依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
110.261756581756591760461760601761431759130.14
210.261766931764821765880.09
单位质量响应值RSD%判断
17145.5217211.310.28数据可信
供试品溶液-2023120821批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113543-135437.0726.3610.277.076.3610.23
212187-121876.3646.36
311714-117146.1176.12
410834-108345.6575.66
511003-110035.7465.75
613772-137727.1927.19
10min118031-180319.4168.966.089.458.996.07
217426-174269.1009.13
317392-173929.0829.12
415463-154638.0758.11
516389-163898.5588.59
618194-181949.5019.54
15min117809-178099.3009.132.209.399.222.21
217554-175549.1669.25
317936-179369.3669.45
416876-168768.8128.89
517266-172669.0169.10
617520-175209.1499.24
20min117179-171798.9719.192.029.119.332.03
217967-179679.3829.52
318060-180609.4319.57
417298-172989.0339.16
517473-174739.1249.25
617639-176399.2119.35
30min117639-176399.2119.090.819.409.280.79
217274-172749.0209.21
317248-172489.0079.20
417426-174269.1009.28
517424-174249.0999.28
617447-174479.1119.31
45min117818-178189.3049.142.159.559.382.04
217480-174809.1289.37
317422-174229.0989.34
417794-177949.2929.52
517717-177179.2529.48
616817-168178.7829.03
60min118107-181079.4559.162.029.759.442.00
217065-170658.9119.20
317507-175079.1429.43
417462-174629.1189.40
517354-173549.0629.34
617722-177229.2549.55
极限118279-182799.5459.092.689.899.422.63
216920-169208.8359.17
317205-172058.9849.32
417203-172038.9839.31
517448-174489.1119.44
617377-173779.0749.42
依折麦布瑞舒伐他汀钙片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.821597431599911603161603431603251601440.17
210.861607361603821605590.16
单位质量响应值RSD%判断
14800.7414784.440.08数据可信
供试品溶液-2023120821批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130889-3088917.24821.9526.4217.2521.9526.41
248175-4817526.90026.90
343100-4310024.06724.07
424527-2452713.69613.70
551686-5168628.86128.86
637478-3747820.92720.93
10min170215-7021539.20745.1811.7639.3045.3111.79
285571-8557147.78247.93
391234-9123450.94451.08
471960-7196040.18240.26
590958-9095850.79050.95
675577-7557742.20142.32
15min195410-9541053.27657.717.5553.5958.087.59
2105953-10595359.16359.58
3109421-10942161.09961.52
498943-9894355.24955.55
5114434-11443463.89964.34
695950-9595053.57753.93
20min1114240-11424063.79068.615.0764.4069.305.08
2124292-12429269.40370.15
3124672-12467269.61570.37
4117227-11722765.45866.06
5125198-12519869.90970.71
6131615-13161573.49274.14
30min1134039-13403974.84675.351.9975.8176.432.05
2134201-13420174.93676.07
3133735-13373574.67675.82
4132373-13237373.91574.89
5140089-14008978.22479.41
6135266-13526675.53176.59
45min1149752-14975283.62080.814.7085.0082.304.63
2148174-14817482.73984.28
3147249-14724982.22283.78
4144864-14486480.89082.27
5147013-14701382.09083.71
6131225-13122573.27474.75
60min1143570-14357080.16878.108.1082.0180.047.87
2119386-11938666.66468.67
3135918-13591875.89577.91
4141165-14116578.82580.65
5149103-14910383.25785.33
6150105-15010583.81785.70
极限1151439-15143984.56284.351.6486.8586.731.63
2146232-14623281.65484.03
3151831-15183184.78187.22
4151196-15119684.42686.69
5153027-15302785.44887.99
6152675-15267585.25287.60
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
110.261752601759621765871765391763761761450.32
210.261741871748521745200.27
单位质量响应值RSD%判断
17168.1317009.750.66数据可信
供试品溶液-2023120821批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112180-121806.3946.097.466.396.097.45
211186-111865.8725.87
311817-118176.2036.20
410034-100345.2675.27
512301-123016.4576.46
612093-120936.3486.35
10min117132-171328.9938.876.249.038.916.25
217380-173809.1239.16
317452-174529.1619.20
414821-148217.7807.81
517703-177039.2939.33
616915-169158.8798.91
15min118174-181749.5409.242.879.639.332.90
217410-174109.1399.22
317876-178769.3849.47
416930-169308.8878.96
517191-171919.0249.11
618061-180619.4819.57
20min118928-189289.9369.452.6210.079.582.60
217709-177099.2969.43
317837-178379.3639.50
417657-176579.2699.39
517856-178569.3739.51
617997-179979.4479.58
30min118136-181369.5209.292.259.719.472.20
216979-169798.9139.10
317579-175799.2289.42
417945-179459.4209.59
517721-177219.3029.49
617790-177909.3399.53
45min118590-185909.7589.282.8210.019.522.84
217135-171358.9959.23
