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%
134.262860632862152861252864672864332862610.07
234.252880142888112884120.20
单位质量响应值RSD%判断
8355.558420.790.55数据可信
中间条件24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%
5min1293756-29375693.73191.504.4193.7391.504.41
2293368-29336893.60893.61
3296030-29603094.45794.46
4296377-29637794.56894.57
5270589-27058986.33986.34
6270467-27046786.30086.30
10min1308276-30827698.36499.292.0998.8999.802.08
2301123-30112396.08296.60
3317774-317774101.395101.92
4318687-318687101.686102.21
5310486-31048699.07099.55
6310773-31077399.16199.64
15min1-0.0000.00-1.071.062.61
2-0.0001.05
3-0.0001.09
4-0.0001.09
5-0.0001.03
6-0.0001.03
20min1-0.0000.00-1.071.062.61
2-0.0001.05
3-0.0001.09
4-0.0001.09
5-0.0001.03
6-0.0001.03
30min1-0.0000.00-1.071.062.61
2-0.0001.05
3-0.0001.09
4-0.0001.09
5-0.0001.03
6-0.0001.03
45min1-0.0000.00-1.071.062.61
2-0.0001.05
3-0.0001.09
4-0.0001.09
5-0.0001.03
6-0.0001.03
60min1-0.0000.00-1.071.062.61
2-0.0001.05
3-0.0001.09
4-0.0001.09
5-0.0001.03
6-0.0001.03
极限1-0.0000.00-1.071.062.61
2-0.0001.05
3-0.0001.09
4-0.0001.09
5-0.0001.03
6-0.0001.03
他达拉非达泊西汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.097489475033748837513874962749820.15
210.127570375598756500.10
单位质量响应值RSD%判断
7431.327475.300.42数据可信
中间条件24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%
5min175029-75029100.596101.442.06100.60101.442.06
274758-74758100.232100.23
377671-77671104.138104.14
477619-77619104.068104.07
574368-7436899.71099.71
674519-7451999.91299.91
10min178964-78964105.872109.732.94106.07109.932.93
282939-82939111.201111.40
379992-79992107.250107.46
480271-80271107.624107.83
584369-84369113.118113.32
684501-84501113.295113.50
15min1-0.0000.00-0.410.421.79
2-0.0000.42
3-0.0000.42
4-0.0000.42
5-0.0000.43
6-0.0000.43
20min1-0.0000.00-0.410.421.79
2-0.0000.42
3-0.0000.42
4-0.0000.42
5-0.0000.43
6-0.0000.43
30min1-0.0000.00-0.410.421.79
2-0.0000.42
3-0.0000.42
4-0.0000.42
5-0.0000.43
6-0.0000.43
45min1-0.0000.00-0.410.421.79
2-0.0000.42
3-0.0000.42
4-0.0000.42
5-0.0000.43
6-0.0000.43
60min1-0.0000.00-0.410.421.79
2-0.0000.42
3-0.0000.42
4-0.0000.42
5-0.0000.43
6-0.0000.43
极限1-0.0000.00-0.410.421.79
2-0.0000.42
3-0.0000.42
4-0.0000.42
5-0.0000.43
6-0.0000.43
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%
134.262879522884802885962882572884542883480.09
234.252875782878412877100.07
单位质量响应值RSD%判断
8416.468400.290.14数据可信
中间条件24月-供试品溶液-2023062021批-达泊西汀-shui(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%
5min1223681-22368171.19981.9114.1371.2081.9114.13
2310209-31020998.74298.74
3216087-21608768.78268.78
4243166-24316677.40277.40
5267548-26754885.16385.16
6283256-28325690.16390.16
10min1267133-26713385.03094.429.1585.4394.879.17
2336818-336818107.212107.76
3277745-27774588.40888.79
4277135-27713588.21488.64
5316490-316490100.741101.21
6304453-30445396.91097.41
15min1292996-29299693.26396.635.0994.1397.615.13
2334761-334761106.557107.70
3298129-29812994.89795.77
4297597-29759794.72795.65
5298079-29807994.88195.91
6299900-29990095.46096.50
20min1299307-29930795.27298.013.0996.6699.533.15
2325223-325223103.521105.26
3301678-30167896.02697.43
4312001-31200199.312100.76
5305481-30548197.23798.80
6303833-30383396.71298.28
30min1303032-30303296.45798.953.0898.37101.013.15
2325722-325722103.680105.99
3308802-30880298.294100.23
4299766-29976695.41897.42
5317785-317785101.153103.25
6310094-31009498.705100.81
45min1302383-30238396.25199.173.0798.70101.783.06
2323778-323778103.061105.95
3313973-31397399.940102.42
4321191-321191102.238104.77
5306053-30605397.419100.08
6301935-30193596.10898.76
60min1308076-30807698.06399.232.85101.05102.392.84
2324539-324539103.303106.76
3311077-31107799.018102.05
4320137-320137101.902105.00
5304650-30465096.972100.18
6302000-30200096.12999.32
极限1303920-30392096.74098.723.44100.27102.433.39
2321451-321451102.320106.35
3310016-31001698.680102.27
4324343-324343103.241106.90
