替米沙坦氨氯地平片项目信息
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%
110.817048357096367087837102687119667090980.38
210.757075037071257073140.04
单位质量响应值RSD%判断
65596.4865796.650.22数据可信
供试品溶液-2026031621批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1226311-22631131.00330.1414.5331.0030.1414.53
2224990-22499030.82230.82
3192529-19252926.37526.38
4277581-27758138.02738.03
5191771-19177126.27126.27
6206929-20692928.34828.35
10min1446675-44667561.19254.5216.9461.3654.6816.93
2412559-41255956.51856.69
3335321-33532145.93746.08
4499739-49973968.46168.67
5329348-32934845.11945.26
6364174-36417449.89050.05
15min1572907-57290778.48570.2716.1879.0070.7416.18
2536189-53618973.45573.94
3428836-42883658.74859.15
4632426-63242686.63887.23
5422893-42289357.93458.33
6484426-48442666.36366.80
20min1647085-64708588.64779.3714.4789.5980.2314.48
2621542-62154285.14786.04
3498310-49831068.26568.99
4686441-68644194.03895.11
5484264-48426466.34167.06
6538461-53846173.76674.57
30min1678918-67891893.00887.008.7094.4588.308.79
2669940-66994091.77893.14
3575338-57533878.81879.93
4702239-70223996.20297.80
5579339-57933979.36680.45
6604727-60472782.84484.06
45min1661262-66126290.58990.082.9492.5591.863.12
2658952-65895290.27292.15
3650853-65085389.16390.71
4689945-68994594.51896.65
5630361-63036186.35687.88
6653727-65372789.55791.23
60min1675960-67596092.60291.162.6095.0693.452.77
2657567-65756790.08392.46
3663739-66373990.92892.97
4694738-69473895.17597.83
5649755-64975589.01291.02
6650917-65091789.17291.34
极限1686907-68690794.10294.022.0097.0896.811.94
2665485-66548591.16794.05
3681639-68163993.38095.93
4690539-69053994.60097.78
5685341-68534193.88796.39
6707796-70779696.96499.63
替米沙坦氨氯地平片项目信息
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%
110.817125377123017115517115647093477114600.18
210.757032667039297035980.07
单位质量响应值RSD%判断
65814.9965450.980.40数据可信
供试品溶液-2026031621批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1235636-23563632.31230.6812.8132.3130.6812.81
2213587-21358729.28929.29
3214812-21481229.45729.46
4276236-27623637.87937.88
5202471-20247127.76427.76
6199813-19981327.40027.40
10min1423202-42320258.03355.4311.1558.2155.6011.16
2407898-40789855.93456.10
3413754-41375456.73756.90
4472019-47201964.72764.94
5348021-34802147.72347.88
6360261-36026149.40249.55
15min1532756-53275673.05570.7511.2973.5671.2311.29
2521772-52177271.54972.02
3536942-53694273.62974.11
4602594-60259482.63283.20
5440808-44080860.44760.87
6460741-46074163.18063.61
20min1595716-59571681.68979.6010.3582.6080.4710.36
2578771-57877179.36580.24
3609789-60978983.61984.51
4669882-66988291.85992.89
5504560-50456069.18969.94
6524218-52421871.88572.66
30min1633921-63392186.92887.436.6988.2988.746.75
2631241-63124186.56087.87
3665296-66529691.23092.58
4705444-70544496.73698.28
5594601-59460181.53682.68
6595043-59504381.59782.77
45min1642176-64217688.06090.613.4189.9092.403.48
2643236-64323688.20590.00
3678365-67836593.02294.88
4697822-69782295.69097.77
5654423-65442389.73991.33
6648409-64840988.91590.54
60min1660476-66047690.56992.282.0892.9094.582.18
2664714-66471491.15093.43
3688871-68887194.46396.84
4692222-69222294.92297.53
5662346-66234690.82692.92
6669085-66908591.75093.87
极限1675703-67570392.65794.502.9895.4997.322.96
2662736-66273690.87993.67
3686134-68613494.08896.99
4715994-71599498.182101.32
5683689-68368993.75296.35
6710700-71070097.456100.09
替米沙坦氨氯地平片项目信息
