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Prednisolone Acetate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Prednisolone Acetate USP CAS No: 52- 21- 1

Batch No: PRE/ 030313 A. R. No 13/ FP/ PRE/ 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 By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

4. Related Substances

Individual Impurity Total Impurity

0.73%

1.52%

NMT 1.0%

NMT 2.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +118º Between +112° to +119°

6. Loss on drying 0.48% NMT 1.0%

7. Assay HPLC 98.19% 97.0% –102.0%

Prednisolone- 2D- skeletal. svg

Prednisolone- 3D- balls. png

Systematic ( IUPAC) name

( 11β ) - 11, 17, 21- trihydroxypregna- 1, 4- diene- 3, 20- dione

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a682794

Licence data US FDA: link

Pregnancy

category

AU: A

US: C ( Risk not ruled out)

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Pharmacokinetic data

Biological half- life 2- 3 hours

Excretion urine

Identifiers

CAS Registry Number 50- 24- 8 Yes

ATC code A07EA01 C05AA04, D07AA03, H02AB06, R01AD02, S01BA04, S02BA03, S03BA02

PubChem CID: 5755

IUPHAR/ BPS 2866

DrugBank DB00860 Yes

ChemSpider 5552 Yes

UNII 9PHQ9Y1OLM Yes

KEGG D00472 Yes

ChEBI CHEBI: 8378 Yes

ChEMBL CHEMBL131 Yes

Synonyms 11, 17- dihydroxy- 17- ( 2- hydroxyacetyl) - 10, 13- dimethyl- dodecahydrocyclopenta [ a] phenanthren- 3- one

Chemical data

Formula C21H28O5

Molecular mass 360.444 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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