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Diphenhydramine Citrate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Diphenhydramine Citrate USP CAS No: 88637- 37- 0

Batch No: DIP/ 030313 A. R. No 13/ FP/ DIP/ 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) Citrate: Meets the requirements

4 Loss on drying 0.13% NMT 0.5%

5. Residue On Ignition 0.04% NMT 0.1%

6. Assay 99.34% 98.0% –100.5%

7. Melting Temperature 147º 146°–150°

Diphenhydramine

Diphenhydramine 2D skeletal. svg

Diphenhydramine 3D ball. png

Systematic ( IUPAC) name

2- ( diphenylmethoxy) - N, N- dimethylethanamine

Clinical data

Trade names Benadryl, Unisom, Sominex, ZzzQuil

AHFS/ Drugs. com monograph

MedlinePlus a682539

Pregnancy

category

AU: A

US: B ( No risk in non- human studies)

Legal status

AU: Pharmacy Only ( S2)

US: Over- the- counter

Dependence

liability Very low

Routes of

administration Oral, IM, IV, topical and suppository

Pharmacokinetic data

Bioavailability 40–60% [ 1]

Protein binding 98–99%

Metabolism Various cytochrome P450 liver enzymes: CYP2D6 ( 80% ) , 3A4 ( 10% ) [ 2]

Biological half- life 7 hours ( children) [ 3]

12 hours ( adults) [ 3]

17 hours ( elderly) [ 3]

Excretion 94% through the urine, 6% through feces[ 4]

Identifiers

CAS Registry Number 58- 73- 1 Yes

ATC code D04AA32 D04AA33, R06AA02

PubChem CID: 3100

IUPHAR/ BPS 1224

DrugBank DB01075 Yes

ChemSpider 2989 Yes

UNII 8GTS82S83M Yes

KEGG D00669

ChEBI CHEBI: 4636 Yes

ChEMBL CHEMBL657 Yes

Chemical data

Formula C17H21NO

Molecular mass 255.355 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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