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%
110.004162218415529141577314160843415961841591400.07
210.064188766418864341887040.01
单位质量响应值RSD%判断
415914.00416372.170.08数据可信
供试品溶液-2025081921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%
5min1224903-2249035.4045.087.005.405.076.99
2213936-2139365.1415.14
3204112-2041124.9054.90
4196546-1965464.7234.72
5196429-1964294.7204.72
6231491-2314915.5635.56
10min1426172-42617210.2419.747.7010.279.767.67
2370910-3709108.9138.94
3386482-3864829.2879.31
4375879-3758799.0329.06
5443972-44397210.66910.69
6428332-42833210.29310.32
15min1564813-56481313.57313.224.0113.6513.294.00
2516316-51631612.40712.48
3563983-56398313.55313.62
4528119-52811912.69112.76
5559054-55905413.43413.51
6567593-56759313.63913.72
20min1699514-69951416.80916.272.4916.9616.412.50
2663080-66308015.93416.07
3662844-66284415.92816.07
4667123-66712316.03116.16
5672452-67245216.15916.30
6696862-69686216.74616.89
30min1916658-91665822.02721.422.1922.2621.642.20
2875523-87552321.03921.25
3883750-88375021.23721.46
4866036-86603620.81121.02
5904275-90427521.73021.95
6903151-90315121.70321.93
45min11191775-119177528.63927.352.9928.9827.682.99
21097902-109790226.38326.70
31113237-111323726.75127.08
41121936-112193626.96027.28
51151866-115186627.68028.01
61152827-115282727.70328.04
60min11413424-141342433.96532.452.8134.4532.912.81
21313509-131350931.56432.01
31327425-132742531.89832.36
41320287-132028731.72732.18
51356893-135689332.60633.08
61369555-136955532.91133.39
120min12063506-206350649.58648.902.0950.2449.532.10
21979973-197997347.57948.19
32002759-200275948.12748.74
42010725-201072548.31848.93
52081855-208185550.02750.66
62072100-207210049.79350.44
180min12593546-259354662.32360.932.3863.2261.812.38
22437088-243708858.56459.41
32502243-250224360.12960.99
42523473-252347360.64061.49
52585768-258576862.13763.02
62572373-257237361.81562.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12947901-294790170.83969.951.6172.0571.121.62
22855458-285545868.61769.75
32857417-285741768.66469.82
42901671-290167169.72870.88
52939547-293954770.63871.83
62962366-296236671.18672.39
360min13492359-349235983.92283.481.1685.4985.011.17
23408589-340858981.90983.39
33460446-346044683.15584.66
43458867-345886783.11784.62
53517486-351748684.52686.07
63506939-350693984.27285.83
480min13859499-385949992.74591.831.0694.7393.781.08
23767694-376769490.53892.43
33785648-378564890.97092.89
43805887-380588791.45693.38
53859182-385918292.73794.71
63851348-385134892.54994.53
600min14021838-402183896.64696.261.4799.1098.661.46
23973001-397300195.47297.81
33972185-397218595.45297.83
43949805-394980594.91597.29
54113338-411333898.844101.28
64003954-400395496.21698.66
720min14120758-412075899.02397.991.46101.96100.871.46
24027456-402745696.78199.60
34001321-400132196.15399.00
44049723-404972397.316100.17
54118979-411897998.980101.91
64147792-414779299.672102.59
极限14100312-410031298.53199.132.34101.96102.502.29
24071992-407199297.851101.16
34051548-405154897.360100.69
44108007-410800798.716102.05
54316719-4316719103.732107.16
64102085-410208598.574101.99
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%
113.001654316457164861656216445164990.32
213.021665816701166800.19
单位质量响应值RSD%判断
1269.151281.110.67数据可信
供试品溶液-2025081921批-达格列净-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%
5min119027-1902795.97895.321.2095.9895.321.20
218798-1879894.82394.82
318546-1854693.55293.55
419082-1908296.25596.26
519136-1913696.52896.53
618787-1878794.76794.77
10min118774-1877494.70297.162.5295.1897.632.52
218906-1890695.36895.84
319158-1915896.63997.11
419258-1925897.14397.62
520156-20156101.673102.16
619313-1931397.42197.89
15min119316-1931697.43697.941.9098.3998.901.89
219011-1901195.89796.85
319141-1914196.55397.50
419397-1939797.84498.81
520047-20047101.123102.11
619580-1958098.76799.73
20min119398-1939897.84998.231.1699.2999.681.16
219418-1941897.95099.38
319171-1917196.70498.14
419371-1937197.71399.17
519718-1971899.464100.96
