3-(4-phenoxyphenyl)-1-(3-piperidyl)pyrazolo[3,4-d]pyrimidin-4-amine/ Ibrutinib intermediate 1022150-12-4

EPA içermez; %40 artış; %50 artış

%99 yukarı

HPLC'ye göre %98 artış

Demir Analizi: %31 yukarı, GMP, DMF, WC

HPLC'ye göre %99 artış

HPLC ile %98 artış

Product Information   Product name L-Alanyl-L-Glutamine; Alanyl Glutamine; L-Ala-L-Gln; Ala-Gln CAS No. 39537-23-0 Molecular Formula C8H15N3O4 Molecular Weight 217.225 Quality Standard 98.5% up by HPLC Appearance White to almost-white crystal or crystalline powder   COA   Test Items Specifications Results Appearance White to almost-white crystal or crystalline powder White crystalline powder Specific optical rotation +9.5°~ +11.0° +10.6° ID(Physico-chemical) Positive Conforms Identification(IR) The IR spectrum of the sample corresponds to the IR spectrum of the RS Conforms pH 5.0 ~6.0 5.7   Appearance of solution Not more opalescent than reference suspension 1 Conforms Not more intensely coloured than reference solution Y1 Conforms Chlorides ≤0.02% Conforms Sulphates ≤ 0.02% Conforms Ammonium salt ≤ 0.08% Conforms Loss on Drying ≤ 0.5% 0.25% Sulphated Ash ≤ 0.1% 0.05% Iron ≤ 10ppm Conforms Heavy metals ≤ 10ppm Conforms Arsenic(AS2O3) ≤ 1ppm Conforms   Related substances 1 Impurity I ≤ 0.2% 0.01% Impurity II ≤ 0.04% ND Impurity III ≤ 0.15% ND Impurity IV ≤ 0.05% ND Impurity V ≤ 0.05% ND Impurity VI ≤ 0.5% 0.03% Any Individual unspecified impurity≤ 0.10% 0.02% Methylene dichloride ≤ 600ppm ND     Related substances 2 Impurity N ≤ 0.10% 0.04% Impurity G ≤ 0.10% ND Impurity H ≤ 0.10% ND Impurity I ≤ 0.10% ND Impurity M ≤ 0.10% ND Assay (on the anhydrous basis) 98.5%~101.0% 100.8% Residual solvents Methanol ≤ 3000ppm ND Bacterial Endotoxins < 0.05EU/mg Conforms   Microbial Limit Total aerobe ≤ 1000cfu/g <10cfu/g Total Yeast and Mold Count ≤ 100cfu/g 5cfu/g Escherichia coli Not detected ND Conclusion It conforms to all the specification   Usage   L-Alanyl-L-Glutamine(Alanyl Glutamine) is a pharmaceutically optimized, stable dipeptide that serves as a superior delivery system for glutamine in the human body. It is specifically designed for use in clinical and therapeutic nutrition, particularly when the body is under severe metabolic stress and glutamine becomes a conditionally essential amino acid. This form solves the critical problem of free glutamine’s instability in aqueous solutions.   Core Functions and Direct Clinical Applications of L-Alanyl-L-Glutamine: 1. Provides a Stable, Bioavailable Source of Glutamine. Primary Application: Parenteral Nutrition (PN) / Intravenous Formulations. Mechanism & Use: The dipeptide bond protects the glutamine molecule, allowing it to remain stable in intravenous (IV) bags during heat sterilization and storage. Once infused, it is rapidly cleaved in the blood to release bioavailable L-glutamine and L-alanine. This makes it an essential component of Total Parenteral Nutrition (TPN) for patients who cannot use their gastrointestinal tract.   2. Serves as the Primary Fuel for Intestinal Lining Cells (Enterocytes). Primary Application: Gut Health Support & Barrier Function. Mechanism & Use: Glutamine is the preferred energy source for the cells of the small intestine. Supplementation with L-Alanyl-L-Glutamine in critically ill, surgical, or oncology patients helps maintain intestinal mucosal integrity, support gut barrier function, and may reduce the risk of bacterial translocation from the gut into the bloodstream.   3. Acts as a Crucial Metabolic Substrate for Immune Cells. Primary Application: Immune Modulation in Critical Care. Mechanism & Use: Lymphocytes, macrophages, and other immune cells require glutamine for optimal function, especially during times of physiological stress. Providing this dipeptide in clinical nutrition protocols helps support immune system competence in patients with sepsis, major trauma, burns, or post-operatively. 4. Improves Nitrogen Balance and Protein Metabolism. Primary Application: Muscle Mass Preservation & Recovery. Mechanism & Use: During severe catabolic states, the body breaks down muscle protein.   L-Alanyl-L-Glutamine helps shift the body’s nitrogen balance towards a more anabolic (building) state, reducing muscle protein breakdown (catabolism) and aiding in the preservation of lean body mass.   Key Product Advantages of L-Alanyl-L-Glutamine 1. Superior Stability: Soluble and heat-stable for reliable inclusion in parenteral formulations. 2. High Bioavailability: Efficiently hydrolyzed to release active glutamine at the target site. 3. Therapeutic Efficacy: Directly addresses glutamine deficiency in critical illness.

% 98 UP, GMP, DMF