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Sitagliptin Phosphate API

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Sitagliptin Phosphate API Specification

Heavy Metal (%)
0.001%

HS Code
29420090

Structural Formula
Available on request

Ph Level
4.0 6.0 (1% aqueous solution)

Molecular Formula
C16H15F6N5OH3PO4

Storage
Store below 25C, protected from light and moisture

Particle Size
D90 < 50 microns

Color
White to off-white

Smell
Odorless

Molecular Weight
523.32 g/mol

Loss on Drying
0.5%

Boiling point
Not applicable (decomposes before boiling)

Solubility
Soluble in water, slightly soluble in ethanol

Taste
Bitter

Melting Point
202-204C

Poisonous
Non-poisonous under prescribed dosage

Shelf Life
36 months

Medicine Name
Sitagliptin Phosphate

Chemical Name
Sitagliptin Phosphate Monohydrate

CAS No
654671-77-9

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as an anti-diabetic agent for the treatment of type 2 diabetes mellitus

Purity(%)
99%

Appearance
White to off-white powder

Physical Form
Solid

Microbial Limits
Within pharmacopeial limits

Related Substances (Total Impurities)
0.5%

Packaging
Fiber drum with double PE bag, net weight 10kg/25kg

Assay (by HPLC)
>=99.0%

Specific Rotation
+96 to +104 (c=1, H2O)

Residual Solvents
Complies with ICH guidelines

Identification
Conforms to standard by IR and HPLC methods

Chloride Content
0.02%

Endotoxin Level
<5 EU/mg

Sitagliptin Phosphate API Trade Information

Supply Ability
1000 Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Sitagliptin Phosphate API

Composition	Sitagliptin
Manufacturer	Cerata Pharmaceuticals LLP
Form	Powder
CAS	486460-32-6
Type	API Powder
Therapeutic Use	Anti Diabetic

Product Information :

Product Name :iSitagliptin Phosphate API

Grade :iIP/BP/USP/IH (Pharma Grade)

Manufacturer :iCerata Pharmaceuticals LLP

Packaging :iHDPE Drum

Shelf Life :i5 years

API Form :iPowder

Country Of Origin :iIndia

Superior API for Diabetes Treatment

Sitagliptin Phosphate acts as a potent anti-diabetic agent, specifically tailored for the management of type 2 diabetes mellitus. Its high assay value (99.0% by HPLC) and minimal impurity profile ensure it is suitable for pharmaceutical formulations demanding the utmost quality, efficacy, and patient safety.

Compliant With International Quality Standards

This API is produced adhering to global regulatory standards, meeting pharmacopoeial thresholds for microbial load, loss on drying, heavy metals, and residual solvents. Each batch undergoes identification by IR and HPLC, ensuring authenticity. Its packaging preserves stability by protecting against moisture and light.

Flexible Supply, Reliable Sourcing

As a trusted exporter, importer, manufacturer, and supplier from India, we offer Sitagliptin Phosphate in 10kg and 25kg drums, catering to varied production needs. Our robust logistics network and bulk packaging optimize the procurement process for clients worldwide.

FAQ's of Sitagliptin Phosphate API:

Q: How should Sitagliptin Phosphate API be stored for optimal stability?

A: Sitagliptin Phosphate API should be stored below 25C, protected from light and moisture, to maintain its chemical integrity and shelf life. Proper storage conditions help ensure the product remains within specification for up to 36 months.

Q: What is the primary benefit of using Sitagliptin Phosphate API in pharmaceutical formulations?

A: The chief benefit is its high assay purity (99.0%) and consistent quality, which result in effective and safe anti-diabetic medications for treating type 2 diabetes mellitus. This ensures patients receive reliable therapy.

Q: When is it appropriate to select Sitagliptin Phosphate Monohydrate for product development?

A: This API is ideal for development when robust regulatory compliance, low impurity content (total 0.5%), and proven efficacy in diabetes management are required. It suits manufacturers seeking high-quality bulk ingredients.

Q: Where is Sitagliptin Phosphate API typically sourced from?

A: Our Sitagliptin Phosphate is manufactured and exported from India, ensuring compliance with international quality standards. We serve global clients as a leading supplier, exporter, importer, and manufacturer.

Q: What identification and quality checks are performed on Sitagliptin Phosphate?

A: Each batch is identified and verified by IR and HPLC methods, and tested for properties such as specific rotation, assay, related substances, heavy metal content, microbial limits, and residual solvents in line with pharmacopeial and ICH guidelines.

Q: How is the API packaged and supplied to manufacturers?

A: The API is securely packaged in fiber drums lined with double PE bags, available in net weights of 10kg and 25kg. This ensures safe handling, storage, and transportation to maintain product efficacy.

Q: What are the usage instructions and safety profile of Sitagliptin Phosphate?

A: This API is intended for formulation into oral medicines for type 2 diabetes. It is odorless and bitter, non-poisonous at prescribed dosages, and should be handled following pharmaceutical manufacturing protocols to ensure worker safety and product integrity.

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