他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212904902909632905322907112905252906440.07
234.162840092844312842200.11
单位质量响应值RSD%判断
8495.888320.261.48数据可信
加速6月-供试品溶液-2023062021批-达泊西汀-水(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1188558-18855860.02866.317.9160.0366.317.91
2222504-22250470.83570.83
3205870-20587065.53965.54
4219075-21907569.74369.74
5224769-22476971.55671.56
6189036-18903660.18060.18
10min1238211-23821175.83580.744.7476.1781.104.74
2268508-26850885.48185.87
3245262-24526278.08078.44
4246038-24603878.32778.71
5261135-26113583.13383.53
6262482-26248283.56283.90
15min1265912-26591284.65486.724.7685.4187.544.73
2279101-27910188.85389.72
3250301-25030179.68480.48
4275841-27584187.81588.64
5275367-27536787.66488.52
6287977-28797791.67992.48
20min1286220-28622091.11989.034.3792.3490.324.33
2276268-27626887.95189.31
3257352-25735281.92983.17
4280606-28060689.33290.64
5292429-29242993.09694.44
6285019-28501990.73792.04
30min1290982-29098292.63590.922.7094.3792.712.68
2290284-29028492.41394.26
3278489-27848988.65890.35
4287693-28769391.58893.39
5292456-29245693.10494.97
6273585-27358587.09788.91
45min1312423-31242399.46195.412.44101.7197.712.38
2298996-29899695.18697.55
3296294-29629494.32696.51
4296833-29683394.49896.81
5302603-30260396.33598.72
6291018-29101892.64794.94
60min1323028-323028102.83796.873.29105.6499.703.19
2297899-29789994.83797.73
3301478-30147895.97798.69
4295490-29549094.07096.91
5307306-30730697.832100.75
6300507-30050795.66898.48
极限1321125-321125102.23197.882.73105.60101.252.68
2309185-30918598.430101.85
3300438-30043895.64698.89
4297506-29750694.71298.08
5310774-31077498.936102.40
6305719-30571997.327100.67
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.487834178519784487852778574784820.12
210.077659876722766600.12
单位质量响应值RSD%判断
7488.747612.711.17数据可信
加速6月-供试品溶液-2023062021批-他达拉非-水(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141723-4172349.70057.769.2749.7057.769.27
250083-5008359.65859.66
348793-4879358.12158.12
452783-5278362.87462.87
552906-5290663.02163.02
644668-4466853.20853.21
10min158673-5867369.89076.794.8570.1777.114.85
266249-6624978.91579.25
364765-6476577.14777.47
463475-6347575.61075.96
566690-6669079.44079.79
666926-6692679.72180.02
15min166557-6655779.28284.404.9779.9585.154.95
269638-6963882.95283.72
367803-6780380.76681.52
474996-7499689.33490.10
571380-7138085.02785.82
674760-7476089.05389.79
20min172240-7224086.05188.355.1487.1689.575.10
269578-6957882.88084.11
370648-7064884.15585.35
477365-7736592.15693.42
576715-7671591.38292.65
678482-7848293.48794.72
30min172999-7299986.95590.453.2888.5492.163.28
273955-7395588.09489.79
377217-7721791.98093.65
479742-7974294.98796.77
576921-7692191.62793.40
674767-7476789.06190.81
45min178799-7879993.86495.153.1895.9397.363.14
276486-7648691.10993.29
382961-8296198.822101.00
482836-8283698.673100.98
579061-7906194.17696.46
679112-7911294.23796.48
60min181469-8146997.04596.633.8299.6399.373.73
276223-7622390.79693.48
385487-85487101.831104.56
482293-8229398.026100.88
579410-7941094.59297.40
681846-8184697.494100.26
极限182172-8217297.88298.482.43101.01101.762.39
279867-7986795.13698.33
385729-85729102.119105.41
482743-8274398.562101.96
581614-8161497.217100.55
683913-8391399.956103.27
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212926762922462921282917852920762921820.12
