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%
110.474254238425254542566524273042427046242613880.23
210.354306630431000143083160.06
单位质量响应值RSD%判断
407009.36416262.421.59数据可信
供试品溶液-2025081621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%
5min1181414-1814144.4084.237.074.414.237.09
2161541-1615413.9253.92
3176974-1769744.3004.30
4193092-1930924.6914.69
5170208-1702084.1354.14
6161437-1614373.9223.92
10min1352340-3523408.5618.414.878.588.434.87
2328593-3285937.9848.00
3364592-3645928.8588.88
4330592-3305928.0328.06
5365381-3653818.8778.90
6335068-3350688.1418.16
15min1487545-48754511.84611.751.6311.9111.811.65
2484362-48436211.76811.83
3492753-49275311.97212.04
4486990-48699011.83211.90
5479809-47980911.65811.72
6470024-47002411.42011.48
20min1610037-61003714.82214.511.9614.9514.641.97
2587495-58749514.27414.39
3611166-61116614.84914.97
4590371-59037114.34414.47
5600667-60066714.59414.72
6584188-58418814.19414.31
30min1799018-79901819.41319.450.8819.6119.640.88
2794755-79475519.31019.50
3813742-81374219.77119.97
4797384-79738419.37419.57
5802004-80200419.48619.68
6795960-79596019.33919.53
45min11061651-106165125.79425.341.5626.0925.641.56
21034463-103446325.13425.42
31057677-105767725.69826.00
41033842-103384225.11925.41
51051117-105111725.53825.83
61020130-102013024.78525.07
60min11247613-124761330.31230.601.8330.7431.021.81
21262953-126295330.68531.10
31292618-129261831.40631.83
41270873-127087330.87831.29
51257790-125779030.56030.98
61224004-122400429.73930.15
120min11899461-189946146.15046.001.6646.7346.571.65
21882772-188277245.74546.31
31947056-194705647.30647.89
41901325-190132546.19546.77
51857617-185761745.13345.71
61870578-187057845.44846.01
180min12430183-243018359.04558.711.2459.8559.511.23
22416963-241696358.72359.52
32435297-243529759.16959.99
42366300-236630057.49358.29
52449176-244917659.50660.31
62399314-239931458.29559.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12818742-281874268.48567.690.8369.5968.790.83
22760671-276067167.07468.16
32791354-279135467.82068.94
42805536-280553668.16469.25
52773867-277386767.39568.49
62767075-276707567.23068.31
360min13342692-334269281.21581.740.4782.6683.170.45
23366412-336641281.79283.21
33360202-336020281.64183.10
43354146-335414681.49482.92
53372985-337298581.95183.39
63388037-338803782.31783.73
480min13780851-378085191.86190.680.7193.7192.520.70
23707956-370795690.09091.92
33731886-373188690.67192.54
43736144-373614490.77592.61
53726849-372684990.54992.39
63710698-371069890.15791.98
600min13909346-390934694.98395.250.2797.2997.550.26
23910719-391071995.01697.30
33915084-391508495.12297.44
43932928-393292895.55697.85
53931809-393180995.52997.83
63923181-392318195.31997.59
720min13974673-397467396.57097.820.7299.35100.590.70
24031974-403197497.962100.72
34039384-403938498.142100.94
44059418-405941898.629101.40
54033721-403372198.005100.78
64016776-401677697.593100.34
极限13974105-397410596.55697.740.8999.82101.000.87
24061533-406153398.681101.93
34027854-402785497.862101.15
44059658-405965898.635101.90
54024686-402468697.785101.05
63989699-398969996.935100.17
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%
112.002993529791300982972129870298830.49
212.023007729977300270.24
单位质量响应值RSD%判断
2490.252498.090.23数据可信
供试品溶液-2025081621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%
5min139456-39456101.75099.761.67101.7599.761.67
238358-3835898.91898.92
339176-39176101.028101.03
438285-3828598.73098.73
537774-3777497.41297.41
639064-39064100.739100.74
10min140069-40069103.331101.301.11103.84101.801.11
238869-38869100.236100.73
339322-39322101.404101.91
438946-38946100.435100.93
539099-39099100.829101.32
639386-39386101.569102.07
15min140001-40001103.155102.321.29104.18103.321.29
239084-39084100.791101.79
340472-40472104.370105.38
439385-39385101.567102.56
539782-39782102.591103.58
639329-39329101.422102.43
20min139641-39641102.227101.990.60103.77103.510.60
239451-39451101.737103.24
339628-39628102.194103.73
439369-39369101.526103.03
539936-39936102.988104.49
639277-39277101.288102.81
