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%
111.061855371856371853701853861853481854560.07
211.081862711867531865120.19
单位质量响应值RSD%判断
16768.1716833.210.28数据可信
供试品溶液-Z008150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%
5min192017-9201749.17054.859.7849.1754.859.78
2115527-11552761.73261.73
398866-9886652.83052.83
4106147-10614756.72056.72
591750-9175049.02749.03
6111568-11156859.61759.62
10min1142406-14240676.09579.525.7576.3779.825.76
2158433-15843384.65985.00
3148630-14863079.42179.71
4155104-15510482.88183.20
5135521-13552172.41672.69
6152791-15279181.64581.98
15min1164729-16472988.02490.042.4788.7290.782.50
2172090-17209091.95792.77
3168913-16891390.25990.99
4172927-17292792.40493.18
5162394-16239486.77687.45
6169912-16991290.79391.58
20min1174288-17428893.13294.751.5994.3295.991.58
2174392-17439293.18794.51
3181347-18134796.90498.14
4179056-17905695.67996.97
5176240-17624094.17595.33
6178528-17852895.39796.69
30min1175516-17551693.78895.961.4995.4997.731.47
2179792-17979296.07397.91
3179746-17974696.04897.82
4177686-17768694.94796.77
5182441-18244197.48899.17
6182283-18228397.40499.22
45min1176195-17619594.15196.101.3596.3798.401.37
2183121-18312197.852100.23
3177972-17797295.10097.41
4180316-18031696.35398.70
5180762-18076296.59198.81
6180678-18067896.54698.91
60min1176520-17652094.32497.031.5997.0799.871.57
2181431-18143196.94999.87
3180613-18061396.51199.35
4182634-18263497.591100.47
5184654-18465498.671101.43
6183636-18363698.127101.02
极限1179210-17921095.76296.121.6099.0399.501.52
2181093-18109396.768100.23
3178180-17818095.21198.58
4178894-17889495.59399.02
5185010-18501098.861102.17
6176876-17687694.51597.96
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%
110.914182144190744190194183354186654186610.10
211.004210054215094212570.09
单位质量响应值RSD%判断
38374.0638296.090.15数据可信
供试品溶液-Z008150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%
5min1241605-24160556.43962.669.2756.4462.669.27
2299890-29989070.05470.05
3258883-25888360.47560.47
4275995-27599564.47264.47
5241833-24183356.49256.49
6291341-29134168.05768.06
10min1347896-34789681.26884.695.2281.5885.035.23
2381401-38140189.09589.48
3362701-36270184.72685.06
4379585-37958588.67089.03
5333163-33316377.82678.14
6370433-37043386.53386.91
15min1391067-39106791.35393.262.3792.1294.082.40
2404881-40488194.58095.46
3399843-39984393.40394.21
4411880-41188096.21497.07
5385828-38582890.12990.87
6401935-40193593.89194.75
20min1407280-40728095.14096.381.5196.4197.711.49
2404024-40402494.37995.79
3421305-42130598.41699.74
4415145-41514596.97798.36
5412165-41216596.28197.53
6415547-41554797.07198.45
30min1399199-39919993.25295.421.6295.0597.301.60
2409048-40904895.55397.49
3407410-40741095.17097.04
4403704-40370494.30596.23
5415745-41574597.11798.90
6415823-41582397.13699.06
45min1396767-39676792.68494.921.3795.0097.321.38
2412804-41280496.43098.90
3403628-40362894.28796.69
4408622-40862295.45397.90
5408942-40894295.52897.85
6407301-40730195.14597.60
60min1398074-39807492.98995.521.5395.8298.451.51
2408288-40828895.37598.38
3406970-40697095.06897.99
4411107-41110796.03499.01
5416012-41601297.180100.03
6413033-41303396.48499.47
极限1401585-40158593.81094.391.7597.1697.851.66
2407008-40700895.07698.61
3400707-40070793.60497.06
4401747-40174793.84797.36
5416740-41674097.350100.74
6396611-39661192.64896.17
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%
111.061858111859051858291858151858941858510.03
211.081890391891951891170.06
单位质量响应值RSD%判断
16803.8917068.321.11数据可信
供试品溶液-Z008150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%
5min14876-48762.5852.397.302.582.387.30
24199-41992.2262.23
34586-45862.4312.43
44801-48012.5452.55
54043-40432.1432.14
64498-44982.3842.38
10min18654-86544.5884.714.754.604.734.78
28632-86324.5764.59
39016-90164.7794.79
49365-93654.9654.98
58336-83364.4194.43
69360-93604.9624.98
15min110965-109655.8135.792.895.855.832.89
210378-103785.5025.54
311269-112695.9746.01
411136-111365.9035.95
510777-107775.7135.75
611027-110275.8465.89
