Sitagliptin Active Pharmaceutical Ingredients

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Sitagliptin Active Pharmaceutical Ingredients

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MOQ : 25 Kilograms

Sitagliptin Active Pharmaceutical Ingredients Specification

Solubility
Soluble in water, slightly soluble in methanol

Heavy Metal (%)
NMT 0.001%

Shelf Life
36 months

Ph Level
4.0 - 6.0 (1% w/v aqueous solution)

Boiling point
Not applicable (decomposes)

Melting Point
206-210C

Structural Formula
Available on request

Taste
Bitter

EINECS No
698-872-8

Particle Size
D90 NMT 150 microns

Storage
Store in a cool, dry place, tightly closed, away from heat and light

HS Code
29420090

Poisonous
NO

Molecular Weight
523.32 g/mol

Molecular Formula
C16H15F6N5OH3PO4H2O

Color
White to off-white

Loss on Drying
NMT 0.5%

Smell
Odorless

Medicine Name
Sitagliptin

Chemical Name
Sitagliptin Phosphate Monohydrate

CAS No
654671-77-9

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Anti-diabetic medication, used for the treatment of type 2 diabetes mellitus

Purity(%)
>= 99%

Appearance
White or off-white powder

Physical Form
Powder

Related Substances
NMT 0.2%

Assay (on dried basis)
Not less than 99.0% and not more than 101.0%

Identification
By HPLC and IR - complies with standard

Packaging
Sealed double polyethylene bags in HDPE container or drum

Endotoxin Level
NMT 0.25 EU/mg

Residual Solvents
Complies with ICH Q3C guidelines

Microbial Limits
Total aerobic microbial count NMT 100 cfu/g

Sitagliptin Active Pharmaceutical Ingredients Trade Information

Minimum Order Quantity
25 Kilograms

Payment Terms
Cash in Advance (CID), Cash Against Delivery (CAD), Cash on Delivery (COD)

Supply Ability
500 Kilograms Per Month

Delivery Time
5-7 Days

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

Main Domestic Market
All India

About Sitagliptin Active Pharmaceutical Ingredients

Sitagliptin Active Pharmaceutical Ingredients (API) from India boasts pharmaceutical grade quality and an immaculate purity of 99%. This API complies meticulously with ICH Q3C, HPLC and IR identification standards, and strict microbial and heavy metal limits. Sealed in top-drawer packaging, it remains intact throughout transit. We guarantee competitive pricing and frequent price cuts, ensuring a remarked value proposition. Instant checkout is available for seamless ordering. As a virtuoso exporter, supplier, and trader, we uphold industry-leading specifications and trusted service for anti-diabetic medication needs.

Medical and Commercial Applications of Sitagliptin API

Sitagliptin Active Pharmaceutical Ingredient is predominantly used as a key component in anti-diabetic medications, specifically indicated for the treatment of type 2 diabetes mellitus. Thanks to its high purity and compliance with global pharmaceutical standards, Sitagliptin API is an indispensable choice for commercial drug manufacturing. Pharmaceutical companies rely on its efficacy for formulation, making it an invaluable ingredient in the creation of trusted diabetes therapies used worldwide.

Payment Terms, Certifications, and Logistics for Sitagliptin API

Order completion and immediate processing are enabled by our streamlined supply chain. Sitagliptin API is handed over swiftly post-payment, ensuring prompt dispatch via reliable logistics networks. Certified to meet strict international standards, we uphold regulatory certificates for quality assurance. Our supply capacity caters to both bulk and custom orders, accommodating diverse business needs. Count on our top-drawer expertise to ensure smooth transactions, compliance, and steady availability year-round.

FAQ's of Sitagliptin Active Pharmaceutical Ingredients:

Q: How is the quality of Sitagliptin API verified before shipping?

A: Each batch of Sitagliptin API undergoes stringent identification by HPLC and IR, and complies with international standards for residual solvents, related substances, and microbial limits to ensure consistent top-drawer quality.

Q: What is the main usage of Sitagliptin API?

A: Sitagliptin API is primarily used in the pharmaceutical industry as an active ingredient for anti-diabetic medications, specifically targeting the management of type 2 diabetes mellitus.

Q: How does Instant Checkout work for Sitagliptin API orders?

A: Instant Checkout allows buyers to place orders quickly online, minimizing processing time and enabling faster order completion and dispatch through secure logistics channels.

Q: What packaging method is used for Sitagliptin API?

A: Sitagliptin API is sealed in double polyethylene bags within an HDPE container or drum, ensuring the product remains secure, dry, and free from contaminants throughout the logistics process.

Q: Where is Sitagliptin API supplied from and who can order it?

A: This Sitagliptin API is exported, supplied, and traded from India, catering to pharmaceutical manufacturers, distributors, and research organizations worldwide looking for consistent, high-purity ingredients.

Q: What certifications and compliance standards are met by Sitagliptin API?

A: The API meets stringent pharmaceutical grade requirements, complies with ICH Q3C guidelines, and holds certifications that validate safety, quality, and efficacy for commercial pharmaceutical use.

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