5303255-30325596.528100.27
6297826-29782694.80098.52
他达拉非达泊西汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.097628076243760827643776373762830.18
210.127541375219753160.19
单位质量响应值RSD%判断
7560.267442.291.12数据可信
中间条件24月-供试品溶液-2023062021批-他达拉非-shui(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%
5min141861-4186155.77068.5914.1255.7768.5914.12
259252-5925278.93978.94
344140-4414058.80658.81
451234-5123468.25768.26
553716-5371671.56371.56
658697-5869778.19978.20
10min162377-6237783.10295.109.9683.2195.249.96
277962-77962103.865104.02
366238-6623888.24688.36
466526-6652688.63088.77
578158-78158104.126104.27
677045-77045102.644102.80
15min173172-7317297.484102.045.1297.76102.375.14
281206-81206108.187108.55
373711-7371198.20298.50
472494-7249496.58196.89
578506-78506104.590104.94
680476-80476107.215107.58
20min176698-76698102.181105.253.84102.65105.783.87
280691-80691107.501108.08
375266-75266100.274100.76
477062-77062102.666103.17
581859-81859109.057109.62
682450-82450109.844110.42
30min179398-79398105.778107.932.66106.46108.672.66
280503-80503107.251108.05
378817-78817105.004105.70
483170-83170110.804111.52
580034-80034106.626107.40
684136-84136112.091112.89
45min180479-80479107.219108.821.51108.11109.771.51
280032-80032106.623107.63
381473-81473108.543109.44
482357-82357109.721110.65
582701-82701110.179111.17
683030-83030110.617111.64
60min181866-81866109.066109.281.99110.17110.451.99
280036-80036106.628107.85
380808-80808107.657108.78
481663-81663108.796109.95
584508-84508112.586113.80
683266-83266110.932112.17
极限180711-80711107.528108.101.61108.85109.501.59
279092-79092105.371106.81
380533-80533107.291108.62
482748-82748110.242111.61
582015-82015109.265110.70
681764-81764108.931110.39
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%
134.262862142865162866162864752863142864270.06
234.252913982921052917520.18
单位质量响应值RSD%判断
8360.398518.311.33数据可信
中间条件24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%
5min1157936-15793650.09268.1620.4550.0968.1620.45
2201045-20104563.76563.76
3173214-17321454.93854.94
4254477-25447780.71280.71
5262562-26256283.27683.28
6240180-24018076.17776.18
10min1212998-21299867.55685.0314.1467.8385.4014.17
2279743-27974388.72589.08
3231411-23141173.39673.70
4300089-30008995.17895.63
5307712-30771297.59698.06
6276528-27652887.70688.13
15min1232872-23287273.85990.0311.2974.5190.8811.34
2293405-29340593.05893.91
3257354-25735481.62482.34
4305519-30551996.90197.88
5316890-316890100.507101.51
6297174-29717494.25495.16
20min1252840-25284080.19292.318.4981.2693.668.57
2300286-30028695.24196.60
3270504-27050485.79586.96
4301007-30100795.46996.98
5320924-320924101.786103.35
6300679-30067995.36596.80
30min1281497-28149789.28296.294.6490.7998.164.79
2304205-30420596.48498.38
3294102-29410293.27994.92
4308565-30856597.86799.91
5321515-321515101.974104.10
6311765-31176598.882100.85
45min1282496-28249689.59895.883.4591.6098.283.59
2300859-30085995.42397.85
3304741-30474196.65498.82
4305701-30570196.95899.55
5312345-31234599.065101.76
6307697-30769797.591100.10
60min1295338-29533893.67196.802.4396.1799.732.47
2299780-29978095.08098.04
3314485-31448599.744102.44
4301844-30184495.73598.86
5311624-31162498.837102.08
6308137-30813797.731100.79
极限1288668-28866891.55695.742.9794.5899.213.13
2299099-29909994.86498.35
3300868-30086895.42598.68
4303701-30370196.32499.98
5316537-316537100.395104.19
6302381-30238195.90599.50
他达拉非达泊西汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.097502475160752347501074956750770.16
210.127640976518764640.11
单位质量响应值RSD%判断
7440.737555.731.09数据可信
中间条件24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%
5min135722-3572247.61068.5921.8047.6168.5921.80
251532-5153268.68168.68
340904-4090454.51754.52
464809-6480986.37786.38
560011-6001179.98279.98
655798-5579874.36774.37
10min156771-5677175.66495.4713.7275.7695.6113.73
276370-76370101.785101.92
363952-6395285.23585.34
483339-83339111.074111.25
