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)1.5补液体积(ml)1.5
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1250
标示量(mg)10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%
112.518066280719808198089680693807580.13
212.578063680393805140.22
单位质量响应值RSD%判断
6455.486405.250.56数据可信
供试品溶液-WM1800批-达格列净-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%
5min127310-2731027.31742.8918.6527.3242.8918.65
246315-4631546.32746.33
347037-4703747.05047.05
448373-4837348.38648.39
546825-4682546.83846.84
641397-4139741.40841.41
10min157720-5772057.73675.8012.1357.7875.8612.13
275814-7581475.83475.90
380960-8096080.98281.05
480094-8009480.11680.19
577374-7737477.39577.47
682693-8269382.71582.78
15min172329-7232972.34985.958.0972.4886.128.10
286946-8694686.96987.15
388013-8801388.03788.23
487994-8799488.01888.21
587746-8774687.77087.96
692505-9250592.53092.72
20min180666-8066680.68889.465.1280.9289.775.14
290407-9040790.43190.75
390124-9012490.14890.47
490171-9017190.19590.52
590974-9097490.99991.32
694273-9427394.29894.62
30min187986-8798688.01092.053.0388.3792.503.05
291636-9163691.66192.11
391945-9194591.97092.43
491129-9112991.15491.61
592907-9290792.93293.39
696575-9657596.60197.07
45min192593-9259392.61893.832.1393.1194.412.14
292045-9204592.07092.66
394690-9469094.71695.31
492350-9235092.37592.97
593825-9382593.85094.44
697334-9733497.36097.97
60min194155-9415594.18094.202.6494.8194.922.63
292233-9223392.25892.98
393161-9316193.18693.93
492461-9246192.48693.22
594060-9406094.08594.82
698964-9896498.99199.75
120min195788-9578895.81494.682.3796.5895.542.35
292819-9281992.84493.71
393678-9367893.70394.58
492655-9265592.68093.55
594397-9439794.42295.30
698565-9856598.59299.50
180min197060-9706097.08695.432.4598.0096.432.43
292967-9296792.99293.99
394376-9437694.40195.42
493510-9351093.53594.55
595363-9536395.38996.41
699128-9912899.155100.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min197428-9742897.45495.412.4398.5196.562.40
293202-9320293.22794.37
394158-9415894.18395.34
493477-9347793.50294.66
595107-9510795.13396.29
698941-9894198.968100.17
360min197612-9761297.63895.202.6698.8496.492.63
292485-9248592.51093.79
394036-9403694.06195.36
493166-9316693.19194.48
594926-9492694.95296.25
698834-9883498.861100.21
480min1100723-100723100.75098.122.61102.1099.562.58
295591-9559195.61797.04
396950-9695096.97698.42
495827-9582795.85397.29
597788-9778897.81499.26
6101692-101692101.719103.22
600min1100181-100181100.20897.522.65101.7199.102.62
294649-9464994.67596.24
396372-9637296.39897.99
495507-9550795.53397.11
597180-9718097.20698.80
6101064-101064101.091102.74
720min199628-9962899.65597.172.70101.3198.892.67
294233-9423394.25895.96
395924-9592495.95097.68
495249-9524995.27597.00
596842-9684296.86898.61
6100960-100960100.987102.79
960min199159-9915999.18696.282.83100.9998.162.79
293419-9341993.44495.29
395073-9507395.09996.98
494002-9400294.02795.89
595919-9591995.94597.83
699973-99973100.000101.95
1440min197897-9789797.92395.182.7599.8797.192.72
292262-9226292.28794.27
394058-9405894.08396.10
493013-9301393.03895.04
595005-9500595.03197.06
698689-9868998.716100.82
极限197530-9753097.55694.942.7199.6597.102.67
292168-9216892.19394.32
393784-9378493.80995.97
492918-9291892.94395.09
594566-9456694.59296.76
698534-9853498.561100.81
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)1.5补液体积(ml)1.5
