Carbamazepine API

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Carbamazepine API Specification

Melting Point
399.6 45.0

Solubility
very slightly soluble in water ,freely soluble in methylene chloride, sparingly soluble in acetone and in ethanol (96%)

Storage
Room Temperature

Boiling point
189-192

Molecular Formula
C15H12N2O

Molecular Weight
236.27 Grams (g)

Shelf Life
5 Years

Medicine Name
Carbamazepine

Chemical Name
benzo[b][1]benzazepine-11-carboxamide

CAS No
298-46-4

Type
Cardiovascular Agents

Grade
Medicine Grade

Usage
Anticonvulsant

Appearance
White to off-white powder

Physical Form
Powder

Carbamazepine API Trade Information

FOB Port
ALL INDIA

Payment Terms
Western Union, Paypal, Telegraphic Transfer (T/T), Cash in Advance (CID), Cash Advance (CA)

Delivery Time
2-3 Week

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

Packaging Details
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Main Domestic Market
All India

Certifications
WHO,GMP,COA,MSDS As Per Client Requirement

Carbamazepine API About

Carbamazepine (CBZ) is an anticonvulsant and mood-stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder, as well as trigeminal neuralgia. It is also used off-label for a variety of indications, including attention-deficit hyperactivity disorder (ADHD), schizophrenia, phantom limb syndrome, complex regional pain syndrome, paroxysmal extreme pain disorder, neuromyotonia, intermittent explosive disorder, borderline personality disorder and post-traumatic stress disorder.

PRODUCT NAME	Carbamazepine
Item	Specification	Results
Appearance	White or almost white, crystalline powder	Conforms
Solubility	very slightly soluble in water ,freely soluble in methylene chloride, sparingly soluble in acetone and in ethanol (96%)	Conforms
Identification	(1) Melting Point : 189-193 (2) IR: very slightly soluble in water ,freely soluble in methylene Chloride, sparingly soluble in acetone and in ethanol (96%)	Conforms
PH	Positive	Conforms
Related substances (BY HPLC)	Impurity :Not More than 0.1% Impurity :Not More than 0.1% Unspecified impurities :Not More than 0.1% Total impurities : Not more than 0.5% Disregard limit:Not more than 0.05%	Conforms Conforms Conforms 0.31% Conforms
Heavy metals	<20ppm	Conforms
Loss on drying	<0.5%	0.3 %
Sulphated ash	<0.1%	0.02%
Chlorides	<140ppm	Conforms
Assay (on dried substance)	98.0% ~ 102.0%	100.4%
Conclusion	It Conforms to BP2010 standards.

Packaging details:

Packaging details:	25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.
Storage:	Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat
Shelf Life:	5 years if sealed and store away from direct sun light.

Reliable Anticonvulsant API

Carbamazepine is trusted for its anticonvulsant activity, proving indispensable in the pharmaceutical industry for manufacturing drugs that manage seizures and some cardiovascular conditions. Its consistent quality and reliable supply across India make it a preferred choice for medicine manufacturers, wholesalers, and suppliers.

Optimized Storage and Stability

This API is designed for ease of storage, requiring only room temperature conditions and maintaining a long shelf life of up to 5 years. Its stable physical properties and controlled solubility ensure predictable performance in various formulations, making it ideal for large-scale pharmaceutical processes.

FAQ's of Carbamazepine API:

Q: How should Carbamazepine API be stored to maintain its quality?

A: Carbamazepine API should be stored at room temperature in a tightly sealed container, protected from moisture and light, to ensure stability and preserve its five-year shelf life.

Q: What is the primary use of Carbamazepine API in the pharmaceutical industry?

A: Carbamazepine API is primarily used as an active ingredient in the production of anticonvulsant medicines, particularly for managing seizures and certain neurological disorders.

Q: When does Carbamazepine API expire, and how long can it be stored?

A: Carbamazepine API has a shelf life of 5 years from the date of manufacture, provided it is stored properly under recommended conditions.

Q: Where is Carbamazepine API sourced and distributed?

A: This API is manufactured, supplied, exported, and traded throughout India by established pharmaceutical companies, ensuring broad availability and compliance with industry standards.

Q: What is the solubility profile of Carbamazepine API?

A: Carbamazepine API is very slightly soluble in water, freely soluble in methylene chloride, and sparingly soluble in acetone and ethanol (96%), allowing for flexibility in various pharmaceutical formulations.

Q: How can Carbamazepine API benefit medicine manufacturers?

A: Manufacturers benefit from its consistent quality, reliable supply, suitability for anticonvulsant drug production, and extended shelf life, making it an efficient choice for large-scale pharmaceutical manufacturing.

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