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Pseudoephedrine Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Pseudoephedrine Hydrochloride USP CAS No: 345- 78- 8

Batch No: PSE/ 030313 A. R. No 13/ FP/ PSE/ 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) Chloride: Meets the requirements.

4. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +61.5º Between +61.0° to +62.5°

5. pH 5.1 Between 4.6–6.0

6. Loss on drying 0.4% NMT 0.5%

7. Heavy Metals Complies 10ppm

8. Residue On Ignition 0.026% NMT 0.1%

9. Assay 99.17% 98.0% –100.5%

10. Melting Temperature 183º 182°–186°

Pseudoephedrine

( +) - Pseudoephedrin. svg

( 1S, 2S) - Pseudoephedrine molecule ball. png

Systematic ( IUPAC) name

( S, S) - 2- methylamino- 1- phenylpropan- 1- ol

Clinical data

Trade names Afrinol, Sudafed, Sinutab( UK)

AHFS/ Drugs. com monograph

MedlinePlus a682619

Pregnancy

category

AU: B2

US: C ( Risk not ruled out)

Legal status

AU: Pharmacist Only ( S3)

CA: S3

UK: Pharmacy medicines

US: Behind the Counter ( BTC) Rx only in Oregon and Mississippi

Dependence

liability Low

Routes of

administration oral, insufflation

Pharmacokinetic data

Bioavailability ~100% [ 1]

Metabolism hepatic ( 10–30% )

Biological half- life 4.3–8 hours[ 1]

Excretion 43–96% renal[ 1]

Identifiers

CAS Registry Number 90- 82- 4 Yes

ATC code R01BA02

PubChem CID: 7028

DrugBank DB00852 Yes

ChemSpider 6761 Yes

UNII 7CUC9DDI9F Yes

KEGG D08449 Yes

ChEBI CHEBI: 51209 Yes

ChEMBL CHEMBL1590 Yes

Chemical data

Formula C10H15NO

Molecular mass 165.23


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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