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(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.069397759417629406129405839401759405810.08
210.049373649353129363380.16
单位质量响应值RSD%判断
93497.1293260.760.18数据可信
供试品溶液-WM1800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%
5min128888-288883.0942.889.373.092.889.32
228871-288713.0923.09
326896-268962.8802.88
429019-290193.1083.11
523955-239552.5652.57
623643-236432.5322.53
10min161254-612546.5606.744.916.566.744.92
267249-672497.2027.21
363101-631016.7586.76
465924-659247.0607.06
560608-606086.4916.49
659494-594946.3716.38
15min188774-887749.50710.275.299.5210.285.28
2103450-10345011.07911.09
396933-9693310.38110.40
498930-9893010.59410.61
593949-9394910.06110.07
693369-933699.99910.01
20min1115842-11584212.40613.444.8612.4313.474.88
2133841-13384114.33314.37
3127133-12713313.61513.64
4129071-12907113.82213.85
5123411-12341113.21613.24
6123770-12377013.25513.28
30min1161635-16163517.31018.724.4317.3618.774.42
2184128-18412819.71819.77
3177611-17761119.02019.07
4179653-17965319.23919.29
5172770-17277018.50218.55
6173099-17309918.53718.59
45min1222010-22201023.77525.565.0523.8525.645.04
2244859-24485926.22226.31
3257453-25745327.57127.65
4240680-24068025.77525.86
5233556-23355625.01225.09
6233538-23353825.01025.09
60min1271719-27171929.09930.773.5829.2130.893.58
2293623-29362331.44431.57
3284847-28484730.50430.62
4289496-28949631.00231.12
5282539-28253930.25730.37
6301826-30182632.32332.44
120min1422167-42216745.21046.441.7845.3646.601.79
2445195-44519547.67647.85
3433091-43309146.38046.55
4437705-43770546.87447.04
5429923-42992346.04146.20
6433825-43382546.45946.62
180min1537186-53718657.52858.381.2757.7558.611.27
2555668-55566859.50759.75
3545002-54500258.36558.60
4550194-55019458.92159.16
5539275-53927557.75157.98
6543509-54350958.20558.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1625878-62587867.02667.421.1067.3367.741.11
2640666-64066668.60968.94
3629210-62921067.38367.71
4634074-63407467.90368.23
5621219-62121966.52766.84
6626297-62629767.07167.39
360min1750834-75083480.40780.320.9380.8180.740.93
2759285-75928581.31281.75
3749771-74977180.29480.72
4754935-75493580.84781.27
5739668-73966879.21279.63
6745504-74550479.83780.26
480min1861032-86103292.20991.640.9192.7492.180.92
2865925-86592592.73393.29
3855330-85533091.59892.14
4858513-85851391.93992.49
5846381-84638190.64091.17
6847068-84706890.71391.25
600min1910644-91064497.52296.800.8298.1997.480.82
2912671-91267197.73998.43
3903194-90319496.72497.41
4906142-90614297.03997.73
5894791-89479195.82496.49
6896032-89603295.95796.63
720min1940204-940204100.68799.660.90101.50100.490.89
2938295-938295100.483101.32
3928946-92894699.481100.31
4933848-933848100.006100.84
5919572-91957298.47899.29
6923031-92303198.84899.67
960min1956407-956407102.422101.360.89103.39102.330.89
2954659-954659102.235103.23
3943917-943917101.085102.06
4949043-949043101.634102.61
5935115-935115100.142101.10
6939755-939755100.639101.61
1440min1957641-957641102.554101.410.93103.67102.540.93
2956117-956117102.391103.54
3944012-944012101.095102.22
4948587-948587101.585102.72
5936582-936582100.299101.41
6938802-938802100.537101.66
极限1955726-955726102.349101.250.89103.62102.520.88
2954072-954072102.172103.47
3943430-943430101.033102.31
4946302-946302101.340102.63
5935317-935317100.164101.43
6937661-937661100.415101.68
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)1.5补液体积(ml)1.5
