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Paricalcitol Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Paricalcitol USP CAS No: 131918- 61- 1

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

0.03%

0.27%

NMT 0.1%

NMT 0.5%

5. Loss on drying 1.1% NMT 2.0%

6. Assay HPLC 98.47% 97.0% –103.0%

Paricalcitol. svg

Paricalcitol3Dan. gif

Systematic ( IUPAC) name

( 1R, 3R, 7E, 17β ) - 17- [ ( 1R, 2E, 4S) - 5- hydroxy- 1, 4, 5- trimethylhex- 2- en- 1- yl] - 9, 10- secoestra- 5, 7- diene- 1, 3- diol

Clinical data

Trade names Zemplar

AHFS/ Drugs. com monograph

MedlinePlus a682335

Pregnancy

category

AU: C

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral, Intravenous

Pharmacokinetic data

Bioavailability 72% [ 1]

Protein binding 99.8% [ 1]

Metabolism Hepatic[ 1]

Biological half- life 14- 20 hours[ 1]

Excretion Faeces ( 74% ) , urine ( 16% ) [ 1]

Identifiers

CAS Registry Number 131918- 61- 1 Yes

ATC code H05BX02

PubChem CID: 5281104

IUPHAR/ BPS 2791

DrugBank DB00910

ChemSpider 4444552 Yes

UNII 6702D36OG5 Yes

KEGG D00930

ChEBI CHEBI: 7931

ChEMBL CHEMBL1200622 Yes

Synonyms ( 1R, 3S) - 5- [ 2- [ ( 1R, 3aR, 7aS) - 1- [ ( 2R, 5S) - 6- hydroxy- 5, 6- dimethyl- 3E- hepten- 2- yl] - 7a- methyl- 2, 3, 3a, 5, 6, 7- hexahydro- 1H- inden- 4- ylidene] ethylidene] - cyclohexane- 1, 3- diol

Chemical data

Formula C27H44O3

Molecular mass 416.636 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 12, 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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