578214-78214104.243104.40
671164-7116494.84795.00
15min165581-6558187.406103.9510.9987.65104.2811.00
283628-83628111.459111.80
369290-6929092.34992.63
486278-86278114.991115.39
583902-83902111.824112.19
679300-79300105.690106.03
20min172786-7278697.009107.717.5697.43108.247.59
285714-85714114.239114.80
373522-7352297.99098.45
485026-85026113.322113.95
585904-85904114.492115.08
681926-81926109.190109.74
30min181523-81523108.653112.883.22109.27113.633.27
286520-86520115.313116.11
380941-80941107.878108.54
487074-87074116.052116.90
585711-85711114.235115.06
686379-86379115.125115.89
45min182130-82130109.462112.301.78110.29113.271.83
285419-85419113.846114.87
383796-83796111.683112.56
486024-86024114.652115.74
583110-83110110.768111.82
685059-85059113.366114.36
60min186065-86065114.707113.281.61115.76114.481.53
284777-84777112.990114.24
386675-86675115.520116.62
484721-84721112.916114.23
582712-82712110.238111.51
684997-84997113.283114.51
极限184069-84069112.047112.031.43113.33113.461.46
284369-84369112.446113.92
382618-82618110.113111.44
486138-86138114.804116.34
583891-83891111.809113.30
683270-83270110.982112.43
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%
134.262885262891532887152888532885022887500.10
234.252899442896332897880.08
单位质量响应值RSD%判断
8428.208460.960.28数据可信
中间条件24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%
5min1172500-17250054.67370.3417.7354.6770.3417.74
2226372-22637271.74771.75
3179060-17906056.75256.75
4271263-27126385.97585.98
5252689-25268980.08880.09
6229681-22968172.79672.80
10min1232456-23245673.67682.5611.2273.9882.9511.25
2278645-27864588.31588.71
3217666-21766668.98869.30
4289005-28900591.59892.08
5282861-28286189.65190.10
6262262-26226283.12283.53
15min1287035-28703590.97487.307.9091.6988.157.91
2285334-28533490.43591.32
3235917-23591774.77275.47
4293489-29348993.02094.01
5286551-28655190.82191.76
6264397-26439783.79984.67
20min1296069-29606993.83791.276.8695.0692.606.89
2294025-29402593.18994.58
3248677-24867778.81779.93
4300303-30030395.17996.68
5300287-30028795.17496.62
6288449-28844991.42292.75
30min1305108-30510896.70293.315.1098.4495.155.14
2295173-29517393.55395.46
3264516-26451683.83785.39
4301778-30177895.64797.68
5300447-30044795.22597.20
6299419-29941994.89996.74
45min1305869-30586996.94394.523.1699.2296.883.23
2296814-29681494.07396.50
3280388-28038888.86790.88
4302139-30213995.76198.32
5298952-29895294.75197.26
6305151-30515196.71699.08
60min1306985-30698597.29794.902.10100.1197.781.92
2289307-28930791.69494.65
3304121-30412196.38998.90
4296610-29661094.00997.10
5297950-29795094.43397.47
6301518-30151895.56498.47
极限1302898-30289896.00294.432.9999.3697.842.70
2290760-29076092.15595.62
3313084-31308499.230102.28
4288982-28898291.59195.21
5294772-29477293.42696.98
6297069-29706994.15497.59
他达拉非达泊西汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.097560075929758327556875685757230.21
210.127569375892757920.19
单位质量响应值RSD%判断
7504.767489.330.15数据可信
中间条件24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%
5min141988-4198855.96768.5617.6955.9768.5617.69
251655-5165568.85268.85
342169-4216956.20856.21
464162-6416285.52385.52
559782-5978279.68579.69
648840-4884065.10065.10
10min162631-6263183.48391.7312.4183.5991.8612.41
273717-7371798.25998.40
357611-5761176.79176.90
477560-77560103.382103.55
577504-77504103.307103.47
663879-6387985.14685.28
15min177171-77171102.86399.5210.07103.1499.8410.08
278432-78432104.544104.88
363443-6344384.56584.83
480778-80778107.671108.05
581084-81084108.079108.45
667084-6708489.41889.72
20min180962-80962107.916105.478.81108.40105.998.82
282291-82291109.688110.23
367156-6715689.51489.95
483737-83737111.615112.21
585875-85875114.465115.05
674740-7474099.623100.10
30min183817-83817111.722109.066.82112.42109.786.84
284729-84729112.938113.70
371474-7147495.27095.88
485026-85026113.333114.15
586328-86328115.069115.88
679523-79523105.998106.68
