氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163215733214313212563213433213343213870.04
214.143212393216513214450.10
单位质量响应值RSD%判断
22696.8222733.030.12数据可信
供试品溶液-1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1166207-16620742.45944.465.3242.4644.465.32
2182001-18200146.49446.49
3182434-18243446.60546.60
4173566-17356644.33944.34
5160008-16000840.87640.88
6180025-18002545.98945.99
10min1326644-32664483.44583.302.7783.5283.382.77
2326010-32601083.28383.36
3339451-33945186.71686.79
4320040-32004081.75881.83
5313242-31324280.02180.09
6331092-33109284.58184.66
15min1376933-37693396.29194.383.1996.5094.593.19
2362066-36206692.49492.71
3380348-38034897.16497.39
4361119-36111992.25292.46
5354081-35408190.45490.66
6382058-38205897.60197.82
20min1375283-37528395.87094.282.5696.2494.662.56
2367552-36755293.89594.27
3381168-38116897.37397.76
4360065-36006591.98292.35
5356670-35667091.11591.47
6373693-37369395.46495.84
30min1368547-36854794.14993.892.7694.6894.422.76
2366693-36669393.67694.20
3382622-38262297.74598.29
4360643-36064392.13092.65
5353312-35331290.25790.76
6373401-37340195.38995.93
45min1374324-37432495.62593.992.7696.3194.672.76
2366665-36666593.66894.35
3380856-38085697.29498.00
4358457-35845791.57292.24
5354256-35425690.49891.15
6373013-37301395.29095.99
极限1371627-37162794.93693.722.3295.7894.562.32
2367864-36786493.97594.81
3377132-37713296.34297.21
4360036-36003691.97592.80
5353829-35382990.38991.19
6370625-37062594.68095.54
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163222753221963221193219453219423220950.05
214.143204553210253207400.13
单位质量响应值RSD%判断
22746.8222683.170.20数据可信
供试品溶液-1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1177651-17765145.38346.634.6145.3846.634.62
2175358-17535844.79744.80
3180471-18047146.10346.10
4175598-17559844.85844.86
5191167-19116748.83648.84
6194848-19484849.77649.78
10min1328446-32844683.90584.632.5483.9884.712.54
2319192-31919281.54181.62
3327769-32776983.73283.81
4333941-33394185.30985.38
5334074-33407485.34385.42
6344385-34438587.97788.06
15min1373502-37350295.41596.101.5895.6396.311.58
2373653-37365395.45395.66
3381695-38169597.50897.72
4379240-37924096.88197.10
5366798-36679893.70293.93
6382100-38210097.61197.84
20min1373211-37321195.34096.561.6295.7296.941.61
2380652-38065297.24197.61
3381840-38184097.54597.92
4382187-38218797.63498.01
5367715-36771593.93694.32
6382308-38230897.66498.06
30min1374362-37436295.63597.282.7396.1797.822.72
2380666-38066697.24597.78
3398721-398721101.857102.40
4381570-38157097.47698.02
5367633-36763393.91694.45
6381757-38175797.52498.08
45min1370923-37092394.75695.812.2195.4596.522.20
2378524-37852496.69897.39
3379545-37954596.95997.67
4381047-38104797.34298.05
5359940-35994091.95092.64
6380399-38039997.17797.89
极限1372066-37206695.04895.941.5495.9096.801.54
2376698-37669896.23197.09
3378107-37810796.59197.46
4380252-38025297.13998.01
5365562-36556293.38694.23
6380569-38056997.22098.10
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163209733211443208793208343209383209540.04
214.143204913207193206050.06
单位质量响应值RSD%判断
22666.2422673.620.03数据可信
供试品溶液-1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1211236-21123654.07050.604.0554.0750.604.05
2196892-19689250.39850.40
3197042-19704250.43650.44
4201207-20120751.50251.50
5189412-18941248.48348.48
6190286-19028648.70748.71
10min1354088-35408890.63588.653.1990.7388.743.19
2334223-33422385.55085.63
3357173-35717391.42591.51
4352094-35209490.12590.21
5330806-33080684.67684.76
6349705-34970589.51389.59
15min1381677-38167797.69798.442.8697.9498.672.86
2367292-36729294.01594.24
3400231-400231102.446102.68
4391363-391363100.176100.41
5382441-38244197.89298.11
6384523-38452398.42598.66
20min1376958-37695896.48998.093.3396.8998.483.33
2363236-36323692.97793.36
3401599-401599102.796103.20
4388751-38875199.50899.91
5382785-38278597.98098.37
6385843-38584398.76399.16
30min1378118-37811896.78698.152.9597.3598.712.94
2365520-36552093.56194.10
3399274-399274102.201102.78
4389271-38927199.641100.21
5384645-38464598.45799.00
6383897-38389798.26598.82
45min1377770-37777096.69798.343.0597.4299.063.04
2364604-36460493.32794.02
3398674-398674102.048102.80
4389803-38980399.777100.51
5386671-38667198.97599.69
6387511-38751199.19099.91
极限1377589-37758996.65097.782.7797.5498.662.77
2364506-36450693.30294.15
3395771-395771101.304102.22
4388378-38837899.412100.31
5383681-38368198.21099.09
6381977-38197797.77498.66