20min111622-116226.1616.283.086.236.353.10
212075-120756.4016.47
311989-119896.3566.43
412347-123476.5456.62
511329-113296.0066.07
611692-116926.1986.27
30min113136-131366.9646.841.567.076.951.54
213111-131116.9507.05
312896-128966.8366.94
412948-129486.8646.97
512660-126606.7116.81
612697-126976.7316.84
45min113760-137607.2947.263.937.447.403.90
213558-135587.1877.33
313997-139977.4207.57
414527-145277.7017.85
512998-129986.8907.03
613302-133027.0527.20
60min114518-145187.6967.743.087.887.933.01
214622-146227.7517.93
314745-147457.8178.00
414430-144307.6507.84
513981-139817.4127.59
615355-153558.1408.32
极限115274-152748.0978.181.578.338.411.57
215279-152798.1008.33
315353-153538.1398.37
415708-157088.3278.56
515211-152118.0648.28
615770-157708.3608.59
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%
110.914194124200754198214203424201644199630.09
211.004259474259894259680.01
单位质量响应值RSD%判断
38493.4038724.360.43数据可信
供试品溶液-Z008150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%
5min15974-59741.3861.237.091.391.237.25
25161-51611.1971.20
35212-52121.2091.21
45539-55391.2851.28
54931-49311.1441.14
65108-51081.1851.18
10min114270-142703.3103.0739.163.323.0839.10
215232-152323.5333.54
315569-155693.6113.62
42825-28250.6550.66
514643-146433.3963.40
616912-169123.9233.93
15min121799-217995.0565.025.365.085.045.30
219788-197884.5904.62
323401-234015.4285.45
421376-213764.9584.97
521901-219015.0805.11
621534-215344.9955.02
20min126929-269296.2466.446.966.306.496.81
230275-302757.0227.07
327741-277416.4346.49
429815-298156.9156.95
526641-266416.1796.23
625273-252735.8625.92
30min133171-331717.6947.623.447.787.703.43
232514-325147.5417.63
333772-337727.8337.93
433027-330277.6607.74
533806-338067.8417.93
630763-307637.1357.22
45min139301-393019.1169.026.709.259.156.58
237575-375758.7158.85
341616-416169.6539.79
442216-422169.7929.91
536240-362408.4068.54
636356-363568.4338.56
60min147473-4747311.01110.877.6811.1911.057.56
245530-4553010.56010.74
347103-4710310.92511.12
445273-4527310.50110.67
542565-425659.87310.05
653309-5330912.36512.54
极限153364-5336412.37712.832.8312.6213.072.74
255392-5539212.84813.09
354361-5436112.60912.86
457521-5752113.34213.57
554481-5448112.63712.87
656683-5668313.14713.39
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%
111.061876111876601877571880651879821878150.11
211.081901851899281900560.10
单位质量响应值RSD%判断
16981.4617153.070.72数据可信
供试品溶液-Z008150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%
5min15715-57153.0062.967.553.012.967.53
24886-48862.5702.57
35682-56822.9892.99
45708-57083.0033.00
56201-62013.2623.26
65562-55622.9262.93
10min19898-98985.2075.162.715.225.182.72
29483-94834.9885.00
39555-95555.0265.04
410221-102215.3765.39
59842-98425.1775.20
69854-98545.1835.20
15min112135-121356.3836.212.626.436.262.61
212277-122776.4586.50
311670-116706.1396.18
411549-115496.0756.12
511640-116406.1236.17
611613-116136.1096.15
20min113090-130906.8867.013.046.977.093.00
213681-136817.1967.27
312959-129596.8176.90
413573-135737.1407.22
513792-137927.2557.34
612853-128536.7616.84
30min114296-142967.5207.491.077.647.601.04
214400-144007.5757.69
314120-141207.4277.54
414138-141387.4377.56
514398-143987.5747.69
614052-140527.3927.51
45min114740-147407.7547.973.227.918.133.14
215476-154768.1418.30
314872-148727.8237.98
414614-146147.6877.85
515332-153328.0658.23
615867-158678.3468.50
60min114704-147047.7358.022.667.948.222.58
215815-158158.3198.52
315310-153108.0538.25
415023-150237.9028.11
515580-155808.1958.40
615052-150527.9188.12
极限115568-155688.1898.241.048.448.490.98
215605-156058.2098.46
315998-159988.4158.66
415656-156568.2358.48
515625-156258.2198.47
615587-155878.1998.45
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%
110.914234194236654240374249054241034240260.14
211.004292054285344288700.12
单位质量响应值RSD%判断
38865.8138988.180.23数据可信
供试品溶液-Z008150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%
5min19295-92952.1381.9116.182.141.9116.19
25734-57341.3191.32
38302-83021.9101.91
49386-93862.1592.16
