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%
110.204266318426631842670284265581426368342659160.03
210.274301619431009143058550.14
单位质量响应值RSD%判断
418227.06419265.340.18数据可信
加速6月-供试品溶液-2025081922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%
5min1193287-1932874.6164.777.134.624.777.10
2178681-1786814.2674.27
3198677-1986774.7454.74
4218671-2186715.2225.22
5212349-2123495.0715.07
6196568-1965684.6944.69
10min1367270-3672708.7719.156.488.799.186.46
2365694-3656948.7338.75
3423819-42381910.12110.14
4383713-3837139.1639.19
5399937-3999379.5519.58
6358972-3589728.5738.60
15min1527337-52733712.59312.763.1212.6612.833.14
2512335-51233512.23512.30
3539614-53961412.88612.96
4541639-54163912.93513.01
5560494-56049413.38513.46
6524855-52485512.53412.60
20min1648249-64824915.48115.693.2415.6115.833.24
2638697-63869715.25315.38
3667704-66770415.94516.08
4661054-66105415.78715.92
5692275-69227516.53216.67
6635134-63513415.16815.30
30min1849372-84937220.28420.682.2920.4920.892.31
2858009-85800920.49020.69
3886551-88655121.17221.39
4880205-88020521.02021.24
5882220-88222021.06821.29
6839131-83913120.03920.24
45min11117270-111727026.68126.871.2526.9927.181.27
21103790-110379026.35926.66
31125514-112551426.87827.20
41136302-113630227.13627.46
51143335-114333527.30427.63
61124035-112403526.84327.15
60min11325948-132594831.66532.081.2732.1132.531.29
21323609-132360931.60932.05
31362877-136287732.54733.01
41348340-134834032.20032.66
51361223-136122332.50732.97
61338079-133807931.95432.39
120min11987717-198771747.46848.210.9948.0748.821.00
22015632-201563248.13548.73
32016746-201674648.16248.78
42021162-202116248.26748.88
52050305-205030548.96349.59
62021967-202196748.28648.89
180min12463689-246368958.83559.841.1759.6760.701.16
22537741-253774160.60361.44
32511852-251185259.98560.85
42520877-252087760.20161.06
52524722-252472260.29361.16
62476724-247672459.14659.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12847342-284734267.99768.590.6269.1369.740.62
22874536-287453668.64669.78
32898673-289867369.22370.38
42877998-287799868.72969.89
52875559-287555968.67169.84
62858956-285895668.27469.41
360min13329423-332942379.50981.261.7680.9882.751.72
23399473-339947381.18282.66
33386457-338645780.87182.38
43411494-341149481.46982.97
53379200-337920080.69882.21
63509947-350994783.82185.30
480min13706600-370660088.51788.520.9690.3990.420.94
23660435-366043587.41489.30
33685391-368539188.01089.92
43710248-371024888.60490.51
53710193-371019388.60390.52
63766821-376682189.95591.85
600min13888746-388874692.86793.300.8695.1895.640.83
23956475-395647594.48496.81
33902202-390220293.18895.54
43929276-392927693.83496.19
53859172-385917292.16094.52
63905371-390537193.26495.61
720min13952739-395273994.39594.921.1597.1797.721.12
24009375-400937595.74798.54
33986134-398613495.19298.01
43971107-397110794.83397.66
53899547-389954793.12495.95
64028429-402842996.20299.02
极限14014683-401468395.87494.510.8399.1297.800.79
23964782-396478294.68297.96
33929596-392959693.84297.14
43945597-394559794.22497.52
53925530-392553093.74597.03
63965704-396570494.70498.00
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)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%
112.611618616186160401633216272161960.62
212.741626216191162260.31
单位质量响应值RSD%判断
1284.381273.630.60数据可信
加速6月-供试品溶液-2025081922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%
5min116915-169150.4250.442.590.430.441.85
217310-173100.4350.44
317975-179750.4520.45
417974-179740.4520.45
517878-178780.4500.45
617315-173150.4350.44
10min117427-174270.4380.452.350.440.452.28
218164-181640.4570.46
318022-180220.4530.46
418012-180120.4530.46
518353-183530.4610.46
617291-172910.4350.44
15min117751-177510.4460.461.690.450.461.77
218171-181710.4570.46
318489-184890.4650.47
418556-185560.4670.47
518387-183870.4620.47
618114-181140.4550.46
