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%
110.521805051804641805261803441806571804990.07
210.471815861820211818040.17
单位质量响应值RSD%判断
17157.7017364.280.85数据可信
供试品溶液-2024011221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%
5min111292-112925.8735.1112.205.875.1112.16
29983-99835.1925.19
37704-77044.0074.01
410380-103805.3995.40
510111-101115.2595.26
69491-94914.9364.94
10min115473-154738.0487.972.678.088.002.69
215934-159348.2888.32
314935-149357.7687.79
415318-153187.9678.00
515454-154548.0388.07
614803-148037.6997.73
15min115493-154938.0588.071.888.148.141.90
216055-160558.3518.43
315510-155108.0678.13
415292-152927.9548.03
515518-155188.0718.15
615233-152337.9237.99
20min115129-151297.8697.951.717.998.071.67
215540-155408.0838.20
315680-156808.1568.27
415061-150617.8347.95
515254-152547.9348.05
615082-150827.8447.96
30min114290-142907.4337.561.317.607.721.26
214430-144307.5057.67
314452-144527.5177.67
414841-148417.7197.88
514569-145697.5787.74
614620-146207.6047.76
45min114640-146407.6157.601.297.827.811.27
214318-143187.4477.65
314743-147437.6687.87
414528-145287.5567.76
514868-148687.7337.94
614605-146057.5967.80
60min114313-143137.4457.441.697.697.681.63
214312-143127.4447.69
314416-144167.4987.74
414680-146807.6357.88
514058-140587.3127.56
614025-140257.2957.54
极限114345-143457.4617.501.477.757.781.41
214222-142227.3977.69
314795-147957.6957.98
414512-145127.5487.84
514350-143507.4647.75
614262-142627.4187.70
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.741474821475971474881476841473851475270.08
210.731482861483861483360.05
单位质量响应值RSD%判断
13736.2213824.420.46数据可信
供试品溶液-2024011221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%
5min1128357-12835777.10166.9124.1477.1066.9024.14
2125453-12545375.35675.36
357560-5756034.57534.57
4125066-12506675.12475.12
5115035-11503569.09969.10
6116832-11683270.17870.18
10min1151167-15116790.80290.182.9991.2390.553.05
2157801-15780194.78795.21
3144541-14454186.82287.01
4150770-15077090.56490.98
5147257-14725788.45488.84
6149251-14925189.65190.04
15min1153701-15370192.32492.952.9193.2693.822.83
2159331-15933195.70696.65
3161185-16118596.82097.49
4152667-15266791.70392.62
5149863-14986390.01990.89
6151709-15170991.12892.02
20min1153388-15338892.13693.063.8393.5894.453.74
2161765-16176597.16898.65
3162718-16271897.74198.95
4152101-15210191.36392.79
5148185-14818589.01190.39
6151399-15139990.94292.34
30min1148840-14884089.40491.253.3691.3693.163.27
2156422-15642293.95995.98
3159694-15969495.92497.68
4151485-15148590.99392.93
5146767-14676788.15990.03
6148300-14830089.08090.98
45min1153440-15344092.16893.164.3194.6295.584.22
2164230-16423098.649101.19
3162354-16235497.52299.81
4148817-14881789.39191.83
5148749-14874989.35091.71
6152994-15299491.90094.29
60min1156220-15622093.83794.365.0196.8097.294.89
2167108-167108100.378103.46
3166244-16624499.859102.69
4153062-15306291.94194.88
5148232-14823289.03991.90
6151672-15167291.10694.01
极限1162053-16205397.34198.762.43100.83102.222.30
2160463-16046396.386100.03
3170909-170909102.661106.05
4165247-16524799.260102.71
5161182-16118296.818100.17
6166652-166652100.104103.51
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%
110.521808801811571807721804341801361806760.23
210.471815291816351815820.05
单位质量响应值RSD%判断
17174.5217343.080.70数据可信
供试品溶液-2024011222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%
5min110488-104885.4565.248.595.465.248.62
29736-97365.0645.06
38617-86174.4824.48
410733-107335.5835.58
510992-109925.7185.72
69852-98525.1255.12
10min115492-154928.0598.392.338.098.422.31
216060-160608.3548.38
316080-160808.3658.39
416145-161458.3988.43
516533-165338.6008.63
616486-164868.5768.60
15min116794-167948.7368.452.168.818.522.15
216005-160058.3268.40
316078-160788.3638.43
416132-161328.3928.47
516543-165438.6058.68
615894-158948.2688.34
20min115571-155718.1008.231.788.228.351.80
215642-156428.1378.26
315857-158578.2498.37
415646-156468.1398.26
