Description

Insulin, Isophane is an intermediate-acting insulin suspension, also known as NPH insulin, widely used in the formulation of therapeutic pharmaceuticals. Its primary value lies in providing a prolonged duration of action for effective glycemic control in diabetic patients. This product is essential for pharmaceutical manufacturers and research institutions developing and producing injectable diabetes treatments, including vials, cartridges, and pens.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of intermediate-acting insulin injections for diabetes management.
• Biosimilar Development: Critical reference material for the research, development, and quality control of biosimilar insulin products.
• Combination Therapy Formulations: Used in premixed insulin preparations that combine rapid-acting and intermediate-acting insulins.
• Clinical Research: Serves as a standard in pharmacokinetic and pharmacodynamic studies for diabetes therapeutics.
• Veterinary Medicine: Application in the treatment of diabetes mellitus in companion animals.
• Biopharmaceutical Manufacturing: Key intermediate in downstream processing and final drug product manufacturing under GMP conditions.

Basic Information

Product Name	Insulin, Isophane
CAS No.	53027-39-7
Molecular Formula	C257H383N65O77S6
Molecular Weight	~5808 g/mol
Synonyms	Isophane Insulin; NPH Insulin; Neutral Protamine Hagedorn Insulin; Insulin Isophane Suspension; Isophane Insulin Human; Human Insulin Isophane; Protamine Zinc Insulin (related); Insulin NPH; Isophan Insulin; INS (Isophane)
EINECS	Contact for details

Quality Control

Our Insulin, Isophane is manufactured and tested to meet stringent pharmaceutical standards. Quality assurance protocols include identity confirmation, potency (assay) determination, purity profiling, and tests for related proteins and impurities. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing compliance with relevant pharmacopeial monographs (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store unopened vials at 2°C to 8°C (refrigerated, do not freeze). Once in use, follow specific product labeling for in-use storage conditions, typically below 25°C for a limited period. Avoid exposure to excessive heat and direct sunlight.

Specification

Item	Specification
Appearance	White or almost white suspension
Identification (HPLC/IR)	Conforms to standard
pH	6.9 - 7.8
Assay (HPLC)	90.0% - 110.0% of labeled potency
Zinc Content	10 µg to 40 µg per 100 IU
Related Proteins (HPLC)	NMT 3.0%
High Molecular Weight Proteins	NMT 1.0%
Bacterial Endotoxins	< 10 IU per 100 IU
Sterility	Sterile (where applicable)

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