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%
110.851262191261031260171261471261361261240.06
210.881271861271861271860.00
单位质量响应值RSD%判断
11624.3311689.890.40数据可信
供试品溶液-24020201批-匹伐他汀钙-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%
5min1117697-11769787.50886.403.3587.5186.403.35
2114580-11458085.19085.19
3117492-11749287.35587.36
4119092-11909288.54588.54
5109055-10905581.08281.08
6119315-11931588.71188.71
10min1124867-12486792.83992.722.1092.9892.872.09
2123826-12382692.06592.21
3127609-12760994.87795.02
4124970-12497092.91593.06
5120202-12020289.37089.51
6126805-12680594.28094.43
15min1125023-12502392.95592.511.9593.2692.811.95
2123523-12352391.83992.13
3126937-12693794.37894.68
4124603-12460392.64292.94
5120153-12015389.33489.62
6126302-12630293.90694.21
20min1124139-12413992.29792.101.9492.7592.551.94
2123082-12308291.51291.96
3126756-12675694.24394.70
4124146-12414692.30392.76
5119709-11970989.00489.44
6125389-12538993.22793.69
30min1124051-12405192.23291.871.9892.8492.481.98
2122660-12266091.19891.80
3126392-12639293.97394.59
4123769-12376992.02292.63
5119339-11933988.72989.31
6125204-12520493.08993.71
45min1123169-12316991.57691.492.1192.3492.252.11
2122148-12214890.81791.57
3126370-12637093.95694.73
4123661-12366191.94292.71
5118609-11860988.18688.92
6124327-12432792.43793.21
60min1122846-12284691.33691.252.0992.2592.172.09
2121837-12183790.58691.49
3125695-12569593.45494.39
4123314-12331491.68492.60
5118281-11828187.94288.82
6124439-12443992.52093.45
极限1122552-12255291.11790.912.0092.1991.972.00
2121598-12159890.40891.46
3125334-12533493.18694.27
4122516-12251691.09192.16
5118027-11802787.75388.78
6123609-12360991.90392.98
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%
110.933702353699593699863699483698093699870.05
211.003727803728633728220.02
单位质量响应值RSD%判断
33850.5933892.910.09数据可信
供试品溶液-24020201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%
5min114374-143743.8193.497.043.823.497.03
212757-127573.3903.39
313913-139133.6973.70
412078-120783.2093.21
513442-134423.5723.57
612254-122543.2563.26
10min129948-299487.9577.971.687.967.971.68
229256-292567.7747.78
330376-303768.0718.08
429645-296457.8777.88
530661-306618.1478.15
630055-300557.9867.99
15min131981-319818.4988.572.198.528.592.19
231971-319718.4958.51
331870-318708.4688.49
433484-334848.8978.92
532637-326378.6728.69
631530-315308.3788.40
20min132133-321338.5388.651.448.578.681.43
232198-321988.5558.59
332443-324438.6208.65
432934-329348.7518.78
533300-333008.8488.88
632295-322958.5818.61
30min130525-305258.1118.593.028.168.643.00
232152-321528.5438.59
332406-324068.6118.66
433195-331958.8208.87
533136-331368.8058.85
632605-326058.6638.71
45min131816-318168.4548.561.358.528.621.35
232035-320358.5128.57
332186-321868.5528.61
431751-317518.4378.50
532872-328728.7348.80
632548-325488.6488.71
60min131773-317738.4428.631.688.528.701.68
232320-323208.5888.66
332716-327168.6938.77
433157-331578.8108.89
532892-328928.7408.82
631966-319668.4948.57
极限132055-320558.5178.631.218.618.721.19
232385-323858.6058.69
332057-320578.5188.61
433079-330798.7898.88
532668-326688.6808.77
632556-325568.6508.74
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%
110.851260111259621261151261261260711260570.06
210.881267931266991267460.06
单位质量响应值RSD%判断
11618.1611649.450.20数据可信
供试品溶液-24020201批-匹伐他汀钙-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%
5min1111570-11157083.11884.354.3883.1284.354.38
2121327-12132790.38790.39
3111382-11138282.97882.98
4109985-10998581.93781.94
5108101-10810180.53480.53
6116962-11696287.13587.14
10min1120171-12017189.52691.861.6489.6692.001.64
2126015-12601593.87994.03
3124816-12481692.98693.12
4123397-12339791.92992.07
5122475-12247591.24291.38
6122912-12291291.56891.71
15min1120078-12007889.45691.741.6089.7492.031.61
2125772-12577293.69894.01
3124591-12459192.81993.11
4123059-12305991.67791.97
5122162-12216291.00991.30
6123175-12317591.76492.06
20min1119655-11965589.14191.371.5889.5891.811.58
2125126-12512693.21793.68
3124184-12418492.51592.96
4122887-12288791.54991.99
5121619-12161990.60491.04
6122388-12238891.17791.63
30min1119333-11933388.90191.041.6089.4991.641.60
2124852-12485293.01393.63
3123791-12379192.22392.82
4122147-12214790.99891.59
5121156-12115690.25990.85
6121912-12191290.82391.43
45min1118598-11859888.35490.641.5689.0991.391.56
2123809-12380992.23693.01
3123545-12354592.03992.80
4121459-12145990.48591.23
5121066-12106690.19290.93
6121535-12153590.54291.30
60min1118751-11875188.46890.521.4789.3591.421.47
2123805-12380592.23393.16
3122929-12292991.58092.49
4121770-12177090.71791.61
5120687-12068789.91090.80
6121123-12112390.23591.14
极限1118227-11822788.07790.271.5689.1191.321.56
2123540-12354092.03693.12
3122794-12279491.48092.54
4121179-12117990.27791.33
5120268-12026889.59890.64
6120974-12097490.12491.18
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%
110.933698353698833702493699663701123700090.05
211.003695483692763694120.06
单位质量响应值RSD%判断
33852.6133582.910.57数据可信
供试品溶液-24020201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%
5min117083-170834.5604.804.174.564.804.13
219124-191245.1055.10
317956-179564.7934.79
418244-182444.8704.87
517255-172554.6064.61
618305-183054.8864.89
10min128410-284107.5837.852.177.597.862.18
229820-298207.9607.97
330306-303068.0898.10
429223-292237.8007.81
529468-294687.8667.87
629269-292697.8137.82
15min131114-311148.3058.226.458.338.246.41
232402-324028.6498.67
332321-323218.6278.65
430328-303288.0958.12
531530-315308.4168.44
627064-270647.2247.25
20min132310-323108.6248.543.218.668.583.20
232693-326938.7278.76
332800-328008.7558.79
429995-299958.0068.04
532064-320648.5598.59
632156-321568.5838.62
30min131719-317198.4678.372.088.528.422.06
230077-300778.0288.08
331468-314688.4008.45
431796-317968.4878.54
531702-317028.4628.51
631473-314738.4018.45
45min131927-319278.5228.521.858.588.581.87
232294-322948.6208.68
332603-326038.7038.77
432129-321298.5768.64
531655-316558.4508.51
630915-309158.2528.31
60min129498-294987.8748.403.357.958.483.32
231834-318348.4978.58
332085-320858.5648.64
432034-320348.5518.63
532280-322808.6168.69
631058-310588.2908.37
极限131872-318728.5078.681.988.608.771.96
233329-333298.8968.99
333151-331518.8498.94
432598-325988.7018.79
532402-324028.6498.74
631766-317668.4798.57
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