Xylometazoline Active Pharmaceutical Ingredients

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Xylometazoline Active Pharmaceutical Ingredients

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MOQ : 25 Kilograms

Xylometazoline Active Pharmaceutical Ingredients Specification

Loss on Drying
Not more than 0.5%

Color
White

Heavy Metal (%)
Not more than 0.001% (10 ppm)

Ph Level
4.5 - 6.5 (1% solution)

HS Code
29333990

Poisonous
Non-poisonous at therapeutic dose

Solubility
Soluble in water, slightly soluble in alcohol

Structural Formula
C16H24N2 HCl

Melting Point
178-182C

Shelf Life
36 months

Molecular Formula
C16H24N2 HCl

Molecular Weight
282.84 g/mol

Particle Size
90% < 100 m

Taste
Slightly Bitter

EINECS No
214-936-0

Smell
Odorless

Storage
Store in a tightly closed container, protected from light and moisture

Medicine Name
Xylometazoline Active Pharmaceutical Ingredients

Chemical Name
Xylometazoline Hydrochloride

CAS No
1218-35-5

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Nasal decongestant; used in the formulation of nasal sprays and drops

Purity(%)
>=99%

Appearance
White to almost white crystalline powder

Physical Form
Solid

Packaging
HDPE drums with double polyethylene bags, 1 kg, 5 kg, 25 kg

Chloride Content
Within official pharmacopoeia specifications

Related Substances
Within pharmacopoeial limits

Residue on Ignition
Not more than 0.1%

Manufacturing Standard
GMP/WHO-GMP certified facility

Specific Optical Rotation
+34 to +38 (c=2 in methanol)

Animal Origin
Free from animal origin

Assay (by HPLC)
98.5% - 101.0%

Endotoxin Level
<0.25 EU/mg

Residual Solvents
Meets ICH Q3C guidelines

Bacterial Endotoxins
<0.5 IU/mg

Genotoxic Impurities
Complies with latest pharmacopeial requirements

Identification
IR, HPLC and chemical tests comply

Xylometazoline 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 Xylometazoline Active Pharmaceutical Ingredients

Spotlight on Xylometazoline Active Pharmaceutical Ingredients: This gilt-edged pharmaceutical-grade API is a monumental inclusion in the landscape of nasal decongestants. Manufactured in a crowning GMP/WHO-GMP certified facility, Xylometazoline Hydrochloride is ensured to meet competitive pricing and stringent regulatory requirements. Key attributes include chloride content, related substances, and bacterial endotoxins all within official pharmacopoeia specifications, with a purity index of 99%. The hot deal includes secure HDPE drum packaging in 1 kg, 5 kg, and 25 kg options. Compliant with ICH Q3C, non-poisonous at therapeutic dose, and with a shelf life of 36 months, this API is ideal for formulation into nasal sprays and drops.

Versatile Application and Use Type

Xylometazoline Active Pharmaceutical Ingredients are engineered for use in pharmaceutical formulations, predominantly for nasal decongestant applications. Its media of use encompasses a variety of nasal sprays and drops formulated for quick relief. As a highly refined pharmaceutical-grade solid, it serves as the active ingredient in both prescription and over-the-counter products, ensuring rapid patient benefit and safety across diverse clinical settings.

Shipping, Valuation, and Delivery Logistics

Shipped goods containing Xylometazoline API originate from India, with FOB Port options including Mumbai and other key export hubs. Valuation reflects competitive market rates and robust packaging standards. Payment terms are flexible, catering to LC, TT, and negotiated methods, while dispatching is streamlined to guarantee delivery typically within 2-3 weeks of order confirmation. Our export experience ensures secure, timely, and compliant shipments for international clients.

FAQ's of Xylometazoline Active Pharmaceutical Ingredients:

Q: How is the quality of Xylometazoline API verified before dispatching?

A: Each batch undergoes rigorous quality checks, including IR, HPLC, and chemical tests to confirm identity and purity, as well as microbiological and impurity assessments within pharmacopoeial limits.

Q: What use types are suitable for this Xylometazoline API?

A: Designed for pharmaceutical formulations, this API is primarily used in the manufacturing of nasal sprays and drops, targeting effective relief from nasal congestion.

Q: Where are the goods shipped from, and which FOB ports are available?

A: Goods are shipped from India, frequently utilizing Mumbai and other major ports. Shipment logistics are coordinated to meet international export requirements.

Q: When can clients expect delivery after placing an order?

A: Typically, dispatched goods are delivered within 2-3 weeks following order confirmation and completion of payment terms.

Q: What process ensures the API remains free from animal origin and genotoxic impurities?

A: The manufacturing follows stringent GMP/WHO-GMP procedures and uses plant-based processes, ensuring no animal-derived content while complying with the latest pharmacopeial standards on genotoxic impurities.

Q: How should Xylometazoline API be stored for optimal shelf life?

A: For best results, store the API in a tightly closed container, protected from light and moisture, maintaining a shelf life of 36 months under recommended conditions.

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