依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911714961714281712751712051715531713910.09
29.991710181710691710440.03
单位质量响应值RSD%判断
17294.7517121.520.72数据可信
供试品溶液-B25010111批-依折麦布-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%
5min17998-79984.1733.1026.554.173.1026.54
26712-67123.5023.50
37112-71123.7103.71
45145-51452.6842.68
53779-37791.9721.97
64957-49572.5862.59
10min113516-135167.0517.043.067.077.063.10
213670-136707.1327.15
313887-138877.2457.27
413881-138817.2427.26
512892-128926.7266.74
613105-131056.8376.85
15min114628-146287.6327.622.177.697.682.16
215184-151847.9227.98
314304-143047.4637.52
414406-144067.5167.57
514449-144497.5387.59
614697-146977.6687.72
20min114720-147207.6807.552.477.787.652.45
214764-147647.7037.81
313964-139647.2857.39
414640-146407.6387.73
514085-140857.3487.44
614703-147037.6717.77
30min114241-142417.4307.481.497.587.621.49
214454-144547.5417.69
313992-139927.3007.44
414525-145257.5787.72
514224-142247.4217.55
614530-145307.5817.72
45min113146-131466.8587.153.237.057.333.07
214196-141967.4067.59
313192-131926.8827.07
413732-137327.1647.35
514052-140527.3317.50
613902-139027.2537.43
60min113359-133596.9706.983.307.207.213.17
213844-138447.2237.45
312985-129856.7747.00
412860-128606.7096.93
513953-139537.2797.49
613318-133186.9487.17
极限113419-134197.0016.872.317.277.132.26
213419-134197.0017.27
312798-127986.6776.94
413363-133636.9727.23
513211-132116.8927.15
612774-127746.6646.92
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961538251535111535201531551534611534940.16
210.971531501531261531380.02
单位质量响应值RSD%判断
14004.9313959.710.23数据可信
供试品溶液-B25010111批-阿托伐他汀钙-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%
5min1113260-11326066.90855.9014.5866.9155.9014.58
299828-9982858.97358.97
391249-9124953.90553.91
4103072-10307260.89060.89
586421-8642151.05351.05
673960-7396043.69243.69
10min1145997-14599786.24779.316.1786.6279.626.18
2136800-13680080.81481.14
3121073-12107371.52471.82
4136073-13607380.38580.72
5129904-12990476.74077.02
6135660-13566080.14180.38
15min1157364-15736492.96286.776.2493.8187.526.22
2152871-15287190.30891.08
3132460-13246078.25078.95
4142424-14242484.13784.92
5143495-14349584.76985.48
6152722-15272290.22090.91
20min1160161-16016194.61588.986.8595.9890.226.82
2159662-15966294.32095.60
3135690-13569080.15981.29
4146755-14675586.69587.95
5142972-14297284.46085.64
6158507-15850793.63894.83
30min1168765-16876599.69894.975.82101.5996.705.82
2167680-16768099.057100.86
3143848-14384884.97886.55
4158337-15833793.53795.27
5159565-15956594.26395.91
6166395-16639598.297100.01
45min1166059-16605998.09995.994.28100.5598.244.28
2164167-16416796.98199.33
3148839-14883987.92689.98
4162018-16201895.71297.97
5166758-16675898.512100.69
6167061-16706198.691100.95
60min1171748-171748101.46096.914.95104.4599.704.94
2167798-16779899.126102.02
3150407-15040788.85391.39
4158697-15869793.75096.54
5170342-170342100.629103.35
6165277-16527797.637100.44
极限1174080-174080102.83798.812.82106.39102.142.86
2166645-16664598.445101.89
3160787-16078794.98598.02
4170717-170717100.851104.16
5167288-16728898.825102.11
6164091-16409196.936100.28
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911713881713611715811711691713091713620.09
29.991717711720081718900.10
单位质量响应值RSD%判断
17291.8317206.210.36数据可信
供试品溶液-B25010111批-依折麦布-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%
5min17632-76323.9722.7826.863.972.7826.81
25719-57192.9772.98
33545-35451.8451.85
44995-49952.6002.60
55891-58913.0663.07
64233-42332.2032.20
10min113634-136347.0966.863.387.126.883.42
213530-135307.0427.06
312648-126486.5836.59
412759-127596.6416.66
513559-135597.0577.07
612942-129426.7366.75
15min114271-142717.4287.352.827.497.402.82
214278-142787.4317.49
313351-133516.9497.00
414073-140737.3257.38