317550-175509.2139.45
417425-174259.1479.37
517530-175309.2029.44
617800-178009.3449.59
60min116646-166468.7388.941.839.049.231.73
216693-166938.7639.05
317343-173439.1049.40
417255-172559.0589.33
517294-172949.0789.37
616985-169858.9169.21
极限117557-175579.2168.992.009.579.331.93
216896-168968.8699.20
316775-167758.8069.15
417418-174189.1439.47
517309-173099.0869.43
616806-168068.8229.17
依折麦布瑞舒伐他汀钙片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.821614641612841616251615711612071614300.12
210.861586841592521589680.26
单位质量响应值RSD%判断
14919.5914637.941.35数据可信
供试品溶液-2023120821批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147613-4761326.61421.3337.6026.6121.3337.61
228614-2861415.99415.99
342089-4208923.52623.53
413550-135507.5747.57
550995-5099528.50428.50
646098-4609825.76725.77
10min166323-6632337.07238.1328.9037.2238.2528.91
258279-5827932.57632.66
372423-7242340.48240.61
438168-3816821.33421.38
597298-9729854.38654.54
676849-7684942.95643.10
15min1111614-11161462.38849.9225.1262.7450.2525.07
273386-7338641.02041.29
390311-9031150.48050.84
462036-6203634.67634.84
578984-7898444.14944.61
6119539-11953966.81867.20
20min1126436-12643670.67360.7018.4571.3761.3118.50
291706-9170651.26051.76
3105216-10521658.81259.45
480796-8079645.16245.52
5114726-11472664.12764.83
6132706-13270674.17774.93
30min1132490-13249074.05767.3412.0475.1568.2812.09
2104470-10447058.39559.18
3118900-11890066.46067.42
4107335-10733559.99660.60
5142086-14208679.42180.48
6117573-11757365.71966.88
45min1145098-14509881.10476.458.6182.6177.778.72
2117807-11780765.85066.96
3132644-13264474.14375.47
4131429-13142973.46474.40
5149633-14963383.63985.14
6144070-14407080.52982.06
60min1148129-14812982.79882.512.0484.7584.262.01
2147013-14701382.17583.65
3150512-15051284.13085.87
4147290-14729082.32983.67
5150465-15046584.10486.07
6142318-14231879.55081.53
极限1158783-15878388.75386.311.6891.1788.511.74
2154617-15461786.42588.35
3155868-15586887.12489.34
4152445-15244585.21187.01
5152421-15242185.19787.63
6152305-15230585.13387.55
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
110.261735481740761751321758241761691749500.64
210.261741051745011743030.17
单位质量响应值RSD%判断
17051.6616988.600.27数据可信
供试品溶液-2023120822批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110363-103635.4626.4614.325.466.4614.34
215142-151427.9807.98
311423-114236.0206.02
413557-135577.1457.15
511729-117296.1826.18
611348-113485.9815.98
10min115851-158518.3548.974.798.389.004.85
217821-178219.3929.44
316509-165098.7018.73
417943-179439.4579.50
517284-172849.1099.14
616671-166718.7868.82
15min116771-167718.8399.253.258.929.343.27
217529-175299.2399.34
316968-169688.9439.02
418117-181179.5489.64
517900-179009.4349.52
618032-180329.5049.59
20min118515-185159.7589.531.649.889.671.60
217978-179789.4759.62
317671-176719.3139.44
418092-180929.5359.68
518315-183159.6539.79
617959-179599.4659.60
30min117376-173769.1589.8513.409.3410.0413.17
217557-175579.2539.45
317783-177839.3729.56
417750-177509.3559.55
523785-2378512.53612.73
617882-178829.4259.61
45min118292-182929.6419.525.689.879.775.53
217595-175959.2739.53
317447-174479.1959.43
420055-2005510.57010.82
517394-173949.1679.43
617632-176329.2939.53
60min117806-178069.3859.301.439.679.601.37
217427-174279.1859.49
317395-173959.1689.45
417533-175339.2419.55
517635-176359.2949.61
618055-180559.5169.81
极限117802-178029.3829.221.859.729.571.75
217966-179669.4699.82
317494-174949.2209.56
417175-171759.0529.41
517347-173479.1439.51
617207-172079.0699.41
依折麦布瑞舒伐他汀钙片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.821581671591071598001603041605361595830.61
210.861586611588521587560.09
单位质量响应值RSD%判断
14748.8914618.420.63数据可信
供试品溶液-2023120822批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131835-3183517.90918.2444.7317.9118.2444.72
250825-5082528.59128.59
327416-2741615.42315.42
448676-4867627.38227.38
517953-1795310.09910.10
617806-1780610.01710.02
10min174997-7499742.18938.5021.9942.2938.6022.03
283982-8398247.24347.40
361544-6154434.62134.71
481865-8186546.05246.20
564307-6430736.17536.23
643892-4389224.69124.75
15min1100074-10007456.29651.6215.2356.6351.9415.26
2104142-10414258.58459.01
386794-8679448.82549.10
