替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.455040150351503485026650408503550.12
213.435030850266502870.06
单位质量响应值RSD%判断
3743.873744.380.01数据可信
供试品溶液-F94945批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138433-3843373.68570.294.4873.6970.294.48
236923-3692370.79070.79
335826-3582668.68768.69
437440-3744071.78271.78
537538-3753871.97071.97
633804-3380464.81164.81
10min145419-4541987.07986.522.9187.4986.922.91
245099-4509986.46686.86
344024-4402484.40584.79
447224-4722490.54090.94
545536-4553687.30487.70
643473-4347383.34883.71
15min149398-4939894.70894.984.7195.6095.854.69
248720-4872093.40894.28
347511-4751191.09091.94
452694-52694101.027101.93
551946-5194699.593100.48
646968-4696890.04990.87
20min149190-4919094.30995.542.8195.7396.942.82
249281-4928194.48495.88
349161-4916194.25495.61
452196-52196100.073101.54
550777-5077797.35298.79
648377-4837792.75194.07
30min151832-5183299.37598.801.80101.32100.741.83
251714-5171499.148101.07
350715-5071597.23399.11
452809-52809101.248103.27
551916-5191699.536101.51
650223-5022396.29098.13
45min151237-5123798.23499.921.68100.73102.401.66
252406-52406100.475102.94
350806-5080697.40899.83
452802-52802101.234103.82
552794-52794101.219103.75
652653-52653100.949103.32
60min154298-54298104.103100.092.70107.14103.122.67
251334-5133498.420101.45
350476-5047696.77599.74
453252-53252102.097105.24
552448-52448100.556103.65
651413-5141398.571101.51
90min151794-5179499.30299.882.49102.92103.462.40
253702-53702102.960106.53
350028-5002895.91699.42
451969-5196999.637103.35
551812-5181299.336102.99
653253-53253102.099105.58
120min152571-52571100.79199.051.19104.96103.201.20
251315-5131598.383102.53
351442-5144298.627102.66
451854-5185499.417103.68
552006-5200699.708103.91
650803-5080397.402101.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限150806-5080697.40898.301.71102.14103.001.68
250563-5056396.942101.63
350229-5022996.301100.88
451976-5197699.651104.47
552452-52452100.563105.32
651618-5161898.964103.55
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所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1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.061752871752051753771752311754691753140.07
211.081753291753051753170.01
单位质量响应值RSD%判断
15851.1815822.830.13数据可信
供试品溶液-F94945批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112404-124047.0498.0522.917.058.0522.91
216832-168329.5659.57
311239-112396.3876.39
411436-114366.4996.50
519285-1928510.95910.96
613761-137617.8207.82
10min131194-3119417.72720.2915.4817.7720.3315.49
242342-4234224.06324.12
329734-2973416.89816.93
434257-3425719.46819.50
542607-4260724.21324.27
634049-3404919.35019.39
15min151122-5112229.05231.6713.5929.1931.8213.61
264712-6471236.77536.96
346006-4600626.14526.27
455652-5565231.62631.77
564573-6457336.69636.89
652271-5227129.70529.86
20min165579-6557937.26840.3011.7237.5740.6411.74
280771-8077145.90146.29
359274-5927433.68533.96
471218-7121840.47240.79
579836-7983645.37045.77
668844-6884439.12339.44
30min191139-9113951.79355.2911.3252.3055.8511.34
2112297-11229763.81764.46
383692-8369247.56148.02
493911-9391153.36953.91
5108904-10890461.88962.54
693851-9385153.33553.87
45min1110808-11080862.97169.5413.3363.7670.4113.32
2138505-13850578.71179.71
3100922-10092257.35358.08
4116481-11648166.19567.04
5143276-14327681.42282.42
6124230-12423070.59971.43
60min1133150-13315075.66878.9311.8776.8180.1811.88
2153793-15379387.39988.84
3114331-11433164.97366.02
4132466-13246675.27976.49
5160302-16030291.09892.55
6139283-13928379.15380.37
90min1148539-14853984.41392.326.8685.9894.016.94
2174557-17455799.199101.12
3152624-15262486.73588.14
4157277-15727789.37991.01
5173684-17368498.703100.66
6168045-16804595.49897.16
120min1167670-16767095.28596.112.6597.3298.312.73
2170006-17000696.61399.09
3170499-17049996.89398.78
4164005-16400593.20295.33
5176759-176759100.450102.95
6165788-16578894.21696.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1165994-16599494.33396.992.4996.9099.722.57
2168810-16881095.93398.94
3170687-17068797.00099.43
4170064-17006496.64699.29