30min139619-39619102.170102.690.61104.22104.720.59
239838-39838102.735104.74
339530-39530101.941103.99
439743-39743102.490104.50
540043-40043103.264105.28
640152-40152103.545105.57
45min140254-40254103.808102.361.03106.37104.901.01
239663-39663102.284104.81
339534-39534101.951104.51
439206-39206101.105103.63
540101-40101103.413105.95
639404-39404101.616104.16
60min139425-39425101.670102.190.66104.75105.240.63
239645-39645102.237105.27
339576-39576102.059105.12
439934-39934102.983106.01
539906-39906102.910105.96
639278-39278101.291104.34
120min139737-39737102.475101.551.11106.07105.121.08
239343-39343101.459105.00
340061-40061103.310106.88
439169-39169101.010104.55
538974-38974100.507104.07
638995-38995100.561104.12
180min139961-39961103.052102.811.82107.16106.881.75
239723-39723102.439106.49
339718-39718102.426106.52
438684-3868499.759103.81
540874-40874105.407109.48
640241-40241103.774107.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min140187-40187103.635102.250.76108.25106.840.74
239444-39444101.719106.28
339396-39396101.595106.20
439461-39461101.763106.31
539776-39776102.575107.17
639644-39644102.235106.81
360min139767-39767102.552102.590.88107.69107.680.84
239675-39675102.315107.39
339335-39335101.438106.55
439559-39559102.016107.07
540039-40039103.253108.36
640311-40311103.955109.05
480min140618-40618104.747102.191.40110.40107.801.35
239345-39345101.464107.05
339408-39408101.626107.24
439029-39029100.649106.22
539846-39846102.756108.38
639512-39512101.894107.50
600min139395-39395101.593100.941.00107.77107.060.97
239004-39004100.584106.68
339006-39006100.590106.72
438492-3849299.264105.33
539524-39524101.925108.06
639436-39436101.698107.82
720min139327-39327101.417100.730.56108.10107.360.55
239054-39054100.713107.31
338775-3877599.994106.62
438920-38920100.368106.93
539296-39296101.337107.99
638996-38996100.564107.19
极限138705-3870599.813100.140.77107.00107.260.72
239218-39218101.136108.23
338779-38779100.004107.13
438483-3848399.241106.31
539162-39162100.992108.15
638634-3863499.630106.76
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%
110.474329855433024343271504321851431453343247260.16
210.354356687433301643448520.39
单位质量响应值RSD%判断
413058.83419792.461.15数据可信
供试品溶液-2025081621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%
5min1181722-1817224.3644.186.944.364.186.88
2161449-1614493.8773.88
3176296-1762964.2344.23
4192119-1921194.6144.61
5170826-1708264.1024.10
6161130-1611303.8703.87
10min1352246-3522468.4598.304.818.488.324.82
2328328-3283287.8857.90
3364136-3641368.7458.77
4329859-3298597.9227.94
5363602-3636028.7328.75
6334615-3346158.0368.06
15min1491285-49128511.79811.621.9311.8611.681.95
2484753-48475311.64211.70
3492316-49231611.82311.89
4488260-48826011.72611.79
5478375-47837511.48811.55
6467803-46780311.23511.29
20min1609499-60949914.63714.341.8214.7614.461.82
2584843-58484314.04514.16
3607942-60794214.60014.72
4597871-59787114.35814.48
5598130-59813014.36414.49
6584345-58434514.03314.15
30min1796294-79629419.12319.200.9019.3219.390.92
2796253-79625319.12219.31
3813570-81357019.53819.74
4795204-79520419.09719.29
5800309-80030919.22019.41
6795269-79526919.09919.28
45min11062525-106252525.51725.051.6625.8125.341.67
21039815-103981524.97225.25
31058809-105880925.42825.72
41034480-103448024.84425.13
51047114-104711425.14725.44
61015287-101528724.38324.66
60min11246993-124699329.94730.191.8730.3730.611.86
21270601-127060130.51430.92
31287094-128709430.91031.33
41268564-126856430.46530.88
51250914-125091430.04130.46
61219671-121967129.29129.69
120min11902825-190282545.69745.591.4146.2746.161.42
21894072-189407245.48746.05
31936635-193663546.50947.09
41917591-191759146.05246.62
51874951-187495145.02845.59
61864391-186439144.77445.32
180min12432384-243238458.41557.961.2659.2158.751.25
22416296-241629658.02858.82
32434855-243485558.47459.28
42363193-236319356.75357.55
52441399-244139958.63159.42
62391958-239195857.44458.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12815641-281564167.61966.980.7968.7168.060.79
22783636-278363666.85067.93
32810409-281040967.49368.59
