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Dextroamphetamine Sulfate Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Dextroamphetamine Sulfate USP CAS No: 51- 63- 8

Batch No: DEX/ 030313 A. R. No 13/ FP/ DEX/ 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 Sulfate: Meets the requirements

4. Related Substances

Individual Impurity Total Impurity

0.05%

0.13%

NMT 0.1%

NMT 0.5%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +21.1º Between +20° to +23.5°

6. pH 5.1 Between 5.0–6.0

7. Loss on drying 0.4% NMT 1.0%

8. Residue On Ignition 0.06% NMT 0.1%

. .

Dextroamphetamine

D- amphetamine. svg

Systematic ( IUPAC) name

( 2S) - 1- phenylpropan- 2- amine

Clinical data

Trade names Dexedrine, Dextrostat, Metamina

AHFS/ Drugs. com monograph

MedlinePlus a605027

Licence data US Daily Med: link

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

AU: Controlled ( S8)

CA: Schedule I

UK: Class B

US: Schedule II

℞ ( Prescription only)

Dependence

liability Physical: None

Psychological: Moderate

Addiction

liability Moderate

Routes of

administration oral, nasal inhalation

Pharmacokinetic data

Bioavailability Oral 75–100% [ 1]

Metabolism CYP2D6, [ 2] DBH, [ 3] FMO3, [ 4] XM- ligase, [ 5] and ACGNAT[ 6]

Onset of action IR dosing: Immediate

XR dosing: 1.5–2 hours[ 7] [ 8]

Biological half- life 9–11 hours[ 2] [ 9]

pH- dependent: 8–31 hours[ 10]

Duration of action IR dosing: 3–7 hours[ 7] [ 11]

XR dosing: 12 hours[ 7] [ 8] [ 11]

Excretion Renal ( 45% ) ; [ 12] urinary pH- dependent

Identifiers

CAS Registry Number 51- 64- 9 Yes

ATC code N06BA02

PubChem CID: 5826

IUPHAR/ BPS 2147

DrugBank DB01576 Yes

ChemSpider 5621 Yes

UNII TZ47U051FI Yes

KEGG D03740 Yes

ChEBI CHEBI: 4469 Yes

ChEMBL CHEMBL612 Yes

Chemical data

Formula C9H13N

Molecular mass 135.20622

SMILES[ show]

InChI[ show]

Physical data

Density 0.913 g/ cm3

Boiling point 201.5 °C ( 394.7 °F)

Solubility in water 20 mg/ mL ( 20 °C)


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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