58. Weight Loss Ingredient Orlistat CAS 96829-58-2
58.减肥成分Orlistat CAS 96829-58-2
产品名称： 奥利司他
测定：99％
cas no .: 96829-58-2
用途：减肥
出现：白色细粉
也称为：（s）-2-甲酰氨基-4-甲基 - 戊酸-1 - （（（2s，3s）-3-己基-4-氧代-2-氧杂环丁烷基）甲基）十二烷基酯; ro-18-0647; （ - ） - 四氢脂抑素; （1s）-1 - （（（2s，3s）-3-己基-4-氧代-2-氧杂环丁烷基）甲基）十二烷基酯; （ - ） - 四氢脂抑素（等效物）。奥利帕斯特（1s）-1 - {（（2r，3s）-3-己基-4-氧代氧杂环丁烷-2-基）甲基}十二烷基n-甲酰基-D-亮氨酸酯; （（1s）-1 - （（（2S）-3-己基-4-氧代 - 氧杂环丁烷-2-基）甲基）十二烷基）（2S）-2-甲酰胺基-4-甲基 - 戊酸酯
描述
奥利司他 用于治疗肥胖。用奥利司他实现的减肥量变化。在一年的临床试验中，在35.5％和54.8％之间的受试者实现了5％或更大的体重下降，尽管不是所有的这一质量都必然是脂肪。在16.4％和24.8％之间实现了至少10％的体重下降。在停用奥利司他后，大量的受试者恢复了体重 - 高达他们失去的体重的35％。
与安慰剂（9.0％）相比，奥利司他在4年内的肥胖人群中2型糖尿病的发生率降低（6.2％）。长期使用奥利司他还导致血压的适度降低（分别在收缩压和舒张压下平均降低2.5和1.9mmHg）。
基本数据
测定：99％
cas no .: 96829-58-2
用途：减肥
出现：白色细粉
也称为：（s）-2-甲酰氨基-4-甲基 - 戊酸-1 - （（（2s，3s）-3-己基-4-氧代-2-氧杂环丁烷基）甲基）十二烷基酯; ro-18-0647; （ - ） - 四氢脂抑素; （1s）-1 - （（（2s，3s）-3-己基-4-氧代-2-氧杂环丁烷基）甲基）十二烷基酯; （ - ） - 四氢脂抑素（等效物）。奥利帕斯特（1s）-1 - {（（2r，3s）-3-己基-4-氧代氧杂环丁烷-2-基）甲基}十二烷基n-甲酰基-D-亮氨酸酯; （（1s）-1 - （（（2S）-3-己基-4-氧代 - 氧杂环丁烷-2-基）甲基）十二烷基）（2S）-2-甲酰胺基-4-甲基 - 戊酸酯
描述
奥利司他 用于治疗肥胖。用奥利司他实现的减肥量变化。在一年的临床试验中，在35.5％和54.8％之间的受试者实现了5％或更大的体重下降，尽管不是所有的这一质量都必然是脂肪。在16.4％和24.8％之间实现了至少10％的体重下降。在停用奥利司他后，大量的受试者恢复了体重 - 高达他们失去的体重的35％。
与安慰剂（9.0％）相比，奥利司他在4年内的肥胖人群中2型糖尿病的发生率降低（6.2％）。长期使用奥利司他还导致血压的适度降低（分别在收缩压和舒张压下平均降低2.5和1.9mmHg）。
基本数据
| 项目 | 规格 |
| 出现 | 白色或几乎白色结晶性粉末 |
| 比旋光度 | -48°〜-51.0°（基于无水，无溶剂） |
| 识别 | A.HPLC：样品溶液的主峰的保留时间对应于标准溶液的保留时间。 |
| B.IR：样品的IR光谱与参考值一致 | |
| 相关物质 | |
| 总杂质 | 不超过1.0％ |
| 相关化合物A | 不超过0.2％ |
| 相关化合物B. | 不超过0.05％ |
| 相关化合物C. | 不超过0.05％ |
| 相关化合物D | 不超过0.2％ |
| 相关化合物 | 不超过0.2％ |
| 甲酰亮氨酸 | 不超过0.2％ |
| Orlistat开环差向异构体 | 不超过0.2％ |
| D-亮氨酸奥利司他 | 不超过0.2％ |
| Orlistat开环酰胺 | 不超过0.1％ |
| 个人未认出的杂质 | 不超过0.1％ |
| 残留溶剂 | |
| 正己烷 | 不大于5000ppm |
| 异丙醚 | 不大于5000ppm |
| 残留点火 | 不超过0.1％ |
| 重金属 | 不超过20ppm |
| 水 | 不超过0.2％ |
| 测定 | 98.0％〜101.5％（无水，无溶剂） |
| 结论 | 符合USP35 |
Product Name: Orlistat
Assay: 99%
CAS No.: 96829-58-2
Usages: Weight loss
Appearance: White fine powder
Also Name: (S)-2-FORMYLAMINO-4-METHYL-PENTANOIC ACID (S)-1-(((2S, 3S)-3-HEXYL-4-OXO-2-OXETANYL)METHYL)-DODECYL ESTER; RO-18-0647; (-)-TETRAHYDROLIPSTATIN; N-FORMYL-L-LEUCINE (1S)-1-(((2S, 3S)-3-HEXYL-4-OXO-2-OXETANYL)METHYL)DODECYL ESTER; (-)-Tetrahydrolipstatin(EquivalentToOrlistat); Orlipastat; (1S)-1-{((2R, 3S)-3-hexyl-4-oxooxetan-2-yl)methyl}dodecyl N-formyl-D-leucinate; ((1S)-1-(((2S)-3-hexyl-4-oxo-oxetan-2-yl)methyl)dodecyl) (2S)-2-formamido-4-methyl-pentanoate
Descriptions
Orlistat is used for the treatment of obesity. The amount of weight loss achieved with orlistat varies. In one year clinical trials, between 35.5% and 54.8% of subjects achieved a 5% or greater decrease in body mass, although not all of this mass was necessarily fat. Between 16.4% and 24.8% achieved at least a 10% decrease in body mass. After orlistat was stopped, a significant number of subjects regained weight- Up to 35% of the weight they had lost.
