依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00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%
111.411891881893201894661889221892761892340.11
211.381895361895691895520.02
单位质量响应值RSD%判断
16584.9316656.590.31数据可信
影响因素30天-供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104654-10465456.67059.9211.3556.6759.9211.35
2115696-11569662.64962.65
3112405-11240560.86760.87
4118764-11876464.31064.31
588641-8864147.99948.00
6123815-12381567.04567.05
10min1162670-16267088.08586.873.5588.4087.203.57
2162000-16200087.72288.07
3163519-16351988.54588.88
4162891-16289188.20588.56
5148858-14885880.60680.87
6162567-16256788.02988.40
15min1178726-17872696.77993.952.1797.5894.772.18
2171980-17198093.12693.96
3173053-17305393.70794.54
4176946-17694695.81596.66
5168367-16836791.17091.88
6171961-17196193.11693.98
20min1179559-17955997.23096.592.6998.5797.932.68
2171979-17197993.12694.48
3178062-17806296.42097.77
4186634-186634101.061102.44
5176356-17635695.49696.72
6177722-17772296.23597.61
30min1182408-18240898.77397.661.82100.6599.531.81
2174452-17445294.46596.33
3181792-18179298.439100.33
4183662-18366299.452101.39
5179213-17921397.04398.79
6180534-18053497.75899.67
45min1179708-17970897.31198.401.7999.74100.821.77
2178316-17831696.55798.95
3181180-18118098.108100.54
4187517-187517101.539104.03
5183046-18304699.118101.41
6180535-18053597.759100.22
60min1182496-18249698.82199.162.05101.79102.122.02
2178956-17895696.90499.83
3184222-18422299.755102.73
4189396-189396102.557105.61
5183843-18384399.550102.39
6179767-17976797.343100.34
极限1188031-188031101.818101.361.68105.34104.871.68
2182281-18228198.704102.17
3186494-186494100.985104.52
4191879-191879103.901107.53
5186239-186239100.847104.24
6188144-188144101.879105.42
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.984182484181114188274184764186064184540.07
211.024195874191114193490.09
单位质量响应值RSD%判断
38110.5638053.450.11数据可信
影响因素30天-供试品溶液-2024012921批--pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1264471-26447162.19153.8149.9262.1953.8149.92
2294616-29461669.27969.28
3284401-28440166.87766.88
4300351-30035170.62870.63
5226963-22696353.37053.37
62093-20930.4920.49
10min12376-23760.5590.572.500.900.8716.40
22405-24050.5660.95
32398-23980.5640.94
42472-24720.5810.97
52349-23490.5520.85
62508-25080.5900.59
15min12530-25300.5950.602.510.940.9016.55
22566-25660.6030.99
32470-24700.5810.96
42667-26670.6271.02
52564-25640.6030.90
62583-25830.6070.61
20min12547-25470.5990.633.360.950.9315.57
22598-25980.6111.00
32636-26360.6201.00
42791-27910.6561.06
52712-27120.6380.94
62720-27200.6400.65
30min12646-26460.6220.637.570.980.9414.99
22668-26680.6271.02
32282-22820.5370.92
42820-28200.6631.07
52777-27770.6530.96
62809-28090.6610.67
45min12716-27160.6390.673.691.000.9815.26
22848-28480.6701.07
32750-27500.6471.03
43008-30080.7071.11
52900-29000.6820.99
62877-28770.6770.69
60min12836-28360.6670.692.841.031.0115.09
22954-29540.6951.10
32861-28610.6731.06
43069-30690.7221.13
52964-29640.6971.01
62943-29430.6920.71
极限12992-29920.7040.704.931.071.0212.32
22998-29980.7051.11
33009-30090.7081.10
42801-28010.6591.07
52815-28150.6620.98
63199-31990.7520.78
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00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%
111.411894991905351903811896641901741900510.24
211.381907961909661908810.07
单位质量响应值RSD%判断
16656.5316773.370.50数据可信
影响因素30天-供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180987-8098743.60751.2616.7543.6151.2616.74
287789-8778947.27047.27
3115172-11517262.01462.01
478647-7864742.34742.35
5113652-11365261.19661.20
694994-9499451.14951.15
10min1146633-14663378.95481.114.0679.2081.404.08
2142360-14236076.65376.92
3157268-15726884.68085.02
4152416-15241682.06882.30
5157434-15743484.77085.11
6147736-14773679.54879.83
15min1172799-17279993.04392.262.1493.7293.002.13
2168303-16830390.62291.31
3175294-17529494.38695.20
4175485-17548594.48995.18
5169115-16911591.05991.87
6167092-16709289.97090.70
20min1179386-17938696.59096.041.0697.7997.291.03
2177425-17742595.53496.73
3177851-17785195.76397.10
4181670-18167097.82099.04
5177415-17741595.52996.85
6176473-17647395.02196.25
30min1185631-18563199.95299.232.02101.69101.011.96
2184140-18414099.150100.87
3183086-18308698.582100.45
4190638-190638102.648104.41
5179506-17950696.65498.50
