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%
110.204289909428591542956454297072429698142931040.12
210.274375214436811143716620.12
单位质量响应值RSD%判断
420892.55425673.030.80数据可信
长期6月-供试品溶液-2025081821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%
5min1184802-1848024.3664.497.154.374.487.18
2206809-2068094.8864.89
3206655-2066554.8824.88
4182475-1824754.3114.31
5183827-1838274.3434.34
6174524-1745244.1234.12
10min1376771-3767718.9018.623.578.928.643.57
2379211-3792118.9598.98
3360103-3601038.5088.53
4361831-3618318.5488.57
5367251-3672518.6778.70
6343432-3434328.1148.13
15min1497812-49781211.76111.992.7611.8312.062.75
2527552-52755212.46412.53
3502952-50295211.88311.95
4507453-50745311.98912.05
5519448-51944812.27212.34
6489609-48960911.56711.63
20min1625215-62521514.77114.912.9514.9015.032.92
2646808-64680815.28115.41
3628562-62856214.85014.98
4653441-65344115.43815.56
5631192-63119214.91215.04
6600534-60053414.18814.31
30min1837720-83772019.79219.872.3719.9920.072.37
2879498-87949820.77920.99
3837506-83750619.78719.99
4835392-83539219.73719.94
5835945-83594519.75019.95
6820778-82077819.39119.58
45min11085603-108560325.64825.702.4925.9526.002.49
21130448-113044826.70827.02
31083876-108387625.60725.91
41078166-107816625.47225.77
51099694-109969425.98126.28
61048246-104824624.76525.05
60min11293045-129304530.54930.671.4130.9831.101.43
21331683-133168331.46231.91
31299395-129939530.69931.13
41300077-130007730.71531.14
51285985-128598530.38230.81
61279120-127912030.22030.63
120min11967384-196738446.48146.491.5447.0647.071.55
21994286-199428647.11647.72
32005939-200593947.39247.97
41955282-195528246.19546.78
51963131-196313146.38046.96
61920423-192042345.37145.93
180min12433477-243347757.49257.521.1558.3058.341.16
22485582-248558258.72359.56
32423514-242351457.25758.08
42423704-242370457.26258.07
52439810-243981057.64258.46
62403087-240308756.77457.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12804375-280437566.25566.901.5567.3568.001.55
22918903-291890368.96170.09
32832185-283218566.91268.02
42814626-281462666.49767.60
52812661-281266166.45167.55
62807584-280758466.33167.40
360min13345105-334510579.03079.141.4680.4680.581.46
23424036-342403680.89582.37
33362302-336230279.43680.88
43315790-331579078.33879.77
53369783-336978379.61381.05
63281832-328183277.53578.94
480min13745689-374568988.49487.301.7690.3289.131.75
23745400-374540088.48790.37
33729951-372995188.12289.96
43628784-362878485.73287.55
53724002-372400287.98289.81
63597076-359707684.98386.78
600min13963488-396348893.64091.722.3095.9193.992.26
23871130-387113091.45893.78
33978512-397851293.99596.27
43826749-382674990.40992.66
53911822-391182292.41994.69
63742227-374222788.41290.63
720min14010317-401031794.74693.972.4297.4896.702.39
24133000-413300097.645100.43
33993017-399301794.33897.08
43872695-387269591.49594.20
53977568-397756893.97396.71
63878972-387897291.64394.30
极限14040780-404078095.46693.361.9498.6896.561.92
23999906-399990694.50097.77
33970633-397063393.80997.03
43894985-389498592.02195.18
53974449-397444993.89997.10
63829903-382990390.48493.60
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%
112.611633616565164471633116297163950.68
212.741676116600166800.69
单位质量响应值RSD%判断
1300.161309.260.50数据可信
长期6月-供试品溶液-2025081821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%
5min119376-193760.4780.471.560.480.461.80
218827-188270.4640.46
319218-192180.4740.47
418712-187120.4610.46
518746-187460.4620.46
618744-187440.4620.46
10min119548-195480.4820.472.200.480.472.19
218788-187880.4630.47
319633-196330.4840.49
418634-186340.4590.46
518890-188900.4660.47
618938-189380.4670.47
15min119345-193450.4770.471.250.480.481.32
219128-191280.4710.48
319423-194230.4790.48
418855-188550.4650.47
519504-195040.4810.49
619201-192010.4730.48
20min119347-193470.4770.471.170.480.481.32