514245-142457.4147.47
614485-144857.5397.59
20min114562-145627.5797.402.227.687.492.22
213840-138407.2037.30
313986-139867.2797.36
413996-139967.2847.38
514311-143117.4487.55
614570-145707.5837.67
30min114621-146217.6107.333.077.757.473.05
213752-137527.1577.29
313528-135287.0417.17
413903-139037.2367.37
514259-142597.4217.56
614486-144867.5397.67
45min113531-135317.0427.103.777.237.283.70
213027-130276.7806.96
313412-134126.9817.15
413652-136527.1057.28
514580-145807.5887.77
613676-136767.1187.29
60min113659-136597.1097.031.527.347.251.59
213364-133646.9567.17
313219-132196.8807.08
413501-135017.0277.24
513527-135277.0407.26
613797-137977.1817.40
极限113456-134567.0037.063.067.277.313.01
213159-131596.8497.10
313020-130206.7767.02
413805-138057.1857.44
514081-140817.3297.59
613813-138137.1897.44
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961532201532021528731529681531771530880.11
210.971530511531931531220.07
单位质量响应值RSD%判断
13967.8813958.250.05数据可信
供试品溶液-B25010111批-阿托伐他汀钙-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%
5min1112326-11232666.44854.6216.6866.4554.6216.69
299993-9999359.15259.15
383743-8374349.53949.54
472798-7279843.06443.06
5104252-10425261.67161.67
680921-8092147.87047.87
10min1140959-14095983.38678.133.6983.7578.443.70
2127234-12723475.26775.60
3128075-12807575.76476.04
4131990-13199078.08078.32
5131828-13182877.98478.33
6132372-13237278.30678.57
15min1151286-15128689.49583.725.1390.3384.465.11
2134087-13408779.32180.07
3133671-13367179.07579.77
4146160-14616086.46387.14
5138153-13815381.72682.50
6145776-14577686.23586.94
20min1157772-15777293.33287.714.8894.6688.914.86
2138092-13809281.69082.88
3142746-14274684.44385.58
4152601-15260190.27391.43
5146313-14631386.55387.78
6152083-15208389.96691.15
30min1171564-171564101.49194.964.77103.3496.654.76
2149078-14907888.18989.83
3155247-15524791.83893.44
4161936-16193695.79597.45
5163341-16334196.62698.34
6161976-16197695.81997.50
45min1165755-16575598.05497.213.95100.4799.433.90
2151302-15130289.50491.64
3165719-16571998.033100.15
4166746-16674698.640100.83
5168747-16874799.824102.07
6167701-16770199.205101.42
60min1172023-172023101.76298.953.37104.72101.713.37
2156970-15697092.85795.49
3165861-16586198.117100.78
4167226-16722698.924101.66
5172004-172004101.751104.55
6169514-169514100.278103.04
极限1170519-170519100.872100.612.33104.39103.922.33
2167348-16734898.997102.14
3163589-16358996.77399.98
4172595-172595102.100105.39
5174329-174329103.126106.49
6172121-172121101.820105.14
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911714701715941716351715321714871715440.05
29.991710961710801710880.01
单位质量响应值RSD%判断
17310.1917125.930.76数据可信
供试品溶液-B25010311批-依折麦布-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%
5min15314-53142.7713.6214.802.773.6214.86
27758-77584.0454.05
36789-67893.5403.54
47740-77404.0364.04
56239-62393.2533.25
67842-78424.0894.09
10min112988-129886.7727.073.196.797.093.18
213241-132416.9046.93
313400-134006.9877.01
413761-137617.1757.20
514190-141907.3997.42
613753-137537.1717.19
15min114088-140887.3467.163.837.407.223.76
213435-134357.0057.07
313768-137687.1797.24
414057-140577.3307.39
514251-142517.4317.49
612843-128436.6976.76
20min113629-136297.1067.143.017.207.242.96
213821-138217.2067.31
313712-137127.1507.25
412947-129476.7516.85
513863-138637.2287.33
614182-141827.3957.49
30min114350-143507.4827.172.997.627.312.92
213449-134497.0137.15
314137-141377.3717.51
413666-136667.1267.27
513304-133046.9377.08
613555-135557.0687.21
45min113131-131316.8476.821.537.026.991.49
212740-127406.6436.82
313332-133326.9527.13
413044-130446.8016.98
513014-130146.7866.96
613184-131846.8747.05
60min113047-130476.8036.821.547.027.041.53
212767-127676.6576.87
313269-132696.9197.14
413314-133146.9427.16
513097-130976.8297.05