20min117894-178940.4500.461.800.460.471.75
217993-179930.4520.46
318745-187450.4710.48
418481-184810.4650.47
518453-184530.4640.47
618120-181200.4560.46
30min118156-181560.4570.461.140.470.471.35
218413-184130.4630.47
318568-185680.4670.48
418499-184990.4650.47
518324-183240.4610.47
618033-180330.4530.46
45min117909-179090.4500.461.460.460.471.60
218119-181190.4560.47
318184-181840.4570.47
418539-185390.4660.48
518307-183070.4600.47
618604-186040.4680.48
60min118233-182330.4580.460.900.470.481.16
218157-181570.4570.47
318577-185770.4670.48
418477-184770.4650.48
518339-183390.4610.47
618511-185110.4650.48
120min118258-182580.4590.470.960.470.481.57
218602-186020.4680.48
318612-186120.4680.48
418451-184510.4640.48
518689-186890.4700.49
618721-187210.4710.49
180min118399-183990.4630.471.190.480.491.55
219065-190650.4790.50
318727-187270.4710.49
418524-185240.4660.48
518591-185910.4670.49
618612-186120.4680.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118623-186230.4680.470.420.490.490.00
218671-186710.4690.49
318753-187530.4720.49
418699-186990.4700.49
518564-185640.4670.49
618553-185530.4670.49
360min118088-180880.4550.472.460.480.492.00
218520-185200.4660.49
318686-186860.4700.49
418552-185520.4660.49
518370-183700.4620.49
619428-194280.4890.51
480min118463-184630.4640.461.160.490.491.55
218156-181560.4570.48
318340-183400.4610.49
418179-181790.4570.48
518501-185010.4650.49
618734-187340.4710.50
600min118313-183130.4600.460.800.490.491.05
218598-185980.4680.50
318304-183040.4600.49
418406-184060.4630.49
518539-185390.4660.49
618603-186030.4680.50
720min118043-180430.4540.461.730.480.491.68
218696-186960.4700.50
318238-182380.4590.49
418019-180190.4530.48
517807-178070.4480.48
618404-184040.4630.49
极限118463-184630.4640.460.940.500.491.30
218216-182160.4580.49
318045-180450.4540.49
417989-179890.4520.48
518098-180980.4550.49
618248-182480.4590.49
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%
110.204270159427087142711264269863427122542706490.02
210.274330457432225643263560.14
单位质量响应值RSD%判断
418691.08421261.540.44数据可信
加速6月-供试品溶液-2025081922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%
5min1213441-2134415.0825.057.675.085.057.66
2205596-2055964.8954.90
3237057-2370575.6455.64
4217331-2173315.1755.17
5211712-2117125.0415.04
6187090-1870904.4554.45
10min1396547-3965479.4429.242.889.479.272.88
2367590-3675908.7538.78
3390861-3908619.3079.34
4392491-3924919.3469.37
5397347-3973479.4619.49
6383599-3835999.1349.16
15min1551950-55195013.14312.683.2113.2212.753.22
2528996-52899612.59612.66
3530340-53034012.62812.70
4536040-53604012.76412.84
5545317-54531712.98513.06
6502727-50272711.97012.04
20min1675680-67568016.08915.622.3116.2315.752.33
2662521-66252115.77515.91
3658625-65862515.68315.82
4657227-65722715.64915.79
5651558-65155815.51415.65
6629838-62983814.99715.12
30min1895643-89564321.32620.731.7021.5520.941.72
2868135-86813520.67120.88
3865653-86565320.61220.83
4872787-87278720.78221.00
5870315-87031520.72320.94
6850083-85008320.24120.44
45min11159057-115905727.59826.891.5727.9227.211.58
21130269-113026926.91327.23
31130306-113030626.91427.23
41128776-112877626.87727.20
51124081-112408126.76627.08
61103628-110362826.27926.58
60min11378911-137891132.83332.161.7233.3032.611.72
21320315-132031531.43831.89
31356537-135653732.30132.75
41364750-136475032.49632.95
51357960-135796032.33532.79
61324909-132490931.54831.98
120min12063490-206349049.13448.411.8749.7649.021.85
22077959-207795949.47850.08
32036464-203646448.49049.11
42037865-203786548.52449.14
52009582-200958247.85048.46
61972791-197279146.97447.57
180min12542636-254263660.54359.321.3461.4260.181.34
22502814-250281459.59560.45
32496166-249616659.43660.29
42470107-247010758.81659.67
52493138-249313859.36460.22
62443699-244369958.18759.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12888457-288845768.77767.501.0969.9568.651.09
