Valganciclovir Active Pharmaceutical Ingredients

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Valganciclovir Active Pharmaceutical Ingredients

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MOQ : 25 Kilograms

Valganciclovir Active Pharmaceutical Ingredients Specification

Color
White to off-white

Ph Level
Neutral (5.0-7.0 in solution)

Poisonous
Yes, handle with care

Shelf Life
24 months

Solubility
Soluble in water, slightly soluble in methanol

Boiling point
Not applicable (decomposes)

Storage
Store at 2-8C, protected from light

Taste
Bitter

Molecular Formula
C14H22N6O5

Loss on Drying
< 1.0%

Melting Point
168-170C

Smell
Odorless

EINECS No
695-227-5

Particle Size
D90 < 150 m

HS Code
29349900

Molecular Weight
390.37 g/mol

Structural Formula
Refer to product literature or certificate of analysis

Heavy Metal (%)
< 0.001%

Medicine Name
Valganciclovir

Chemical Name
(2S)-2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-3-hydroxypropyl (2S)-2-amino-3-methylbutanoate

CAS No
175865-59-5

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in the treatment of cytomegalovirus (CMV) infections in immunocompromised patients

Purity(%)
>= 99%

Appearance
White to off-white crystalline powder

Physical Form
Solid

Stability
Stable under recommended storage conditions

Specific Optical Rotation
+120 to +150 (in water)

Packaging
Double polyethylene bags in HDPE drums or as per customer requirement

Formulation Compatibility
Suitable for use in oral solid dosage forms

Assay (by HPLC)
>= 99.0%

Microbial Limits
Total aerobic microbial count NMT 100 cfu/g

Related Substances
NMT 0.2% each impurity

Residual Solvents
Complies with ICH guidelines

Identification
IR, HPLC, GC as per pharmacopoeia

Valganciclovir Active Pharmaceutical Ingredients Trade Information

Minimum Order Quantity
25 Kilograms

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

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 Valganciclovir Active Pharmaceutical Ingredients

Valganciclovir Active Pharmaceutical Ingredient (API) embodies a marvelous pharmaceutical solution renowned for its commanding efficacy against cytomegalovirus (CMV) infections, especially in immunocompromised patients. Recognized as a blue-ribbon product, it boasts unparalleled purity (99%) and complies with rigorous pharmacopoeial standards, ensuring maximum safety and effectiveness. With a scarcity in the market, proactive procurement is advised to leverage competitive discounts. Each batch undergoes extensive identification by IR, HPLC, and GC, guaranteeing all parameters, from related substances to microbial limits, meet the most stringent criteria. Timely acquisition secures this high-quality, stable API, packaged with precision for global supply.

Applications and Usage of Valganciclovir API

Valganciclovir API is primarily utilized in oral solid dosage formulations designed for the treatment of cytomegalovirus (CMV) infections, targeting immunocompromised patient populations, such as transplant recipients and individuals with HIV/AIDS. Its blue-ribbon quality ensures compatibility across diverse application media, including water-soluble preparations. The API's purity and consistency make it the preferred choice for pharmaceutical manufacturers requiring reliable, high-efficacy solutions in antiviral therapy. Type of usage remains strictly professional, adhering to regulated pharmaceutical application protocols.

Supply Ability and Trade Terms for Valganciclovir API

Our stock of Valganciclovir API is ready for immediate dispatch, backed by robust transport services ensuring prompt and secure delivery. Multiple packaging options are available, including double polyethylene bags in HDPE drums, or customized solutions per customer needs. Standard payment terms are accepted, and competitive FOB ports across India, such as Mumbai, are provided for seamless international trade. Clients benefit from swift order processing, reliable supply ability, and professional export support to streamline procurement and distribution.

FAQ's of Valganciclovir Active Pharmaceutical Ingredients:

Q: How should Valganciclovir API be stored to maintain its stability?

A: Valganciclovir API should be stored at 2-8C, protected from light, to preserve its stability and efficacy over its 24-month shelf life.

Q: What are the recommended application areas for Valganciclovir API?

A: Valganciclovir API is indicated for the formulation of oral solid dosage forms used in the treatment of cytomegalovirus (CMV) infections, mainly in immunocompromised patients such as those with HIV/AIDS or organ transplants.

Q: Where does your Valganciclovir API supply originate, and which ports do you use for export?

A: Our Valganciclovir API is sourced and manufactured in India, with stock dispatched from major FOB ports, including Mumbai, ensuring reliable international shipments.

Q: How can pharmaceutical companies procure Valganciclovir API at discounted rates?

A: Pharmaceutical companies can procure Valganciclovir API directly from our stock. Discounts may be available based on order volumes or current promotional offers. Early procurement is advised due to limited availability.

Q: What is the process for verifying the identity and quality of Valganciclovir API?

A: Each batch is identified and tested using IR, HPLC, and GC methods per pharmacopoeial standards. Additional tests ensure assay, impurities, microbial limits, and compliance with ICH residual solvent guidelines.

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