18291.50
533966-3396682.94284.12
636898-3689890.10291.40
75min130387-3038774.20284.578.4675.8386.248.42
238493-3849393.99695.82
332692-3269279.83181.27
435424-3542486.50288.27
533918-3391882.82584.42
636876-3687690.04891.80
90min135139-3513985.80687.715.2687.8189.805.32
238173-3817393.21595.50
333443-3344381.66583.50
437405-3740591.34093.54
534330-3433083.83185.84
637029-3702990.42292.62
105min133970-3397082.95287.005.3985.3889.535.44
237907-3790792.56695.32
333545-3354581.91484.16
437379-3737991.27693.93
534261-3426183.66286.09
636705-3670589.63092.28
120min134236-3423683.60186.475.8286.4589.445.86
237860-3786092.45195.67
332388-3238879.08981.74
436711-3671189.64592.76
534442-3444284.10486.95
636834-3683489.94593.05
极限130312-3031274.01974.895.8877.2878.295.91
233248-3324881.18984.87
328185-2818568.82571.88
431765-3176577.56781.13
529328-2932871.61674.88
631175-3117576.12779.68
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