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Glimepiride (CAS No 93479-97-1), (original trade name Amaryl) is an orally available medium-to-long-acting sulfonylurea antidiabetic drug. It is sometimes classified as either the first third-generation sulfonylurea,[1] or as second-generation.Practically insoluble in water, soluble in DMF, slightly soluble in methylene chloride & methanol.

Specification

Appearance                                    White or almost white powder

Related substances, %                    Impurity A≤0.80

 Impurity B                                    ≤0.40

 Impurity C                                    ≤0.10

 Impurity D                                    ≤0.20

Any other impurity, %                     ≤0.10

Total impurities, %                         ≤0.50

Water, %                                       ≤0.50

Heavy metals, %                            ≤0.001

Residue on ignition, %                    ≤0.20

Residual solvents, ppm   Acetone     ≤5000

Assay,%                                         98.00 ~ 102.00

Application

Glimepiride (Glimer) is indicated to treat type 2 diabetes mellitus; its mode of action is to increase insulin production by the pancreas. It is not used for type 1 diabetes because in type 1 diabetes the pancreas is not able to produce insulin.Its use is contraindicated in patients with hypersensitivity to glimepiride or other sulfonylureas, and during pregnancy.

Packaging&Storage

5kg per aluminium tin, or 25kg per fiber drum, or as per customer’s requirements.

Store in a well-closed container away from moisture.