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DSMF-387-240606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(%)99.75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%
111.061844541844661844931843671842941844150.05
211.081841701844201842950.10
单位质量响应值RSD%判断
16674.0516633.120.18数据可信
供试品溶液-25080101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%
5min189193-8919348.08251.0718.9748.0851.0718.97
2117320-11732063.24463.24
371944-7194438.78338.78
4113497-11349761.18361.18
595914-9591451.70551.70
680556-8055643.42643.43
10min1151973-15197381.92583.056.9982.1983.347.02
2158382-15838285.38085.73
3138671-13867174.75474.97
4170392-17039291.85492.19
5157378-15737884.83885.13
6147598-14759879.56679.81
15min1168458-16845890.81192.793.2391.5393.543.27
2171886-17188692.65993.48
3167483-16748390.28690.92
4182874-18287498.58399.43
5170177-17017791.73892.50
6171908-17190892.67193.35
20min1170473-17047391.89896.102.4793.1297.362.47
2176744-17674495.27896.62
3178622-17862296.29097.42
4183336-18333698.832100.23
5180249-18024997.16898.44
6180170-18017097.12598.32
30min1169908-16990891.59397.483.6293.3399.273.58
2181786-18178697.99699.87
3187106-187106100.864102.53
4183336-18333698.832100.78
5186273-186273100.415102.22
6176530-17653095.16396.90
45min1173787-17378793.68498.372.7695.93100.712.69
2182253-18225398.248100.66
3189071-189071101.923104.15
4181304-18130497.736100.23
5183967-18396799.172101.54
6184502-18450299.460101.73
60min1175065-17506594.37397.711.8897.14100.591.85
2179635-17963596.83799.80
3183710-18371099.033101.83
4182211-18221198.225101.26
5183613-18361398.981101.90
6183299-18329998.812101.63
极限1180274-18027497.18197.971.07100.47101.391.06
2180202-18020297.142100.64
3184251-18425199.325102.67
4182094-18209498.162101.75
5183761-18376199.061102.53
6179793-17979396.922100.29
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100601-201906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500
标示量(mg)20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%
110.914144294149414148884144034143364145990.08
211.004145734139534142630.11
单位质量响应值RSD%判断
38001.7437660.270.64数据可信
供试品溶液-25080101批-辛伐他汀-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%
5min1222279-22227952.61756.2917.6952.6256.2917.69
2290163-29016368.68668.69
3184145-18414543.59043.59
4281987-28198766.75166.75
5242151-24215157.32157.32
6206031-20603148.77148.77
10min1359946-35994685.20586.686.2985.5086.996.33
2373193-37319388.34188.72
3334527-33452779.18879.43
4402169-40216995.20095.57
5374848-37484888.73289.05
6352344-35234483.40583.68
15min1390753-39075392.49795.172.8993.2695.972.93
2400684-40068494.84895.72
3393044-39304493.04093.72
4423527-423527100.255101.16
5402354-40235495.24396.05
6401993-40199395.15895.89
20min1392485-39248592.90797.742.7194.1999.062.70
2408863-40886396.78498.18
3414722-41472298.17199.37
4421723-42172399.828101.29
5422279-42227999.960101.30
6417296-41729698.780100.04
30min1389982-38998292.31598.563.8894.11100.433.83
2418421-41842199.047100.98
3431436-431436102.128103.87
4419803-41980399.374101.39
5432427-432427102.362104.26
6406177-40617796.14897.96
45min1397865-39786594.18199.002.8596.49101.412.78
2418434-41843499.050101.54
3432785-432785102.447104.76
4413397-41339797.857100.42
5424340-424340100.448102.91
6422487-422487100.009102.36
60min1399279-39927994.51597.881.9497.35100.841.92
2409837-40983797.015100.05
3419373-41937399.272102.15
4414474-41447498.112101.22
5421057-42105799.671102.69
6416845-41684598.674101.58
极限1408925-40892596.79997.851.29100.16101.361.29
2410351-41035197.136100.71
3417924-41792498.929102.36
4413436-41343697.867101.52
5421346-42134699.739103.32
6408131-40813196.611100.06
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DSMF-387-240606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(%)99.75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%
111.061873951879381882871886071885271881510.27
211.081873631873901873760.02
单位质量响应值RSD%判断
17011.8416911.190.42数据可信
供试品溶液-25080101批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17481-74813.9603.846.673.963.846.67
26946-69463.6763.68
37073-70733.7443.74
47871-78714.1664.17
56570-65703.4773.48
67630-76304.0384.04
10min110885-108855.7615.666.135.785.686.15
210313-103135.4595.48
310704-107045.6665.69
411588-115886.1336.16
59654-96545.1105.13
610987-109875.8155.84
15min112259-122596.4896.431.956.546.482.01
212139-121396.4256.48
311846-118466.2706.32
412411-124116.5696.63