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%
110.817126367117207115867112627089457112300.20
210.757106377083477094920.23
单位质量响应值RSD%判断
65793.7165999.260.23数据可信
供试品溶液-2026031721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184616-18461625.21528.766.9625.2128.766.97
2214057-21405729.23629.24
3205205-20520528.02728.03
4222549-22254930.39530.40
5225193-22519330.75630.76
6211949-21194928.94828.95
10min1328558-32855844.87451.4110.8645.0151.5710.84
2388906-38890653.11653.28
3325984-32598444.52244.68
4415671-41567156.77256.94
5418762-41876257.19457.36
6380736-38073652.00052.16
15min1433745-43374559.24066.9411.0159.6367.3811.00
2512942-51294270.05770.51
3423080-42308057.78358.19
4538852-53885273.59574.08
5552358-55235875.44075.93
6479668-47966865.51265.96
20min1501334-50133468.47176.809.1969.1977.629.19
2599888-59988881.93282.78
3495350-49535067.65468.38
4608791-60879183.14884.04
5601489-60148982.15083.06
6566883-56688377.42478.24
30min1582395-58239579.54286.116.3080.6487.356.34
2657518-65751889.80391.10
3576950-57695078.79979.90
4649663-64966388.73090.08
5663673-66367390.64392.01
6652529-65252989.12190.37
45min1645487-64548788.15991.583.6689.7093.303.71
2689422-68942294.16095.96
3639292-63929287.31388.85
4666603-66660391.04392.89
5682211-68221193.17595.04
6700257-70025795.64097.38
60min1674782-67478292.16093.453.1994.1995.683.16
2679085-67908592.74895.07
3669434-66943491.43093.45
4673728-67372892.01794.37
5680323-68032392.91795.30
6728021-72802199.432101.70
极限1678488-67848892.66793.052.2895.2195.802.28
2695499-69549994.99097.83
3667316-66731691.14193.67
4668183-66818391.25994.12
5673322-67332291.96194.86
6704975-70497596.28499.11
替米沙坦氨氯地平片项目信息
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%
110.817096857077847087857082057107097090340.17
210.757045387033197039280.13
单位质量响应值RSD%判断
65590.5665481.670.12数据可信
供试品溶液-2026031721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1251939-25193934.59930.898.3834.6030.888.38
2243369-24336933.42233.42
3224290-22429030.80230.80
4206179-20617928.31428.31
5209774-20977428.80828.81
6213889-21388929.37329.37
10min1462800-46280063.55655.5512.7163.7555.7212.69
2469270-46927064.44464.63
3382949-38294952.59052.76
4353700-35370048.57348.73
5353864-35386448.59648.76
6404588-40458855.56255.72
15min1588759-58875980.85471.0514.7381.4071.5314.70
2623699-62369985.65286.20
3464754-46475463.82464.29
4445023-44502361.11561.54
5450874-45087461.91862.35
6530898-53089872.90873.38
20min1607280-60728083.39777.9013.2284.3978.7813.21
2692707-69270795.12996.15
3514694-51469470.68271.50
4494417-49441767.89868.66
5516458-51645870.92571.70
6577954-57795479.37080.25
30min1677435-67743593.03187.248.0994.4988.558.15
2709699-70969997.46299.01
3610100-61010083.78484.99
4574154-57415478.84879.99
5597407-59740782.04183.21
6643006-64300688.30389.62
45min1687209-68720994.37491.454.3596.3593.254.44
2695631-69563195.53097.62
3622159-62215985.44087.12
4647639-64763988.94090.52
5655220-65522089.98191.60
6687849-68784994.46296.27
60min1689241-68924194.65393.703.0097.1596.003.11
2710877-71087797.624100.24
3648472-64847289.05491.20
4677645-67764593.06095.14
5678541-67854193.18395.31
6688827-68882794.59696.93
极限1677079-67707992.98393.860.8496.0196.680.83
2684956-68495694.06497.23
3678379-67837993.16195.81
4681149-68114993.54196.13
5692314-69231495.07597.72
6686909-68690994.33297.19
替米沙坦氨氯地平片项目信息