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166426076432786443556431826429826432810.11
214.146453866460876457360.08
单位质量响应值RSD%判断
45429.4545667.330.37数据可信
供试品溶液-2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1241164-24116430.72430.705.8130.7230.705.80
2226191-22619128.81628.82
3233717-23371729.77529.78
4259570-25957033.06933.07
5229259-22925929.20729.21
6255917-25591732.60332.60
10min1500758-50075863.79666.663.4063.8566.713.40
2506990-50699064.59064.64
3519329-51932966.16266.21
4545278-54527869.46869.52
5526478-52647867.07367.12
6540448-54044868.85268.91
15min1688171-68817187.67289.892.0187.8390.052.02
2692298-69229888.19888.35
3706375-70637589.99190.15
4723713-72371392.20092.37
5703383-70338389.61089.77
6719317-71931791.64091.81
20min1750120-75012095.56496.981.7695.8797.301.77
2753131-75313195.94896.25
3749922-74992295.53995.85
4766389-76638997.63797.96
5763392-76339297.25597.56
6784652-78465299.964100.29
30min1762443-76244397.13498.002.0397.6098.482.03
2751271-75127195.71196.17
3756181-75618196.33696.81
4780175-78017599.39399.88
5773052-77305298.48698.96
6792530-792530100.967101.46
45min1759086-75908696.70798.432.1197.3399.072.11
2751218-75121895.70496.33
3772354-77235498.39799.03
4788362-788362100.436101.09
5771234-77123498.25498.89
6793537-793537101.096101.75
极限1760429-76042996.87897.871.8497.6698.671.84
2748114-74811495.30996.09
3768774-76877497.94198.73
4779380-77938099.292100.11
5764740-76474097.42798.23
6787964-787964100.386101.21
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166493396508566506266494416503536501230.11
214.146466906464956465920.03
单位质量响应值RSD%判断
45912.6445727.860.29数据可信
供试品溶液-2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1253664-25366432.12532.584.4132.1232.584.42
2252060-25206031.92131.92
3258926-25892632.79132.79
4278570-27857035.27935.28
5255015-25501532.29632.30
6245375-24537531.07531.07
10min1534261-53426167.66068.852.4467.7168.902.44
2549263-54926369.56069.61
3528890-52889066.98067.03
4563702-56370271.38971.45
5551136-55113669.79769.85
6534789-53478967.72767.78
15min1705081-70508189.29391.091.1789.4691.261.16
2720599-72059991.25891.43
3722558-72255891.50691.67
4726107-72610791.95692.13
5727178-72717892.09292.26
6714268-71426890.45790.62
20min1757111-75711195.88296.980.9296.2097.300.91
2766779-76677997.10797.43
3776644-77664498.35698.67
4762501-76250196.56596.90
5770290-77029097.55197.88
6761363-76136396.42196.74
30min1754748-75474895.58396.950.9196.0697.440.90
2764175-76417596.77797.26
3774970-77497098.14498.63
4763405-76340596.67997.17
5770644-77064497.59698.08
6765486-76548696.94397.42
45min1758807-75880796.09796.740.9296.7397.380.91
2761695-76169596.46397.11
3775399-77539998.19898.84
4756896-75689695.85596.51
5768895-76889597.37598.02
6761382-76138296.42397.06
极限1753569-75356995.43496.621.0596.2397.431.05
2759906-75990696.23697.04
3772164-77216497.78998.60
4756091-75609195.75396.57
5772380-77238097.81698.63
6763628-76362896.70897.51
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166516346522916534126526946526636525390.10
214.146540576537066538820.04
单位质量响应值RSD%判断
46083.2646243.420.25数据可信
供试品溶液-2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1250416-25041631.47833.734.0631.4833.734.06
2270380-27038033.98733.99
3275158-27515834.58834.59
4266756-26675633.53233.53
5264720-26472033.27633.28
6282670-28267035.53235.53
10min1548092-54809268.89672.052.5468.9572.112.54
2570709-57070971.73971.80
3579244-57924472.81272.87
4568395-56839571.44871.50
5588578-58857873.98574.04
6584191-58419173.43373.49
15min1724314-72431491.04792.691.6591.2192.861.65
2743017-74301793.39893.57
3736192-73619292.54092.72
4733462-73346292.19792.37
5758376-75837695.32995.51
6728770-72877091.60791.79
20min1766521-76652196.35296.650.9896.6796.980.98
2773409-77340997.21897.55
3762818-76281895.88796.22
4762336-76233695.82696.16
5781963-78196398.29498.63
6766272-76627296.32196.66
30min1768737-76873796.63196.771.2997.1197.261.29
2773354-77335497.21197.71
3762943-76294395.90396.40
4763406-76340695.96196.45
5788107-78810799.06699.57
6762365-76236595.83096.32
45min1763447-76344795.96696.371.4296.6197.021.41
2767354-76735496.45797.11
3756077-75607795.04095.69
4763896-76389696.02396.67
5787390-78739098.97699.64
6761723-76172395.74996.40
极限1766921-76692196.40396.031.3097.2096.841.30
2767780-76778096.51197.33
3753387-75338794.70295.51
4754142-75414294.79695.60
5779891-77989198.03398.86
6761549-76154995.72796.54
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