依折麦布阿托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%
110.051742871742991742061743111743281742860.03
210.091761371769061765220.31
单位质量响应值RSD%判断
17341.8917494.750.63数据可信
供试品溶液-X027068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%
5min111165-111655.7555.356.355.755.356.34
29390-93904.8404.84
310604-106045.4655.47
410463-104635.3935.39
59815-98155.0595.06
610827-108275.5805.58
10min115991-159918.2428.292.768.278.322.78
215575-155758.0288.05
316548-165488.5298.56
416679-166798.5978.63
515750-157508.1188.15
615909-159098.2008.23
15min116208-162088.3548.361.508.438.431.50
216020-160208.2578.33
316381-163818.4438.52
416571-165718.5418.62
516199-161998.3498.42
615900-159008.1958.27
20min116299-162998.4018.282.178.528.402.14
216021-160218.2578.37
316452-164528.4808.60
416269-162698.3858.51
515563-155638.0218.14
615744-157448.1158.24
30min115799-157998.1438.051.428.318.221.40
215531-155318.0058.17
315593-155938.0378.21
415952-159528.2228.39
515350-153507.9128.08
615478-154787.9788.14
45min115474-154747.9767.872.078.198.082.04
214995-149957.7297.94
315609-156098.0458.26
415523-155238.0018.22
514839-148397.6487.86
615150-151507.8098.02
60min114875-148757.6677.781.497.938.041.46
214967-149677.7147.96
315366-153667.9208.18
415175-151757.8218.08
514876-148767.6677.92
615335-153357.9048.16
极限115077-150777.7717.861.778.078.161.74
215329-153297.9018.19
315448-154487.9628.27
415668-156688.0768.38
515002-150027.7328.03
615027-150277.7458.04
依折麦布阿托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%
111.041476461475601474771474861475751475490.05
211.071492181498081495130.28
单位质量响应值RSD%判断
13364.9513506.140.75数据可信
供试品溶液-X027068批-阿托伐他汀钙-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%
5min1117068-11706871.97459.7519.6271.9759.7519.62
279175-7917548.67748.68
3121646-12164674.78874.79
482707-8270750.84950.85
580789-8078949.66949.67
6101746-10174662.55462.55
10min1162881-162881100.140100.331.82100.54100.661.85
2162081-16208199.64899.92
3168643-168643103.682104.10
4162373-16237399.828100.11
5163424-163424100.474100.75
6159718-15971898.19598.54
15min1166684-166684102.478103.162.27103.43104.052.24
2167812-167812103.172104.00
3169188-169188104.017105.01
4170097-170097104.576105.41
5171977-171977105.732106.57
6160979-16097998.97199.86
20min1169503-169503104.211103.751.89105.74105.221.86
2171149-171149105.223106.62
3169005-169005103.905105.47
4171125-171125105.208106.63
5169199-169199104.024105.45
6162563-16256399.944101.39
30min1167390-167390102.912103.171.74105.02105.201.69
2168034-168034103.308105.29
3166473-166473102.348104.49
4171440-171440105.402107.40
5170274-170274104.685106.68
6163213-163213100.344102.34
45min1166431-166431102.322102.221.71105.00104.841.68
2166866-166866102.590105.15
3166908-166908102.616105.33
4169592-169592104.266106.85
5166824-166824102.564105.15
6160978-16097898.970101.53
60min1163168-163168100.316102.511.29103.56105.691.24
2165103-165103101.506104.63
3168203-168203103.412106.70
4167720-167720103.115106.28
5168683-168683103.707106.86
6167541-167541103.005106.11
极限1165820-165820101.947103.171.98105.75106.921.92
2170307-170307104.705108.40
3167884-167884103.216107.08
4171145-171145105.221108.96
5169487-169487104.201107.93
6162254-16225499.754103.43
依折麦布阿托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%
110.051758631762541765001770921771441765710.32
210.091757921763691760800.24
单位质量响应值RSD%判断
17569.2517450.940.48数据可信
供试品溶液-X027068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%
5min110875-108755.5765.505.365.585.505.37
210406-104065.3355.34
39780-97805.0145.01
411234-112345.7605.76
511331-113315.8105.81
610786-107865.5305.53
10min116091-160918.2508.192.178.288.222.17
216395-163958.4068.44
315716-157168.0588.09
415800-158008.1018.13
515527-155277.9617.99
616306-163068.3608.39
15min116491-164918.4558.371.408.538.441.40
216618-166188.5208.60
316000-160008.2038.28
416277-162778.3458.42
516135-161358.2738.35
616388-163888.4028.48
20min116643-166438.5338.242.338.668.372.30
216211-162118.3128.44
315890-158908.1478.27
415972-159728.1898.31
515533-155337.9648.09
616206-162068.3098.43
30min116258-162588.3368.072.458.518.242.43
216077-160778.2438.41
315425-154257.9098.07
415427-154277.9108.08
515376-153767.8838.05
615912-159128.1588.33
45min115944-159448.1757.931.998.398.141.98
215723-157238.0618.28
315277-152777.8338.04
415282-152827.8358.05
515144-151447.7647.97
615413-154137.9028.12
60min115730-157308.0657.861.518.338.111.51
215388-153887.8908.15
315173-151737.7798.03
415071-150717.7277.98
515349-153497.8708.12
615227-152277.8078.07
极限116693-166938.5597.884.898.878.184.79
215524-155247.9598.26
314957-149577.6697.96
414822-148227.5997.90
514638-146387.5057.80
615573-155737.9848.29
依折麦布阿托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%
111.041490301492511495291498741498601495090.25
211.071490021498151494080.39
单位质量响应值RSD%判断
13542.4813496.660.24数据可信
供试品溶液-X027068批-阿托伐他汀钙-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%
5min1128767-12876778.67362.9023.4078.6762.9023.40
2117279-11727971.65471.65
363785-6378538.97138.97
489800-8980054.86554.86
5120163-12016373.41673.42
697946-9794659.84259.84
10min1163502-16350299.89494.9510.44100.3395.3010.47
2166232-166232101.562101.96
3122805-12280575.03075.25
4159339-15933997.35197.66
5158588-15858896.89297.30
6162016-16201698.98799.32
15min1167832-167832102.54098.1510.11103.5399.0310.14
2170664-170664104.270105.23
3127952-12795278.17578.81
4168784-168784103.122103.97
5163204-16320499.712100.66
6165478-165478101.102101.98
20min1165771-165771101.28197.169.72102.8498.589.75
2168598-168598103.008104.55
3128186-12818678.31879.39
4167349-167349102.245103.66
5159224-15922497.28198.78
6164999-164999100.809102.25
30min1165437-165437101.07797.439.38103.2099.409.42
2170555-170555104.204106.32
3129572-12957279.16480.67
4165003-165003100.812102.80
5161257-16125798.523100.56
6165023-165023100.824102.83
45min1166095-166095101.47997.218.16104.1699.718.24
2169525-169525103.574106.27
3133553-13355381.59783.54
4164158-164158100.295102.84
5159634-15963497.531100.12
6161695-16169598.790101.35
60min1164513-164513100.51297.496.91103.76100.537.02
2166750-166750101.879105.15
3137274-13727483.87086.27
4163340-16334099.796102.90
5162592-16259299.339102.47
6162921-16292199.540102.65
极限1164564-164564100.54399.932.42104.35103.522.43
2169097-169097103.313107.15
3163056-16305699.622102.48
4161748-16174898.823102.48
5157318-15731896.11699.80
6165592-165592101.171104.84
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