22829195-282919567.36668.52
32851374-285137467.89469.05
42803279-280327966.74967.90
52821830-282183067.19168.34
62815331-281533167.03668.16
360min13470654-347065482.64081.381.0384.1682.871.02
23429953-342995381.67183.16
33368867-336886780.21681.71
43408990-340899081.17282.66
53395672-339567280.85582.34
63433117-343311781.74683.20
480min13778356-377835689.96788.871.3891.9090.771.36
23694914-369491487.98089.88
33797702-379770290.42792.32
43747216-374721689.22591.12
53663787-366378787.23989.13
63711859-371185988.38390.25
600min14013265-401326595.56093.161.4297.9495.501.41
23918386-391838693.30195.64
33927906-392790693.52895.88
43873531-387353192.23394.57
53865458-386545892.04194.37
63876950-387695092.31494.62
720min14097065-409706597.55694.811.79100.4297.621.77
23923993-392399393.43596.24
34020139-402013995.72498.54
44002329-400232995.30098.10
53917981-391798193.29196.08
63929478-392947893.56596.33
极限14059113-405911396.65294.791.36100.0098.071.35
23962343-396234394.34897.62
34030338-403033895.96799.26
43974432-397443294.63697.91
53917243-391724393.27496.53
63942174-394217493.86797.10
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)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%
112.611607215985160721606915988160370.29
212.741618416251162180.30
单位质量响应值RSD%判断
1271.771273.000.07数据可信
加速6月-供试品溶液-2025081922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%
5min118324-183240.4630.461.890.460.461.65
218169-181690.4590.46
318749-187490.4740.47
417901-179010.4520.45
518272-182720.4620.46
617819-178190.4500.45
10min118834-188340.4760.461.380.480.471.75
218208-182080.4600.46
318426-184260.4660.47
418265-182650.4620.46
518328-183280.4630.47
618134-181340.4580.46
15min118613-186130.4700.461.750.480.471.91
218382-183820.4650.47
318589-185890.4700.47
418098-180980.4570.46
518669-186690.4720.48
617897-178970.4520.46
20min118715-187150.4730.471.910.480.482.21
218968-189680.4790.49
318776-187760.4750.48
418144-181440.4590.47
518459-184590.4670.47
618074-180740.4570.46
30min118904-189040.4780.471.690.490.481.57
218747-187470.4740.48
318947-189470.4790.49
418075-180750.4570.47
518658-186580.4720.48
618651-186510.4710.48
45min119061-190610.4820.472.170.490.482.05
218964-189640.4790.49
318754-187540.4740.49
418006-180060.4550.47
518526-185260.4680.48
618324-183240.4630.47
60min118716-187160.4730.471.920.490.481.69
218505-185050.4680.48
318977-189770.4800.49
417998-179980.4550.47
518868-188680.4770.49
618448-184480.4660.48
120min118940-189400.4790.482.180.500.492.46
219347-193470.4890.51
318828-188280.4760.49
418249-182490.4610.48
518997-189970.4800.50
618402-184020.4650.48
180min118741-187410.4740.472.060.490.492.59
218843-188430.4760.50
318906-189060.4780.50
417957-179570.4540.47
518870-188700.4770.50
618302-183020.4630.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118643-186430.4710.472.050.490.492.02
218700-187000.4730.49
318777-187770.4750.50
417745-177450.4490.47
518649-186490.4710.49
618425-184250.4660.49
360min118930-189300.4780.482.520.500.502.20
219297-192970.4880.51
318768-187680.4740.50
418053-180530.4560.48
519337-193370.4890.51
618970-189700.4790.50
480min118701-187010.4730.471.580.500.501.98
218907-189070.4780.50
319041-190410.4810.51
418187-181870.4600.48
518561-185610.4690.50
618580-185800.4700.50
600min118996-189960.4800.472.520.510.502.35
219169-191690.4850.51
318574-185740.4690.50
417872-178720.4520.48
518759-187590.4740.50
618346-183460.4640.49
720min118922-189220.4780.471.820.510.501.52
218714-187140.4730.50
318485-184850.4670.50
418098-180980.4570.49
518534-185340.4680.50
618090-180900.4570.49
极限118549-185490.4690.461.790.500.501.70
218628-186280.4710.50
318599-185990.4700.50
417851-178510.4510.48
518380-183800.4650.50
618055-180550.4560.49
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