42792454-279245467.06268.14
52770761-277076166.54167.62
62760132-276013266.28667.35
360min13368720-336872080.90180.960.6882.3382.380.66
23391034-339103481.43782.85
33365530-336553080.82582.26
43360221-336022180.69782.11
53338674-333867480.18081.60
63402661-340266181.71683.11
480min13799328-379932891.24389.610.9893.0791.440.97
23736052-373605289.72391.54
33729593-372959389.56891.41
43720632-372063289.35391.17
53708679-370867989.06690.88
63694959-369495988.73690.54
600min13915037-391503794.02194.460.6696.3196.730.64
23955693-395569394.99897.27
33926434-392643494.29596.59
43917928-391792894.09196.36
53973870-397387095.43497.70
63910673-391067393.91796.16
720min13949939-394993994.86096.771.2897.6299.511.24
24064250-406425097.605100.35
34054270-405427097.365100.13
44093563-409356398.309101.04
54005580-400558096.19698.94
64009446-400944696.28999.00
极限14021890-402189096.58897.221.0199.82100.450.99
24091905-409190598.269101.50
34081606-408160698.022101.27
44068888-406888897.716100.94
54041307-404130797.054100.27
63984702-398470295.69498.89
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%
112.002987529988300752989830100299870.34
212.023055030596305730.11
单位质量响应值RSD%判断
2498.922543.511.26数据可信
供试品溶液-2025081621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%
5min139691-39691101.26698.442.17101.2798.442.17
238146-3814697.32497.32
339629-39629101.108101.11
438043-3804397.06197.06
537996-3799696.94196.94
638005-3800596.96496.96
10min140179-40179102.511100.051.48103.02100.541.49
238639-3863998.58299.07
339348-39348100.391100.90
438771-3877198.91899.40
538857-3885799.13899.62
639495-39495100.766101.25
15min140587-40587103.552101.101.28104.57102.101.28
239182-3918299.967100.95
339593-39593101.016102.02
439414-39414100.559101.54
539679-39679101.235102.22
639310-39310100.294101.28
20min139610-39610101.059100.860.54102.60102.360.53
239399-39399100.521102.00
339435-39435100.613102.13
439772-39772101.472102.96
539739-39739101.388102.87
639238-39238100.110101.60
30min139508-39508100.799101.940.73102.84103.940.70
240163-40163102.470104.45
339665-39665101.199103.22
440151-40151102.439104.43
540083-40083102.266104.26
640155-40155102.450104.44
45min140228-40228102.636101.191.18105.18103.701.16
239620-39620101.085103.58
339533-39533100.863103.38
439680-39680101.238103.74
540035-40035102.143104.65
638879-3887999.194101.70
60min139341-39341100.373101.150.57103.43104.170.54
239772-39772101.472104.47
339506-39506100.794103.82
439718-39718101.335104.34
539560-39560100.931103.95
639978-39978101.998105.00
120min139623-39623101.092101.051.18104.65104.571.15
239464-39464100.687104.19
339806-39806101.559105.09
440364-40364102.983106.50
539423-39423100.582104.10
638958-3895899.396102.90
180min140077-40077102.251101.641.51106.32105.671.45
239917-39917101.842105.85
339876-39876101.738105.78
438727-3872798.806102.84
540535-40535103.419107.44
639888-39888101.768105.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min140411-40411103.103101.200.98107.68105.740.96
239466-39466100.692105.21
339720-39720101.340105.89
439365-39365100.434104.96
539604-39604101.044105.58
639432-39432100.605105.12
360min139994-39994102.039101.430.93107.13106.470.89
239830-39830101.620106.64
339485-39485100.740105.79
439279-39279100.215105.24
539634-39634101.120106.17
640305-40305102.832107.85
480min140852-40852104.228101.171.59109.83106.721.53
239673-39673101.220106.75
339424-39424100.584106.14
439035-3903599.592105.12
539584-39584100.993106.54
639343-39343100.378105.91
600min139800-39800101.544100.920.80107.67106.980.76
239601-39601101.036107.07
339030-3903099.579105.64
439684-39684101.248107.27
539867-39867101.715107.77
639356-39356100.411106.44
720min138880-3888099.19799.730.50105.83106.290.45
239451-39451100.653107.20
339072-3907299.686106.24
438995-3899599.490106.02
539084-3908499.717106.28
639060-3906099.656106.19
极限139554-39554100.916100.001.20108.04107.061.15
239602-39602101.039108.08
339293-39293100.250107.31
438509-3850998.250105.28
539500-39500100.778107.84
638708-3870898.758105.79
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