612969-129696.7626.98
极限113248-132486.9086.824.207.167.074.03
213124-131246.8437.10
312727-127276.6366.89
413747-137477.1687.42
512184-121846.3536.61
613394-133946.9847.24
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961537771538481536011537781535631537130.09
210.971532651529951531300.13
单位质量响应值RSD%判断
14024.9113958.980.34数据可信
供试品溶液-B25010311批-阿托伐他汀钙-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%
5min173377-7337743.31837.2516.4643.3237.2516.46
266659-6665939.35239.35
345119-4511926.63626.64
462765-6276537.05337.05
571940-7194042.46942.47
658720-5872034.66534.66
10min1141582-14158283.58275.177.3083.8275.377.31
2122208-12220872.14572.36
3117987-11798769.65369.80
4121809-12180971.90972.11
5135994-13599480.28380.52
6124392-12439273.43473.63
15min1152351-15235189.93980.519.3890.6481.139.37
2127621-12762175.34075.96
3129776-12977676.61277.15
4135619-13561980.06280.67
5151305-15130589.32290.00
6121576-12157671.77272.37
20min1152577-15257790.07384.266.5491.2885.336.56
2138693-13869381.87682.91
3137532-13753281.19182.15
4132836-13283678.41979.47
5156128-15612892.16993.35
6138630-13863081.83982.84
30min1170284-170284100.52690.817.54102.2392.357.53
2142559-14255984.15985.65
3144193-14419385.12386.53
4158119-15811993.34494.83
5162926-16292696.18297.87
6144910-14491085.54787.00
45min1156642-15664292.47390.274.8194.7492.324.85
2148640-14864087.74989.71
3143872-14387284.93486.82
4159353-15935394.07396.08
5161902-16190295.57897.80
6147068-14706886.82188.75
60min1160950-16095095.01691.594.9997.7994.135.01
2149999-14999988.55191.00
3148655-14865587.75790.11
4163083-16308396.27598.80
5162184-16218495.74498.50
6145978-14597886.17788.59
极限1163667-16366796.62094.513.9899.9297.573.81
2161425-16142595.29698.24
3159621-15962194.23197.08
4168063-16806399.215102.28
5149038-14903887.98491.27
6158780-15878093.73596.62
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911716201718001718831715251716271716910.09
29.991715401716061715730.03
单位质量响应值RSD%判断
17325.0317174.470.62数据可信
供试品溶液-B25010311批-依折麦布-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%
5min17397-73973.8503.7510.103.853.7510.12
27168-71683.7313.73
36451-64513.3573.36
46368-63683.3143.31
57596-75963.9533.95
68294-82944.3174.32
10min113935-139357.2537.043.357.277.063.32
213875-138757.2217.24
312815-128156.6706.69
413601-136017.0797.10
513136-131366.8376.86
613795-137957.1807.20
15min114485-144857.5397.343.657.607.403.63
214748-147487.6767.74
314254-142547.4197.47
414162-141627.3717.43
513478-134787.0157.07
613515-135157.0347.10
20min114333-143337.4607.352.477.567.452.42
214505-145057.5497.65
314242-142427.4127.51
414197-141977.3897.49
513523-135237.0387.14
613935-139357.2537.36
30min113812-138127.1887.133.507.337.273.41
214232-142327.4077.55
314184-141847.3827.52
413522-135227.0387.18
512983-129836.7576.90
613437-134376.9937.14
45min113604-136047.0806.842.317.277.022.31
213004-130046.7686.95
312850-128506.6886.87
413212-132126.8767.06
512832-128326.6786.85
613339-133396.9427.12
60min113095-130956.8156.842.287.047.062.19
213223-132236.8827.11
313638-136387.0987.31
413014-130146.7736.99
513160-131606.8497.06
612722-127226.6216.84
极限113305-133056.9256.812.257.197.072.22
213323-133236.9347.20
313072-130726.8037.06
413107-131076.8227.08
512521-125216.5176.77
613166-131666.8527.11
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961544831548351542891544121544061544850.14
210.971531031533161532100.10
单位质量响应值RSD%判断
14095.3513966.270.66数据可信
供试品溶液-B25010311批-阿托伐他汀钙-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%
5min154234-5423431.92836.9310.2831.9336.9310.28
267550-6755039.76839.77
369212-6921240.74640.75
456264-5626433.12433.12
567847-6784739.94339.94
661254-6125436.06136.06
10min1125086-12508673.64074.583.9673.8274.783.97
2134455-13445579.15679.38