619761-1976199.680101.14
30min119392-1939297.81998.121.7599.75100.061.74
219261-1926197.15899.08
319262-1926297.16399.08
419337-1933797.54299.49
520137-20137101.577103.57
619320-1932097.45699.41
45min119363-1936397.67397.461.61100.0999.891.60
219075-1907596.22098.63
319000-1900095.84298.24
419446-1944698.092100.52
519852-19852100.139102.64
619189-1918996.79599.24
60min119446-1944698.09296.911.58101.0099.831.56
219272-1927297.214100.10
318855-1885595.11097.99
419154-1915496.61999.54
519636-1963699.050102.05
618912-1891295.39898.32
120min119331-1933197.51198.081.42100.91101.481.42
219400-1940097.859101.23
319126-1912696.47799.84
419450-1945098.112101.52
519956-19956100.664104.16
619394-1939497.829101.23
180min119260-1926097.15397.412.12101.04101.312.09
218979-1897995.73699.60
318913-1891395.40399.24
419209-1920996.896100.79
520036-20036101.068105.07
619470-1947098.213102.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119091-1909196.30196.991.56100.67101.381.56
219188-1918896.790101.13
318936-1893695.51999.84
419152-1915296.608100.99
519808-1980899.918104.42
619193-1919396.815101.20
360min119141-1914196.55396.971.32101.41101.841.33
219084-1908496.265101.09
319026-1902695.973100.77
419151-1915196.603101.47
519723-1972399.489104.49
619222-1922296.962101.83
480min118943-1894395.55496.191.26100.89101.541.26
218971-1897195.695101.00
318916-1891695.418100.69
418899-1889995.332100.68
519513-1951398.429103.93
619172-1917296.709102.06
600min118508-1850893.36095.402.4399.17101.232.36
218971-1897195.695101.48
318766-1876694.661100.41
418570-1857093.67399.50
519777-1977799.761105.76
618881-1888195.241101.08
720min118964-1896495.66095.181.57101.94101.501.55
218847-1884795.070101.33
318509-1850993.36599.59
418604-1860493.844100.14
519336-1933697.537104.03
618957-1895795.625101.94
极限118592-1859293.78496.703.12100.54103.482.99
218964-1896495.660102.40
319279-1927997.249103.94
418952-1895295.600102.36
520304-20304102.420109.40
618927-1892795.474102.26
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%
110.004214641421638542155714212391421394642145870.04
210.064211189421164042114140.01
单位质量响应值RSD%判断
421458.70418629.620.48数据可信
供试品溶液-2025081921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%
5min1200100-2001004.7645.056.544.765.056.58
2213607-2136075.0855.09
3204285-2042854.8634.86
4225492-2254925.3685.37
5231447-2314475.5105.51
6197925-1979254.7124.71
10min1446168-44616810.6229.687.4910.659.717.49
2373853-3738538.9008.93
3388406-3884069.2479.27
4428087-42808710.19210.22
5425697-42569710.13510.16
6377660-3776608.9919.01
15min1556053-55605313.23813.104.0613.3213.174.05
2516126-51612612.28812.36
3562395-56239513.38913.46
4568994-56899413.54613.62
5568579-56857913.53613.61
6528902-52890212.59212.66
20min1671174-67117415.97916.082.4416.1216.222.45
2660534-66053415.72615.86
3665857-66585715.85215.99
4701975-70197516.71216.86
5688988-68898816.40316.55
6663841-66384115.80415.94
30min1907068-90706821.59521.212.3021.8221.432.31
2871348-87134820.74420.95
3880024-88002420.95121.17
4914049-91404921.76121.99
5905386-90538621.55521.78
6866881-86688120.63820.85
45min11152610-115261027.44127.123.1427.7727.453.14
21100218-110021826.19326.51
31108164-110816426.38226.70
41195609-119560928.46428.80
51155730-115573027.51527.85
61122880-112288026.73327.05
60min11359245-135924532.36032.142.6432.8332.602.65
21305188-130518831.07331.52
31337398-133739831.84032.29
41405257-140525733.45533.94
51368385-136838532.57833.05
61324244-132424431.52731.97
120min12127244-212724450.64448.602.7351.2749.222.72
21977296-197729647.07447.67
32003810-200381047.70548.32
42053345-205334548.88549.53
52078406-207840649.48150.12
62009156-200915647.83348.44
180min12599267-259926761.88260.572.6062.7661.432.60
22442987-244298758.16159.00
32513606-251360659.84260.69
42612106-261210662.18763.08
52586520-258652061.57862.46
62510553-251055359.76960.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12958758-295875870.44069.902.1571.6371.072.15
22860578-286057868.10369.23