516336-163368.4988.63
615850-158508.2458.37
30min114467-144677.5257.812.407.697.982.36
214903-149037.7527.92
315444-154448.0348.20
414853-148537.7267.90
515357-153577.9888.16
615092-150927.8518.02
45min114438-144387.5107.722.547.727.932.49
215296-152967.9578.17
315148-151487.8808.09
414361-143617.4707.68
514807-148077.7027.92
614950-149507.7777.99
60min114636-146367.6137.681.897.877.941.78
214710-147107.6527.91
315325-153257.9728.22
414579-145797.5847.84
514662-146627.6277.89
614678-146787.6357.89
极限114453-144537.5187.681.487.817.981.47
214682-146827.6377.93
315013-150137.8098.11
415015-150157.8118.11
514802-148027.7008.00
614678-146787.6357.93
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.741473451473941472981472541471611472900.07
210.731479881476941478410.15
单位质量响应值RSD%判断
13714.1513778.290.33数据可信
供试品溶液-2024011222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%
5min1124085-12408574.71965.2611.4474.7265.2611.44
2109720-10972066.06966.07
396497-9649758.10758.11
499433-9943359.87559.87
5122356-12235673.67873.68
698207-9820759.13759.14
10min1150289-15028990.49888.852.6390.9189.222.65
2148629-14862989.49989.87
3140135-14013584.38484.71
4146760-14676088.37388.71
5150456-15045690.59991.01
6149059-14905989.75890.09
15min1153886-15388692.66490.582.8593.5891.432.88
2149426-14942689.97990.84
3143970-14397086.69387.48
4150022-15002290.33891.16
5156317-15631794.12895.04
6148891-14889189.65790.48
20min1154667-15466793.13591.262.7894.5792.622.80
2148886-14888689.65491.02
3147352-14735288.73090.00
4148912-14891289.66990.99
5158386-15838695.37496.81
6151167-15116791.02792.35
30min1149939-14993990.28890.903.0092.2492.762.97
2145363-14536387.53289.39
3153485-15348592.42394.19
4147824-14782489.01490.84
5158263-15826395.30097.27
6150827-15082790.82292.65
45min1151201-15120191.04891.923.9493.5094.303.83
2147453-14745388.79191.14
3163331-16333198.352100.63
4147698-14769888.93891.26
5155579-15557993.68496.18
6150681-15068190.73493.07
60min1154754-15475493.18793.083.4796.1495.963.38
2149733-14973390.16493.01
3163665-16366598.553101.38
4149171-14917189.82592.64
5157024-15702494.55497.57
6153101-15310192.19295.03
极限1161951-16195197.52197.531.05101.00100.931.04
2158773-15877395.60798.95
3161752-16175297.401100.77
4162981-16298198.141101.45
5163170-16317098.255101.80
6163194-16319498.269101.62
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%
110.521811021819371826731819671820661819490.31
210.471800881805021802950.17
单位质量响应值RSD%判断
17295.5317220.150.31数据可信
供试品溶液-2024011223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%
5min110050-100505.2285.6712.685.235.6712.67
212059-120596.2736.27
38712-87124.5324.53
410772-107725.6045.60
511297-112975.8775.88
612483-124836.4946.49
10min115574-155748.1028.161.848.138.191.84
215518-155188.0728.11
315569-155698.0998.12
415503-155038.0658.10
515712-157128.1738.21
616257-162578.4578.49
15min115550-155508.0898.231.488.168.311.50
215725-157258.1808.26
315974-159748.3108.38
415606-156068.1188.19
515948-159488.2968.37
616144-161448.3988.48
20min115393-153938.0078.172.038.138.302.04
216204-162048.4298.55
315356-153567.9888.10
415803-158038.2218.34
515654-156548.1438.27
615872-158728.2578.39
30min114466-144667.5257.681.457.697.851.43
214533-145337.5607.73
314809-148097.7047.86
414926-149267.7657.93
514913-149137.7587.93
614952-149527.7787.95
45min114276-142767.4267.581.707.637.791.64
214501-145017.5437.76
314745-147457.6707.87
414496-144967.5417.75
514975-149757.7908.00
614452-144527.5187.74
60min114287-142877.4327.603.937.687.863.85
215688-156888.1618.42
314255-142557.4157.66
414566-145667.5777.83
514136-141367.3547.61
614770-147707.6837.94
极限114269-142697.4237.520.827.717.810.86
214399-143997.4907.79
314422-144227.5027.79
414443-144437.5137.81
514575-145757.5827.88
614583-145837.5867.89
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.741476271478871480821480541477631478830.14
210.731466091466481466280.02
单位质量响应值RSD%判断
