依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.851309691308801310881307851308341309110.10
210.881312881309661311270.18
单位质量响应值RSD%判断
12065.5312052.110.08数据可信
供试品溶液-2024061321批-匹伐他汀钙-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%
5min1120191-12019186.38592.504.6086.3892.504.60
2128013-12801392.00692.01
3129103-12910392.79092.79
4124959-12495989.81189.81
5137144-13714498.56998.57
6132766-13276695.42395.42
10min1131708-13170894.66298.312.4394.8198.472.43
2134987-13498797.01997.17
3136884-13688498.38298.54
4137370-13737098.73298.88
5141648-141648101.806101.97
6138132-13813299.27999.44
15min1130931-13093194.10498.142.7894.4198.462.78
2134788-13478896.87697.19
3136092-13609297.81398.13
4137596-13759698.89499.21
5142479-142479102.404102.74
6137377-13737798.73799.06
20min1130620-13062093.88098.072.5694.3498.552.56
2135805-13580597.60798.08
3136231-13623197.91398.39
4137547-13754798.85999.34
5141427-141427101.647102.15
6137069-13706998.51599.00
30min1131174-13117494.27898.092.6394.8998.742.63
2134538-13453896.69697.34
3136327-13632797.98298.63
4137320-13732098.69699.34
5141979-141979102.044102.72
6137529-13752998.84699.50
45min1131240-13124094.32697.742.4695.1098.542.46
2133846-13384696.19997.00
3135816-13581697.61598.42
4136588-13658898.17098.98
5141110-141110101.420102.26
6137315-13731598.69299.51
60min1130851-13085194.04697.812.6994.9898.792.69
2134299-13429996.52497.49
3135315-13531597.25598.23
4137154-13715498.57699.55
5141878-141878101.972102.98
6137052-13705298.50399.49
极限1130577-13057793.84997.582.6194.9498.722.61
2133576-13357696.00597.13
3135658-13565897.50198.63
4136859-13685998.36499.50
5141074-141074101.394102.58
6136903-13690398.39699.54
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113770633786823776613792573800353785400.32
210.933756843762073759460.10
单位质量响应值RSD%判断
34412.7334395.790.04数据可信
供试品溶液-2024061321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%
5min120424-204245.3435.319.595.345.319.63
222390-223905.8575.86
320393-203935.3355.33
416638-166384.3524.35
520747-207475.4275.43
621278-212785.5665.57
10min132535-325358.5118.641.668.528.651.66
233196-331968.6848.69
333762-337628.8328.84
432278-322788.4448.45
533022-330228.6388.65
633373-333738.7308.74
15min134011-340118.8978.914.228.928.934.20
231286-312868.1848.21
334972-349729.1499.17
434088-340888.9178.94
534870-348709.1229.15
635121-351219.1879.21
20min133164-331648.6768.873.308.718.913.26
234486-344869.0219.06
334481-344819.0209.06
435162-351629.1989.23
534143-341438.9328.97
632066-320668.3888.43
30min134545-345459.0379.001.419.099.061.41
233437-334378.7478.80
334620-346209.0569.11
434550-345509.0389.09
534542-345429.0369.09
634762-347629.0949.15
45min134165-341658.9378.901.199.008.971.18
233314-333148.7158.78
334415-344159.0039.07
434272-342728.9659.03
534231-342318.9559.02
633851-338518.8558.92
60min134103-341038.9219.012.139.009.102.12
233986-339868.8918.97
334153-341538.9349.02
435919-359199.3969.48
534118-341188.9259.01
634471-344719.0179.10
极限134012-340128.8978.734.288.998.834.23
234234-342348.9559.05
334326-343268.9809.08
430552-305527.9928.09
533384-333848.7338.83
633794-337948.8408.94
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.851307751312081316471318361318801314690.36
210.881302661306961304810.24
单位质量响应值RSD%判断
12116.9611992.740.73数据可信
供试品溶液-2024061321批-匹伐他汀钙-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%
5min1129712-12971293.26195.011.4393.2695.011.43
2130876-13087694.09894.10
3131117-13111794.27194.27
4133617-13361796.06896.07
5132853-13285395.51995.52
6134710-13471096.85496.85
10min1135153-13515397.17399.981.7597.33100.141.75
2140988-140988101.368101.52
3137024-13702498.51898.68
4139652-139652100.407100.57
5140387-140387100.936101.10
6141134-141134101.473101.63
15min1134487-13448796.69499.691.7597.01100.021.75
2140664-140664101.135101.46
3136995-13699598.49798.82
4139613-139613100.379100.71
5140166-140166100.777101.10
6140024-140024100.675101.01
20min1134977-13497797.04699.681.8097.52100.171.80
2140420-140420100.960101.45
3136184-13618497.91498.40
4141229-141229101.541102.04
5139337-139337100.181100.68
6139660-139660100.413100.91
30min1133313-13331395.85099.341.9596.49100.001.95
2139794-139794100.509101.17
3136692-13669298.27998.93
4139344-139344100.186100.85
5139646-139646100.403101.07
6140221-140221100.817101.48
45min1134133-13413396.43999.301.8497.24100.121.84
2140224-140224100.819101.65
3135828-13582897.65898.47
4139665-139665100.417101.25
5138698-13869899.721100.55
6140104-140104100.732101.57
60min1133885-13388596.26199.191.6597.22100.181.65
2139785-139785100.503101.50
3136941-13694198.45899.43
4138203-13820399.366100.36
5139143-139143100.041101.04
6139811-139811100.522101.52
极限1133686-13368696.11898.981.7597.24100.141.75
2139707-139707100.447101.61
3135816-13581697.64998.79
4138487-13848799.570100.73
5138811-13881199.803100.97
6139504-139504100.301101.47
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113819213821693825263826543829003824340.11
210.933755623778303766960.43
单位质量响应值RSD%判断
34766.7334464.410.62数据可信
供试品溶液-2024061321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%
5min119543-195435.0815.169.105.085.169.08
219770-197705.1405.14
323162-231626.0226.02
417761-177614.6184.62
518929-189294.9224.92
619846-198465.1605.16
10min131788-317888.2658.512.178.278.522.19
232346-323468.4108.42
333793-337938.7868.80
432941-329418.5658.57
532380-323808.4198.43
633160-331608.6228.63
15min133639-336398.7468.791.508.778.811.52
233831-338318.7968.82
334315-343158.9228.95
434096-340968.8658.89
532878-328788.5488.57
634009-340098.8428.87
20min133357-333578.6738.791.518.718.831.51
233468-334688.7028.74
334588-345888.9939.03
434215-342158.8968.93
533372-333728.6778.71
633945-339458.8268.86
30min133461-334618.7008.641.568.758.691.55
232222-322228.3788.43
333498-334988.7108.76
433365-333658.6758.73
533188-331888.6298.68
633643-336438.7478.80
45min133359-333598.6738.582.048.748.652.02
233576-335768.7308.80
332189-321898.3698.44
433773-337738.7818.85
532278-322788.3928.46
632839-328398.5388.61
60min134221-342218.8988.681.828.988.761.79
233282-332828.6538.73
334042-340428.8518.93
432991-329918.5788.66
532877-328778.5488.63
632865-328658.5458.63
极限132491-324918.4488.561.198.548.661.16
233568-335688.7288.82
333175-331758.6268.72
432624-326248.4828.58
532935-329358.5638.66
632853-328538.5428.64
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