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Carbamazepine Manufacturing Thailand, the United Kingdom and USA
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Carbamazepine

  • Product Name : Carbamazepine
  • Grade : IP / BP / USP
  • Therapeutic Category : Anticonvulsant
  • CAS No : 298-46-4
  • COA : Available
  • MSDS : Available

Description

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) A. Melting Point : 189°C to 193°C

(2) B. 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 A:Not More than 0.1%

Impurity E: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.

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