6182727-18272798.389100.14
45min1179568-17956896.68898.841.3198.98101.171.31
2185086-18508699.659101.93
3185119-18511999.677102.10
4181682-18168297.826100.16
5185573-18557399.921102.31
6184317-18431799.245101.55
60min1181655-18165597.81298.381.88100.64101.261.83
2185858-185858100.075102.90
3182175-18217598.092101.06
4176847-17684795.22398.10
5186243-186243100.282103.22
6183504-18350498.807101.66
极限1198319-198319106.784101.443.17110.15104.863.07
2187198-187198100.796104.18
3192627-192627103.719107.24
4183017-18301798.545101.95
5185621-18562199.947103.44
6183550-18355098.832102.23
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.984192534213874208504199854204084203770.20
211.024223464228974226220.10
单位质量响应值RSD%判断
38285.7038350.450.12数据可信
影响因素30天-供试品溶液-2024012921批--pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207756-20775648.55356.7915.8548.5556.7915.85
2224143-22414352.38352.38
3293202-29320268.52268.52
4204047-20404747.68647.69
5285173-28517366.64566.65
6243639-24363956.93956.94
10min1349476-34947681.67383.443.5181.9483.763.53
2337564-33756478.88979.18
3370329-37032986.54786.93
4365409-36540985.39785.66
5366291-36629185.60385.97
6353175-35317582.53882.85
15min1396614-39661492.68992.342.0293.4193.122.00
2390949-39094991.36692.09
3405099-40509994.67295.53
4403601-40360194.32295.06
5386833-38683390.40491.25
6387633-38763390.59191.37
20min1408407-40840795.44595.211.1596.6896.501.11
2407020-40702095.12196.36
3406608-40660895.02596.41
4415254-41525497.04698.31
5400737-40073793.65395.00
6406261-40626194.94496.22
30min1417276-41727697.51897.182.0299.2999.001.96
2415387-41538797.07798.84
3414762-41476296.93198.85
4430001-430001100.492102.29
5403943-40394394.40296.27
6413715-41371596.68698.49
45min1399364-39936493.33247.74108.4895.6450.10103.36
22017-20170.4712.78
32013-20130.4702.92
4406875-40687595.08797.45
5413224-41322496.57198.96
62059-20590.4812.82
60min12048-20480.4790.492.613.313.129.07
22139-21390.5002.81
32106-21060.4922.95
42028-20280.4743.36
52171-21710.5073.44
62132-21320.4982.84
极限12360-23600.55216.66237.063.3819.28205.53
22260-22600.5282.84
32371-23710.5543.01
42231-22310.5213.41
5416181-41618197.262100.19
62264-22640.5292.88
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00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%
111.411903681906121902951904051904991904360.07
211.381938921938411938660.02
单位质量响应值RSD%判断
16690.2717035.681.45数据可信
影响因素30天-供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168297-6829736.45539.756.7336.4539.766.73
269966-6996637.34637.35
380003-8000342.70342.70
477074-7707441.14041.14
572146-7214638.50938.51
679390-7939042.37642.38
10min1128438-12843868.55671.234.1868.7671.454.18
2124586-12458666.50066.71
3137411-13741173.34673.58
4136367-13636772.78973.02
5138212-13821273.77373.99
6135670-13567072.41772.65
15min1167727-16772789.52890.032.7290.1190.652.71
2164799-16479987.96588.54
3170765-17076591.14991.79
4172439-17243992.04392.68
5174074-17407492.91593.54
6162246-16224686.60287.24
20min1181196-18119696.71796.510.9797.8097.630.98
2179208-17920895.65696.72
3183033-18303397.69798.85
4182357-18235797.33798.48
5180527-18052796.36097.50
6178537-17853795.29896.42
30min1186020-18602099.29298.881.13100.91100.531.12
2183703-18370398.05599.65
3187057-18705799.845101.54
4182397-18239797.35899.04
5184460-18446098.459100.13
6187872-187872100.280101.93
45min1187050-18705099.84299.740.70102.01101.940.70
2186226-18622699.402101.54
3189062-189062100.916103.16
4185110-18511098.806101.03
5186899-18689999.761101.98
6186813-18681399.715101.92
60min1186153-18615399.36399.560.73102.09102.320.72
2186370-18637099.479102.17
3188638-188638100.689103.50
4184565-18456598.515101.29
5186237-18623799.408102.18
6187219-18721999.932102.69
极限1185081-18508198.791100.051.21102.07103.361.18
2187601-187601100.136103.38
3187476-187476100.069103.44
4184823-18482398.653101.98
5190697-190697101.788105.12
6188952-188952100.857104.17
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.984208784214244210704210124212944211360.06
211.024289534286654288090.05
单位质量响应值RSD%判断
38354.8338911.891.02数据可信
影响因素30天-供试品溶液-2024012921批--pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176040-17604040.80744.887.1440.8144.887.14
2180369-18036941.81141.81
3208025-20802548.22248.22
4202246-20224646.88246.88
5188706-18870643.74343.74