511877-118776.2866.33
612324-123246.5236.58
20min113144-131446.9576.893.227.056.983.20
212862-128626.8086.89
313073-130736.9197.01
413605-136057.2017.29
512323-123236.5226.61
613064-130646.9157.01
30min113638-136387.2187.253.377.357.383.28
214226-142267.5307.65
312850-128506.8016.93
413865-138657.3397.47
513743-137437.2747.39
613871-138717.3427.47
45min113831-138317.3217.703.507.497.873.43
214453-144537.6507.82
314627-146277.7427.91
415350-153508.1258.30
514732-147327.7987.96
614259-142597.5477.72
60min114617-146177.7377.862.947.958.072.85
214358-143587.6007.81
315384-153848.1438.35
415236-152368.0648.28
515091-150917.9888.19
614448-144487.6477.86
极限115340-153408.1197.972.648.378.222.57
215453-154538.1798.43
315152-151528.0208.27
414661-146617.7608.02
514485-144857.6677.91
615299-152998.0988.35
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100601-201906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500
标示量(mg)20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%
110.914205714220504228824233564236684225050.30
211.004206714210604208660.07
单位质量响应值RSD%判断
38726.4038260.550.86数据可信
供试品溶液-25080101批-辛伐他汀-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113556-135563.1543.134.823.153.134.81
213349-133493.1063.11
312791-127912.9762.98
414342-143423.3373.34
512709-127092.9572.96
613997-139973.2563.26
10min122953-229535.3405.148.045.365.168.00
220153-201534.6894.71
322071-220715.1355.15
423415-234155.4475.47
519813-198134.6094.63
624165-241655.6225.64
15min129407-294076.8416.744.186.896.794.18
229128-291286.7766.82
327153-271536.3176.36
428547-285476.6416.69
528836-288366.7096.75
630867-308677.1817.23
20min132530-325307.5687.776.497.657.856.43
232805-328057.6327.71
332672-326727.6017.68
437262-372628.6698.75
530894-308947.1877.27
634162-341627.9488.04
30min141284-412849.6059.445.819.739.565.75
243181-4318110.04610.17
336664-366648.5308.65
439696-396969.2359.37
540032-400329.3139.43
642599-425999.91010.04
45min143940-4394010.22211.215.3810.4011.395.32
249526-4952611.52211.70
348711-4871111.33211.50
451757-5175712.04112.23
547543-4754311.06111.23
647693-4769311.09611.28
60min151651-5165112.01612.364.5612.2512.604.46
251914-5191412.07812.32
355563-5556312.92613.16
455502-5550212.91213.16
554429-5442912.66312.90
649604-4960411.54011.79
极限157921-5792113.47513.055.7413.7813.365.60
260785-6078514.14114.45
355006-5500612.79713.10
453645-5364512.48012.80
551894-5189412.07312.38
657385-5738513.35013.66
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DSMF-387-240606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(%)99.75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%
111.061874521879771885311886231888021882770.30
211.081850341851821851080.06
单位质量响应值RSD%判断
17023.2416706.501.33数据可信
供试品溶液-25080101批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17647-76474.0714.164.064.074.164.06
28340-83404.4404.44
37592-75924.0424.04
48032-80324.2764.28
57507-75073.9964.00
67734-77344.1174.12
10min111253-112535.9916.141.816.016.171.82
211774-117746.2686.29
311522-115226.1346.16
411750-117506.2556.28
511352-113526.0436.07
611575-115756.1626.19
15min113647-136477.2657.032.557.327.082.52
213372-133727.1197.18
313230-132307.0437.10
413309-133097.0857.14
512687-126876.7546.81
612958-129586.8986.96
20min114354-143547.6427.461.947.747.551.93
214037-140377.4737.57
313678-136787.2827.38
413781-137817.3377.43
513895-138957.3977.49
614278-142787.6017.70
30min114635-146357.7917.662.447.937.802.42
214547-145477.7447.88
314590-145907.7677.90
414656-146567.8027.94
514125-141257.5207.65
613801-138017.3477.48
45min115490-154908.2468.142.598.438.322.54
214931-149317.9498.13
314750-147507.8528.03
415689-156898.3528.53
515683-156838.3498.53
615202-152028.0938.27
60min115503-155038.2538.231.438.488.461.38
215173-151738.0788.31
315656-156568.3358.56
415749-157498.3848.61
515382-153828.1898.41
615282-152828.1368.36
极限115650-156508.3328.363.608.618.633.47
214680-146807.8158.09
315717-157178.3678.64
416389-163898.7259.00
515941-159418.4868.75
615833-158338.4298.70
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100601-201906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500
标示量(mg)20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%
110.914197104209764219054200524210884207460.21
211.004150184159684154930.17
单位质量响应值RSD%判断
38565.1737772.091.47数据可信
供试品溶液-25080101批-辛伐他汀-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122766-227665.3425.498.575.345.498.56
