Basic Chemical Information
Common name: Sibutramine raw material
English name: Sibutramine Hydrochloride Monohydrate
Free base CAS: 106650-56-0; Hydrochloric acid monohydrate CAS: 84485-00-7
Chemical name: (±) -1- [1- (4-chlorophenyl) cyclobutyl] - N, N-3-trimethylbut-1-amine hydrochloride monohydrate
Molecular formula: \ (\ ce {C_ {17}H_{26}ClN ·HCl·H_ {2}O }\)
Molecular weight: 334.33
Appearance: White or off white crystalline powder, no special odor
Solubility: soluble in methanol, ethanol, and chloroform; Slightly soluble in water
Melting point: 194-197 ℃
Water content: theoretical water content of monohydrate 5.0-6.5%
Stability: Stable in solid state under light and dry conditions; Degradation occurs when encountering strong acids and bases; Under illumination, oxidation impurities will be generated
Storage conditions: Sealed, cool and dry place, temperature 15-25 ℃, away from light and moisture; Stay away from oxidants; The validity period of scientific research standards is 24 months
Quality and purity indicators
Research/Reference Level
HPLC content: 98.0% -102.0% (anhydrous)
Related substances: Single maximum impurity ≤ 0.5%, total impurity ≤ 1.0%
Burning residue: ≤ 0.1%
Heavy metal: ≤ 10ppm
Moisture content: 5.0-6.5% (monohydrate)
Identification: HPLC retention time, infrared IR spectrum consistent with the reference substance
Our company's raw material indicators for sibutramine refer to early pharmacopoeias and scientific research standard specifications, and we use high-performance liquid chromatography for quality control. The HPLC content is controlled between 98.0% and 102.0% (calculated as anhydrous). In terms of substances, known impurities such as N-monodimethylsibutramine and N, N-didimethylsibutramine should not exceed 0.15% each, individual unknown impurities should not exceed 0.10%, and total impurities should be ≤ 1.0%. The moisture control of monohydrate is 5.0% -6.5%, the ignition residue is ≤ 0.1%, the heavy metal limit is ≤ 10ppm, and the residual solvents such as methanol and dichloromethane meet the requirements of organic solvent limits. The identification items include HPLC retention time comparison and infrared spectrum comparison, and the spectrum should be consistent with the standard reference substance. COA quality inspection report can be issued for each batch, only applicable to laboratory research
Appearance and packaging method
Sibutramine raw material is a white to off white crystalline powder, with no special odor, and uniform properties in solid powder state; Exposure to light and high humidity environments can easily produce oxidative impurities, so it is necessary to store in the dark and isolated from moisture. This product is only used as a research reference and does not have industrial bulk raw material packaging. For small quantities, brown sealed glass sample bottles are used, paired with anti-theft sealed bottle caps, which can avoid light and leakage. The regular filling amounts are 10mg, 50mg, 100mg, 500mg, 1g, and 5g. The bottles are treated with shock protection, and product information labels are affixed to the bottle body. COA quality inspection reports and MSDS safety instructions are included with the goods. This product does not provide kilogram level large packaging and supports the circulation of laboratory small standard products. It is recommended to use the packaging as soon as possible after opening, and the remaining samples need to be sealed and stored in a dark place. This product is only for scientific research and development of detection methods
Testing methods and logistics transportation
1. High performance liquid chromatography (HPLC) (quantification of raw materials and reference standards)
Reverse phase C18 chromatographic column, detection wavelength 223nm; used for content determination and impurity inspection of related substances; It can separate sibutramine and M1, M2 metabolic impurities, which is an early pharmacopoeia legal method.
2 LC‑MS / LC‑MS/MS
High sensitivity, screening; Trace detection of sibutramine and its active metabolites M1 and M2 in biological samples plasma and tissues; Corresponding to the national standard GB 31660.5-2019
3. Infrared spectroscopy (IR)
Qualitative identification, comparison of sample infrared spectra with standard reference materials.
4. Thin layer chromatography (TLC)
Rapid qualitative screening is commonly used for rapid screening of large quantities of samples.
logistics transportation
1. This product is only a laboratory research reference substance and is circulated between research institutions,
2. Not classified as hazardous chemicals.
3. The entire transportation process should be protected from light and moisture, avoiding direct sunlight and high temperature environments to prevent oxidation and degradation of materials due to temperature and humidity.
4. The outer packaging is made of shock-absorbing and cushioning materials, which should be loaded and unloaded lightly. Heavy pressure, throwing, and squeezing are prohibited to prevent the glass bottle of the inner packaging from being damaged and leaking powder.
5. Do not mix and transport with strong oxidants or food products to avoid material contamination and chemical reaction risks.
6. Domestic transportation comes with MSDS safety instructions and COA quality inspection reports, and complete records of shipment, receipt, and circulation are kept to ensure traceability of origin and destination.
7. Attach corresponding warning labels on the exterior of the transportation packaging, indicating that it is for scientific research experiments only and that human contact is prohibited.
8. International exports are indeed the import and export of scientific research benchmark products, and the recipient must complete all local import approval procedures.
9. Only scientific research reference materials can be declared for external customs declaration.
10. If packaging damage or powder leakage occurs during transportation, it is necessary to dispose of it according to chemical safety operating procedures and not dispose of it at will.
11. This product is used for scientific research and development of detection methods.
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