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Promethazine Hydrochloride Usp Ip Bp Ep Manfuacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Promethazine Hydrochloride USP CAS No: 58- 33- 3

Batch No: PRO/ 030313 A. R. No 13/ FP/ PRO/ 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. pH 4.2 Between 4.0–5.0

5. Loss on drying 0.31% NMT 0.5%

6. Completeness And Clarity Of Solution Complies A 1- in- 10 solution of it and a 1- in- 10 solution of it in chloroform are practically clear and show NMT a light yellow color.

7. Residue On Ignition 0.073% NMT 0.1%

8. Assay 98.48% 97.0% –101.5%

Promethazine. svg

1: 1 mixture ( racemate)

Systematic ( IUPAC) name

( RS) - N, N- dimethyl- 1- ( 10H- phenothiazin- 10- yl) propan- 2- amine

Clinical data

Trade names Phenergan

AHFS/ Drugs. com monograph

MedlinePlus a682284

Pregnancy

category

AU: C

US: C ( Risk not ruled out)

Legal status

US: ℞ - only

( injection POM( UK) )

Routes of

administration Oral, rectal, IV, IM, topical

Pharmacokinetic data

Bioavailability 88% absorbed but after first- pass metabolism reduced to 25% absolute bioavailability[ 1]

Protein binding 93%

Metabolism Hepatic glucuronidation and sulfoxidation

Biological half- life 16- 19 hours[ 1] [ 2]

Excretion Renal and biliary

Identifiers

CAS Registry Number 60- 87- 7 Yes

58- 33- 3 ( hydrochloride)

ATC code D04AA10 R06AD02

PubChem CID: 4927

IUPHAR/ BPS 7282

DrugBank DB01069 Yes

ChemSpider 4758 Yes

UNII FF28EJQ494 Yes

KEGG D00494 Yes

ChEBI CHEBI: 8461 Yes

ChEMBL CHEMBL643 Yes

Chemical data

Formula C17H20N2S

Molecular mass 284.42 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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