恩格列净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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
19.844552874557824556324557934558244556640.05
29.894571574572664572120.02
单位质量响应值RSD%判断
46307.3246229.730.12数据可信
供试品溶液-3215076批-恩格列净-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%
5min1-0.0002.22114.510.002.22114.50
218267-182673.5533.55
3-0.0000.00
4-0.0000.00
529633-296335.7645.76
620546-205463.9974.00
10min1196242-19624238.17233.6411.4438.1733.6511.43
2177247-17724734.47834.48
3186208-18620836.22136.22
4176476-17647634.32834.33
5161365-16136531.38831.40
6140194-14019427.27027.28
15min1347303-34730367.55664.105.1067.6264.165.10
2327784-32778463.76063.82
3326595-32659563.52863.59
4349687-34968768.02068.08
5320856-32085662.41262.47
6305013-30501359.33059.38
20min1415418-41541880.80679.191.7380.9879.361.73
2404693-40469378.72078.89
3400792-40079277.96178.13
4415387-41538780.80080.97
5399090-39909077.63077.80
6407422-40742279.25079.40
30min1484221-48422194.18989.732.8894.5090.022.88
2454738-45473888.45488.76
3451808-45180887.88488.18
4469003-46900391.22991.53
5448802-44880287.30087.59
6459104-45910489.30389.59
45min1482277-48227793.81191.382.2494.2891.832.24
2467374-46737490.91291.36
3462260-46226089.91790.36
4481670-48167093.69394.15
5455882-45588288.67789.12
6469140-46914091.25691.69
60min1483745-48374594.09791.522.3094.7292.122.30
2467784-46778490.99291.59
3462888-46288890.04090.63
4482700-48270093.89394.51
5456612-45661288.81989.41
6469268-46926891.28191.86
120min1486801-48680194.69191.682.4195.4792.432.40
2469123-46912391.25292.00
3465165-46516590.48291.23
4482753-48275393.90494.67
5456776-45677688.85189.59
6467309-46730990.89991.64
240min1485672-48567294.47191.902.1395.4192.802.13
2471822-47182291.77792.68
3466393-46639390.72191.61
4482903-48290393.93394.86
5459685-45968589.41690.30
6468159-46815991.06591.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1490212-49021295.35492.252.4096.4593.302.40
2470349-47034991.49192.55
3471859-47185991.78592.83
4485777-48577794.49295.57
5461368-46136889.74490.78
6465842-46584290.61491.65
480min1487937-48793794.91291.942.2696.1793.152.26
2466209-46620990.68591.89
3470980-47098091.61492.81
4481945-48194593.74694.99
5458569-45856989.19990.38
6470362-47036291.49392.68
600min1485385-48538594.41691.632.2595.8392.992.25
2466732-46673290.78792.15
3472673-47267391.94393.29
4480790-48079093.52294.92
5458314-45831489.15090.48
6462435-46243589.95191.29
720min1497553-49755396.78293.602.3598.3595.122.35
2476733-47673392.73394.24
3482041-48204193.76595.27
4490324-49032495.37696.93
5466352-46635290.71392.19
6474309-47430992.26193.75
840min1495568-49556896.39692.922.5798.1394.602.57
2472169-47216991.84593.51
3479088-47908893.19194.85
4487658-48765894.85896.57
5462515-46251589.96791.60
6469230-46923091.27392.92
960min1491689-49168995.64292.292.4497.5394.122.43
2468615-46861591.15492.97
3476774-47677492.74194.56
4482447-48244793.84495.71
5459780-45978089.43591.22
6467297-46729790.89792.70
极限1489629-48962995.24191.852.5297.2993.832.51
2466778-46677890.79692.77
3473761-47376192.15494.12
4481707-48170793.70095.73
5458329-45832989.15391.08
6462944-46294490.05092.00
恩格列净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%
19.919415779447529473089496149508349468170.40
29.969530059528579529310.02
单位质量响应值RSD%判断
95541.5795675.800.10数据可信
供试品溶液-3215076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%
5min1-0.0000.39137.560.000.39137.29
24198-41980.3950.40
3-0.0000.00
4-0.0000.00
514495-144951.3641.36
66200-62000.5840.58
10min19753-97530.9181.1247.440.921.1247.42
216174-161741.5231.52
319424-194241.8281.83
414340-143401.3501.35
56277-62770.5910.59
65409-54090.5090.51
15min134948-349483.2904.4949.893.294.4949.93
242490-424904.0004.00
328489-284892.6822.68
493851-938518.8358.84
549852-498524.6934.70
636238-362383.4113.41
20min169200-692006.5148.0732.276.528.0832.23
273132-731326.8846.89
374764-747647.0387.05
474370-743707.0017.02
581189-811897.6437.65
6141617-14161713.33113.34
30min1185196-18519617.43314.6510.5317.4514.6710.49
2147048-14704813.84213.86
3142786-14278613.44113.46
4144791-14479113.63013.66
5164198-16419815.45715.48
6149550-14955014.07814.11
