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%
112.497924679135792567894479452792070.24
212.587918379030791060.14
单位质量响应值RSD%判断
6341.636288.240.60数据可信
供试品溶液-WL0116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%
5min186804-8680488.41588.284.1388.4188.284.13
283252-8325284.79784.80
387285-8728588.90588.90
493085-9308594.81294.81
583418-8341884.96684.97
686215-8621587.81587.81
10min194249-9424995.99897.172.8296.1397.312.83
291928-9192893.63493.76
395206-9520696.97397.11
498392-98392100.218100.36
593864-9386495.60695.73
698783-98783100.616100.75
15min196157-9615797.94199.422.6098.2299.702.60
295100-9510096.86597.13
396283-9628398.07098.35
499728-99728101.579101.87
596713-9671398.50898.78
6101677-101677103.564103.85
20min197012-9701298.812100.731.9499.24101.161.94
299120-99120100.959101.37
396848-9684898.64599.07
4100154-100154102.012102.46
598407-98407100.233100.65
6101849-101849103.739104.18
30min197582-9758299.393101.091.8499.96101.671.84
299279-99279101.121101.69
397296-9729699.10199.68
4100352-100352102.214102.81
598825-98825100.659101.23
6102166-102166104.062104.66
45min1102833-102833104.741102.172.13105.46102.902.13
298569-98569100.398101.11
397498-9749899.307100.03
4100992-100992102.866103.62
599566-99566101.414102.13
6102416-102416104.316105.07
60min198076-9807699.896101.361.99100.77102.251.99
298316-98316100.140101.01
397518-9751899.328100.20
4101017-101017102.891103.80
599524-99524101.371102.24
6102646-102646104.551105.46
120min198121-9812199.942101.741.75100.97102.771.75
298843-98843100.677101.69
398556-98556100.385101.41
4101126-101126103.003104.06
5100000-100000101.856102.88
6102661-102661104.566105.63
180min198216-98216100.039101.731.94101.22102.921.94
298689-98689100.520101.69
398013-9801399.832101.00
4101059-101059102.934104.15
5100347-100347102.209103.39
6102942-102942104.852106.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min198658-98658100.489101.681.87101.82103.021.87
298851-98851100.685102.00
397602-9760299.413100.73
4101081-101081102.957104.33
5100080-100080101.937103.27
6102719-102719104.625106.00
360min1101150-101150103.027104.131.90104.51105.621.90
2101057-101057102.932104.40
399898-99898101.752103.22
4103389-103389105.307106.83
5102630-102630104.534106.02
6105274-105274107.227108.76
480min1100138-100138101.996103.501.98103.63105.151.98
2100528-100528102.393104.02
399183-99183101.023102.65
4102953-102953104.863106.54
5102324-102324104.223105.86
6104547-104547106.487108.18
600min199487-99487101.333102.852.01103.12104.662.01
299987-99987101.842103.62
398620-98620100.450102.22
4102396-102396104.296106.13
5101314-101314103.194104.99
6104080-104080106.011107.87
720min199152-99152100.992102.292.34102.93104.252.33
299172-99172101.012102.94
397634-9763499.446101.37
4101382-101382103.263105.26
5100887-100887102.759104.71
6104348-104348106.284108.30
960min197888-9788899.704101.102.15101.79103.212.14
298086-9808699.906101.99
396749-9674998.544100.62
4100509-100509102.374104.52
599670-99670101.519103.62
6102627-102627104.531106.70
1440min196634-9663498.427100.573.86100.67102.843.81
296561-9656198.353100.58
395552-9555297.32599.55
498799-98799100.632102.94
598879-98879100.714102.97
6106020-106020107.987110.32
极限196006-9600697.78799.442.13100.17101.852.13
296387-9638798.176100.55
395453-9545397.22499.59
498815-98815100.649103.10
598172-9817299.994102.40
6100940-100940102.813105.30
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%
19.835225215244665247375255995253055245260.24
29.825229955229545229740.01
单位质量响应值RSD%判断
53359.7253256.010.14数据可信
供试品溶液-WL0116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%
5min124465-244654.5894.256.914.594.256.94
224018-240184.5064.51
323461-234614.4014.40
421639-216394.0594.06
520424-204243.8313.83
621984-219844.1244.12
10min149983-499839.3768.935.529.388.935.49
246713-467138.7638.77
350842-508429.5379.54
447889-478898.9838.99
543552-435528.1708.18
646578-465788.7388.74
15min169329-6932913.00512.565.0013.0312.585.00
264873-6487312.17012.19
370536-7053613.23213.25
468573-6857312.86412.88
561427-6142711.52311.54
666858-6685812.54212.56
20min185534-8553416.04516.113.6816.0916.143.66
291402-9140217.14617.18
387110-8711016.34116.38
485204-8520415.98316.02
582866-8286615.54515.58
683046-8304615.57915.62
30min1112136-11213621.03620.354.5221.1020.414.50
2105314-10531419.75619.82