3131138-13113877.20377.43
4121360-12136071.44771.63
5124125-12412573.07473.30
6123896-12389672.94073.14
15min1138771-13877181.69783.134.4982.2883.744.49
2150454-15045488.57589.24
3147030-14703086.55987.21
4140055-14005582.45383.03
5137407-13740780.89481.52
6133473-13347378.57879.18
20min1146220-14622086.08287.302.7487.1288.382.76
2154742-15474291.09992.25
3151525-15152589.20590.34
4143861-14386184.69385.73
5147427-14742786.79387.87
6145973-14597385.93786.98
30min1154373-15437390.88290.643.1192.4092.213.11
2159421-15942193.85495.51
3157898-15789892.95794.59
4145819-14581985.84687.36
5153798-15379890.54392.10
6152465-15246589.75991.28
45min1158422-15842293.26692.351.7295.2994.421.67
2157226-15722692.56294.74
3153152-15315290.16392.31
4154081-15408190.71092.70
5159986-15998694.18696.25
6158373-15837393.23795.26
60min1160735-16073594.62792.193.5797.1794.773.51
2155403-15540391.48894.18
3161683-16168395.18697.83
4150231-15023188.44490.93
5161652-16165295.16797.75
6149886-14988688.24090.78
极限1163482-16348296.24595.041.9899.3198.141.96
2165425-16542597.389100.59
3163372-16337296.18099.36
4160695-16069594.60497.59
5157518-15751892.73495.85
6158122-15812293.08996.12
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911708151705721707471707391711721708090.13
29.991712341709291710820.13
单位质量响应值RSD%判断
17236.0217125.330.46数据可信
供试品溶液-B25010511批-依折麦布-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%
5min18480-84804.4314.325.804.434.325.82
28210-82104.2904.29
37598-75983.9703.97
48586-85864.4874.49
57846-78464.1004.10
68876-88764.6384.64
10min114904-149047.7887.662.337.817.682.30
214644-146447.6527.68
314921-149217.7977.82
414979-149797.8277.85
514147-141477.3927.42
614361-143617.5047.53
15min115494-154948.0967.773.598.167.833.55
214723-147237.6937.76
314625-146257.6427.71
415532-155328.1168.18
514209-142097.4257.49
614595-145957.6267.69
20min115437-154378.0667.664.018.187.774.01
214775-147757.7217.83
314131-141317.3847.49
415218-152187.9528.07
513980-139807.3057.41
614421-144217.5367.65
30min114476-144767.5647.432.607.727.592.58
214350-143507.4987.65
314365-143657.5067.66
414544-145447.6007.76
513549-135497.0807.23
614073-140737.3547.51
45min113902-139027.2647.114.277.467.304.22
213068-130686.8297.02
313706-137067.1627.35
414582-145827.6207.82
513120-131206.8567.04
613272-132726.9357.13
60min114659-146597.6607.114.857.907.344.79
213152-131526.8727.10
313187-131876.8917.12
414195-141957.4177.66
513080-130806.8357.06
613360-133606.9817.21
极限113870-138707.2486.996.137.537.266.00
213675-136757.1467.42
313727-137277.1737.44
414222-142227.4327.72
512049-120496.2966.56
612727-127276.6506.92
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961532831531951535281539461536981535300.20
210.971534421534281534350.01
单位质量响应值RSD%判断
14008.2113986.780.11数据可信
供试品溶液-B25010511批-阿托伐他汀钙-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%
5min194681-9468155.87254.708.8555.8754.708.85
277064-7706445.47645.48
3101349-10134959.80759.81
493153-9315354.97054.97
593941-9394155.43555.44
696021-9602156.66356.66
10min1131395-13139577.53775.436.1977.8575.736.19
2123523-12352372.89273.14
3142288-14228883.96584.30
4122239-12223972.13472.44
5121800-12180071.87572.18
6125665-12566574.15674.47
15min1140493-14049382.90679.925.0383.6580.645.03
2129486-12948676.41077.07
3145228-14522885.70086.50
4132085-13208577.94478.65
5127753-12775375.38876.10
6137518-13751881.15081.88
20min1149813-14981388.40683.994.7389.6185.164.73
2136741-13674180.69281.77
3148317-14831787.52388.80
4138389-13838981.66482.80
5134057-13405779.10880.23
6146671-14667186.55187.73
30min1159923-15992394.37289.094.6796.0690.724.66
2147228-14722886.88088.41
3156106-15610692.11993.88
4145616-14561685.92987.52
5141932-14193283.75585.32
6155053-15505391.49893.16
45min1161010-16101095.01391.783.5397.2393.903.53