226437-264376.2036.20
323113-231135.4235.42
424555-245555.7625.76
520416-204164.7904.79
623045-230455.4075.41
10min138862-388629.1199.302.359.159.332.34
240183-401839.4299.46
338523-385239.0399.07
441037-410379.6299.66
539258-392589.2129.24
639887-398879.3599.39
15min152540-5254012.32811.255.8512.4111.345.80
248506-4850611.38211.47
348642-4864211.41311.49
447028-4702811.03511.12
543971-4397110.31710.40
647102-4710211.05211.13
20min154636-5463612.82012.565.8712.9712.715.79
250105-5010511.75711.91
350903-5090311.94412.09
452568-5256812.33512.48
554152-5415212.70612.84
658828-5882813.80413.95
30min155137-5513712.93712.396.1913.1612.616.08
252911-5291112.41512.63
354636-5463612.82013.03
455290-5529012.97313.19
552328-5232812.27812.48
646622-4662210.93911.16
45min157038-5703813.38413.538.6813.6813.818.48
254884-5488412.87813.16
349809-4980911.68711.97
458471-5847113.72014.01
563283-6328314.84915.12
662471-6247114.65814.94
60min157589-5758913.51313.562.2313.8813.912.20
256667-5666713.29613.65
357018-5701813.37913.73
459721-5972114.01314.38
556669-5666913.29713.65
658949-5894913.83214.19
极限161589-6158914.45114.637.6814.8915.077.47
254411-5441112.76713.20
362530-6253014.67215.09
469133-6913316.22216.66
562008-6200814.55014.98
664518-6451815.13915.58
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DSMF-387-240606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(%)99.75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%
111.061874501878901882161882181881891879930.18
211.081899601901071900340.06
单位质量响应值RSD%判断
16997.5617151.080.64数据可信
供试品溶液-25080101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%
5min16179-61793.2493.327.043.253.326.97
25609-56092.9492.95
36856-68563.6053.60
46215-62153.2683.27
56718-67183.5323.53
66267-62673.2953.30
10min19717-97175.1095.002.755.135.022.82
29197-91974.8364.85
39826-98265.1675.19
49695-96955.0985.12
59329-93294.9054.92
69328-93284.9054.92
15min110653-106535.6015.751.495.655.801.48
211002-110025.7855.83
311087-110875.8305.88
411088-110885.8305.88
510925-109255.7445.79
610902-109025.7325.78
20min112048-120486.3356.213.766.416.293.74
211671-116716.1376.21
311684-116846.1436.22
412404-124046.5226.60
512001-120016.3106.39
611102-111025.8375.91
30min112737-127376.6976.382.836.816.502.80
211793-117936.2016.31
311932-119326.2746.39
411976-119766.2976.41
512328-123286.4826.60
612052-120526.3376.45
45min113282-132826.9846.783.227.136.933.17
212550-125506.5996.74
313522-135227.1107.26
412829-128296.7456.90
512582-125826.6166.77
612584-125846.6176.76
60min113077-130776.8766.843.577.067.023.44
213376-133767.0337.21
312323-123236.4796.67
413115-131156.8967.08
513535-135357.1177.30
612593-125936.6216.80
极限113567-135677.1346.913.597.367.143.43
213752-137527.2317.45
312667-126676.6606.89
412649-126496.6516.88
513317-133177.0027.23
612909-129096.7887.01
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100601-201906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500
标示量(mg)20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%
110.914204334210764224224226164223264217750.23
211.004257424263074260240.10
单位质量响应值RSD%判断
38659.4938729.450.13数据可信
供试品溶液-25080101批-辛伐他汀-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%
5min13813-38130.8821.0411.360.881.0411.43
24158-41580.9620.96
34749-47491.0991.10
44284-42840.9910.99
55233-52331.2111.21
64759-47591.1011.10
10min14875-48751.1281.116.631.131.126.46
24485-44851.0381.04
35172-51721.1971.20
45003-50031.1581.16
54363-43631.0101.02
64987-49871.1541.16
15min14957-49571.1471.316.661.161.326.67
25833-58331.3501.36
35897-58971.3651.38
45849-58491.3541.37
55523-55231.2781.29
65932-59321.3731.39
20min16909-69091.5991.516.631.621.536.60
26677-66771.5451.56
36119-61191.4161.44
47028-70281.6261.65
56528-65281.5111.53
65934-59341.3731.39
30min17527-75271.7421.678.591.771.708.35
26781-67811.5691.60
36564-65641.5191.55
46730-67301.5581.59
57428-74281.7191.75
68174-81741.8921.92
45min18838-88382.0451.955.682.081.995.58
27664-76641.7741.81
38783-87832.0332.07
48794-87942.0352.07
58058-80581.8651.90
68475-84751.9612.00
60min19088-90882.1032.056.132.152.106.02
29243-92432.1392.18
37806-78061.8071.85
48900-89002.0602.11
59270-92702.1452.19
68895-88952.0592.11
极限19634-96342.2302.195.612.292.255.43
29662-96622.2362.29
38693-86932.0122.07
49024-90242.0882.15
510168-101682.3532.41
69714-97142.2482.31
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