Diabetes Drug API Nateglinide CAS 105816-04-4

• Powder: Yes
• Customized: Customized
• Certification: GMP, HSE, ISO 9001, USP, BP
• Suitable for: Elderly, Children, Adult
• State: White Powder
• Purity: >99%
• Model NO.: Frazer-Nateglinide
• Appearance: White Powder
• CAS No: 105816-04-4
• Shelf Life: 2 Years
• Test Method: HPLC
• MOQ: 1kg
• Storage: Store Cool Dry Place
• Resource: Natural
• Quality Requirement: Strictly Quality Control
• Mf: C19h27no3
• MW: 317.42
• Transport Package: Foil Bag
• Specification: 99%
• Trademark: Xi′an Frazer Biotech Co., Ltd.
• Origin: China
• Production Capacity: 1000kg/Month

Product Description

Diabetes Drug API Nateglinide CAS 105816-04-4

Specification of Analysis

Appearance	White or off-white solid powder		Complies
Identification	By IR		Complies
	By HPLC		Complies
Solubility	Soluble in DMF, sparingly soluble in THF, slightly soluble in me'thanol and a'cetonitrile, very sightly soluble in ethanol, insoluble in water		Complies
Polymorphic Form	Polymorphic form 1		Complies
Melting Point	211ºC~216ºC		212.8ºC~214.9ºC
Water Content	≤ 0.50%		0.10%
Heavy Metals	≤ 20ppm		Complies
Residue on Ignition	≤ 0.20%		0.09%
Related Substance	Any single impurity: ≤0.10%		0.06%
	Total Impurities: ≤1.00%		0.16%
Assay                  (on the anhydrous basis)	98.0%~102.0%		99.94%
Particle Size	D90: ≤100µm		Complies
Reference Standard	In-house Standard
Conclusion	The product complied to In-house standard.
Storage	Preserve in tight,light-resistant containers in a cool place

Description

Nateglinide is an oral antihyperglycemic agent used for the treatment of non-in'sulin-Diabetes drug API Nateglinide/trans-d-phenylalanine CAS 105816-04-4 dependent diabetes mellitus (NIDDM). It belongs to the meglitinide class of short-acting in'sulin secretagogues, which act by binding to β cells of the pancreas to stimulate in'sulin release. Nateglinide is an amino acid derivative that induces an early in'sulin response to meals decreasing postprandial blood glucose levels. It should only be taken with meals and meal-time doses should be skipped with any skipped meal. Approximately one month of therapy is required before a decrease in fasting blood glucose is seen. Meglitnides may have a neutral effect on weight or cause a slight increase in weight. The average weight gain caused by meglitinides appears to be lower than that caused by sulfonylureas and in'sulin and appears to occur only in those naïve to oral antidiabetic agents. Due to their mechanism of action, meglitinides may cause hypoglycemia although the risk is thought to be lower than that of sulfonylureas since their action is dependent on the presence of glucose. In addition to reducing postprandial and fasting blood glucose, meglitnides have been shown to decrease glycosylated hemoglobin (HbA1c) levels, which are reflective of the last 8-10 weeks of glucose control. Meglitinides appear to be more effective at lowering postprandial blood glucose than metformin, sulfonylureas and thiazolidinediones. Nateglinide is extensively metabolized in the liver and excreted in urine (83%) and feces (10%). The major metabolites possess less activity than the parent compound. One minor metabolite, the isoprene, has the same potency as its parent compound.

Function and Application

1. Nateglinide is used for the treatment of the form of diabetes mellitus that appears most frequently in adulthood -- known as type 2 or non-in'sulin-dependent diabetes -- that cannot be managed by exercise and control of diet alone.

2. Nateglinide may be added to diet and exercise to manage the disease, or it may be combined with metformin when diet, exercise, and either drug alone cannot provide adequate control of blood sugar.