Description

Repaglinide CAS NO 135062-02-1 is a potent, fast-acting oral hypoglycemic agent belonging to the meglitinide class. It is a critical active pharmaceutical ingredient (API) used in the management of type 2 diabetes mellitus, offering a rapid onset of action to control postprandial blood glucose spikes. This high-purity compound is essential for pharmaceutical manufacturers developing and producing effective anti-diabetic medications. Our supply ensures the stringent quality and reliable consistency required for global drug formulation and regulatory compliance.

Application

• Primary Pharmaceutical Ingredient: Core active component in the formulation of oral anti-diabetic tablets for type 2 diabetes treatment.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of repaglinide-based medications.
• Combination Therapy Development: Used in research and development of fixed-dose combination drugs with other anti-diabetic agents.
• Clinical Research Material: Serves as a reference standard and raw material for pharmacokinetic and pharmacodynamic studies.
• Dosage Form Innovation: Applicable in the development of novel drug delivery systems to optimize therapeutic profiles.

Basic Information

Product Name	Repaglinide
CAS No.	135062-02-1
Molecular Formula	C27H36N2O4
Molecular Weight	452.59 g/mol
Synonyms	2-Ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid; (S)-(+)-2-Ethoxy-4-[2-(3-methyl-1-[2-(1-piperidinyl)phenyl]butylamino)-2-oxoethyl]benzoic Acid; AG-EE 623 ZW; Prandin (trade name); NovoNorm (trade name); S 21403; Repaglinidum
EINECS	Contact for details

Quality Control

Our Repaglinide is manufactured and tested under strict quality management systems to meet the rigorous standards of the global pharmaceutical industry. Each batch is controlled against comprehensive specifications, including identity, purity, and impurity profiles, aligning with major pharmacopoeial guidelines. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to ensure full traceability and compliance for our customers.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF Titration)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Optical Rotation	+6.5° to +8.5° (c=1 in methanol)

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