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Selegiline Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Selegiline Hydrochloride USP CAS No: 14611- 52- 0

Batch No: SEL/ 030313 A. R. No 13/ FP/ SEL/ 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.

Complies c) Chloride: Meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.08%

0.68%

NMT 0.2%

NMT 1.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 11º Between - 10° to - 12°

6. Loss on drying 0.45% NMT 1.0%

7. Heavy Metals Complies NMT 20ppm

8. Residue On Ignition 0.09% NMT 0.2%

9. Assay HPLC 99.23% 98.0% –101.0%

10. Melting Temperature 142º 141°–145°

Selegiline2DCSD. svg

Selegiline- 3D- balls. png

Systematic ( IUPAC) name

( R) - N- methyl- N- ( 1- phenylpropan- 2- yl) prop- 1- yn- 3- amine

Clinical data

Trade names Eldepryl, Selgene

AHFS/ Drugs. com monograph

MedlinePlus a697046

Licence data US FDA: link

Pregnancy

category

AU: B2

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral, transdermal, buccal

Pharmacokinetic data

Bioavailability 4.4% ( oral, fasted) , 20% ( oral, after food) , 18% ( patch)

Protein binding 90%

Metabolism liver

Biological half- life 10 hours ( oral) , 18- 25 hours ( transdermal)

Excretion urine

Identifiers

CAS Registry Number 14611- 51- 9 Yes

14611- 52- 0 ( HCl)

ATC code N04BD01 QN06AX90

PubChem CID: 26757

IUPHAR/ BPS 6639

DrugBank DB01037 Yes

ChemSpider 24930 Yes

UNII 2K1V7GP655 Yes

KEGG D03731 Yes

ChEBI CHEBI: 9086 Yes

ChEMBL CHEMBL972 Yes

Chemical data

Formula C13H17N

Molecular mass 187.281 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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