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BROMPHENIRAMINE MALEATE

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BROMPHENIRAMINE MALEATE Specification

Heavy Metal (%)
0.001%

Poisonous
No (when used as directed)

Taste
Bitter

Shelf Life
5 years (when properly stored)

Structural Formula
(provided upon request)

Color
White to off-white

Loss on Drying
0.5%

HS Code
29420090

Molecular Formula
C16H19BrN2C4H4O4

Solubility
Freely soluble in water, soluble in alcohol

Smell
Odorless

Boiling point
Not applicable (decomposes before boiling)

Melting Point
Approximately 230C (decomposes)

EINECS No
213-561-8

Molecular Weight
435.3 g/mol

Storage
Store in tightly closed container, in a cool dry place, away from light

Particle Size
Customizable as per requirement, typically NLT 90% passes through 80 mesh

Medicine Name
BROMPHENIRAMINE MALEATE

Chemical Name
Brompheniramine maleate

CAS No
980-71-2

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Antihistamine, used for allergy relief

Purity(%)
98%

Appearance
White to off-white crystalline powder

Physical Form
Solid

BROMPHENIRAMINE MALEATE Trade Information

FOB Port
All Indian Port

Payment Terms
Letter of Credit at Sight (Sight L/C), Paypal, Western Union, 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)
North America, South America, Eastern Europe, Western Europe, Middle East, Central America, Africa, Australia, Asia

Certifications
ISO, GMP, WHO, MSDS

About BROMPHENIRAMINE MALEATE

Product Name: BROMPHENIRAMINE MALEATE

Grade: IP/BP/USP

brompheniramine maleate is an antihistamine drug of the propylamine (alkylamine) class. It is readily available over the counter and is indicated for the treatment of the symptoms of the common cold and allergic rhinitis, such as runny nose, itchy eyes, watery eyes, and sneezing. It is a first-generation antihistamine and one of the drugs of highest anticholinergic activity.

Brompheniramine is part of a series of antihistamines including pheniramine and its halogenated derivatives and others including fluorpheniramine, chlorpheniramine, dexchlorpheniramine (Polaramine), triprolidine (Actifed), and iodopheniramine.

Brompheniramine has antidepressant properties, inhibiting reuptake of the neurotransmitter serotonin and norepinephrine.

Product Specifications

Shelf Life
5 Years
Molecular Formula
C16H19BrN2

Storage
Keep away from moisture
Molecular Weight
319.24 g/mol

Chemical Name
BROMPHENIRAMINE MALEATE
CAS No
86-22-6

Type
Other
Grade
Medicine Grade

Usage
Antihistamine drug
Appearance
white crystalline powder

Physical Form
Powder

Exceptional Pharmaceutical Quality

Brompheniramine Maleate is produced under strict regulatory frameworks, ensuring compliance with USP, EP, and IP standards. Its high purity (98.0102.0%), minimal residue on ignition (0.1%), and stringent microbial limits make it a reliable choice for formulation in allergy relief medications.

Versatile and Safe for Formulation

This API is compatible with most common excipients, making it adaptable for a variety of pharmaceutical dosage forms. Its absence of known allergens and heavy metals (0.001%) enhances safety, and its customizable particle size streamlines the manufacturing process.

Efficient Packaging and Long Shelf Life

Packaged in robust fiber drums with inner polyethylene liners, Brompheniramine Maleate remains stable and protected from moisture and light. With an impressive five-year shelf life when stored properly, it ensures consistent supply and product integrity.

FAQs of BROMPHENIRAMINE MALEATE:

Q: How is Brompheniramine Maleate typically used in pharmaceutical applications?

A: Brompheniramine Maleate serves as an active ingredient in antihistamine medications that provide relief from allergy symptoms such as sneezing, itching, and runny nose. Its high purity and compatibility make it suitable for tablets, syrups, and other dosage forms.

Q: What are the key quality specifications of Brompheniramine Maleate?

A: This API meets stringent standards: purity of 98.0% to 102.0%, residue on ignition 0.1%, related substances 0.5%, and total aerobic microbial count not more than 1000 cfu/g. It also satisfies identification by IR and HPLC and complies with heavy metal, chloride, and sulfate limits.

Q: When is Brompheniramine Maleate recommended for use?

A: It is recommended when formulating pharmaceuticals intended to provide effective allergy relief, given its proven therapeutic efficacy and safe impurity profile. It is not used directly by patients, but as an ingredient during pharmaceutical manufacturing.

Q: Where is Brompheniramine Maleate manufactured and how is it packaged for export?

A: Manufactured in India, Brompheniramine Maleate is packaged in fiber drums with inner polyethylene bags to ensure product stability and integrity during transit, in accordance with international export standards.

Q: What is the process for ensuring the quality and safety of Brompheniramine Maleate?

A: Quality is assured through strict adherence to regulatory protocols: all batches must pass IR and HPLC identification, meet microbial and impurity limits, and are regularly monitored for compliance with USP, EP, and IP pharmacopeias.

Q: What are the storage recommendations and shelf life for Brompheniramine Maleate?

A: The API should be stored in tightly closed containers, in a cool, dry location away from direct light. When stored under these conditions, its shelf life extends up to five years.

Q: What benefits does Brompheniramine Maleate offer to pharmaceutical manufacturers?

A: Manufacturers benefit from its consistent high quality, broad compatibility with excipients, customizable particle size, and reliable supply chain. Its compliance with major regulatory standards ensures ease of product registration globally.

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