45min1218451-21845120.56420.922.0020.6120.962.01
2222047-22204720.90220.95
3217003-21700320.42720.47
4222177-22217720.91420.97
5229543-22954321.60821.66
6223909-22390921.07721.13
60min1276725-27672526.04926.351.8126.1326.441.81
2278930-27893026.25726.34
3273659-27365925.76125.84
4278767-27876726.24126.33
5287630-28763027.07627.16
6283966-28396626.73126.82
120min1430086-43008640.48640.911.3140.6141.041.33
2435429-43542940.98941.11
3427005-42700540.19640.31
4433357-43335740.79440.92
5441908-44190841.59841.73
6439940-43994041.41341.55
240min1632227-63222759.51460.682.1659.7160.882.16
2665598-66559862.65562.85
3630755-63075559.37559.56
4636708-63670859.93660.13
5655221-65522161.67861.88
6647209-64720960.92461.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1780866-78086673.50674.000.6773.8074.300.67
2787290-78729074.11174.41
3781896-78189673.60373.89
4784109-78410973.81174.11
5795253-79525374.86075.16
6787357-78735774.11774.42
480min1877593-87759382.61183.541.2683.0283.961.27
2884273-88427383.24083.66
3881421-88142182.97183.38
4881936-88193683.02083.44
5891509-89150983.92184.35
6908284-90828485.50085.93
600min1944262-94426288.88789.650.5789.4490.210.57
2954174-95417489.82090.38
3951711-95171189.58890.13
4948969-94896989.33089.89
5959559-95955990.32790.89
6955628-95562889.95790.53
720min11005560-100556094.65795.270.5795.3695.980.57
21013253-101325395.38196.09
31011093-101109395.17895.87
41005690-100569094.66995.38
51017847-101784795.81496.53
61018830-101883095.90696.63
840min11022857-102285796.28596.720.4397.1497.580.43
21026338-102633896.61397.48
31025763-102576396.55997.41
41024078-102407896.40097.27
51033283-103328397.26798.14
61032305-103230597.17598.05
960min11027877-102787796.75897.040.4797.7898.070.47
21029214-102921496.88497.91
31029751-102975196.93497.95
41025450-102545096.52997.56
51038556-103855697.76398.80
61034723-103472397.40298.44
极限11024170-102417096.40996.790.4897.5997.980.48
21027342-102734296.70897.90
31027223-102722396.69697.87
41024291-102429196.42097.61
51037360-103736097.65198.85
61029184-102918496.88198.08
恩格列净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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
19.844551554553654550634553394552554552350.03
29.894600934598634599780.04
单位质量响应值RSD%判断
46263.7246509.400.38数据可信
供试品溶液-3215076批-恩格列净-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%
5min1-0.0001.30165.710.001.30165.73
2-0.0000.00
326243-262435.0925.09
4-0.0000.00
5-0.0000.00
613823-138232.6822.68
10min1234147-23414745.43037.6116.1145.4337.6116.11
2168309-16830932.65632.66
3210741-21074140.88940.90
4204096-20409639.59939.60
5198516-19851638.51738.52
6147094-14709428.54028.54
15min1366429-36642971.09668.057.9471.1768.117.95
2318211-31821161.74061.79
3359786-35978669.80769.88
4383129-38312974.33674.40
5362227-36222770.28070.34
6314614-31461461.04261.09
20min1433356-43335684.08183.264.4884.2883.444.49
2404152-40415278.41578.57
3442361-44236185.82886.02
4443049-44304985.96286.15
5446078-44607886.54986.73
6405708-40570878.71778.87
30min1476532-47653292.45893.052.9592.7993.372.95
2465274-46527490.27490.56
3466973-46697390.60490.94
4493025-49302595.65895.99
5500216-50021697.05397.38
6475541-47554192.26692.55
45min1499884-49988496.98995.582.8497.4896.052.84
2477298-47729892.60793.05
3475317-47531792.22292.71
4503412-50341297.67498.17
5509046-50904698.76799.25
6490634-49063495.19495.63
60min1484356-48435693.97695.292.9394.6395.922.92
2477438-47743892.63493.23
3476395-47639592.43293.07
4505246-50524698.02998.68
5510615-51061599.07199.72
6492646-49264695.58596.18
120min1481762-48176293.47395.392.8094.2896.182.78
2479777-47977793.08893.84
3477484-47748492.64393.44
4502673-50267397.53098.35
5510106-51010698.97299.79
6497920-49792096.60897.36
240min1480330-48033093.19595.872.6294.1696.822.61
2482040-48204093.52794.43
3486995-48699594.48895.44
4504864-50486497.95598.94
5511751-51175199.292100.27
6498782-49878296.77597.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1483033-48303393.72096.582.1594.8497.692.14
2488360-48836094.75395.81
3497228-49722896.47497.58
4505674-50567498.11299.26
5511617-51161799.266100.41
6500728-50072897.15398.23
480min1479949-47994993.12196.062.2794.4097.342.27
