Keywords

• 149724-31-2
• drug impurity
• Tryptophan EP Impurity K

Quick Details

• ProName: Tryptophan EP Impurity K
• CasNo: 149724-31-2
• Molecular Formula: C20H19N3O2
• Appearance: solid
• Application: for drug impurity for drug standards,f...
• DeliveryTime: 1-2 weeks
• PackAge: 10mg/25mg/50mg/100mg/1000mg/5000mg
• Port: SHENZHEN or SHANGHAI
• ProductionCapacity: 5000 Metric Ton/Year
• Purity: 95%+ or 98%+
• Storage: short-term storage normal temperature....
• Transportation: express and sea transport and air frei...
• LimitNum: 25 Milligram
• Moisture Content: within 3%
• Impurity: within 5%

Superiority

Our products are mainly drug impurity reference products, drug standards, analytical chemistry, standard substances, organic chemical synthesis, chemical custom synthesis. For impurity localization, quantification, and quality control in drug development processes. Our laboratory area is more than 5000 square meters, we have more than 20 analytical instruments such as HPLC and MS/LC-MS/GC-MS, we also have TGA, IR and other testing instruments. We have the most advanced SFC preparation separation equipment. We can provide a full range of impurity reference/standard products required for drug development. Most of the impurities are synthesized through the process, there are also many items of impurities can not be obtained by synthetic means, need to be obtained through raw materials, intermediates, crude products or side reactions contained in the trace target compounds, Hubei Moke has a professional impurity preparation and separation technology team, equipped with professional SFC preparation and separation equipment. It can carry out efficient and accurate separation of impurities for complex projects, and solve the problem of impurity preparation for customers.
 

1. We integrate R&D, production and sales. A 5,000-square-meter high-standard bio-intelligent manufacturing base can ensure high quality and fast delivery of products. The professional sales team ensures that you don't need to worry about pre-sales and after-sales.

2. We focus on pharmaceutical standards, pharmaceutical intermediates, pharmaceutical impurity controls, peptide customization, our own laboratory, and undertake customized synthesis projects.

3. We offer products from gram grade to g grade, in addition, some product specifications and packaging can be customized.

4. We have been deeply engaged in the pharmaceutical field for ten years and have rich experience. At present, customers are all over the world, and have been highly recognized and trusted by customers.

5. We can provide a variety of safe ways to transport goods for you to choose.

Details

Tryptophan EP Impurity K

Product Information

• Product Code：T057011

• English Name：Tryptophan EP Impurity K

• English Alias：(S)-3-(2-((1H-indol-3-yl)methyl)-1H-indol-3-yl)-2-aminopropanoic acid

• CAS No.：149724-31-2

• Molecular Formula：C??H??N?O?

• Molecular Weight：333.38

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, compliant with EP (European Pharmacopoeia) impurity standards for Tryptophan quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in aqueous solution (pH 5-7) within 6 months.

Applications

• Quality Control Testing：Used for HPLC and LC-MS detection of EP Impurity K in Tryptophan API and formulations, controlling content to meet EP standards (≤0.1%).

• Process Optimization Research：Monitors impurity formation during Tryptophan synthesis, reducing generation by >50% by adjusting condensation temperature (e.g., 70-80℃) and reaction time.

• Method Validation：Serves as an EP standard for developing impurity detection methods, verifying HPLC resolution (≥2.5) and LOD (0.01 ng/mL).

Background Description

Tryptophan, an essential amino acid, is used in nutritional supplements and pharmaceutical intermediates. Impurity K, specified by EP, may originate from alkylation side reactions of the indole ring or raw material residues during synthesis. Its bis-indole system may affect Tryptophan's stability and biological activity. With stricter EMA enforcement of EP standards, studying such officially designated impurities is crucial for drug registration and manufacturing.

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 3.5 minutes, with LOD of 0.003 ng/mL for EP-compliant trace analysis.

• Formation Mechanism：Formed by reaction of 3-indolecarboxaldehyde with Tryptophan under acidic conditions (e.g., acetic acid catalysis); optimizing catalyst dosage and solvent polarity (e.g., ethanol-water system) inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 178.6 μM against C2C12 myoblasts (Tryptophan IC??=21.3 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing to monitor degradation under different pH conditions.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.

This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!