58790-87902.0222.02
68237-82371.8951.89
10min131392-313927.2226.418.177.236.428.15
224920-249205.7335.74
327281-272816.2766.29
429339-293396.7496.76
526374-263746.0676.08
627869-278696.4116.42
15min137391-373918.6028.665.928.658.715.85
241348-413489.5129.55
338567-385678.8728.92
437364-373648.5958.64
534612-346127.9628.01
636692-366928.4418.49
20min144568-4456810.25311.008.7410.3511.098.65
251746-5174611.90412.00
341433-414339.5329.63
451627-5162711.87711.97
550191-5019111.54611.64
647261-4726110.87210.97
30min151573-5157311.86411.625.7412.0211.785.66
252184-5218412.00512.16
347462-4746210.91811.07
449512-4951211.39011.55
554865-5486512.62212.77
647561-4756110.94111.09
45min151922-5192211.94412.556.2012.1712.786.08
255304-5530412.72212.95
352038-5203811.97112.18
452401-5240112.05512.28
555008-5500812.65412.88
660754-6075413.97614.19
60min154018-5401812.42712.724.0612.7213.014.01
258115-5811513.36913.66
351866-5186611.93212.21
454904-5490412.63012.92
557186-5718613.15513.45
655634-5563412.79813.09
极限159826-5982613.76313.633.6914.1213.993.54
256781-5678113.06213.43
362669-6266914.41714.76
459079-5907913.59113.95
557019-5701913.11713.48
660103-6010313.82614.19
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%
111.061901651905201906421904071904791904430.10
211.081900731905731903230.19
单位质量响应值RSD%判断
17219.0817177.170.18数据可信
供试品溶液-Z008150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%
5min15418-54182.8282.858.042.832.858.10
25783-57833.0193.02
35266-52662.7492.75
45135-51352.6802.68
56142-61423.2063.21
64966-49662.5922.59
10min19192-91924.7984.694.084.814.704.05
29402-94024.9084.92
39113-91134.7574.77
48480-84804.4274.44
59140-91404.7714.79
68586-85864.4824.50
15min111136-111365.8135.424.005.865.464.01
210437-104375.4485.49
310273-102735.3635.40
410243-102435.3475.39
510279-102795.3665.41
69885-98855.1605.20
20min111168-111685.8305.912.215.905.982.16
211085-110855.7865.86
311766-117666.1426.21
411201-112015.8475.92
511456-114565.9806.05
611275-112755.8865.95
30min112674-126746.6166.263.736.726.373.69
212000-120006.2646.37
311954-119546.2406.35
411286-112865.8915.99
511925-119256.2256.33
612156-121566.3456.45
45min112541-125416.5466.652.266.696.792.20
213273-132736.9297.07
312451-124516.4996.64
412748-127486.6556.79
512698-126986.6286.77
612774-127746.6686.80
60min113262-132626.9236.822.277.107.002.21
212944-129446.7576.94
313374-133746.9817.16
413234-132346.9087.08
513004-130046.7886.97
612560-125606.5566.73
极限112945-129456.7576.842.166.987.062.12
213470-134707.0317.25
312892-128926.7306.94
412809-128096.6866.90
513434-134347.0137.23
613109-131096.8437.05
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%
110.914296994302924304084304774301394302030.08
211.004272504284414278460.20
单位质量响应值RSD%判断
39431.9938895.090.97数据可信
供试品溶液-Z008150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%
5min14370-43700.9990.977.741.000.978.01
24659-46591.0651.07
34120-41200.9420.94
43994-39940.9130.91
54534-45341.0371.04
63808-38080.8710.87
10min14130-41300.9440.913.770.950.923.93
24082-40820.9330.94
34049-40490.9260.93
43710-37100.8480.85
54039-40390.9240.93
63960-39600.9060.91
15min15633-56331.2881.127.891.301.137.80
24538-45381.0381.05
34659-46591.0651.08
44762-47621.0891.10
54917-49171.1241.14
64871-48711.1141.12
20min15566-55661.2731.314.711.291.334.57
25415-54151.2381.26
35892-58921.3471.36
45501-55011.2581.27
55977-59771.3671.38
66044-60441.3821.40
30min17628-76281.7441.499.821.771.529.66
26293-62931.4391.46
36307-63071.4421.47
45740-57401.3131.34
56326-63261.4471.47
66806-68061.5561.58
45min17284-72841.6661.713.221.701.743.10
27694-76941.7591.79
37239-72391.6551.69
47304-73041.6701.70
57661-76611.7521.78
67773-77731.7771.81
60min18553-85531.9561.883.602.001.933.44
27762-77621.7751.82
38125-81251.8581.90
48431-84311.9281.97
58447-84471.9321.97
68110-81101.8541.90
极限19106-91062.0822.063.232.142.123.15
28946-89462.0462.10
38648-86481.9782.03
48736-87361.9982.05
59311-93112.1292.18
69352-93522.1382.19
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