Description

Novosol Basal Insulin is a high-purity, long-acting insulin analog designed for stable glycemic control. It is a critical active pharmaceutical ingredient (API) for the formulation of modern basal insulin therapies, offering a consistent and prolonged release profile. This product is essential for pharmaceutical manufacturers developing injectable treatments for diabetes management, catering to the needs of a global patient population.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of long-acting basal insulin injection pens and vials.
• Diabetes Treatment Formulations: Used in the development of biosimilar and innovative insulin therapies for Type 1 and Type 2 diabetes.
• Drug Delivery System Research: A key component in advanced research for sustained-release drug delivery platforms and pump systems.
• Clinical Trial Material: Serves as the reference standard or bulk API for pre-clinical and clinical studies.
• Regulatory Submission Batches: Production of compliant batches for regulatory filings (e.g., ANDA, NDA, MAA) with global health authorities.

Basic Information

Product Name	Novosol Basal Insulin
CAS No.	117442-98-5
Molecular Formula	C257H383N65O77S6
Molecular Weight	~5823.5 g/mol
Synonyms	Insulin Detemir; NN304; Levemir® (Brand Name); Insulin (B29-Nε-tetradecanoyl, desB30) human; Lys(B29-tetradecanoyl) des(B30) human insulin; Long-Acting Insulin Analog; Basal Insulin API; rDNA Insulin Detemir
EINECS	Contact for details

Quality Control

Our Novosol Basal Insulin is manufactured under strict cGMP guidelines to ensure the highest standards of purity and consistency. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing specifications for identity, purity, potency, and related substances. We adhere to relevant pharmacopoeial standards (e.g., USP, EP) for pharmaceutical-grade APIs, ensuring reliability for critical drug manufacturing processes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	≥ 95.0% (on anhydrous basis)
Related Proteins (HPLC)	≤ 5.0% total
Water Content (KF)	≤ 10.0%
Bacterial Endotoxins	< 10.0 IU/mg
Sterility (where applicable)	Sterile

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