3112898-11289821.17921.24
4111353-11135320.88920.95
5100201-10020118.79718.86
6108850-10885020.41920.48
45min1147713-14771327.70926.284.9827.8126.374.98
2134222-13422225.17925.27
3145196-14519627.23727.33
4143569-14356926.93227.03
5129487-12948724.29024.38
6140232-14023226.30626.40
60min1170820-17082032.04430.874.5032.1831.004.50
2158121-15812129.66229.79
3169756-16975631.84431.98
4169529-16952931.80231.94
5152802-15280228.66428.79
6166249-16624931.18731.32
120min1245227-24522746.00244.824.2246.1944.994.21
2228551-22855142.87443.05
3247157-24715746.36446.55
4245383-24538346.03146.21
5223772-22377241.97742.14
6243331-24333145.64645.82
180min1298225-29822555.94454.793.6856.2055.043.68
2280231-28023152.56852.81
3300702-30070256.40956.66
4298324-29832455.96356.21
5276480-27648051.86552.09
6298480-29848055.99256.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1339768-33976863.73762.623.0964.0862.953.09
2322663-32266360.52860.85
3340684-34068463.90964.25
4340516-34051663.87764.21
5318568-31856859.76060.07
6340634-34063463.89964.23
360min1407113-40711376.37075.712.2176.8076.132.22
2394034-39403473.91774.33
3407873-40787376.51376.95
4410981-41098177.09677.53
5390602-39060273.27373.67
6410799-41079977.06277.49
480min1446899-44689983.83483.521.5884.3884.061.59
2438988-43898882.35082.87
3448499-44849984.13484.68
4451779-45177984.74985.30
5434413-43441381.49182.00
6450895-45089584.58385.13
600min1474021-47402188.92188.691.2189.6089.351.22
2468326-46832687.85388.50
3474436-47443688.99989.68
4477945-47794589.65890.33
5463754-46375486.99687.62
6478157-47815789.69790.37
720min1490468-49046892.00791.831.0092.8192.621.01
2485178-48517891.01491.79
3488123-48812391.56792.38
4492780-49278092.44093.25
5483681-48368190.73491.49
6496770-49677093.18993.99
960min1504177-50417794.57894.440.9095.5295.370.90
2501564-50156494.08895.00
3500522-50052293.89394.84
4505370-50537094.80295.75
5498126-49812693.44394.34
6510913-51091395.84296.79
1440min1508672-50867295.42295.721.0296.5196.791.02
2508896-50889695.46496.52
3507060-50706095.11996.21
4509350-50935095.54996.64
5506857-50685795.08196.12
6520622-52062297.66398.75
极限1506909-50690995.09195.570.8096.3296.790.80
2509851-50985195.64396.84
3508001-50800195.29696.53
4508414-50841495.37396.61
5506360-50636094.98896.17
6517344-51734497.04898.28
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%
112.498043980601807698059580670806150.15
212.588061280721806660.10
单位质量响应值RSD%判断
6454.366412.240.47数据可信
供试品溶液-WL0116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%
5min191207-9120791.19085.605.2991.1985.605.29
285606-8560685.59085.59
389589-8958989.57289.57
478499-7849978.48478.48
585259-8525985.24385.24
683530-8353083.51483.51
10min197610-9761097.59195.391.8197.7395.511.81
296122-9612296.10496.23
395875-9587595.85795.99
492377-9237792.35992.48
595170-9517095.15295.28
695266-9526695.24895.37
15min198800-9880098.78197.331.9999.0697.601.99
298708-9870898.68998.96
398142-9814298.12398.40
493622-9362293.60493.86
597095-9709597.07697.35
697720-9772097.70197.97
20min198828-9882898.80998.061.6999.2498.481.69
299188-9918899.16999.59
398626-9862698.60799.03
494792-9479294.77495.17
598105-9810598.08698.50
698944-9894498.92599.34
30min199323-9932399.30498.841.1399.8899.411.13
299857-9985799.838100.41
399175-9917599.15699.73
496727-9672796.70897.25
598716-9871698.69799.26
699364-9936499.34599.91
45min199295-9929599.27699.421.50100.00100.131.49
2100061-100061100.042100.76
399565-9956599.546100.27
496904-9690496.88597.57
5101468-101468101.449102.16
699328-9932899.309100.02
60min198999-9899998.98099.161.1299.86100.021.13
2100288-100288100.269101.14
399750-9975099.731100.60
497263-9726397.24498.07
598738-9873898.71999.58
6100009-10000999.990100.85
120min199684-9968499.66599.240.99100.69100.251.00
2100275-100275100.256101.28
399830-9983099.811100.83
497518-9751897.49998.47
598820-9882098.80199.81
699448-9944899.429100.44
180min199478-9947899.45999.872.29100.63101.022.27
2104275-104275104.255105.42
399567-9956799.548100.72
497577-9757797.55898.68
598893-9889398.874100.03
699528-9952899.509100.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min199276-9927699.25799.370.99100.58100.680.99
2100262-100262100.243101.57
399920-9992099.901101.22
497508-9750897.48998.76
599685-9968599.666100.97
699694-9969499.675100.98
360min1101801-101801101.781101.590.90103.25103.050.91