6206377-20637747.84047.84
10min1308475-30847571.50774.384.1171.7374.634.11
2300947-30094769.76169.99
3330325-33032576.57276.84
4327926-32792676.01576.28
5333804-33380477.37877.62
6323755-32375575.04975.31
15min12073-20730.48115.03237.071.1015.69227.13
22048-20480.4751.09
32089-20890.4841.18
42089-20890.4841.17
52141-21410.4961.17
6378546-37854687.74988.43
20min12268-22680.52616.53237.191.1517.28226.61
2416531-41653196.55597.18
32279-22790.5281.22
42278-22780.5281.21
52245-22450.5201.20
62237-22370.5191.69
30min12373-23730.5500.552.081.181.3918.72
22327-23270.5391.70
32390-23900.5541.25
42333-23330.5411.23
52326-23260.5391.22
62450-24500.5681.74
45min12491-24910.5770.563.901.211.4017.35
22461-24610.5701.73
32445-24450.5671.27
42410-24100.5591.25
52420-24200.5611.24
62227-22270.5161.69
60min12525-25250.5850.569.661.221.4018.38
22158-21580.5001.67
32558-25580.5931.30
42532-25320.5871.28
52060-20600.4781.16
62599-25990.6021.78
极限12614-26140.6060.611.361.251.4617.25
22616-26160.6061.77
32682-26820.6221.33
42623-26230.6081.31
52697-26970.6251.31
62645-26450.6131.80
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00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%
111.411920291925101924691926121922701923780.13
211.381938201936301937250.07
单位质量响应值RSD%判断
16860.4717023.290.68数据可信
影响因素30天-供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117273-11727362.30053.1310.4662.3053.1310.45
296859-9685951.45551.46
3108300-10830057.53357.53
491362-9136248.53548.54
593523-9352349.68349.68
692743-9274349.26949.27
10min1159798-15979884.89178.665.2085.2478.955.22
2151809-15180980.64780.93
3152113-15211380.80981.13
4141494-14149475.16775.44
5141325-14132575.07875.35
6141816-14181675.33875.61
15min1175185-17518593.06590.612.4093.8891.342.42
2171782-17178291.25891.99
3172738-17273891.76592.53
4169705-16970590.15490.84
5163154-16315486.67487.37
6170845-17084590.76091.45
20min1177456-17745694.27293.680.9995.6194.921.02
2177860-17786094.48695.73
3177533-17753394.31395.59
4174565-17456592.73693.92
5176892-17689293.97295.15
6173776-17377692.31793.51
30min1178764-17876494.96795.691.8996.8397.441.83
2178087-17808794.60796.37
3178329-17832994.73696.54
4181534-18153496.43898.14
5186461-18646199.056100.75
6177567-17756794.33196.04
45min1181236-18123696.28096.671.2398.6798.961.17
2183162-18316297.30399.59
3178602-17860294.88197.21
4184911-18491198.232100.47
5183161-18316197.30299.55
6180758-18075896.02698.26
60min1182089-18208996.73397.090.6799.6599.910.64
2180958-18095896.13298.96
3183751-18375197.616100.47
4183979-18397997.737100.52
5183651-18365197.563100.35
6182119-18211996.74999.52
极限1173939-17393992.40395.712.5195.8699.072.38
2179757-17975795.49498.86
3177404-17740494.24497.64
4183822-18382297.654100.98
5186604-18660499.132102.46
6179424-17942495.31798.62
依折麦布辛伐他汀片项目信息
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(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.984243934247904255524257074253524251590.13
211.024278894274304276600.08
单位质量响应值RSD%判断
38721.2238807.620.16数据可信
影响因素30天-供试品溶液-2024012921批--pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1283153-28315365.41119.85152.6665.4119.85152.65
22084-20840.4810.48
32337-23370.5400.54
42058-20580.4750.48
5223788-22378851.69851.70
62035-20350.4700.47
10min13327-33270.7690.715.581.130.8221.66
23160-31600.7300.73
33054-30540.7060.71
43084-30840.7120.72
52820-28200.6510.94
62983-29830.6890.69
15min13519-35190.8130.803.801.180.9217.32
23460-34600.7990.81
33390-33900.7830.79
43639-36390.8410.85
53265-32650.7541.05
63548-35480.8200.83
20min13558-35580.8220.832.771.190.9516.62
23555-35550.8210.83
33650-36500.8430.85
43780-37800.8730.88
53505-35050.8101.10
63549-35490.8200.83
30min13622-36220.8370.842.851.210.9618.71
23609-36090.8340.85
33561-35610.8230.84
43538-35380.8170.83
53821-38210.8831.18
63693-36930.8530.87
45min13779-37790.8730.834.341.250.9619.41
23703-37030.8550.88
33625-36250.8370.86
43496-34960.8080.83
53548-35480.8201.12
63343-33430.7720.79
60min13838-38380.8870.892.391.271.0316.01
23737-37370.8630.89
33839-38390.8870.91
44000-40000.9240.95
53873-38730.8951.20
63948-39480.9120.94
极限13745-37450.8650.914.581.261.0416.37
23812-38120.8810.91
33766-37660.8700.90
44169-41690.9630.99
54098-40980.9471.26
63959-39590.9150.94
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