234.162855062862142858600.18
单位质量响应值RSD%判断
8540.848368.271.45数据可信
加速6月-供试品溶液-2023062021批-达泊西汀-pH1.0(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193736-19373661.33778.1814.6361.3478.1814.63
2292053-29205392.46592.46
3243946-24394677.23477.23
4266627-26662784.41584.41
5267298-26729884.62784.63
6217895-21789568.98668.99
10min1264015-26401583.58893.538.0483.9393.968.07
2320078-320078101.337101.85
3290885-29088592.09592.52
4314629-31462999.612100.08
5311448-31144898.60599.08
6271436-27143685.93786.32
15min1296242-29624293.79198.783.8694.6099.743.93
2326321-326321103.314104.39
3310470-31047098.29599.24
4320505-320505101.472102.49
5318763-318763100.921101.94
6299779-29977994.91195.77
20min1297864-29786494.30498.943.9995.63100.444.06
2326122-326122103.251104.90
3313315-31331599.196100.68
4321253-321253101.709103.30
5319687-319687101.213102.79
6296738-29673893.94895.34
30min1303945-30394596.23099.463.4498.08101.513.49
2323256-323256102.343104.57
3323019-323019102.268104.31
4315808-31580899.985102.14
5320994-320994101.627103.77
6297823-29782394.29196.20
45min1315220-31522099.79999.883.38102.18102.493.42
2331793-331793105.046107.84
3314065-31406599.434102.04
4318514-318514100.842103.55
5314886-31488699.693102.40
6298429-29842994.48396.92
60min1310413-31041398.27799.813.73101.22102.973.76
2326180-326180103.269106.65
3316487-316487100.200103.36
4327228-327228103.601106.87
5315882-315882100.009103.27
6295245-29524593.47596.43
极限1306657-30665797.08897.972.57100.57101.682.65
2317073-317073100.386104.34
3310943-31094398.445102.16
4312009-31200998.783102.63
5314935-31493599.709103.52
6294953-29495393.38396.86
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.487895478906789087884778818788870.07
210.077701677387772020.34
单位质量响应值RSD%判断
7527.397666.531.30数据可信
加速6月-供试品溶液-2023062021批-他达拉非-pH1.0(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138549-3854945.64060.9015.6445.6460.9015.64
261561-6156172.88572.89
352767-5276762.47462.47
451798-5179861.32661.33
557083-5708367.58467.58
646867-4686755.48855.49
10min161572-6157272.89883.688.2873.1584.028.30
276451-7645190.51590.92
368604-6860481.22481.57
474829-7482988.59488.93
575335-7533589.19389.57
667288-6728879.66679.97
15min173530-7353087.05692.853.8487.7193.663.90
281118-8111896.04096.95
376804-7680490.93291.73
480548-8054895.36596.20
580934-8093495.82296.69
677624-7762491.90392.65
20min175885-7588589.84494.973.4390.9996.293.49
282392-8239297.54898.99
378493-7849392.93294.24
482447-8244797.61398.98
582601-8260197.79699.20
679456-7945694.07295.33
30min179645-7964594.29697.332.0195.9499.182.08
282897-8289798.146100.13
382109-8210997.21399.03
481976-8197697.05698.96
584727-84727100.313102.26
681889-8188996.95398.74
45min183655-8365599.04498.432.07101.21100.822.07
285164-85164100.830103.36
380018-8001894.73897.10
482936-8293698.192100.64
583932-8393299.372101.88
683110-8311098.398100.72
60min182973-8297398.23698.071.47100.95101.001.50
283596-8359698.974102.06
380627-8062795.45998.34
483008-8300898.278101.27
584192-8419299.679102.74
682594-8259497.788100.66
极限181501-8150196.49396.572.2899.75100.052.25
281157-8115796.08699.72
378823-7882393.32396.74
481060-8106095.97199.51
584506-84506100.051103.66
682355-8235597.505100.92
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212907512907812904852908422904992906720.06