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1250
标示量(mg)10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%
112.518090580992808718113980995809800.13
212.577999479899799460.09
单位质量响应值RSD%判断
6473.226360.061.25数据可信
供试品溶液-WM1800批-达格列净-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%
5min129565-2956529.63840.8321.0629.6440.8321.05
248792-4879248.91348.91
342878-4287842.98442.98
449543-4954349.66549.67
531110-3111031.18731.19
642499-4249942.60442.60
10min152092-5209252.22171.9718.2152.2772.0418.21
271831-7183172.00972.08
383140-8314083.34583.41
483149-8314983.35483.43
560181-6018160.33060.38
680386-8038680.58580.65
15min163028-6302863.18481.6113.7763.3181.7813.78
282895-8289583.10083.28
391986-9198692.21392.40
490728-9072890.95291.15
573402-7340273.58373.72
686423-8642386.63786.82
20min169434-6943469.60685.8310.8069.8286.1210.82
287530-8753087.74688.05
394510-9451094.74495.07
493310-9331093.54193.88
581228-8122881.42981.68
687694-8769487.91188.23
30min176580-7658076.76989.897.9277.0990.307.94
292046-9204692.27392.71
396535-9653596.77497.24
494818-9481895.05295.53
589213-8921389.43389.80
688794-8879489.01389.46
45min181606-8160681.80892.386.4382.2492.946.46
294274-9427494.50795.08
398601-9860198.84599.46
495673-9567395.90996.53
592836-9283693.06593.57
689938-8993890.16090.74
60min183692-8369283.89992.745.5584.4693.435.58
293600-9360093.83194.55
398014-9801498.25699.02
496055-9605596.29297.06
593932-9393294.16494.81
689750-8975089.97290.69
120min186173-8617386.38693.794.8987.0794.634.92
294247-9424794.48095.34
398528-9852898.77199.68
496613-9661396.85297.76
595597-9559795.83396.62
690215-9021590.43891.29
180min187994-8799488.21194.994.6789.0395.974.70
295487-9548795.72396.72
399615-9961599.861100.92
497432-9743297.67398.73
597148-9714897.38898.32
690883-9088391.10892.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min188611-8861188.83094.984.3789.7896.094.40
295330-9533095.56696.71
399498-9949899.744100.95
497247-9724797.48798.69
596819-9681997.05898.13
690950-9095091.17592.30
360min188728-8872888.94794.754.2690.0396.014.29
295104-9510495.33996.63
399044-9904499.289100.65
496904-9690497.14398.49
596762-9676297.00198.22
690557-9055790.78192.04
480min191738-9173891.96597.804.1793.1899.204.20
298079-9807998.32199.75
3102044-102044102.296103.80
4100061-100061100.308101.80
599939-99939100.186101.55
693506-9350693.73795.13
600min191125-9112591.35097.294.2292.7098.844.25
297714-9771497.95599.53
3101448-101448101.699103.36
499457-9945799.703101.34
599580-9958099.826101.34
692978-9297893.20894.74
720min191167-9116791.39296.864.2392.8898.554.26
297105-9710597.34599.07
3101245-101245101.495103.31
498912-9891299.156100.95
599171-9917199.416101.08
692108-9210892.33694.01
960min190371-9037190.59496.044.1892.2297.884.20
296466-9646696.70498.58
3100222-100222100.470102.44
497759-9775998.00199.94
598569-9856998.813100.63
691456-9145691.68293.50
1440min189245-8924589.46694.744.1791.2396.734.19
294978-9497895.21397.23
398734-9873498.978101.09
496742-9674296.98199.07
597237-9723797.47799.44
690132-9013290.35592.31
极限189103-8910389.32394.644.2391.2296.774.25
295012-9501295.24797.41
398891-9889199.135101.40
496251-9625196.48998.72
597216-9721697.45699.57
689988-8998890.21092.30
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)1.5补液体积(ml)1.5