219036-190360.4690.48
319595-195950.4830.49
419209-192090.4730.48
519207-192070.4730.48
618980-189800.4680.47
30min119585-195850.4830.481.490.490.491.55
219344-193440.4770.49
319760-197600.4870.50
418940-189400.4670.48
519181-191810.4730.48
619370-193700.4770.49
45min119297-192970.4760.471.330.490.481.57
218957-189570.4670.48
319470-194700.4800.49
418786-187860.4630.47
519161-191610.4720.48
618991-189910.4680.48
60min119243-192430.4740.471.640.490.481.87
218699-186990.4610.47
319398-193980.4780.49
418794-187940.4630.48
518606-186060.4590.47
619087-190870.4700.48
120min119216-192160.4740.472.160.490.482.14
218744-187440.4620.48
319710-197100.4860.50
418571-185710.4580.47
518817-188170.4640.48
618973-189730.4680.48
180min119172-191720.4730.471.330.490.491.07
218908-189080.4660.48
319217-192170.4740.49
418569-185690.4580.48
518925-189250.4660.49
619195-191950.4730.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119057-190570.4700.471.610.490.491.83
219073-190730.4700.49
319413-194130.4790.50
418721-187210.4610.48
518674-186740.4600.48
619289-192890.4750.50
360min118940-189400.4670.470.960.490.491.30
218796-187960.4630.49
319181-191810.4730.50
418715-187150.4610.48
518758-187580.4620.49
618931-189310.4670.49
480min119244-192440.4740.471.320.500.491.54
218729-187290.4620.49
319207-192070.4730.50
418601-186010.4590.48
518765-187650.4630.49
618973-189730.4680.49
600min119270-192700.4750.461.990.500.491.83
218416-184160.4540.48
319249-192490.4740.50
418440-184400.4550.48
518679-186790.4600.49
618691-186910.4610.49
720min118992-189920.4680.462.210.500.492.00
218686-186860.4610.49
318902-189020.4660.50
418146-181460.4470.48
518338-183380.4520.48
619244-192440.4740.50
极限118867-188670.4650.461.490.500.492.00
218500-185000.4560.49
318876-188760.4650.50
418289-182890.4510.48
518271-182710.4500.48
618754-187540.4620.50
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)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%
110.204332205433339943312764330845433005143315550.03
210.274273616427626242749390.05
单位质量响应值RSD%判断
424662.25416255.011.42数据可信
长期6月-供试品溶液-2025081821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%
5min1194789-1947894.6334.328.064.634.328.04
2172391-1723914.1004.10
3179834-1798344.2784.28
4178838-1788384.2544.25
5201727-2017274.7984.80
6161751-1617513.8473.85
10min1356352-3563528.4768.545.438.508.565.41
2350085-3500858.3278.35
3353347-3533478.4058.43
4362846-3628468.6318.65
5394355-3943559.3809.40
6336288-3362887.9998.02
15min1511416-51141612.16511.832.4412.2311.902.45
2493510-49351011.73911.80
3493570-49357011.74011.80
4497869-49786911.84211.91
5509351-50935112.11512.19
6478273-47827311.37611.44
20min1629146-62914614.96514.772.6915.0914.892.69
2631553-63155315.02215.14
3607784-60778414.45714.58
4622891-62289114.81614.94
5639311-63931115.20715.34
6594618-59461814.14414.26
30min1845652-84565220.11519.632.7920.3219.832.80
2811184-81118419.29519.49
3809224-80922419.24819.44
4841585-84158520.01820.22
5849592-84959220.20820.42
6795035-79503518.91119.10
45min11102410-110241026.22225.802.4126.5226.092.42
21079187-107918725.66925.96
31073721-107372125.53925.83
41082268-108226825.74326.04
51123424-112342426.72227.03
61046724-104672424.89725.18
60min11301088-130108830.94830.651.8731.3831.081.88
21282908-128290830.51530.94
31277342-127734230.38330.80
41290476-129047630.69531.12
51325965-132596531.53931.98
61254369-125436929.83630.24
120min11987322-198732247.27046.762.3447.8647.342.33
21928589-192858945.87346.45
31991624-199162447.37347.94
41954786-195478646.49647.08
52029559-202955948.27548.87
61903880-190388045.28645.84
180min12437710-243771057.98359.997.5658.8160.807.47
22434222-243422257.90058.70
32471873-247187358.79659.60
42899768-289976868.97469.79
52511632-251163259.74260.58
