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Valproic Acid Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Valproic Acid USP CAS No: 99- 66- 1

Batch No: VAL/ 030313 A. R. No 13/ FP/ VAL/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. Related Substances

Individual Impurity Total Impurity

0.06%

0.16%

NMT 0.1%

NMT 0.3%

5. Heavy Metals Complies NMT 20ppm

6. Water Content by KF 0.4% NMT 1.0%

7. Residue On Ignition 0.05% NMT 0.1%

8. Assay HPLC 98.37% 98.0% –102.0%

Valproic acid. svg

Valproic acid 3d structure. png

Systematic ( IUPAC) name

2- propylpentanoic acid

Clinical data

Trade names Convulex, Depakote, Epilim, Stavzor, Vilapro

AHFS/ Drugs. com monograph

MedlinePlus a682412

Licence data US FDA: link

Pregnancy

category

AU: D

US: X ( Contraindicated) - for control of conditions other than severe epilepsy not amenable to other drugs

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral, intravenous

Pharmacokinetic data

Bioavailability Rapid absorption

Protein binding 80- 90% [ 1]

Metabolism Hepatic—glucuronide conjugation 30–50% , mitochondrial β - oxidation over 40%

Biological half- life 9–16 hours[ 1]

Excretion Urine ( 30- 50% ) [ 1]

Identifiers

CAS Registry Number 99- 66- 1 Yes

ATC code N03AG01

PubChem CID: 3121

DrugBank DB00313 Yes

ChemSpider 3009 Yes

UNII 614OI1Z5WI Yes

KEGG D00399 Yes

ChEBI CHEBI: 39867 Yes

ChEMBL CHEMBL109 Yes

NIAID ChemDB 057177

Synonyms 2- Propylvaleric acid

Chemical data

Formula C8H16O2

Molecular mass 144.211 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 14, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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