2152245-15224589.84191.85
3155956-15595692.03194.30
4154929-15492991.42593.49
5147202-14720286.86588.90
6161811-16181195.48697.65
60min1168950-16895099.69893.944.65102.4496.584.61
2155962-15596292.03494.55
3158083-15808393.28696.07
4153717-15371790.70993.29
5150964-15096489.08591.60
6167508-16750898.847101.54
极限1169268-16926899.88697.742.41103.18100.902.28
2166381-16638198.182101.21
3162363-16236395.81199.11
4168949-16894999.698102.78
5167514-16751498.851101.86
6159268-15926893.98597.23
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911699961711151707591705311701381705080.27
29.991709051706551707800.11
单位质量响应值RSD%判断
17205.6517095.100.46数据可信
供试品溶液-B25010511批-依折麦布-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%
5min19046-90464.7354.385.544.744.385.59
28219-82194.3024.30
38779-87794.5954.60
48115-81154.2484.25
57778-77784.0714.07
68275-82754.3324.33
10min114880-148807.7897.602.207.827.632.19
214559-145597.6217.65
313948-139487.3017.33
414477-144777.5787.60
514740-147407.7167.74
614527-145277.6047.63
15min114931-149317.8167.831.657.897.901.62
214541-145417.6127.68
314845-148457.7717.84
415093-150937.9017.97
515200-152007.9578.02
615151-151517.9318.00
20min115033-150337.8697.682.187.987.792.16
214553-145537.6187.73
314533-145337.6077.72
414557-145577.6207.73
515091-150917.9008.01
614275-142757.4727.58
30min114429-144297.5537.542.497.717.702.44
213949-139497.3027.45
314720-147207.7057.86
414713-147137.7027.85
514672-146727.6807.83
613998-139987.3277.48
45min113634-136347.1377.111.387.347.301.39
213302-133026.9637.15
313581-135817.1097.30
413415-134157.0227.22
513794-137947.2217.42
613721-137217.1827.38
60min114188-141887.4277.262.797.677.502.75
213487-134877.0607.29
313385-133857.0077.24
413808-138087.2287.46
514369-143697.5227.76
613979-139797.3177.55
极限113743-137437.1947.233.497.477.503.42
213011-130116.8117.08
313852-138527.2517.52
413736-137367.1907.46
514494-144947.5877.87
614011-140117.3347.61
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961530921532441534381532351530761532170.10
210.971530911533861532380.14
单位质量响应值RSD%判断
13979.6513968.820.06数据可信
供试品溶液-B25010511批-阿托伐他汀钙-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%
5min197016-9701657.34553.994.7457.3454.004.74
287505-8750551.72351.72
385936-8593650.79650.80
493908-9390855.50855.51
589575-8957552.94752.95
694147-9414755.64955.65
10min1131228-13122877.56774.523.5777.8974.833.57
2123652-12365273.08973.38
3124641-12464173.67473.96
4131805-13180577.90878.22
5120407-12040771.17171.47
6124736-12473673.73074.04
15min1137197-13719781.09579.673.2881.8480.383.28
2130513-13051377.14577.84
3134493-13449379.49780.19
4141352-14135283.55184.29
5129364-12936476.46577.16
6135790-13579080.26480.98
20min1148461-14846187.75382.913.1388.9584.063.12
2137275-13727581.14282.26
3139549-13954982.48683.62
4140999-14099983.34384.55
5136032-13603280.40781.52
6139247-13924782.30783.47
30min1157569-15756993.13789.013.9094.8290.633.87
2146652-14665286.68488.26
3152861-15286190.35491.95
4156618-15661892.57594.24
5143980-14398085.10586.67
6145874-14587486.22487.85
45min1166245-16624598.26592.293.76100.4794.403.73
2153847-15384790.93792.99
3157869-15786993.31495.41
4153601-15360190.79292.97
5148714-14871487.90389.94
6156533-15653392.52594.63
60min1169289-169289100.06595.102.99102.8297.732.99
2159107-15910794.04696.61
3159704-15970494.39997.01
4161152-16115295.25597.94
5154593-15459391.37893.90
6161533-16153395.48098.10
极限1172257-172257101.81999.911.66105.13103.061.62
2170768-170768100.939104.02
3167378-16737898.935102.07
4164447-16444797.203100.42
5168920-16892099.847102.88
6170385-170385100.712103.86
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢超君 于 2025-02-25 15:10:52 完成)
生成报告数据部分下载报告(谢超君 于 2025-02-25 15:11:34 完成)
Current page cost:114 ms