13769.3713665.240.54数据可信
供试品溶液-2024011223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%
5min184462-8446250.96763.1516.2550.9763.1516.25
2112704-11270468.01068.01
392423-9242355.77155.77
492677-9267755.92555.92
5119867-11986772.33272.33
6125806-12580675.91675.92
10min1143408-14340886.53887.913.6986.8288.263.72
2139309-13930984.06484.44
3141995-14199585.68585.99
4145325-14532587.69488.01
5150449-15044990.78691.19
6153565-15356592.66793.09
15min1146029-14602988.11990.703.2188.8891.543.25
2146828-14682888.60189.45
3146802-14680288.58689.37
4149763-14976390.37391.17
5154955-15495593.50694.41
6157486-15748695.03395.97
20min1148031-14803189.32791.453.7090.5892.793.72
2150802-15080291.00092.34
3143072-14307286.33587.61
4152422-15242291.97793.28
5156961-15696194.71696.14
6157998-15799895.34296.81
30min1144691-14469187.31290.023.5989.0691.873.62
2143415-14341586.54288.38
3145978-14597888.08989.85
4150085-15008590.56792.38
5154852-15485293.44395.40
6156014-15601494.14596.14
45min1149329-14932990.11192.212.5692.3594.562.59
2156573-15657394.48296.81
3149171-14917190.01592.26
4149403-14940390.15592.47
5157285-15728594.91297.38
6155049-15504993.56296.08
60min1149992-14999290.51193.313.7893.2596.173.76
2161435-16143597.416100.26
3146555-14655588.43791.18
4153534-15353492.64895.46
5155716-15571693.96596.96
6160537-16053796.87499.91
极限1166390-166390100.406100.182.16103.64103.562.20
2162991-16299198.355101.74
3160819-16081997.044100.28
4166432-166432100.431103.76
5170095-170095102.642106.16
6169344-169344102.188105.76
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%
110.521809881822231823211825191828011821700.39
210.471802471816541809500.55
单位质量响应值RSD%判断
17316.5417282.710.14数据可信
供试品溶液-2024011821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%
5min16942-69423.6024.7216.343.604.7216.38
28352-83524.3344.33
310770-107705.5895.59
48205-82054.2584.26
59916-99165.1465.15
610344-103445.3685.37
10min115604-156048.0988.383.928.128.403.95
216053-160538.3318.35
316719-167198.6768.71
415423-154238.0048.03
515996-159968.3018.33
617054-170548.8508.88
15min116028-160288.3188.362.188.388.442.21
215781-157818.1898.26
316674-166748.6538.73
415776-157768.1878.25
516369-163698.4958.57
616080-160808.3458.42
20min116297-162978.4578.261.928.578.381.91
215631-156318.1128.23
316144-161448.3788.51
415637-156378.1158.23
515655-156558.1248.25
616117-161178.3648.49
30min114597-145977.5757.822.017.737.992.05
214962-149627.7647.93
315458-154588.0228.20
415101-151017.8378.00
514994-149947.7817.95
615320-153207.9508.12
45min114636-146367.5957.711.747.807.921.75
214615-146157.5847.79
315251-152517.9148.13
414950-149507.7587.96
514696-146967.6267.84
615050-150507.8108.03
60min114557-145577.5547.671.057.807.921.11
214808-148087.6847.93
315038-150387.8048.07
414755-147557.6577.90
514736-147367.6477.90
614796-147967.6787.94
极限114576-145767.5647.501.077.857.801.03
214481-144817.5157.80
314585-145857.5697.87
414383-143837.4647.75
514189-141897.3637.66
614552-145527.5527.85
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.742960362960192956762966162976542964000.27
210.732956302955002955650.04
单位质量响应值RSD%判断
27597.7727545.670.14数据可信
供试品溶液-2024011821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%
5min1160971-16097148.32646.9410.4948.3346.9410.49
2183332-18333255.03955.04
3147390-14739044.24944.25
4143540-14354043.09343.09
5139158-13915841.77741.78
6163643-16364349.12849.13
10min1272413-27241381.78278.662.9182.0578.932.90
2264178-26417879.31079.62
3258433-25843377.58577.83
4268537-26853780.61980.86
5255324-25532476.65276.88
6253294-25329476.04276.32
15min1291687-29168787.56982.444.5888.2983.144.54
2269163-26916380.80781.55
3273318-27331882.05482.73
4283800-28380085.20185.89
5274636-27463682.45083.11
6255109-25510976.58777.28
20min1293117-29311787.99883.154.2189.2184.314.18
2271632-27163281.54882.74
3271395-27139581.47782.61
4288678-28867886.66587.83
5274696-27469682.46883.58