4103279-10327958.09958.51
567543-6754337.99638.25
688732-8873249.91550.11
20min1119175-11917567.04163.549.0667.6964.149.12
2119454-11945467.19867.94
3114997-11499764.69165.24
4119374-11937467.15367.88
593065-9306552.35352.82
6111673-11167362.82163.29
30min1130589-13058973.46273.124.8274.4874.084.88
2130278-13027873.28774.41
3137637-13763777.42778.34
4135530-13553076.24177.35
5124858-12485870.23871.00
6121049-12104968.09568.91
45min1147739-14773983.10981.812.2484.5483.172.29
2142175-14217579.97981.51
3149335-14933584.00785.35
4147939-14793983.22284.75
5142202-14220279.99581.14
6143181-14318180.54581.74
60min1147379-14737982.90784.202.7784.8086.022.59
2142492-14249280.15882.13
3153675-15367586.44988.25
4150143-15014384.46286.45
5152509-15250985.79387.39
6151863-15186385.42987.07
极限1149673-14967384.19786.872.0086.5589.151.86
2153590-15359086.40188.82
3158095-15809588.93591.22
4152725-15272585.91488.37
5155389-15538987.41389.48
6157061-15706188.35390.47
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
110.261736441742171750161752151754381747060.44
210.261762821781741772280.76
单位质量响应值RSD%判断
17027.8817273.681.02数据可信
供试品溶液-2023120822批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113339-133396.9776.499.066.986.499.09
212295-122956.4316.43
313614-136147.1217.12
411188-111885.8525.85
513033-130336.8176.82
610962-109625.7345.73
10min117243-172439.0198.935.649.068.965.65
216650-166508.7098.74
317978-179789.4039.44
415717-157178.2218.25
518280-182809.5619.60
616527-165278.6448.68
15min118328-183289.5879.243.059.689.333.08
216843-168438.8108.89
317810-178109.3169.41
417233-172339.0149.09
517788-177889.3049.40
617999-179999.4149.49
20min117340-173409.0709.191.579.219.321.55
217788-177889.3049.44
317659-176599.2379.38
417882-178829.3539.48
517552-175529.1819.32
617153-171538.9729.10
30min116901-169018.8409.054.159.039.244.03
217352-173529.0769.26
316921-169218.8519.05
418727-187279.7959.98
516925-169258.8539.05
616991-169918.8879.07
45min117267-172679.0328.973.379.279.213.25
217409-174099.1069.34
316498-164988.6298.87
418120-181209.4789.71
516745-167458.7599.00
616911-169118.8459.08
60min116507-165078.6348.902.348.939.192.25
217015-170158.9009.19
317131-171318.9609.25
417712-177129.2649.55
516900-169008.8409.13
616861-168618.8199.10
极限118143-181439.4909.013.939.839.353.80
217758-177589.2889.62
316873-168738.8259.17
417513-175139.1609.50
516391-163918.5738.91
616718-167188.7449.07
依折麦布瑞舒伐他汀钙片项目信息
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对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.821587801593531599531600651601471596600.37
210.861616761631191623980.63
单位质量响应值RSD%判断
14756.0114953.780.95数据可信
供试品溶液-2023120822批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146383-4638325.79217.9441.8825.7917.9441.87
227996-2799615.56815.57
345602-4560225.35825.36
49580-95805.3275.33
530876-3087617.16917.17
633172-3317218.44618.45
10min180712-8071244.88236.5630.5445.0236.6630.56
267806-6780637.70537.79
377387-7738743.03343.17
426439-2643914.70214.73
566102-6610236.75736.85
676043-7604342.28542.39
15min1103914-10391457.78449.4723.9158.1849.7823.95
294828-9482852.73153.03
391894-9189451.10051.48
448081-4808126.73626.85
588136-8813649.01049.31
6106934-10693459.46359.80
20min1123990-12399068.94761.1215.3569.6661.7015.44
2122386-12238668.05568.64
3106741-10674159.35660.02
480934-8093445.00545.26
5102660-10266057.08657.66
6122801-12280168.28668.95
30min1138409-13840976.96570.829.6978.0671.749.80
2139619-13961977.63878.61
3119693-11969366.55867.55
4110271-11027161.31861.83
5119798-11979866.61667.51
6136358-13635875.82576.87
45min1142941-14294179.48578.546.2181.0179.866.29
2152788-15278884.96186.36
3132351-13235173.59674.96
4133148-13314874.04074.89
5136192-13619275.73276.99
6150077-15007783.45384.92
60min1149880-14988083.34481.423.5185.3183.163.71
2151543-15154384.26986.14
3143139-14313979.59581.37
4139325-13932577.47578.74
5143370-14337079.72481.40
6151226-15122684.09286.02
极限1153108-15310885.13985.372.2987.5787.572.23
2157629-15762987.65389.99
3148131-14813182.37184.59
4156143-15614386.82788.52
5151019-15101983.97786.10
6155069-15506986.22988.63
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