32857531-285753168.03069.18
43013754-301375471.74972.95
52963719-296371970.55871.75
62961923-296192370.51571.66
360min13562233-356223384.80782.731.6286.3584.251.63
23399957-339995780.94482.41
33434886-343488681.77583.27
43477711-347771182.79584.36
53505156-350515683.44884.99
63470791-347079182.63084.13
480min13865560-386556092.02990.731.1694.0092.661.18
23775406-377540689.88291.75
33763420-376342089.59791.50
43861409-386140991.93093.91
53815406-381540690.83492.80
63785275-378527590.11792.03
600min14111080-411108097.87495.161.45100.3097.541.45
23955297-395529794.16596.49
33965979-396597994.41996.77
43995689-399568995.12797.56
53985858-398585894.89297.31
63968334-396833494.47596.83
720min14139567-413956798.55297.211.39101.47100.081.40
24011792-401179295.51098.30
34023792-402379295.79698.62
44136518-413651898.479101.39
54117044-411704498.016100.91
64071435-407143596.93099.76
极限14191032-419103299.77797.561.41103.19100.911.41
24039828-403982896.17799.45
34042629-404262996.24499.54
44077995-407799597.086100.49
54127996-412799698.276101.66
64107846-410784697.797101.11
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%
113.001670916643167121680816749167240.37
213.021682516796168100.13
单位质量响应值RSD%判断
1286.461291.090.26数据可信
供试品溶液-2025081921批-达格列净-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%
5min119342-1934296.53294.991.3896.5394.981.38
219128-1912895.46495.46
318598-1859892.81992.82
419128-1912895.46495.46
518863-1886394.14194.14
619134-1913495.49495.49
10min120245-20245101.03996.342.66101.5296.822.65
218834-1883493.99794.47
319249-1924996.06896.53
418913-1891394.39194.87
519456-1945697.10197.57
619129-1912995.46995.95
15min120300-20300101.31397.602.32102.3098.562.32
219095-1909595.29996.25
319088-1908895.26496.21
419489-1948997.26698.21
519741-1974198.52399.48
619629-1962997.96498.92
20min119562-1956297.63097.001.5199.1298.441.49
219328-1932896.46297.89
319133-1913395.48996.91
419861-1986199.122100.56
519606-1960697.85099.30
619125-1912595.44996.89
30min120219-20219100.90997.581.89102.8999.511.88
219252-1925296.08397.99
319303-1930396.33798.24
419288-1928896.26398.19
519625-1962597.94499.88
619623-1962397.93499.86
45min119667-1966798.15496.001.29100.6498.421.29
219024-1902494.94597.33
319002-1900294.83597.22
419284-1928496.24398.66
519128-1912895.46497.89
619306-1930696.35298.76
60min119570-1957097.67095.881.57100.6598.781.55
219088-1908895.26498.13
319131-1913195.47998.33
419592-1959297.780100.67
518857-1885794.11197.02
619032-1903294.98597.88
120min119906-1990699.34796.671.68102.81100.041.66
219480-1948097.221100.56
319018-1901894.91598.25
419050-1905095.07598.46
519346-1934696.55299.93
619412-1941296.881100.25
180min120113-20113100.38096.771.94104.34100.631.92
219213-1921395.88899.71
319030-1903094.97598.78
419353-1935396.587100.44
519266-1926696.153100.01
619361-1936196.627100.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min120076-20076100.19597.132.45104.66101.472.40
219273-1927396.188100.49
318752-1875293.58797.87
419483-1948397.236101.58
519290-1929096.272100.61
619896-1989699.297103.63
360min120047-20047100.05195.702.37105.02100.532.33
219145-1914595.549100.33
318803-1880393.84298.59
418825-1882593.95298.78
519100-1910095.324100.14
619130-1913095.474100.31
480min119538-1953897.51095.271.72102.98100.581.69
219164-1916495.644100.91
318750-1875093.57798.80
418897-1889794.31199.61
519394-1939496.792102.09
618795-1879593.80299.11
600min119696-1969698.29994.492.01104.25100.271.98
218851-1885194.08299.82
318678-1867893.21898.90
418736-1873693.50899.28
518807-1880793.86299.64
618824-1882493.94799.73
720min119568-1956897.66094.312.11104.11100.572.07
218930-1893094.476100.69
318449-1844992.07598.23
418683-1868393.24399.48
519090-1909095.274101.52
618664-1866493.14899.40
极限119839-1983999.01295.252.94105.95101.982.82
219722-1972298.429105.11
318641-1864193.03399.65
418514-1851492.40099.10
518873-1887394.191100.92
618925-1892594.451101.16
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