The incidence of type 2 diabetes in an obese population over four years is decreased with orlistat (6.2%) compared to placebo (9.0%). Long-term use of orlistat also leads to a modest reduction in blood pressure (mean reductions of 2.5 and 1.9 mmHg in systolic and diastolic blood pressure respectively).
Basic Data
Assay: 99%
CAS No.: 96829-58-2
Usages: Weight loss
Appearance: White fine powder
Also Name: (S)-2-FORMYLAMINO-4-METHYL-PENTANOIC ACID (S)-1-(((2S, 3S)-3-HEXYL-4-OXO-2-OXETANYL)METHYL)-DODECYL ESTER; RO-18-0647; (-)-TETRAHYDROLIPSTATIN; N-FORMYL-L-LEUCINE (1S)-1-(((2S, 3S)-3-HEXYL-4-OXO-2-OXETANYL)METHYL)DODECYL ESTER; (-)-Tetrahydrolipstatin(EquivalentToOrlistat); Orlipastat; (1S)-1-{((2R, 3S)-3-hexyl-4-oxooxetan-2-yl)methyl}dodecyl N-formyl-D-leucinate; ((1S)-1-(((2S)-3-hexyl-4-oxo-oxetan-2-yl)methyl)dodecyl) (2S)-2-formamido-4-methyl-pentanoate
Descriptions
Orlistat is used for the treatment of obesity. The amount of weight loss achieved with orlistat varies. In one year clinical trials, between 35.5% and 54.8% of subjects achieved a 5% or greater decrease in body mass, although not all of this mass was necessarily fat. Between 16.4% and 24.8% achieved at least a 10% decrease in body mass. After orlistat was stopped, a significant number of subjects regained weight- Up to 35% of the weight they had lost.
The incidence of type 2 diabetes in an obese population over four years is decreased with orlistat (6.2%) compared to placebo (9.0%). Long-term use of orlistat also leads to a modest reduction in blood pressure (mean reductions of 2.5 and 1.9 mmHg in systolic and diastolic blood pressure respectively).
Basic Data
| Items | Specifications |
| Appearance | White or almost white crystalline powder |
| Specific Rotation | -48° ~ -51.0°(on the anhydrous, solvent-free basis) |
| Identification | A. HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution. |
| B. IR: The IR spectrum of sample is consistent to the reference | |
| Related Substances | |
| Total impurity | Not more than 1.0% |
| Related Compound A | Not more than 0.2% |
| Related Compound B | Not more than 0.05% |
| Related Compound C | Not more than 0.05% |
| Related Compound D | Not more than 0.2% |
| Related Compound E | Not more than 0.2% |
| Formyl leucine | Not more than 0.2% |
| Orlistat open ring epimer | Not more than 0.2% |
| D-Leucine orlistat | Not more than 0.2% |
| Orlistat open ring amide | Not more than 0.1% |
| Individual unidentified impurity | Not more than 0.1% |
| Residual Solvents | |
| n-Hexane | Not more than 5000ppm |
| Isopropyl ether | Not more than 5000ppm |
| Residual on ignition | Not more than 0.1% |
| Heavy Metal | Not more than 20ppm |
| Water | Not more than 0.2% |
| Assay | 98.0%~101.5% (on the anhydrous, solvent-free basis) |
| Conclusion | Conform to USP35 |