5178627-178627101.512104.57
6169808-16980896.50099.22
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.455028850208502125025150228502370.07
213.435044850366504070.12
单位质量响应值RSD%判断
3735.093753.310.35数据可信
供试品溶液-23H1439批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135923-3592368.87265.364.7468.8765.364.74
233189-3318963.63063.63
332868-3286863.01563.02
436085-3608569.18369.18
534219-3421965.60565.61
632251-3225161.83261.83
10min145093-4509386.45382.465.7786.8482.825.76
242524-4252481.52881.88
338437-3843773.69274.04
444868-4486886.02286.41
544316-4431684.96385.33
642808-4280882.07282.42
15min146660-4666089.45789.142.6190.3289.962.62
246350-4635088.86389.67
344297-4429784.92785.69
447909-4790991.85292.71
546604-4660489.35090.19
647150-4715090.39791.20
20min149189-4918994.30693.821.6295.6795.131.64
249459-4945994.82496.12
347477-4747791.02492.25
449276-4927694.47395.85
549589-4958995.07396.41
648607-4860793.19094.49
30min151110-5111097.98997.551.2599.8799.381.26
251468-5146898.675100.50
349820-4982095.51697.25
450789-5078997.37399.27
550580-5058096.97398.83
651509-5150998.754100.57
45min151841-5184199.39098.881.71101.82101.261.69
252586-52586100.819103.19
350221-5022196.28498.55
450937-5093797.657100.10
551564-5156498.859101.26
652303-52303100.276102.64
60min152020-5202099.734101.031.50102.71103.961.44
253596-53596102.755105.69
352962-52962101.540104.34
452989-52989101.591104.57
551482-5148298.702101.65
653143-53143101.887104.81
90min151051-5105197.876101.153.54101.41104.643.39
252325-52325100.318103.82
355785-55785106.952110.32
454235-54235103.980107.53
551301-5130198.355101.85
651846-5184699.400102.89
120min150776-5077697.34998.661.18101.43102.711.11
251493-5149398.723102.79
351879-5187999.463103.42
451509-5150998.754102.88
550787-5078797.370101.41
652310-52310100.290104.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限151677-5167799.07699.651.08103.69104.251.03
251604-5160498.936103.55
352382-52382100.428104.94
452251-52251100.176104.85
551234-5123498.227102.81
652705-52705101.047105.65
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所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1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.068828788040882078825388078881730.13
211.088847788361884190.10
单位质量响应值RSD%判断
7972.247980.050.07数据可信
供试品溶液-23H1439批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17582-75828.5557.0830.578.567.0830.55
24251-42514.7974.80
39156-915610.33110.33
46882-68827.7657.77
55049-50495.6975.70
64723-47235.3295.33
10min119259-1925921.73118.7122.6121.7818.7522.63
211348-1134812.80512.83
320891-2089123.57323.63
418789-1878921.20121.24
516083-1608318.14718.18
613115-1311514.79814.83
15min128580-2858032.24929.3321.5432.4229.4821.55
219388-1938821.87721.97
333530-3353037.83438.02
430276-3027634.16234.32
522801-2280125.72825.86
621407-2140724.15524.27
20min136279-3627940.93638.1521.6941.2838.4621.70
225693-2569328.99129.21
343895-4389549.53049.93
439781-3978144.88745.24
530273-3027334.15934.43
626965-2696530.42630.67
30min146280-4628052.22150.4621.1552.8050.9821.16
236121-3612140.75841.14
357921-5792165.35666.03
453651-5365160.53861.14
538374-3837443.30043.77
635971-3597140.58841.00
45min156247-5624763.46761.1617.9064.3361.9617.95
242816-4281648.31248.92
366542-6654275.08476.12
463941-6394172.14973.09
549864-4986456.26556.97
645794-4579451.67252.31
60min163074-6307471.17070.1616.8272.3971.3016.87
249993-4999356.41057.29
375049-7504984.68386.14
473951-7395183.44484.78
556923-5692364.23065.25
654098-5409861.04261.97
90min169098-6909877.96880.1315.5179.5881.6615.57
262581-6258170.61471.80
386739-8673997.87399.80
482668-8266893.28095.08
563842-6384272.03773.41
661181-6118169.03470.30
120min172543-7254381.85584.117.2183.9086.087.44
272236-7223681.50983.09
381724-8172492.21494.68
480902-8090291.28793.61
570292-7029279.31581.09
669552-6955278.48080.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限179364-7936489.55288.816.5192.0591.256.73
277023-7702386.91088.94
383621-8362194.35597.34
484762-8476295.64298.47
576694-7669486.53988.75
670766-7076679.85081.94