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%
110.817401267345697403537293817301167349090.72
210.757414837400777407800.14
单位质量响应值RSD%判断
67984.1868909.770.96数据可信
供试品溶液-2026031821批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1267407-26740735.16333.497.3535.1633.497.35
2265772-26577234.94834.95
3250512-25051232.94132.94
4247479-24747932.54232.54
5222850-22285029.30429.30
6274216-27421636.05836.06
10min1451184-45118459.32858.338.5759.5258.528.56
2455659-45565959.91760.11
3455279-45527959.86760.05
4438425-43842557.65157.83
5373458-37345849.10849.27
6487512-48751264.10564.31
15min1564044-56404474.16975.008.0674.6975.518.06
2583303-58330376.70177.23
3588633-58863377.40277.92
4580854-58085476.37976.88
5484557-48455763.71764.15
6620744-62074481.62582.18
20min1636808-63680883.73784.947.9684.6785.877.94
2650913-65091385.59286.54
3684003-68400389.94390.89
4695308-69530891.42992.35
5550800-55080072.42773.22
6658141-65814186.54287.55
30min1700865-70086592.16091.124.7593.5692.524.79
2691604-69160490.94292.37
3704827-70482792.68194.13
4716529-71652994.22095.65
5628555-62855582.65283.84
6715269-71526994.05495.54
45min1702863-70286392.42392.441.7994.3494.341.84
2697354-69735491.69893.63
3690750-69075090.83092.79
4715646-71564694.10496.06
5690928-69092890.85392.50
6720295-72029594.71596.73
60min1695126-69512691.40592.010.9193.8394.431.00
2702973-70297392.43794.88
3696116-69611691.53694.00
4704490-70449092.63795.12
5691704-69170490.95593.11
6708038-70803893.10395.64
极限1713756-71375693.85592.891.0596.7995.820.93
2705674-70567492.79295.75
3694822-69482291.36594.34
4704866-70486692.68695.68
5715066-71506694.02796.69
6704236-70423692.60395.66
替米沙坦氨氯地平片项目信息
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%
110.817269187267307256327266487268277265510.08
210.757365077331377348220.33
单位质量响应值RSD%判断
67211.0168355.531.20数据可信
供试品溶液-2026031821批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1241134-24113432.01932.759.7832.0232.759.77
2243192-24319232.29232.29
3267717-26771735.54935.55
4203226-20322626.98526.99
5257306-25730634.16734.17
6267156-26715635.47435.47
10min1438104-43810458.17455.717.0158.3555.897.01
2390161-39016151.80851.99
3445866-44586659.20559.40
4378840-37884050.30450.45
5417235-41723555.40355.59
6447031-44703159.35959.56
15min1560241-56024174.39271.436.2874.8971.926.28
2480195-48019563.76364.23
3550893-55089373.15173.68
4520997-52099769.18169.61
5539890-53989071.69072.19
6575553-57555376.42576.95
20min1625487-62548783.05679.206.4583.9780.096.44
2532212-53221270.67071.49
3634873-63487384.30285.23
4571474-57147475.88476.70
5601325-60132579.84780.74
6613290-61329081.43682.39
30min1684753-68475390.92588.495.2992.3089.825.27
2601361-60136179.85281.07
3667682-66768288.65990.06
4677414-67741489.95191.19
5662245-66224587.93789.28
6704928-70492893.60495.01
45min1692878-69287892.00492.704.2093.8994.524.13
2667523-66752388.63790.30
3702125-70212593.23295.13
4748277-74827799.360101.10
5671404-67140489.15390.98
6706478-70647893.81095.73
60min1687853-68785391.33793.021.1893.7395.351.19
2696271-69627192.45594.60
3712449-71244994.60397.01
4703408-70340893.40295.69
5699476-69947692.88095.20
6703529-70352993.41995.86
极限1675920-67592089.75293.222.3792.6596.072.29
2697177-69717792.57595.24
3703553-70355393.42296.36
4727766-72776696.63799.44
5702048-70204893.22296.06
6705628-70562893.69796.66
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