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(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.069441469443509434569432649445589439550.06
210.049280619296959288780.13
单位质量响应值RSD%判断
93832.5092517.731.00数据可信
供试品溶液-WM1800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%
5min128552-285523.0644.0872.413.064.0872.39
294100-9410010.10010.10
326455-264552.8392.84
426333-263332.8262.83
528243-282433.0313.03
624386-243862.6172.62
10min166630-666307.1516.644.747.166.644.72
258478-584786.2766.29
361739-617396.6266.63
462811-628116.7426.75
559089-590896.3426.35
662261-622616.6826.69
15min183963-839639.0129.826.159.039.846.13
290683-906839.7339.76
393725-9372510.06010.07
498035-9803510.52210.54
586126-861269.2449.26
696429-9642910.35010.36
20min1108136-10813611.60612.806.8411.6412.836.81
2118517-11851712.72012.76
3122784-12278413.17813.21
4128445-12844513.78613.82
5111338-11133811.95011.98
6126201-12620113.54513.57
30min1151456-15145616.25618.207.0816.3018.257.09
2182625-18262519.60119.66
3172055-17205518.46718.52
4177396-17739619.04019.09
5158538-15853817.01617.06
6175230-17523018.80718.86
45min1206561-20656122.17024.285.3622.2424.365.36
2228200-22820024.49324.58
3233578-23357825.07025.15
4236606-23660625.39525.47
5216569-21656923.24423.32
6235648-23564825.29225.37
60min1253096-25309627.16529.414.7227.2729.524.72
2274561-27456129.46929.59
3280946-28094630.15430.27
4286943-28694330.79830.92
5264605-26460528.40028.51
6283667-28366730.44630.56
120min1398873-39887342.81145.223.2742.9645.383.28
2421424-42142445.23145.40
3429132-42913246.05946.22
4435824-43582446.77746.94
5411888-41188844.20844.36
6430512-43051246.20746.37
180min1513535-51353555.11857.212.4455.3357.442.44
2532540-53254057.15857.39
3540219-54021957.98258.21
4549019-54901958.92659.16
5522895-52289556.12256.34
6540158-54015857.97558.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1600184-60018464.41866.242.0364.7166.562.04
2615492-61549266.06166.38
3622762-62276266.84167.16
4634287-63428768.07868.40
5606351-60635165.08065.38
6624108-62410866.98667.30
360min1727112-72711278.04179.211.3078.4379.621.31
2737996-73799679.20979.63
3740766-74076679.50779.92
4752774-75277480.79581.22
5727816-72781678.11778.51
6741384-74138479.57379.99
480min1834397-83439789.55690.530.9990.0691.061.00
2845848-84584890.78591.33
3844894-84489490.68391.22
4856783-85678391.95992.50
5834784-83478489.59790.11
6844372-84437290.62791.16
600min1886969-88696995.19995.710.7395.8496.380.74
2895601-89560196.12596.80
3890112-89011295.53696.21
4902692-90269296.88697.57
5884803-88480394.96695.61
6890434-89043495.57096.24
720min1917415-91741598.46698.390.6399.2599.200.64
2921094-92109498.86199.68
3915016-91501698.20999.02
4925151-92515199.297100.13
5909377-90937797.60498.39
6912409-91240997.92998.75
960min1936662-936662100.532100.400.60101.46101.360.61
2943045-943045101.217102.19
3931813-931813100.012100.97
4940642-940642100.959101.94
5931171-93117199.943100.88
6929176-92917699.729100.69
1440min1937551-937551100.627100.380.67101.71101.490.67
2942515-942515101.160102.28
3933120-933120100.152101.26
4941358-941358101.036102.17
5929940-92994099.811100.90
6927128-92712899.509100.62
极限1935648-935648100.423100.130.63101.66101.390.62
2941385-941385101.039102.31
3930721-93072199.894101.16
4935903-935903100.451101.73
5927776-92777699.578100.82
6925915-92591599.379100.64
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-01-06 12:00:13 完成)
生成报告数据部分(等待生成报告)
Current page cost:2.67 s