45min183528-83528111.337109.944.50112.26110.904.54
283663-83663111.517112.51
375532-75532100.679101.48
485258-85258113.643114.69
585502-85502113.968115.01
681419-81419108.526109.42
60min183412-83412111.182110.422.04112.33111.592.07
281541-81541108.688109.90
382279-82279109.672110.68
483658-83658111.510112.78
585428-85428113.869115.14
680724-80724107.599108.71
极限182700-82700110.233110.162.44111.60111.552.39
281801-81801109.035110.46
385566-85566114.053115.28
481353-81353108.438109.93
584344-84344112.424113.92
680098-80098106.765108.09
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%
134.262908492907152907832905132899802905680.13
234.252905542902832904180.07
单位质量响应值RSD%判断
8481.268479.360.02数据可信
中间条件24月-供试品溶液-2023062021批-达泊西汀
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1158268-15826849.95160.8918.1849.9560.8918.18
2209546-20954666.13466.13
3157847-15784749.81849.82
4187321-18732159.12059.12
5193331-19333161.01761.02
6251319-25131979.31879.32
10min1235581-23558174.35177.6812.7574.6378.0212.77
2257614-25761481.30581.67
3209139-20913966.00666.28
4227373-22737371.76172.09
5246534-24653477.80878.15
6300503-30050394.84195.28
15min1257147-25714781.15783.079.2881.8583.849.32
2283719-28371989.54490.36
3230023-23002372.59773.24
4244130-24413077.04977.78
5268976-26897684.89185.66
6295177-29517793.16094.13
20min1270527-27052785.38086.717.9386.5287.937.98
2290983-29098391.83693.15
3246881-24688177.91778.96
4252491-25249179.68880.84
5286879-28687990.54191.78
6300593-30059394.86996.35
30min1296252-29625293.49992.136.2595.1293.846.28
2308973-30897397.51499.34
3269176-26917684.95486.43
4269153-26915384.94786.54
5307467-30746797.03998.78
6300476-30047694.83296.84
45min1306642-30664296.77894.692.3198.9196.922.33
2303516-30351695.79298.16
3297299-29729993.83095.78
4288641-28864191.09793.17
5306421-30642196.70998.99
6297683-29768393.95196.49
60min1321098-321098101.34194.794.51104.0197.544.42
2300177-30017794.73897.64
3299414-29941494.49796.97
4278883-27888388.01890.59
5304608-30460896.13798.96
6297849-29784994.00397.06
极限1307460-30746097.03792.782.97100.2796.062.99
2297711-29771193.96097.39
3285952-28595290.24993.25
4283211-28321189.38392.45
5293859-29385992.74496.10
6295604-29560493.29596.88
他达拉非达泊西汀片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.097625176114761547612676106761500.08
210.127604475898759710.14
单位质量响应值RSD%判断
7547.087507.020.38数据可信
中间条件24月-供试品溶液-2023062021批-他达拉非
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137509-3750949.79864.4819.2049.8064.4819.20
251040-5104067.76267.76
338797-3879751.50851.51
453794-5379471.41871.42
548152-4815263.92863.93
662095-6209582.43982.44
10min162659-6265983.18790.4813.1083.2990.6113.11
269115-6911591.75991.89
356767-5676775.36575.47
470627-7062793.76693.91
566485-6648588.26788.39
683275-83275110.558110.72
15min170067-7006793.02298.158.8393.2998.468.85
276586-76586101.677102.00
363901-6390184.83685.09
476242-76242101.221101.55
573632-7363297.75598.06
683143-83143110.382110.77
20min173416-7341697.469102.757.0497.92103.267.06
279185-79185105.128105.65
369028-6902891.64392.07
478855-78855104.690105.22
579154-79154105.087105.59
684730-84730112.489113.10
30min180005-80005106.216109.274.89106.86109.984.91
285321-85321113.274114.01
375257-7525799.913100.52
483242-83242110.514111.26
585791-85791113.898114.61
684203-84203111.790112.62
45min182282-82282109.239112.012.91110.10112.942.91
283315-83315110.611111.57
383197-83197110.454111.26
488952-88952118.095119.06
585268-85268113.204114.14
683215-83215110.478111.53
60min185430-85430113.419111.371.26114.50112.531.20
282626-82626109.696110.88
383936-83936111.435112.46
483924-83924111.419112.62
584577-84577112.286113.45
682847-82847109.989111.27
极限181590-81590108.321108.912.02109.63110.282.04
281444-81444108.127109.53
380062-80062106.292107.54
485009-85009112.860114.28
581621-81621108.362109.75
682465-82465109.482110.98
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