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Valsartan API

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Valsartan API Specification

Molecular Weight
435.52 g/mol

Smell
Odorless

Poisonous
Non-poisonous as API; use with medical guidance

Solubility
Slightly soluble in water, freely soluble in methanol and ethanol

Structural Formula
See image/standard source

Shelf Life
2-3 years if properly stored

HS Code
29339900

Particle Size
Not less than 90% passes through 60 mesh

Color
White to off-white

Storage
Store in a cool, dry place, protected from light

Loss on Drying
Not more than 0.5%

Heavy Metal (%)
Not more than 0.001%

Melting Point
116-117C

Molecular Formula
C24H29N5O3

Medicine Name
Valsartan API

Chemical Name
(S)-N-(1-Carboxy-2-methylprop-1-yl)-N-pentanoyl-N-[[2-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]amine

CAS No
137862-53-4

Type
API (Active Pharmaceutical Ingredient)

Grade
Pharmaceutical Grade

Usage
Antihypertensive agent (treatment of high blood pressure)

Purity(%)
>99%

Appearance
White to off-white powder

Physical Form
Solid

Residual Solvents
Complies with ICH guidelines

Identification
Conforms to standard IR/UV tests

Application
Used in tablet and capsule formulations for hypertension treatment

Packing
Double LDPE bags inside HDPE/Drum

Endotoxin Level
Below pharmacopeial limits

Polymorphic Form
Form I

Related Substances
Total impurities not more than 0.5%

Documentation
COA, MOA, MSDS available

MOQ
1 kg

Assay (HPLC)
>99.0%

Microbial Limits
Total aerobic microbial count <1000 CFU/g

Valsartan API Trade Information

Supply Ability
100 Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Valsartan API

Packaging Size	25 kg 0
Cas No	137862-53-4
Form	Powder
Colour	White
Purity	100%
Usage	Pharmaceutical Intermediates
Minimum Order Quantity	500 Kg

MOQ :i1000 Kilogram

Business Type	Manufacturer, Supplier
Name of Product	Valsartan
CAS No.	137862-53-4
Physical Appearance	A White or Almost White Powder

High Purity & Quality Assurance

Our Valsartan API boasts a purity level greater than 99%, verified by HPLC, with total impurities maintained below 0.5%. Each batch undergoes robust identification via standard IR/UV tests and conforms to international guidelines for residual solvents, heavy metals, and microbial limits, ensuring pharmaceutical-grade quality for every supply.

Optimal Applications & Usage

Specially synthesized for use in tablet and capsule formulations, Valsartan API serves as a potent antihypertensive agent. Its physical form, particle size distribution, and polymorphic consistency (Form I) make it ideally suited for efficient formulation and consistent delivery in oral solid dosage forms.

Reliable Packaging & Documentation

To preserve integrity during handling and transit, the API is packed in double LDPE bags, secured inside HDPE drums. Each shipment is accompanied by exhaustive documentation, including Certificate of Analysis (COA), Method of Analysis (MOA), and Material Safety Data Sheet (MSDS), facilitating product validation and regulatory compliance.

FAQ's of Valsartan API:

Q: How is the identity of Valsartan API confirmed?

A: Valsartan API identity is confirmed through standard infrared (IR) and ultraviolet (UV) spectroscopy as per pharmacopeial requirements, ensuring the substance matches official reference standards.

Q: What is the typical purity and impurity profile of Valsartan API?

A: The purity is consistently above 99.0% by HPLC assay, while total related impurities do not exceed 0.5%, confirming a high-grade product suitable for pharmaceutical formulations.

Q: When should Valsartan API be used in tablet or capsule manufacturing?

A: Valsartan API is best employed during the formulation phase of antihypertensive tablets and capsules, as it is designed to maintain stability and efficacy throughout standard pharmaceutical processing.

Q: Where should Valsartan API be stored to retain its quality?

A: The API should be stored in a cool, dry place, away from direct light, which helps maintain its stability and extend its shelf life to 2-3 years when properly kept.

Q: What documents are provided with Valsartan API shipments?

A: Each batch is supplied with a Certificate of Analysis (COA), Method of Analysis (MOA), and Material Safety Data Sheet (MSDS), facilitating regulatory compliance and quality assurance.

Q: How is the API packaged to ensure safe delivery and handling?

A: Valsartan API is securely packed in double LDPE bags within an HDPE drum, offering protection against contamination and physical or environmental damage during storage and shipping.

Q: What are the main benefits of using Valsartan API from this supplier?

A: By sourcing Valsartan API from us, you receive a product with superior purity, controlled impurity levels, assured documentation, global regulatory compliance, and robust packaging, optimizing your formulation and regulatory processes.

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