234.162871962869692870820.06
单位质量响应值RSD%判断
8496.708404.040.78数据可信
加速6月-供试品溶液-2023062021批-达泊西汀-pH4.5(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1245596-24559677.78971.3515.3377.7971.3515.33
2157080-15708049.75349.75
3252736-25273680.05080.05
4233150-23315073.84773.85
5230648-23064873.05473.05
6232348-23234873.59373.59
10min1280994-28099489.00182.4912.5889.4382.8912.59
2196390-19639062.20462.48
3269719-26971985.42985.87
4258598-25859881.90782.32
5271394-27139485.96086.37
6285539-28553990.44090.85
15min1291801-29180192.42485.6611.7993.3586.5111.81
2208421-20842166.01466.64
3279004-27900488.37089.29
4266715-26671584.47885.34
5283196-28319689.69890.58
6293456-29345692.94893.86
20min1286549-28654990.76087.488.7992.2088.818.85
2228650-22865072.42173.41
3282109-28210989.35490.76
4275922-27592287.39488.73
5287465-28746591.05092.43
6296504-29650493.91395.34
30min1290280-29028091.94289.858.0693.8991.678.12
2239649-23964975.90577.30
3282977-28297789.62991.54
4288492-28849291.37693.20
5295343-29534393.54595.43
6305350-30535096.71598.66
45min1292673-29267392.70090.575.5795.1592.885.67
2257985-25798581.71383.53
3277512-27751287.89890.30
4288992-28899291.53493.86
5297860-29786094.34396.75
6300598-30059895.21097.70
60min1291969-29196992.47793.193.9195.4596.004.03
2275062-27506287.12289.39
3291128-29112892.21095.10
4305156-30515696.65499.49
5295195-29519593.49996.43
6306750-30675097.158100.17
极限1300218-30021895.09093.891.8798.5797.221.95
2293353-29335392.91595.67
3288328-28832891.32494.73
4294579-29457993.30496.68
5298056-29805694.40597.86
6303967-30396796.27799.83
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.487855578561785627839678531785210.10
210.077699477026770100.03
单位质量响应值RSD%判断
7492.467647.471.45数据可信
加速6月-供试品溶液-2023062021批-他达拉非-pH4.5(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157395-5739568.19763.4514.9668.2063.4514.95
238947-3894746.27746.28
362922-6292274.76474.76
455107-5510765.47865.48
552994-5299462.96862.97
653037-5303763.01963.02
10min173732-7373287.60881.5510.6087.9981.9010.62
254433-5443364.67764.93
373495-7349587.32787.74
469227-6922782.25682.62
568700-6870081.62981.98
672201-7220185.78986.14
15min178986-7898693.85186.439.9494.7287.249.96
259093-5909370.21470.83
377349-7734991.90692.81
471644-7164485.12885.95
572961-7296186.69287.50
676431-7643190.81591.64
20min178160-7816092.87088.936.7694.2690.226.82
265114-6511477.36978.38
378498-7849893.27194.68
474558-7455888.59089.88
574933-7493389.03590.32
677814-7781492.45993.79
30min179423-7942394.37191.465.7996.2793.245.87
268225-6822581.06582.50
379119-7911994.00995.94
478173-7817392.88594.67
576675-7667591.10592.88
680222-8022295.32097.16
45min180015-8001595.07492.192.9997.5094.473.11
273248-7324887.03388.92
377232-7723291.76794.22
478329-7832993.07195.37
577965-7796592.63894.92
678719-7871993.53495.91
60min179602-7960294.58394.742.6297.5497.542.66
277890-7789092.54994.92
381097-8109796.36099.32
482626-8262698.176101.00
576941-7694191.42194.22
680247-8024795.35098.24
极限181930-8193097.34995.562.41100.8398.892.22
283339-8333999.024101.91
380287-8028795.39798.89
479656-7965694.64798.01
577903-7790392.56495.87
679452-7945294.40597.83
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212940622942472939462939542934672939350.10
234.162872902874562873730.05
