Description

Levemir (Tn) CAS NO 169148-63-4 is a high-purity pharmaceutical intermediate and active ingredient, specifically the threonine (Tn) variant of insulin detemir. This compound is critical for the development and production of long-acting basal insulin analogs used in diabetes management. It is essential for pharmaceutical manufacturers, research institutions, and biotechnology companies engaged in the formulation of advanced therapeutic proteins and metabolic disorder treatments.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of long-acting insulin analogs.
• Pharmaceutical Intermediate in the synthesis and modification of therapeutic peptides and proteins.
• Biochemical Research for studying insulin signaling pathways, receptor binding, and metabolic regulation.
• Reference Standard in analytical laboratories for quality control and method development using HPLC and MS.
• Process Development for scaling up the production of biosimilar or novel insulin-based therapeutics.

Basic Information

Item	Details
Product Name	Levemir (Tn)
CAS No.	169148-63-4
Molecular Formula	C267H402N64O76S6
Molecular Weight	~5916.8 g/mol
Synonyms	Insulin Detemir (Threonine variant); B29-Nε-myristoyl-des(B30) insulin; Detemir; NN304; Levemir® intermediate; Long-acting insulin analog; Lys(B29)-tetradecanoyl, des(B30) human insulin
EINECS	Contact for details

Quality Control

Our Levemir (Tn) is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing to ensure identity, purity, and potency. A detailed Certificate of Analysis (COA) is provided, confirming compliance with in-house specifications developed in alignment with ICH Q7 guidelines. We support our partners with full traceability and documentation for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature or as specified on the label. For long-term stability, store at -20°C or below under desiccated conditions. This material is easily oxidized; containers should be sealed under an inert atmosphere such as nitrogen or argon after opening to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Impurity	≤ 1.0%
Water Content (KF)	≤ 5.0%
Bacterial Endotoxins	< 10 EU/mg
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.