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Cetrizine Di Hcl

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Cetrizine Di Hcl Specification

Structural Formula
C21H25ClN2O32HCl

Loss on Drying
NMT 0.5%

Color
White

Boiling point
Not applicable (decomposes)

Molecular Weight
461.82 g/mol

Melting Point
110-115C

EINECS No
617-763-6

Poisonous
Non-poisonous at recommended dose

Smell
Odorless

Taste
Bitter

Shelf Life
5 Years

HS Code
293339

Ph Level
4.0 - 6.0 (in 2% solution)

Storage
Store in a cool, dry place away from light

Solubility
Freely soluble in water, practically insoluble in acetone and in methylene chloride

Heavy Metal (%)
NMT 0.001%

Particle Size
Micronized

Molecular Formula
C21H25ClN2O32HCl

Medicine Name
Cetrizine Di Hcl

Chemical Name
Cetirizine Dihydrochloride

CAS No
83881-52-1

Type
Antihistamine

Grade
Pharmaceutical Grade

Usage
Used as an anti-allergic and antihistamine

Purity(%)
99.5%

Appearance
White or almost white crystalline powder

Physical Form
Powder

Assay
99.0% - 101.0% (on anhydrous basis)

Residue on Ignition
NMT 0.1%

Packaging
HDPE drum or fiber drum, 25 kg net

Related Substances
NMT 0.2%

Identification
Conforms to standard (IR, HPLC)

Hazard Statement
No significant hazards when handled appropriately

Manufacturing Standard
USP/BP/EP/CP

Chloride Content
18.2 - 18.6%

Microbial Limit
Complies with pharmacopeial standards

Cetrizine Di Hcl Trade Information

FOB Port
All Indian Port

Payment Terms
Paypal, Western Union, Letter of Credit at Sight (Sight L/C), Telegraphic Transfer (T/T), Cash in Advance (CID)

Supply Ability
50 Ton Per Month

Delivery Time
7-10 Days

Sample Available
Yes

Sample Policy
Sample costs shipping and taxes has to be paid by the buyer

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

Certifications
ISO, GMP, WHO, MSDS

About Cetrizine Di Hcl

Product Name: Cetrizine Di Hcl

Grade: IP/BP/USP

Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.

Product Specifications

Shelf Life
5 Years
Molecular Weight
461.82 gm/mol

Loss on Drying
0.5% max
Storage
Keep away from moisture

Heavy Metal (%)
10ppm max
Molecular Formula
C21H23ClN2O3,2HCl

Chemical Name
Cetrizine Di Hcl
CAS No
83881-52-1

Type
Other
Grade
Medicine Grade

Usage
Cetirizine is an antihistamine used to relieve allergy symptoms.
Appearance
white to off-white crystalline powder

Physical Form
Powder

Prime Anti-Allergic Solution

Cetirizine Dihydrochloride serves as an effective antihistamine for treating allergies, renowned for its rapid and sustained relief of symptoms such as sneezing, runny nose, and itching. Its high purity, consistent particle size, and compliance with international pharmaceutical standards make it the preferred choice for manufacturers globally.

Stringent Quality and Safety Assurance

Every batch of Cetirizine Dihydrochloride undergoes identification by IR and HPLC, with controlled related substances (NMT 0.2%), stringent assay requirements (99.0%101.0%), and minimal residue on ignition and heavy metals, ensuring product safety and efficacy. The compound is recognized as non-poisonous and presents no significant hazards when handled correctly.

Optimal Handling and Storage

Packaged securely in HDPE or fiber drums with a 25 kg net weight, Cetirizine Dihydrochloride should be stored in a cool, dry environment away from light to maintain its stability and extend shelf life. Its crystalline nature and odorless form facilitate easy processing within pharmaceutical manufacturing facilities.

FAQs of Cetrizine Di Hcl:

Q: How should Cetirizine Dihydrochloride be stored to preserve its quality?

A: Cetirizine Dihydrochloride must be kept in a cool, dry place away from direct light, ideally within its original HDPE or fiber drum packaging, to maintain its five-year shelf life and prevent degradation.

Q: What is the main benefit of using Cetirizine Dihydrochloride in pharmaceuticals?

A: Cetirizine Dihydrochloride is primarily used for its reliable antihistamine properties, offering effective relief from allergy symptoms with high purity and compliance to pharmacopeial standards, ensuring safety and efficacy in medication formulations.

Q: What process is followed to ensure the quality of Cetirizine Dihydrochloride?

A: Quality assurance includes identification by IR and HPLC, monitoring related substances to NMT 0.2%, verifying the assay within 99.0%101.0%, and confirming that all limits for residue, chlorides, and microbials meet USP/BP/EP/CP standards.

Q: When is Cetirizine Dihydrochloride typically used?

A: Cetirizine Dihydrochloride is incorporated in pharmaceutical manufacturing to produce anti-allergic and antihistamine medications designed to alleviate allergy-related symptoms.

Q: Where can Cetirizine Dihydrochloride be sourced from?

A: Cetirizine Dihydrochloride can be obtained directly from manufacturers, suppliers, or exporters in India, commonly supplied in pharmaceutical grade, micronized powder form, packaged in 25 kg drums.

Q: What makes Cetirizine Dihydrochloride safe to handle?

A: The compound is considered non-poisonous at recommended dosages and poses no significant hazards when handled per standard safety guidelines, as highlighted by its non-hazardous statement and compliance with microbial and heavy metal limits.

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