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TENEGLIPTIN IP/BP/EP/USP

Name: TENEGLIPTIN IP/BP/EP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

TENEGLIPTIN IP/BP/EP/USP Specification

Particle Size
Micronized

Moisture (%)
0.5%

Molecular Formula
C22H23N5O.BrH.H2O

HS Code
29420090

Place of Origin
India

Storage
Store in tightly closed container below 25C, protected from moisture

Residue on Ignition
0.1%

Heavy Metal (%)
0.001%

Melting Point
237C 243C

Molecular Weight
414.31 g/mol

Assay
>= 99.0%

Loss on Drying
1.0%

Other Names
Tenegliptin Hydrobromide Hydrate

CAS No
760937-92-6

Type
Pharmaceutical Raw Material

Grade
Pharmaceutical Grade

Usage
Antidiabetic (DPP-4 Inhibitor)

Purity
99%

Appearance
White to off-white crystalline powder

Application
API for oral antidiabetic formulation

Raw Material
Pharmaceutical intermediate

Smell
Odorless

Color
White

Form
Solid

Identification
Complies as per reference standard

Transportation
Non-hazardous, shipped under ambient conditions

Shelf Life
24 Months

Packing Details
HDPE drums / Double polyethylene bags

Particle Size Distribution
d90 < 10 µm

Solubility
Freely soluble in water and methanol

Microbial Limits
Meets USP standards

Impurity Profile
As per pharmacopoeial requirement

About TENEGLIPTIN IP/BP/EP/USP

Tenebliptin is a medication primarily used for treating type 2 diabetes mellitus. As a member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class, it works by blocking the DPP-4 enzyme responsible for breaking down incretin hormones like GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).

Key Features and Composition

Tenegliptin Hydrobromide Hydrate is characterized by its exceptional purity (99%), micronized particle size, and compliance with IP/BP/EP/USP reference standards. With a molecular formula of C22H23N5O.BrH.H2O and a molecular weight of 414.31 g/mol, it appears as a white, odorless crystalline powder and is processed for optimal solubility and performance in antidiabetic formulations.

Packaging and Transportation Details

Tenegliptin is carefully packaged in HDPE drums or double polyethylene bags to maintain product integrity during storage and transit. It is classified as non-hazardous and can be shipped under ambient conditions, making distribution straightforward and cost-effective. Proper storage below 25C ensures its efficacy throughout its 24-month shelf life.

Pharmaceutical Applications and Benefits

As an active pharmaceutical ingredient, Tenegliptin is primarily used in oral antidiabetic medications for the management of type 2 diabetes mellitus. Its mechanism as a DPP-4 inhibitor enables improved glycemic control, making it a valuable option for pharmaceutical manufacturers and healthcare providers aiming to deliver effective diabetes therapies.

FAQ's of TENEGLIPTIN IP/BP/EP/USP:

Q: How should TENEGLIPTIN IP/BP/EP/USP be stored to ensure maximum shelf life?

A: TENEGLIPTIN should be stored in a tightly closed container below 25C and protected from moisture. This ensures stability and maintains its quality over the 24-month shelf life.

Q: What is the primary pharmaceutical use of Tenegliptin Hydrobromide Hydrate?

A: Tenegliptin is mainly used as an active pharmaceutical ingredient (API) in oral formulations for the treatment of type 2 diabetes mellitus, functioning as a DPP-4 inhibitor to improve glycemic control.

Q: When does Tenegliptin need to be used within its shelf life for optimal efficacy?

A: It is recommended to use Tenegliptin within 24 months from the manufacturing date, provided it has been stored as directed, to guarantee optimal performance and regulatory compliance.

Q: Where is this pharmaceutical raw material produced and supplied from?

A: Tenegliptin IP/BP/EP/USP is manufactured and supplied from India by reputable pharmaceutical raw material producers, traders, and suppliers.

Q: What processes ensure the product's compliance with pharmacopoeial requirements?

A: Tenegliptin undergoes rigorous quality control, including assay, impurity profiling, particle size distribution, and microbial limit testing, all adhering to IP/BP/EP/USP standards to ensure consistency and purity.

Q: How is Tenegliptin typically packaged for wholesale distribution?

A: It is packed in HDPE drums or double polyethylene bags, which safeguard against contamination and moisture, facilitating safe transportation under ambient conditions.

Q: What benefits does Tenegliptin offer for pharmaceutical manufacturers and end-users?

A: Tenegliptin's high purity, well-defined particle size, and compliance with international standards provide reliable performance in oral antidiabetic formulations, ensuring effective diabetes management for patients.

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