62376432-237643256.52657.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12793015-279301566.43467.262.3767.5568.372.36
22794007-279400766.45867.55
32804476-280447666.70767.81
42839024-283902467.52968.69
52957288-295728870.34271.48
62777436-277743666.06467.13
360min13319590-331959078.96079.971.2980.4181.421.30
23319153-331915378.94980.37
33388523-338852380.59982.03
43397842-339784280.82182.32
53414409-341440981.21582.71
63331960-333196079.25480.65
480min13689772-368977287.76588.210.9689.6190.060.98
23669720-366972087.28889.11
33693453-369345387.85289.69
43760404-376040489.44591.34
53743500-374350089.04390.94
63693953-369395387.86489.65
600min13827900-382790091.05093.161.2493.3395.441.23
23909821-390982192.99995.25
33929891-392989193.47695.75
43932234-393223493.53295.88
53974566-397456694.53996.88
63924122-392412293.33995.57
720min13891883-389188392.57294.151.2495.3196.901.23
23982525-398252594.72897.45
33924928-392492893.35896.10
43974593-397459394.53997.35
54031492-403149295.89398.71
63944152-394415293.81596.51
极限13915497-391549793.13495.672.2096.3398.892.14
23955341-395534194.08197.28
34069376-406937696.794100.00
43974880-397488094.54697.83
54151462-415146298.746102.04
64065811-406581196.70999.87
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%
112.611645416464163641649016455164450.30
212.741636216470164160.47
单位质量响应值RSD%判断
1304.121288.540.85数据可信
长期6月-供试品溶液-2025081821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%
5min118710-187100.4640.463.100.460.463.00
218482-184820.4590.46
319100-191000.4740.47
418562-185620.4610.46
518694-186940.4640.46
617428-174280.4320.43
10min118708-187080.4640.472.110.470.471.60
218832-188320.4670.47
319330-193300.4800.48
418867-188670.4680.47
519446-194460.4820.48
618371-183710.4560.46
15min119375-193750.4810.471.490.490.482.17
218949-189490.4700.47
319382-193820.4810.49
418914-189140.4690.47
518800-188000.4660.47
618788-187880.4660.47
20min119124-191240.4740.471.600.480.481.32
219621-196210.4870.49
318761-187610.4650.47
418896-188960.4690.48
519214-192140.4770.48
619077-190770.4730.48
30min119540-195400.4850.471.380.490.480.85
218789-187890.4660.48
319027-190270.4720.48
419057-190570.4730.48
519007-190070.4720.48
618920-189200.4690.48
45min119370-193700.4810.481.270.490.490.84
219269-192690.4780.49
319304-193040.4790.49
419146-191460.4750.49
519476-194760.4830.49
618769-187690.4660.48
60min118914-189140.4690.470.950.480.480.85
218676-186760.4630.48
318906-189060.4690.48
418908-189080.4690.48
519221-192210.4770.49
618907-189070.4690.48
120min119344-193440.4800.481.260.500.491.66
218786-187860.4660.48
319293-192930.4790.50
419085-190850.4730.49
519443-194430.4820.50
619065-190650.4730.49
180min119128-191280.4750.497.660.490.517.75
219073-190730.4730.49
319350-193500.4800.50
422863-228630.5670.59
519470-194700.4830.50
618879-188790.4680.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119103-191030.4740.471.490.500.501.70
218842-188420.4670.49
319071-190710.4730.49
418761-187610.4650.49
519550-195500.4850.51
619021-190210.4720.49
360min118893-188930.4690.471.000.490.501.04
218738-187380.4650.49
319273-192730.4780.50
419015-190150.4720.50
519197-191970.4760.50
619040-190400.4720.50
480min119278-192780.4780.470.890.500.500.82
218768-187680.4660.49
319121-191210.4740.50
419034-190340.4720.50
519151-191510.4750.50
618934-189340.4700.50
600min118835-188350.4670.471.010.500.500.82
218858-188580.4680.50
319258-192580.4780.51
419010-190100.4720.50
519171-191710.4760.50
619220-192200.4770.50
720min118405-184050.4570.460.950.490.501.11
218669-186690.4630.49
318767-187670.4660.50
418510-185100.4590.49
518884-188840.4680.50
618797-187970.4660.50
极限118851-188510.4680.472.440.500.502.72
218579-185790.4610.49
319503-195030.4840.52
418329-183290.4550.49
519424-194240.4820.52
619015-190150.4720.50
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