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.455044050229503865039550432503760.17
213.435024550290502680.07
单位质量响应值RSD%判断
3745.433742.960.05数据可信
供试品溶液-23K2033批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132511-3251162.33064.002.7662.3364.002.76
233956-3395665.10165.10
332612-3261262.52462.52
433282-3328263.80963.81
534932-3493266.97266.97
633013-3301363.29363.29
10min143851-4385184.07184.120.6484.4284.470.64
243807-4380783.98784.35
343549-4354983.49283.84
444133-4413384.61284.97
544269-4426984.87385.24
643639-4363983.66584.02
15min152233-52233100.14292.834.23100.9593.654.19
247655-4765591.36592.19
347244-4724490.57791.39
447811-4781191.66492.49
546507-4650789.16490.01
649067-4906794.07294.89
20min150484-5048496.78895.271.5798.1696.611.55
249940-4994095.74597.08
350633-5063397.07498.39
448724-4872493.41494.75
549091-4909194.11895.46
649289-4928994.49795.84
30min152745-52745101.12399.121.40103.03100.991.39
252157-5215799.996101.86
351723-5172399.164101.02
450630-5063097.06898.92
551296-5129698.345100.21
651659-5165999.041100.91
45min152325-52325100.31898.761.34102.79101.181.33
251617-5161798.961101.38
351689-5168999.099101.50
450334-5033496.50198.89
551931-5193199.563101.97
651176-5117698.115100.53
60min152164-52164100.00999.641.26103.04102.601.23
251761-5176199.237102.21
353155-53155101.909104.86
451257-5125798.270101.20
551665-5166599.053102.01
651811-5181199.332102.29
90min155360-55360106.137104.023.31109.72107.543.22
256236-56236107.816111.34
355107-55107105.652109.17
452638-52638100.918104.39
554663-54663104.800108.31
651527-5152798.788102.30
120min153486-53486102.544100.563.57106.72104.663.46
251939-5193999.578103.70
355567-55567106.533110.64
450258-5025896.355100.39
552267-52267100.207104.30
651178-5117898.119102.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限153518-53518102.605100.852.57107.35105.502.50
254319-54319104.141108.82
352411-52411100.483105.18
450643-5064397.093101.66
553170-53170101.938106.59
651548-5154898.828103.43
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所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1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.068845788146884098820388354883140.16
211.088823688319882780.07
单位质量响应值RSD%判断
7984.997967.330.16数据可信
供试品溶液-23K2033批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14059-40594.5806.1725.564.586.1725.53
24489-44895.0655.07
36272-62727.0777.08
45959-59596.7246.72
57652-76528.6348.63
64388-43884.9514.95
10min113957-1395715.74918.2420.8715.7718.2820.87
211939-1193913.47213.50
316627-1662718.76118.80
419504-1950422.00822.04
520599-2059923.24323.29
614385-1438516.23216.26
15min127328-2732830.83630.7515.1030.9530.8815.11
221268-2126823.99824.10
326233-2623329.60029.74
432967-3296737.19937.36
530528-3052834.44734.62
625174-2517428.40528.52
20min131863-3186335.95339.1115.4136.2439.4115.42
228073-2807331.67731.91
334854-3485439.32839.64
442812-4281248.30848.67
538658-3865843.62043.99
631691-3169135.75936.03
30min140923-4092346.17651.3215.9746.6651.8415.97
238405-3840543.33543.75
342737-4273748.22348.75
456777-5677764.06564.70
552169-5216958.86659.48
641876-4187647.25147.73
45min146943-4694352.96960.0318.2753.7160.8418.22
246122-4612252.04252.70
346967-4696752.99653.79
466645-6664575.20076.19
564752-6475273.06474.00
647760-4776053.89154.63
60min150502-5050256.98566.4318.1258.0267.5718.08
252214-5221458.91659.86
352150-5215058.84459.93
473429-7342982.85584.26
571732-7173280.94082.28
653212-5321260.04361.08
90min159704-5970467.36878.0813.3768.7279.5913.41
267487-6748776.15077.42
365394-6539473.78875.20
479380-7938089.57091.44
581737-8173792.22994.02
661489-6148969.38270.75
120min168547-6854777.34683.217.1679.0785.157.32
267036-6703675.64177.33
375574-7557485.27587.10
478543-7854388.62590.99
580056-8005690.33292.64
672694-7269482.02583.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限178229-7822988.27190.132.7290.4392.543.00
278157-7815788.19090.30
379231-7923189.40191.70
481803-8180392.30495.16
583327-8332794.02396.83
678523-7852388.60390.81
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