2486962-48696294.48295.70
3494501-49450195.94597.21
4502331-50233197.46498.77
5511909-51190999.322100.64
6495046-49504696.05097.29
600min1476953-47695392.54095.692.2193.9797.122.21
2484873-48487394.07795.45
3494789-49478996.00097.43
4500359-50035997.08198.55
5507509-50750998.46899.95
6494637-49463795.97197.37
720min1489180-48918094.91297.762.2196.5099.352.21
2494278-49427895.90197.43
3503758-50375897.74199.33
4510596-51059699.067100.70
5520134-520134100.918102.56
6505209-50520998.02299.58
840min1482563-48256393.62897.062.4995.3798.812.48
2491595-49159595.38197.07
3499437-49943796.90298.65
4509043-50904398.766100.56
5517735-517735100.453102.26
6501188-50118897.24298.97
960min1480308-48030893.19196.332.4695.0998.242.45
2487522-48752294.59196.44
3496028-49602896.24198.15
4504314-50431497.84999.81
5514855-51485599.894101.87
6495761-49576196.18998.08
极限1479855-47985593.10395.942.3595.1698.022.35
2485500-48550094.19896.21
3493977-49397795.84397.92
4503625-50362597.71599.84
5511555-51155599.253101.40
6492399-49239995.53797.58
恩格列净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%
19.919492339490999494829497929497229494660.04
29.969569759568369569060.02
单位质量响应值RSD%判断
95808.8896074.900.20数据可信
供试品溶液-3215076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%
5min1-0.0000.08155.380.000.08155.14
2-0.0000.00
32608-26080.2450.24
4-0.0000.00
5-0.0000.00
62301-23010.2160.22
10min18619-86190.8090.7366.970.810.7466.84
213947-139471.3081.31
313614-136141.2771.28
46140-61400.5760.58
53478-34780.3260.33
61179-11790.1110.11
15min139051-390513.6632.7829.163.662.7829.13
222485-224852.1092.11
341304-413043.8753.88
424172-241722.2682.27
529087-290872.7292.73
621487-214872.0162.02
20min181521-815217.6476.6317.567.656.6317.59
260536-605365.6795.68
389630-896308.4088.42
461168-611685.7385.74
570376-703766.6026.61
660702-607025.6945.70
30min1154058-15405814.45213.485.6914.4713.505.71
2138046-13804612.95012.96
3151202-15120214.18414.21
4135417-13541712.70312.72
5147323-14732313.82013.84
6136180-13618012.77512.79
45min1237406-23740622.27020.923.4822.3120.963.49
2219776-21977620.61720.65
3222556-22255620.87720.92
4216392-21639220.29920.33
5224831-22483121.09121.13
6217098-21709820.36520.40
60min1286946-28694626.91826.191.9327.0026.271.94
2275158-27515825.81225.88
3278129-27812926.09026.17
4277563-27756326.03726.11
5284383-28438326.67726.75
6273094-27309425.61825.69
120min1439842-43984241.26040.841.1641.3940.961.16
2432440-43244040.56640.68
3431122-43112240.44240.57
4432525-43252540.57440.69
5443515-44351541.60541.72
6432888-43288840.60840.72
240min1646011-64601160.60060.500.7760.8060.690.78
2639306-63930659.97160.15
3644838-64483860.49060.68
4640967-64096760.12760.31
5653568-65356861.30961.50
6645256-64525660.53060.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1794563-79456374.53674.530.6874.8374.820.68
2787702-78770273.89274.17
3798419-79841974.89775.19
4788422-78842273.95974.24
5799985-79998575.04475.33
6798207-79820774.87775.16
480min1897125-89712584.15784.050.7784.5884.460.78
2885008-88500883.02083.42
3900693-90069384.49184.91
4891133-89113383.59484.00
5904034-90403484.80585.22
6897912-89791284.23084.64
600min1960993-96099390.14890.170.6890.7190.720.69
2950579-95057989.17189.71
3969519-96951990.94891.51
4958475-95847589.91290.45
5965816-96581690.60091.16
6961736-96173690.21890.76
720min11021723-102172395.84595.870.6296.5696.570.62
21011631-101163194.89895.59
31025160-102516096.16796.88
41021563-102156395.83096.52
51030815-103081596.69897.41
61021023-102102395.77996.47
840min11029887-102988796.61197.280.7397.4898.140.73
21029911-102991196.61397.46
31040212-104021297.57998.45
41037235-103723597.30098.15
51049857-104985798.48499.35
61034857-103485797.07797.93
960min11038007-103800797.37297.720.7598.4098.750.75
21034280-103428097.02398.03
31044364-104436497.96999.00
41041646-104164697.71498.73
51055726-105572699.034100.07
61036563-103656397.23798.25
极限11038046-103804697.37697.670.6498.5798.850.64
21033264-103326496.92798.10
31042977-104297797.83999.04
41043299-104329997.86999.05
51052233-105223398.70799.90
61036953-103695397.27398.45
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