单位质量响应值RSD%判断
8592.088412.561.50数据可信
加速6月-供试品溶液-2023062021批-达泊西汀-pH6.8(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1233101-23310173.38664.2419.0873.3964.2519.08
2172853-17285354.41954.42
3201057-20105763.29863.30
4194076-19407661.10061.10
5264260-26426083.19683.20
6159035-15903550.06850.07
10min1294094-29409492.58882.1911.5793.0082.5511.60
2232794-23279473.28973.59
3248259-24825978.15878.51
4260536-26053682.02382.36
5300489-30048994.60295.06
6230305-23030572.50672.78
15min1304887-30488795.98688.397.2796.9189.207.33
2258476-25847681.37582.08
3262227-26222782.55683.34
4285692-28569289.94390.74
5303436-30343695.52996.52
6269791-26979184.93785.62
20min1318497-318497100.27192.406.38101.7393.706.42
2268966-26896684.67785.84
3275563-27556386.75488.00
4301141-30114194.80796.10
5305379-30537996.14197.66
6291380-29138091.73492.89
30min1294094-29409492.58895.935.6894.6097.755.58
2289342-28934291.09292.72
3286832-28683290.30292.03
4325960-325960102.620104.44
5308325-30832597.06999.12
6323765-323765101.929103.59
45min1301892-30189295.04399.545.6397.57101.905.45
2305493-30549396.17798.32
3308797-30879797.21799.45
4319887-319887100.709103.10
5310747-31074797.831100.42
6350316-350316110.288112.52
60min1302246-30224695.155100.105.5198.21103.005.35
2304312-30431295.80598.48
3313163-31316398.592101.36
4320164-320164100.796103.75
5317177-31717799.855102.99
6350632-350632110.388113.23
极限1310987-31098797.907100.884.94101.49104.344.78
2309306-30930697.377100.58
3319562-319562100.606103.92
4318238-318238100.189103.70
5312894-31289498.507102.20
6351672-351672110.715114.17
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.487928679305794277936379318793400.08
210.077778477777777800.01
单位质量响应值RSD%判断
7570.617723.931.42数据可信
加速6月-供试品溶液-2023062021批-他达拉非-pH6.8(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159769-5976970.29958.2621.1670.3058.2621.16
242530-4253050.02350.02
348681-4868157.25857.26
448293-4829356.80156.80
562968-6296874.06274.06
634955-3495541.11441.11
10min181067-8106795.35080.0314.7395.7480.3514.75
262314-6231473.29373.57
364395-6439575.74076.06
468245-6824580.26980.58
577914-7791491.64192.05
654316-5431663.88664.11
15min185361-85361100.40086.8610.67101.3287.6310.72
270113-7011382.46683.15
368494-6849480.56281.30
475149-7514988.38989.15
579951-7995194.03794.96
664048-6404875.33275.92
20min189119-89119104.82090.739.70106.3091.989.75
273737-7373786.72887.87
372030-7203084.72185.91
479241-7924193.20294.45
580604-8060494.80596.25
668085-6808580.08181.08
30min182135-8213596.60694.185.2798.6795.945.32
280038-8003894.13995.76
374954-7495488.16089.82
486071-86071101.235103.01
581650-8165096.03598.01
675613-7561388.93590.38
45min183693-8369398.43896.902.37101.0499.182.46
284415-8441599.288101.44
380485-8048594.66596.81
484021-8402198.824101.16
581872-8187296.29798.80
679808-7980893.86995.81
60min183928-8392898.71597.322.25101.86100.132.39
283980-8398098.776101.48
381593-8159395.96898.64
483901-8390198.683101.56
583595-8359598.323101.36
679442-7944293.43895.90
极限186250-86250101.44697.852.94105.14101.213.02
285320-85320100.352103.60
382918-8291897.527100.73
483190-8319097.847101.28
582161-8216196.637100.22
679339-7933993.31796.30
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原始图谱下载图谱(邵涛明 于 2024-01-18 11:21:38 完成)
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