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Valproic Acid Manufacturing Thailand, the United Kingdom and USA
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Valproic Acid

  • Product Name : Valproic Acid
  • Grade : IP / BP / USP
  • Therapeutic Category : Antiepileptic
  • CAS No : 99-66-1
  • COA : Available
  • MSDS : Available

Description

Valproic acid and its derivative, divalproex, are oral drugs that are used for the treatment of convulsions, migraines and bipolar disorder. The active ingredient in both products is valproic acid. Divalproex is converted to valproic acid in the stomach. The most popular theory is that valproic acid exerts its effects by increasing the concentration of gamma-aminobutyric acid (GABA) in the brain. GABA is a neurotransmitter, a chemical that nerves use to communicate with one another.

 

Specification:

 

Item

Standard

Test Results

Identification

A.H-NMR:Comply with the structure

Complies

B.LC-MS:Comply with the structure

Complies

C.The IR spectrum of sample should be identical with that of reference standard;

Complies

D.HPLC-ESI-MS

The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Complies

Crystallinity

meets the requirements.

Complies

Loss on drying

≤2.0%

0.19%

Heavy metals

≤10 ppm

<10ppm

Water

≤1.0%

0.1%

Sulphated ash

≤0.5%, determined on 1.0 g.

0.009%

Related substances

Unspecified impurities: for each impurity

≤0.10%

<0.10%

Total Impurity

≤0.5%

0.18%

Purity

≥99.0%

99.7%

Assay

99.0%~101.0% (anhydrous substance).

99.8%

Microbiological Analysis

Total plate count

≤1000cfu/g

Complies

Yeast and Moulds

≤100cfu/g

Complies

E. Coli.

Absent

Negative

Salmonella

Absent

Negative

S.aureus

Absent

Negative

Storage

Preserve in well-closed, light-resistant and airtight containers.

Complies

 

 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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