6262336-26233678.75779.88
30min1284716-28471685.47683.933.2287.1785.553.19
2272576-27257681.83183.48
3278840-27884083.71285.30
4290177-29017787.11588.76
5285201-28520185.62187.20
6265990-26599079.85481.41
45min1298681-29868189.66884.824.4591.8486.904.41
2276345-27634582.96385.07
3274883-27488382.52484.57
4293436-29343688.09490.22
5286483-28648386.00688.06
6265292-26529279.64481.65
60min1298158-29815889.51186.363.9692.1888.913.92
2282756-28275684.88787.45
3290628-29062887.25189.76
4295332-29533288.66391.28
5292009-29200987.66590.19
6267034-26703480.16782.61
极限1329173-32917398.82298.851.10101.99101.891.08
2330230-33023099.140102.18
3335587-335587100.748103.74
4328957-32895798.758101.87
5325457-32545797.707100.72
6326261-32626197.948100.84
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%
110.521815411820701822451822451820861820370.16
210.471827871827221827540.03
单位质量响应值RSD%判断
17303.9017455.010.62数据可信
供试品溶液-2024012021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%
5min17458-74583.8534.9315.563.854.9315.55
210460-104605.4035.40
39813-98135.0695.07
410569-105695.4605.46
511020-110205.6935.69
67955-79554.1094.11
10min114519-145197.5008.225.127.528.255.17
216875-168758.7178.75
315970-159708.2508.28
416414-164148.4798.51
516133-161338.3348.37
615537-155378.0268.05
15min115269-152697.8878.324.387.958.394.40
217245-172458.9088.99
315625-156258.0718.15
415866-158668.1968.27
516542-165428.5458.62
616059-160598.2968.36
20min115381-153817.9458.101.138.058.221.22
215896-158968.2118.34
315680-156808.1008.22
415670-156708.0958.22
515800-158008.1628.29
615615-156158.0668.18
30min114340-143407.4087.732.187.567.892.21
214971-149717.7347.91
315168-151687.8358.00
415206-152067.8558.02
515162-151627.8328.00
614915-149157.7057.86
45min114217-142177.3447.652.247.547.862.24
215078-150787.7898.01
314777-147777.6337.84
415063-150637.7817.99
514707-147077.5977.81
615029-150297.7637.96
60min114275-142757.3747.501.277.617.751.30
214698-146987.5937.85
314731-147317.6107.86
414386-143867.4317.69
514579-145797.5317.79
614419-144197.4487.69
极限114250-142507.3617.411.567.647.701.50
214411-144117.4447.75
314481-144817.4807.77
414551-145517.5177.81
513946-139467.2047.50
614464-144647.4727.76
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.742951502951052953602954152956702953400.08
210.732963192961342962260.05
单位质量响应值RSD%判断
27499.0727607.270.28数据可信
供试品溶液-2024012021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%
5min1140185-14018542.11444.6714.8442.1144.6714.84
2151284-15128445.44845.45
3112023-11202333.65433.65
4179244-17924453.84853.85
5153832-15383246.21446.21
6155660-15566046.76346.76
10min1256995-25699577.20680.364.2877.4480.604.26
2283945-28394585.30285.55
3278516-27851683.67183.86
4266710-26671080.12480.42
5262519-26251978.86579.12
6256204-25620476.96877.23
15min1279933-27993384.09785.874.8484.7686.564.79
2304990-30499091.62492.35
3299429-29942989.95490.61
4269511-26951180.96681.71
5285411-28541185.74286.44
6275728-27572882.83383.52
20min1277905-27790583.48786.385.9784.6287.555.91
2307068-30706892.24893.48
3310337-31033793.23194.38
4273053-27305382.03083.22
5285530-28553085.77886.95
6271339-27133981.51582.66
30min1273414-27341482.13886.295.7783.7387.945.71
2302042-30204290.73992.49
3312543-31254393.89395.56
4272578-27257881.88783.54
5285705-28570585.83187.48
6277075-27707583.23884.84
45min1280811-28081184.36088.936.2286.4191.066.15
2316654-31665495.12897.38
3320564-32056496.30398.49
4277078-27707883.23985.34
5293102-29310288.05390.18
6287829-28782986.46988.53
60min1291951-29195187.70792.186.4890.2394.816.41
2329232-32923298.907101.69
3331217-33121799.503102.23
4293942-29394288.30590.87
5309871-30987193.09195.70
6284876-28487685.58288.12
极限1333560-333560100.207100.860.75103.21103.990.77
2334692-334692100.547103.88
3339214-339214101.906105.18
4336170-336170100.991104.05
5332762-33276299.967103.10
6337906-337906101.513104.53
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