2102668-102668102.648104.12
3102040-102040102.020103.49
4100080-100080100.061101.47
5101065-101065101.046102.50
6102023-102023102.003103.46
480min1101278-101278101.259100.870.98102.88102.480.98
2102050-102050102.030103.66
3101279-101279101.260102.88
499161-9916199.142100.71
5100507-100507100.488102.10
6101044-101044101.025102.64
600min1100705-100705100.686100.651.82102.46102.411.81
2104052-104052104.032105.82
3100408-100408100.389102.16
498600-9860098.581100.29
599800-9980099.781101.54
6100436-100436100.417102.18
720min1100203-100203100.18499.631.01102.11101.541.02
2100780-100780100.761102.70
399667-9966799.648101.57
497911-9791197.89299.75
599183-9918399.164101.07
6100135-100135100.116102.03
960min199276-9927699.25798.651.03101.34100.711.04
299701-9970199.682101.77
399043-9904399.024101.10
496849-9684996.83098.84
598227-9822798.208100.27
698918-9891898.899100.96
1440min199420-9942099.40198.511.20101.63100.721.20
299424-9942499.405101.65
398544-9854498.525100.75
496325-9632596.30798.46
598266-9826698.247100.45
699172-9917299.153101.37
极限199238-9923899.21998.441.04101.60100.801.05
299201-9920199.182101.57
398470-9847098.451100.82
496622-9662296.60398.90
598042-9804298.023100.38
699154-9915499.135101.50
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%
19.835336485345555334235328695341675337320.13
29.825321395320035320710.02
单位质量响应值RSD%判断
54296.2454182.380.15数据可信
供试品溶液-WL0116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%
5min121273-212733.9223.966.443.923.966.47
220055-200553.6983.70
324067-240674.4374.44
421237-212373.9153.92
521624-216243.9873.99
620634-206343.8043.80
10min146832-468328.6349.028.178.649.028.17
245507-455078.3908.40
350101-501019.2379.24
456356-5635610.39010.40
548201-482018.8878.89
646383-463838.5528.56
15min165740-6574012.12012.264.0412.1412.284.03
265193-6519312.02012.04
369966-6996612.90012.92
462496-6249611.52211.54
568849-6884912.69412.71
666768-6676812.31012.33
20min180512-8051214.84415.164.2314.8815.194.23
280753-8075314.88814.92
386885-8688516.01916.06
477318-7731814.25514.29
585295-8529515.72615.76
682522-8252215.21415.25
30min1105292-10529219.41320.023.3819.4720.083.40
2106876-10687619.70519.76
3114238-11423821.06221.13
4105196-10519619.39519.45
5111735-11173520.60020.66
6108154-10815419.94020.00
45min1135052-13505224.89926.026.0824.9926.116.07
2137969-13796925.43725.53
3147455-14745527.18627.28
4132237-13223724.38024.47
5155168-15516828.60828.70
6138935-13893525.61525.70
60min1159679-15967929.44030.363.7529.5730.493.75
2164108-16410830.25630.38
3174575-17457532.18632.32
4157022-15702228.95029.08
5167601-16760130.90031.04
6165088-16508830.43730.57
120min1235345-23534543.39044.293.3443.5644.463.34
2239738-23973844.20044.37
3254529-25452946.92747.11
4230918-23091842.57442.74
5241889-24188944.59744.78
6238834-23883444.03344.21
180min1288413-28841353.17454.683.5253.4154.923.51
2310232-31023257.19757.43
3308599-30859956.89657.15
4285479-28547952.63352.87
5294082-29408254.21954.47
6292659-29265953.95754.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1330726-33072660.97562.072.3861.2962.402.38
2336291-33629162.00162.33
3351352-35135264.77865.12
4328930-32893060.64460.96
5338375-33837562.38662.72
6334399-33439961.65361.97
360min1401290-40129073.98574.891.9674.3975.311.97
2404798-40479874.63275.05
3421982-42198277.80078.24
4400987-40098773.92974.33
5405568-40556874.77475.20
6402651-40265174.23674.65
480min1442342-44234281.55482.591.7882.0783.121.78
2445786-44578682.18982.72
3463837-46383785.51786.07
4445572-44557282.14982.66
5446609-44660982.34182.88
6443529-44352981.77382.30
600min1469188-46918886.50387.621.4787.1488.271.48
2472791-47279187.16887.82
3489001-48900190.15690.84
4473875-47387587.36888.00
5473751-47375187.34588.00
6472713-47271387.15387.80
720min1487370-48737089.85690.821.2390.6291.611.24
2489031-48903190.16290.94
3504333-50433392.98393.80
4492803-49280390.85791.63
5490404-49040490.41591.21
6491790-49179090.67191.45
960min1503000-50300092.73793.581.1493.6494.501.15
2504569-50456993.02793.94
3518704-51870495.63396.59
4508499-50849993.75194.66
5504530-50453093.01993.95
6506233-50623393.33394.25
1440min1515889-51588995.11495.720.8896.1696.790.89
2515276-51527695.00196.06
3527372-52737297.23198.33
4521567-52156796.16097.21
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