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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. |
